Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2025-12-25 @ 9:01 PM
Study NCT ID:
NCT03541356
Status:
COMPLETED
Last Update Posted:
2020-08-12
First Post:
2018-04-05
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Therapeutic Potential for Intranasal Levodopa in Parkinson's Disease -Off Reversal
Sponsor:
Organization:
Raw JSON
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'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010649', 'term': 'Phenylalanine'}, {'id': 'D024322', 'term': 'Amino Acids, Aromatic'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D014443', 'term': 'Tyrosine'}, {'id': 'D008750', 'term': 'Methyldopa'}, {'id': 'D006834', 'term': 'Hydrazines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kcraig@impelnp.com', 'phone': '206-568-1466', 'title': 'Karen Craig, PhD (Medical Writer)', 'organization': 'Impel NeuroPharma'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': 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'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'sinus pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 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{'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'nasal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'nasal dryness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'nasal oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'paranasal sinus discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'paranasal sinus hyposecretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'sneezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 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0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'feeling abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 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'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'joint noise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}], 'frequencyThreshold': '0.1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo: Delivered via the I231 POD (Precision Olfactory Delivery) device'}, {'id': 'OG001', 'title': 'L-dopa 35 mg', 'description': 'L-dopa 35 mg: Delivered via the I231 POD (Precision Olfactory Delivery) device via one puff to one nostril'}, {'id': 'OG002', 'title': 'L-dopa 70 mg', 'description': 'L-dopa 70mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril'}, {'id': 'OG003', 'title': 'L-dopa 140 mg', 'description': 'L-dopa 140 mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with four puffs, two to each nostril'}, {'id': 'OG004', 'title': 'L-dopa 70 mg/Carbidopa 7 mg', 'description': 'L-dopa 70mg/carbidopa 7mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '7 days', 'description': 'Assessment of treatment emergent adverse events after single dosing with INP103 (L-dopa or L-dopa/carbidopa)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'AUC0-2hr for L-dopa', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'L-dopa 35 mg', 'description': 'L-dopa 35 mg: Delivered via the I231 POD (Precision Olfactory Delivery) device via one puff to one nostril'}, {'id': 'OG001', 'title': 'L-dopa 70 mg', 'description': 'L-dopa 70mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril'}, {'id': 'OG002', 'title': 'L-dopa 140 mg', 'description': 'L-dopa 140 mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with four puffs, two to each nostril'}, {'id': 'OG003', 'title': 'L-dopa 70 mg/Carbidopa 7 mg', 'description': 'L-dopa 70mg/carbidopa 7mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril'}], 'classes': [{'categories': [{'measurements': [{'value': '240.71', 'spread': '117.819', 'groupId': 'OG000'}, {'value': '463.49', 'spread': '260.093', 'groupId': 'OG001'}, {'value': '725.29', 'spread': '456.566', 'groupId': 'OG002'}, {'value': '552.75', 'spread': '177.979', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'For L-dopa 35 mg, 70 mg, 140 mg plasma samples were taken at pre-dose, 30, 60, 90 and 120 minutes post-dose. For L-dopa 70 mg/carbidopa 7 mg, plasma samples were taken at pre-dose, 5, 10, 15, 30, 45, 60, 90 and 120 min', 'description': 'Area under the Plasma Concentration-time Curve for L-dopa from Time = 0 to Time = 2 hours post dose. For the L-dopa 35 mg, L-dopa 70 mg, L-dopa 140 mg plasma samples were taken at pre-dose, 30, 60, 90 and 120 minutes post-dose. For the L-dopa 70 mg/carbidopa 7 mg treatment arm, plasma samples were taken at pre-dose, 5, 10, 15, 30, 45, 60, 90 and 120 minutes post-dose.', 'unitOfMeasure': 'hours*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who received L-dopa or L-dopa/carbidopa. Placebo subjects therefore not included.'}, {'type': 'SECONDARY', 'title': 'Cmax of L-dopa', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'L-dopa 35 mg', 'description': 'L-dopa 35 mg: Delivered via the I231 POD (Precision Olfactory Delivery) device via one puff to one nostril'}, {'id': 'OG001', 'title': 'L-dopa 70 mg', 'description': 'L-dopa 70mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril'}, {'id': 'OG002', 'title': 'L-dopa 140 mg', 'description': 'L-dopa 140 mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with four puffs, two to each nostril'}, {'id': 'OG003', 'title': 'L-dopa 70 mg/Carbidopa 7 mg', 'description': 'L-dopa 70mg/carbidopa 7mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril'}], 'classes': [{'categories': [{'measurements': [{'value': '185.80', 'spread': '78.144', 'groupId': 'OG000'}, {'value': '362.68', 'spread': '195.265', 'groupId': 'OG001'}, {'value': '643.65', 'spread': '462.469', 'groupId': 'OG002'}, {'value': '445.75', 'spread': '183.746', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'For L-dopa 35 mg, 70 mg, 140 mg plasma samples were taken at pre-dose, 30, 60, 90 and 120 minutes post-dose. For L-dopa 70 mg/carbidopa 7 mg, plasma samples were taken at pre-dose, 5, 10, 15, 30, 45, 60, 90 and 120 minutes post-dose.', 'description': 'Maximum Observed Plasma Concentration of L-dopa from Time = 0 to Time = 2 hours post dose. For the L-dopa 35 mg, L-dopa 70 mg, L-dopa 140 mg plasma samples were taken at pre-dose, 30, 60, 90 and 120 minutes post-dose. For the L-dopa 70 mg/carbidopa 7 mg treatment arm, plasma samples were taken at pre-dose, 5, 10, 15, 30, 45, 60, 90 and 120 minutes post-dose.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who received L-dopa. Placebo subjects not included.'}, {'type': 'SECONDARY', 'title': 'Tmax of L-dopa', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'L-dopa 35 mg', 'description': 'L-dopa 35 mg: Delivered via the I231 POD (Precision Olfactory Delivery) device via one puff to one nostril'}, {'id': 'OG001', 'title': 'L-dopa 70 mg', 'description': 'L-dopa 70mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril'}, {'id': 'OG002', 'title': 'L-dopa 140 mg', 'description': 'L-dopa 140 mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with four puffs, two to each nostril'}, {'id': 'OG003', 'title': 'L-dopa 70 mg/Carbidopa 7 mg', 'description': 'L-dopa 70mg/carbidopa 7mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril'}], 'classes': [{'categories': [{'measurements': [{'value': '60.17', 'spread': '37.950', 'groupId': 'OG000'}, {'value': '66.00', 'spread': '38.735', 'groupId': 'OG001'}, {'value': '70.00', 'spread': '15.505', 'groupId': 'OG002'}, {'value': '92.00', 'spread': '27.481', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'For L-dopa 35 mg, 70 mg, 140 mg plasma samples were taken at pre-dose, 30, 60, 90 and 120 minutes post-dose. For L-dopa 70 mg/carbidopa 7 mg, plasma samples were taken at pre-dose, 5, 10, 15, 30, 45, 60, 90 and 120 minutes post-dose.', 'description': 'Time to Reach the Maximum Plasma Concentration (Cmax) of L-dopa', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who received L-dopa. Placebo subjects not included.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in MDS-UPDRS Score Over 2 Hours for C1, C2, C3 and Change From Baseline at 30, 60, 90, 120 Minutes for C4, in MDS-UPDRS Part III Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo: Delivered via the I231 POD (Precision Olfactory Delivery) device'}, {'id': 'OG001', 'title': 'L-dopa 35 mg', 'description': 'L-dopa 35 mg: Delivered via the I231 POD (Precision Olfactory Delivery) device via one puff to one nostril'}, {'id': 'OG002', 'title': 'L-dopa 70 mg', 'description': 'L-dopa 70mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril'}, {'id': 'OG003', 'title': 'L-dopa 140 mg', 'description': 'L-dopa 140 mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with four puffs, two to each nostril'}, {'id': 'OG004', 'title': 'L-dopa 70 mg/Carbidopa 7 mg', 'description': 'L-dopa 70mg/carbidopa 7mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril'}], 'classes': [{'title': '15 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-3.5', 'spread': '3.89', 'groupId': 'OG000'}, {'value': '-4.5', 'spread': '4.46', 'groupId': 'OG001'}, {'value': '0.8', 'spread': '9.20', 'groupId': 'OG002'}, {'value': '-9.0', 'spread': '6.16', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Participants in this arm were not tested at this time point.', 'groupId': 'OG004'}]}]}, {'title': '30 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-8.5', 'spread': '6.52', 'groupId': 'OG000'}, {'value': '-6.7', 'spread': '4.89', 'groupId': 'OG001'}, {'value': '-8.5', 'spread': '9.09', 'groupId': 'OG002'}, {'value': '-12.7', 'spread': '7.79', 'groupId': 'OG003'}, {'value': '-3.7', 'spread': '3.83', 'groupId': 'OG004'}]}]}, {'title': '45 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-13.5', 'spread': '7.09', 'groupId': 'OG000'}, {'value': '-4.7', 'spread': '4.03', 'groupId': 'OG001'}, {'value': '-12.8', 'spread': '11.05', 'groupId': 'OG002'}, {'value': '-13.7', 'spread': '8.91', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Participants in this arm were not tested at this time point.', 'groupId': 'OG004'}]}]}, {'title': '60 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-12.5', 'spread': '7.87', 'groupId': 'OG000'}, {'value': '-6.8', 'spread': '4.54', 'groupId': 'OG001'}, {'value': '-15.7', 'spread': '9.58', 'groupId': 'OG002'}, {'value': '-13.5', 'spread': '8.29', 'groupId': 'OG003'}, {'value': '-0.8', 'spread': '10.63', 'groupId': 'OG004'}]}]}, {'title': '90 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-10.8', 'spread': '9.35', 'groupId': 'OG000'}, {'value': '-10.3', 'spread': '13.56', 'groupId': 'OG001'}, {'value': '-15.5', 'spread': '10.03', 'groupId': 'OG002'}, {'value': '-9.0', 'spread': '5.76', 'groupId': 'OG003'}, {'value': '-3.7', 'spread': '10.76', 'groupId': 'OG004'}]}]}, {'title': '120 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-8.8', 'spread': '10.61', 'groupId': 'OG000'}, {'value': '-11.0', 'spread': '9.47', 'groupId': 'OG001'}, {'value': '-13.8', 'spread': '11.97', 'groupId': 'OG002'}, {'value': '-7.2', 'spread': '9.09', 'groupId': 'OG003'}, {'value': '-3.2', 'spread': '9.22', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'For L-dopa 35 mg, 70 mg, 140 mg, assessment occurred at pre-dose, 15, 30, 45, 60, 90 and 120 minutes post-dose. For L-dopa 70 mg/carbidopa 7 mg, assessment occurred at pre-dose, 30, 60, 90 and 120 minutes post-dose.', 'description': "MDS-UPDRS is a clinimetric assessment of subjective and objective symptoms and signs of Parkinson's disease created by the Movement Disorder Society with high internal consistency. MDS-UPDRS retains the four-scale structure with a reorganization of the various subscales. The subscale used in this study is Part III, motor examination (18 items). The subscale has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. Maximum score is 132, minimum is zero. High score means worse outcome. For the L-dopa 35 mg, L-dopa 70 mg, L-dopa 140 mg treatment groups, assessment occurred at pre-dose, 15, 30, 45, 60, 90 and 120 minutes post-dose. For the L-dopa 70 mg/carbidopa 7 mg treatment arm, assessment occurred at pre-dose, 30, 60, 90 and 120 minutes post-dose.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants were analyzed.'}, {'type': 'SECONDARY', 'title': 'Time to Response (Defined as Improvement of 30% in MDS-UPDRS Part III Score From Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo: Delivered via the I231 POD (Precision Olfactory Delivery) device'}, {'id': 'OG001', 'title': 'L-dopa 35 mg', 'description': 'L-dopa 35 mg: Delivered via the I231 POD (Precision Olfactory Delivery) device via one puff to one nostril'}, {'id': 'OG002', 'title': 'L-dopa 70 mg', 'description': 'L-dopa 70mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril'}, {'id': 'OG003', 'title': 'L-dopa 140 mg', 'description': 'L-dopa 140 mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with four puffs, two to each nostril'}, {'id': 'OG004', 'title': 'L-dopa 70 mg/Carbidopa 7 mg', 'description': 'L-dopa 70mg/carbidopa 7mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril'}], 'classes': [{'categories': [{'measurements': [{'value': '45.0', 'comment': 'The upper bound of the 95% CI could not be calculated due to the number of participants not achieving a response in the analysis time frame', 'groupId': 'OG000', 'lowerLimit': '35.0', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'The median and the upper bound of the 95% CI could not be calculated due to the number of participants not achieving a response in the analysis time frame', 'groupId': 'OG001', 'lowerLimit': '40.0', 'upperLimit': 'NA'}, {'value': '54.0', 'comment': 'The upper bound of the 95% CI could not be calculated due to the number of participants not achieving a response in the analysis time frame', 'groupId': 'OG002', 'lowerLimit': '15.0', 'upperLimit': 'NA'}, {'value': '30.0', 'comment': 'The upper bound of the 95% CI could not be calculated due to the number of participants not achieving a response in the analysis time frame', 'groupId': 'OG003', 'lowerLimit': '15.0', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'The median and the upper bound of the 95% CI could not be calculated due to the number of participants not achieving a response in the analysis time frame', 'groupId': 'OG004', 'lowerLimit': '32.0', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '2 hours', 'description': "MDS-UPDRS is a clinimetric assessment of subjective and objective symptoms and signs of Parkinson's disease created by the Movement Disorder Society with high internal consistency. MDS-UPDRS retains the four-scale structure with a reorganization of the various subscales. The subscale used in this study is Part III, motor examination (18 items). The subscale now has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe.", 'unitOfMeasure': 'minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants were analyzed.'}, {'type': 'SECONDARY', 'title': 'Cumulative Number of Responders (Defined as Improvement of 30% in MDS-UPDRS Part III Score From Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo: Delivered via the I231 POD (Precision Olfactory Delivery) device'}, {'id': 'OG001', 'title': 'L-dopa 35 mg', 'description': 'L-dopa 35 mg: Delivered via the I231 POD (Precision Olfactory Delivery) device via one puff to one nostril'}, {'id': 'OG002', 'title': 'L-dopa 70 mg', 'description': 'L-dopa 70mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril'}, {'id': 'OG003', 'title': 'L-dopa 140 mg', 'description': 'L-dopa 140 mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with four puffs, two to each nostril'}, {'id': 'OG004', 'title': 'L-dopa 70 mg/Carbidopa 7 mg', 'description': 'L-dopa 70mg/carbidopa 7mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril'}], 'classes': [{'title': '15 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': 'NA', 'comment': 'Subjects in this arm were not analyzed at this time point.', 'groupId': 'OG004'}]}]}, {'title': '30 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': '45 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': 'NA', 'comment': 'Subjects in this arm were not analyzed at this time point.', 'groupId': 'OG004'}]}]}, {'title': '60 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': '90 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': '120 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From time = 0 to 2 hours post-dose', 'description': "MDS-UPDRS is a clinimetric assessment of subjective and objective symptoms and signs of Parkinson's disease created by the Movement Disorder Society with high internal consistency. MDS-UPDRS retains the four-scale structure with a reorganization of the various subscales. The subscale used in this study is Part III, motor examination (18 items). The subscale now has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants were analyzed.'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve (AUC) of Change From Baseline in MDS-UPDRS Part III Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo: Delivered via the I231 POD (Precision Olfactory Delivery) device'}, {'id': 'OG001', 'title': 'L-dopa 35 mg', 'description': 'L-dopa 35 mg: Delivered via the I231 POD (Precision Olfactory Delivery) device via one puff to one nostril'}, {'id': 'OG002', 'title': 'L-dopa 70 mg', 'description': 'L-dopa 70mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril'}, {'id': 'OG003', 'title': 'L-dopa 140 mg', 'description': 'L-dopa 140 mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with four puffs, two to each nostril'}, {'id': 'OG004', 'title': 'L-dopa 70 mg/Carbidopa 7 mg', 'description': 'L-dopa 70mg/carbidopa 7mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril'}], 'classes': [{'title': '15 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-26.25', 'spread': '29.144', 'groupId': 'OG000'}, {'value': '-33.50', 'spread': '33.697', 'groupId': 'OG001'}, {'value': '7.00', 'spread': '69.206', 'groupId': 'OG002'}, {'value': '-67.50', 'spread': '46.233', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Participants in this arm were not assessed at this time point.', 'groupId': 'OG004'}]}]}, {'title': '30 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-237.63', 'spread': '276.197', 'groupId': 'OG000'}, {'value': '-138.58', 'spread': '138.105', 'groupId': 'OG001'}, {'value': '-50.50', 'spread': '203.053', 'groupId': 'OG002'}, {'value': '-232.83', 'spread': '153.638', 'groupId': 'OG003'}, {'value': '-230.08', 'spread': '250.832', 'groupId': 'OG004'}]}]}, {'title': '45 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-264.92', 'spread': '178.969', 'groupId': 'OG000'}, {'value': '-201.92', 'spread': '162.256', 'groupId': 'OG001'}, {'value': '-210.50', 'spread': '334.216', 'groupId': 'OG002'}, {'value': '-426.83', 'spread': '274.566', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Participants in this arm were not assessed at this time point.', 'groupId': 'OG004'}]}]}, {'title': '60 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-573.88', 'spread': '371.782', 'groupId': 'OG000'}, {'value': '-296.50', 'spread': '241.271', 'groupId': 'OG001'}, {'value': '-424.25', 'spread': '464.545', 'groupId': 'OG002'}, {'value': '-630.58', 'spread': '401.947', 'groupId': 'OG003'}, {'value': '-295.25', 'spread': '412.042', 'groupId': 'OG004'}]}]}, {'title': '90 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-919.75', 'spread': '530.872', 'groupId': 'OG000'}, {'value': '-575.17', 'spread': '486.241', 'groupId': 'OG001'}, {'value': '-896.67', 'spread': '671.116', 'groupId': 'OG002'}, {'value': '-968.08', 'spread': '587.629', 'groupId': 'OG003'}, {'value': '-362.75', 'spread': '676.456', 'groupId': 'OG004'}]}]}, {'title': '120 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-1215.75', 'spread': '765.287', 'groupId': 'OG000'}, {'value': '-903.67', 'spread': '804.196', 'groupId': 'OG001'}, {'value': '-1324.83', 'spread': '863.122', 'groupId': 'OG002'}, {'value': '-1210.58', 'spread': '714.512', 'groupId': 'OG003'}, {'value': '-465.25', 'spread': '932.842', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'For L-dopa 35 mg, 70 mg, 140 mg, assessments were made at pre-dose, 15, 30, 45, 60, 90, 120 minutes post-dose. For L-dopa 70 mg/carbidopa 7 mg, assessments were made at pre-dose, 50, 60, 90, 120 minutes post-dose.', 'description': "MDS-UPDRS is a clinimetric assessment of subjective and objective symptoms and signs of Parkinson's disease created by the Movement Disorder Society with high internal consistency. MDS-UPDRS retains the four-scale structure with a reorganization of the various subscales. The subscale used in this study is Part III, motor examination (18 items). The subscale now has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe.", 'unitOfMeasure': 'change in score*minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants were included in the analysis'}, {'type': 'SECONDARY', 'title': 'Mean Maximum Change From Baseline in MDS-UPDRS Part III Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo: Delivered via the I231 POD (Precision Olfactory Delivery) device'}, {'id': 'OG001', 'title': 'L-dopa 35 mg', 'description': 'L-dopa 35 mg: Delivered via the I231 POD (Precision Olfactory Delivery) device via one puff to one nostril'}, {'id': 'OG002', 'title': 'L-dopa 70 mg', 'description': 'L-dopa 70mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril'}, {'id': 'OG003', 'title': 'L-dopa 140 mg', 'description': 'L-dopa 140 mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with four puffs, two to each nostril'}, {'id': 'OG004', 'title': 'L-dopa 70 mg/Carbidopa 7 mg', 'description': 'L-dopa 70mg/carbidopa 7mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril'}], 'classes': [{'categories': [{'measurements': [{'value': '-15.5', 'spread': '6.35', 'groupId': 'OG000'}, {'value': '-14.0', 'spread': '11.15', 'groupId': 'OG001'}, {'value': '-20.3', 'spread': '11.18', 'groupId': 'OG002'}, {'value': '-15.3', 'spread': '8.12', 'groupId': 'OG003'}, {'value': '-7.5', 'spread': '6.72', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From time = 0 to 2 hours post-dose', 'description': "MDS-UPDRS is a clinimetric assessment of subjective and objective symptoms and signs of Parkinson's disease created by the Movement Disorder Society with high internal consistency. MDS-UPDRS retains the four-scale structure with a reorganization of the various subscales. The subscale used in this study is Part III, motor examination (18 items). The subscale now has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The total of the subscales has a maximum value of 132 and a minimum value of zero. Lower scores indicate better motor function. A negative change from baseline indicates improved motor function.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects were included in this analysis'}, {'type': 'SECONDARY', 'title': 'Subjective Time to "ON" as Evaluated by the Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo: Delivered via the I231 POD (Precision Olfactory Delivery) device'}, {'id': 'OG001', 'title': 'L-dopa 35 mg', 'description': 'L-dopa 35 mg: Delivered via the I231 POD (Precision Olfactory Delivery) device via one puff to one nostril'}, {'id': 'OG002', 'title': 'L-dopa 70 mg', 'description': 'L-dopa 70mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril'}, {'id': 'OG003', 'title': 'L-dopa 140 mg', 'description': 'L-dopa 140 mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with four puffs, two to each nostril'}, {'id': 'OG004', 'title': 'L-dopa 70 mg/Carbidopa 7 mg', 'description': 'L-dopa 70mg/carbidopa 7mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril'}], 'classes': [{'categories': [{'measurements': [{'value': '45.0', 'groupId': 'OG000', 'lowerLimit': '30', 'upperLimit': '240'}, {'value': '240.0', 'comment': 'One or more subjects in this arm did not achieve ON by the end of the assessment period. Therefore upper range was \\>240 minutes.', 'groupId': 'OG001', 'lowerLimit': '90', 'upperLimit': 'NA'}, {'value': '30.0', 'groupId': 'OG002', 'lowerLimit': '15', 'upperLimit': '240'}, {'value': '30.0', 'groupId': 'OG003', 'lowerLimit': '15', 'upperLimit': '240'}, {'value': '240.0', 'groupId': 'OG004', 'lowerLimit': '30', 'upperLimit': '240'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '4 hours', 'description': 'Investigators will evaluate subjects\' fluctuations in motor functions at 15, 30, 45, 60, 90, 120, and 240 minutes post-dose to determine if they are "ON".', 'unitOfMeasure': 'minutes', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants were included in the analysis'}, {'type': 'SECONDARY', 'title': 'Assessment of Time to "ON" as Evaluated by Subject Self-assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo: Delivered via the I231 POD (Precision Olfactory Delivery) device'}, {'id': 'OG001', 'title': 'L-dopa 35 mg', 'description': 'L-dopa 35 mg: Delivered via the I231 POD (Precision Olfactory Delivery) device via one puff to one nostril'}, {'id': 'OG002', 'title': 'L-dopa 70 mg', 'description': 'L-dopa 70mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril'}, {'id': 'OG003', 'title': 'L-dopa 140 mg', 'description': 'L-dopa 140 mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with four puffs, two to each nostril'}, {'id': 'OG004', 'title': 'L-dopa 70 mg/Carbidopa 7 mg', 'description': 'L-dopa 70mg/carbidopa 7mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril'}], 'classes': [{'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000', 'lowerLimit': '15', 'upperLimit': '240'}, {'value': '240.0', 'comment': 'One or more participants in this arm did not perceive themselves to be "ON" by the end of the assessment period, therefore the full range is 95 to \\>240 minutes', 'groupId': 'OG001', 'lowerLimit': '95', 'upperLimit': 'NA'}, {'value': '39.0', 'groupId': 'OG002', 'lowerLimit': '15', 'upperLimit': '240'}, {'value': '30.0', 'groupId': 'OG003', 'lowerLimit': '15', 'upperLimit': '240'}, {'value': '232.5', 'groupId': 'OG004', 'lowerLimit': '31', 'upperLimit': '240'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '4 hours', 'description': 'Subjects were asked to provide self-assessments at 15, 30, 45, 60, 90, 120, and 240 minutes post-dose as to whether they considered themselves to be "ON".', 'unitOfMeasure': 'minutes', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'AUC0-2h for Carbidopa', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'L-dopa 70 mg/Carbidopa 7 mg', 'description': 'L-dopa 70mg/carbidopa 7mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril'}], 'classes': [{'categories': [{'measurements': [{'value': '114.80', 'spread': '30.384', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Plasma samples were taken at pre-dose, 5, 10, 15, 30, 45, 60, 90 and 120 minutes post-dose and AUC calculated from these from time 0 to 120 minutes.', 'description': 'Area under the concentration time curve for carbidopa', 'unitOfMeasure': 'hours*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who received the combination of L-dopa/carbidopa'}, {'type': 'SECONDARY', 'title': 'Cmax of Carbidopa', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'L-dopa 70 mg/Carbidopa 7 mg', 'description': 'L-dopa 70mg/carbidopa 7mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril'}], 'classes': [{'categories': [{'measurements': [{'value': '80.23', 'spread': '22.945', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'For L-dopa 70 mg/carbidopa 7 mg, plasma samples were taken at pre-dose, 5, 10, 15, 30, 45, 60, 90 and 120 minutes post-dose.', 'description': 'Maximum concentration of carbidopa', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who received L-dopa/carbidopa'}, {'type': 'SECONDARY', 'title': 'Tmax of Carbidopa', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'L-dopa 70 mg/Carbidopa 7 mg', 'description': 'L-dopa 70mg/carbidopa 7mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril'}], 'classes': [{'categories': [{'measurements': [{'value': '44.50', 'spread': '13.882', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'For L-dopa 70 mg/carbidopa 7 mg, plasma samples were taken at pre-dose, 5, 10, 15, 30, 45, 60, 90 and 120 minutes post-dose.', 'description': 'Time to reach the maximum concentration of carbidopa', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who received L-dopa/carbidopa'}, {'type': 'SECONDARY', 'title': 'Duration of Response, Where Response is Defined as an Improvement of 30% in MDS-UPDRS Part III Score From Baseline.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo: Delivered via the I231 POD (Precision Olfactory Delivery) device'}, {'id': 'OG001', 'title': 'L-dopa 35 mg', 'description': 'L-dopa 35 mg: Delivered via the I231 POD (Precision Olfactory Delivery) device via one puff to one nostril'}, {'id': 'OG002', 'title': 'L-dopa 70 mg', 'description': 'L-dopa 70mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril'}, {'id': 'OG003', 'title': 'L-dopa 140 mg', 'description': 'L-dopa 140 mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with four puffs, two to each nostril'}, {'id': 'OG004', 'title': 'L-dopa 70 mg/Carbidopa 7 mg', 'description': 'L-dopa 70mg/carbidopa 7mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril'}], 'classes': [{'categories': [{'measurements': [{'value': '66.9', 'spread': '48.35', 'groupId': 'OG000'}, {'value': '23.3', 'spread': '36.70', 'groupId': 'OG001'}, {'value': '57.3', 'spread': '42.72', 'groupId': 'OG002'}, {'value': '37.5', 'spread': '42.25', 'groupId': 'OG003'}, {'value': '15.0', 'spread': '25.10', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 hours', 'description': "MDS-UPDRS is a clinimetric assessment of subjective and objective symptoms and signs of Parkinson's disease created by the Movement Disorder Society with high internal consistency. MDS-UPDRS retains the four-scale structure with a reorganization of the various subscales. The subscale used in this study is Part III, motor examination (18 items). The subscale has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. Maximum score is 132, minimum is zero. High score means worse outcome.", 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants were analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo: Delivered via the I231 POD (Precision Olfactory Delivery) device'}, {'id': 'FG001', 'title': 'L-dopa 35 mg', 'description': 'L-dopa 35 mg: Delivered via the I231 POD (Precision Olfactory Delivery) device via one puff to one nostril'}, {'id': 'FG002', 'title': 'L-dopa 70 mg', 'description': 'L-dopa 70mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril'}, {'id': 'FG003', 'title': 'L-dopa 140 mg', 'description': 'L-dopa 140 mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with four puffs, two to each nostril'}, {'id': 'FG004', 'title': 'L-dopa 70 mg/Carbidopa 7 mg', 'description': 'L-dopa 70mg/carbidopa 7mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}], 'recruitmentDetails': "Parkinson's disease patients at movement disorder clinics in Australia", 'preAssignmentDetails': 'Confirmation of L-dopa responsiveness at Visit 2, prior to randomization'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '32', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo: Delivered via the I231 POD (Precision Olfactory Delivery) device'}, {'id': 'BG001', 'title': 'L-dopa 35 mg', 'description': 'L-dopa 35 mg: Delivered via the I231 POD (Precision Olfactory Delivery) device via one puff to one nostril'}, {'id': 'BG002', 'title': 'L-dopa 70 mg', 'description': 'L-dopa 70mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril'}, {'id': 'BG003', 'title': 'L-dopa 140 mg', 'description': 'L-dopa 140 mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with four puffs, two to each nostril'}, {'id': 'BG004', 'title': 'L-dopa 70 mg/Carbidopa 7 mg', 'description': 'L-dopa 70mg/carbidopa 7mg: Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '18', 'groupId': 'BG005'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '14', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '12', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '20', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '32', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '28', 'groupId': 'BG005'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Australia', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '32', 'groupId': 'BG005'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-02-01', 'size': 1215415, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-05-26T18:44', 'hasProtocol': True}, {'date': '2019-06-10', 'size': 811762, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-05-26T18:45', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double blind'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Thirty-Two (32) to Thirty-Six (36) subjects will be randomized to treatment or placebo. INP103 is a drug-device combination product containing a drug component, L-dopa, and device component, the I231 Precision Olfactory Delivery (POD) device. In Cohorts 1, 2, and 3, L-dopa will be administered intranasally in single doses of one (35 mg), two (70 mg) or four (140 mg) puffs of INP103, 60 minutes after oral benserazide hydrochloride 25 mg.\n\nIn Cohort 4 the INP103 formulation will contain L-dopa:carbidopa administered nasally. Dosing will take place once OFF episode is confirmed and will not include predosing with oral benserazide.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2019-06-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-27', 'studyFirstSubmitDate': '2018-04-05', 'resultsFirstSubmitDate': '2020-05-26', 'studyFirstSubmitQcDate': '2018-05-17', 'lastUpdatePostDateStruct': {'date': '2020-08-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-07-27', 'studyFirstPostDateStruct': {'date': '2018-05-30', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Treatment Emergent Adverse Events', 'timeFrame': '7 days', 'description': 'Assessment of treatment emergent adverse events after single dosing with INP103 (L-dopa or L-dopa/carbidopa)'}], 'secondaryOutcomes': [{'measure': 'AUC0-2hr for L-dopa', 'timeFrame': 'For L-dopa 35 mg, 70 mg, 140 mg plasma samples were taken at pre-dose, 30, 60, 90 and 120 minutes post-dose. For L-dopa 70 mg/carbidopa 7 mg, plasma samples were taken at pre-dose, 5, 10, 15, 30, 45, 60, 90 and 120 min', 'description': 'Area under the Plasma Concentration-time Curve for L-dopa from Time = 0 to Time = 2 hours post dose. For the L-dopa 35 mg, L-dopa 70 mg, L-dopa 140 mg plasma samples were taken at pre-dose, 30, 60, 90 and 120 minutes post-dose. For the L-dopa 70 mg/carbidopa 7 mg treatment arm, plasma samples were taken at pre-dose, 5, 10, 15, 30, 45, 60, 90 and 120 minutes post-dose.'}, {'measure': 'Cmax of L-dopa', 'timeFrame': 'For L-dopa 35 mg, 70 mg, 140 mg plasma samples were taken at pre-dose, 30, 60, 90 and 120 minutes post-dose. For L-dopa 70 mg/carbidopa 7 mg, plasma samples were taken at pre-dose, 5, 10, 15, 30, 45, 60, 90 and 120 minutes post-dose.', 'description': 'Maximum Observed Plasma Concentration of L-dopa from Time = 0 to Time = 2 hours post dose. For the L-dopa 35 mg, L-dopa 70 mg, L-dopa 140 mg plasma samples were taken at pre-dose, 30, 60, 90 and 120 minutes post-dose. For the L-dopa 70 mg/carbidopa 7 mg treatment arm, plasma samples were taken at pre-dose, 5, 10, 15, 30, 45, 60, 90 and 120 minutes post-dose.'}, {'measure': 'Tmax of L-dopa', 'timeFrame': 'For L-dopa 35 mg, 70 mg, 140 mg plasma samples were taken at pre-dose, 30, 60, 90 and 120 minutes post-dose. For L-dopa 70 mg/carbidopa 7 mg, plasma samples were taken at pre-dose, 5, 10, 15, 30, 45, 60, 90 and 120 minutes post-dose.', 'description': 'Time to Reach the Maximum Plasma Concentration (Cmax) of L-dopa'}, {'measure': 'Mean Change From Baseline in MDS-UPDRS Score Over 2 Hours for C1, C2, C3 and Change From Baseline at 30, 60, 90, 120 Minutes for C4, in MDS-UPDRS Part III Score', 'timeFrame': 'For L-dopa 35 mg, 70 mg, 140 mg, assessment occurred at pre-dose, 15, 30, 45, 60, 90 and 120 minutes post-dose. For L-dopa 70 mg/carbidopa 7 mg, assessment occurred at pre-dose, 30, 60, 90 and 120 minutes post-dose.', 'description': "MDS-UPDRS is a clinimetric assessment of subjective and objective symptoms and signs of Parkinson's disease created by the Movement Disorder Society with high internal consistency. MDS-UPDRS retains the four-scale structure with a reorganization of the various subscales. The subscale used in this study is Part III, motor examination (18 items). The subscale has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. Maximum score is 132, minimum is zero. High score means worse outcome. For the L-dopa 35 mg, L-dopa 70 mg, L-dopa 140 mg treatment groups, assessment occurred at pre-dose, 15, 30, 45, 60, 90 and 120 minutes post-dose. For the L-dopa 70 mg/carbidopa 7 mg treatment arm, assessment occurred at pre-dose, 30, 60, 90 and 120 minutes post-dose."}, {'measure': 'Time to Response (Defined as Improvement of 30% in MDS-UPDRS Part III Score From Baseline)', 'timeFrame': '2 hours', 'description': "MDS-UPDRS is a clinimetric assessment of subjective and objective symptoms and signs of Parkinson's disease created by the Movement Disorder Society with high internal consistency. MDS-UPDRS retains the four-scale structure with a reorganization of the various subscales. The subscale used in this study is Part III, motor examination (18 items). The subscale now has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe."}, {'measure': 'Cumulative Number of Responders (Defined as Improvement of 30% in MDS-UPDRS Part III Score From Baseline)', 'timeFrame': 'From time = 0 to 2 hours post-dose', 'description': "MDS-UPDRS is a clinimetric assessment of subjective and objective symptoms and signs of Parkinson's disease created by the Movement Disorder Society with high internal consistency. MDS-UPDRS retains the four-scale structure with a reorganization of the various subscales. The subscale used in this study is Part III, motor examination (18 items). The subscale now has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe."}, {'measure': 'Area Under the Curve (AUC) of Change From Baseline in MDS-UPDRS Part III Scores', 'timeFrame': 'For L-dopa 35 mg, 70 mg, 140 mg, assessments were made at pre-dose, 15, 30, 45, 60, 90, 120 minutes post-dose. For L-dopa 70 mg/carbidopa 7 mg, assessments were made at pre-dose, 50, 60, 90, 120 minutes post-dose.', 'description': "MDS-UPDRS is a clinimetric assessment of subjective and objective symptoms and signs of Parkinson's disease created by the Movement Disorder Society with high internal consistency. MDS-UPDRS retains the four-scale structure with a reorganization of the various subscales. The subscale used in this study is Part III, motor examination (18 items). The subscale now has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe."}, {'measure': 'Mean Maximum Change From Baseline in MDS-UPDRS Part III Score', 'timeFrame': 'From time = 0 to 2 hours post-dose', 'description': "MDS-UPDRS is a clinimetric assessment of subjective and objective symptoms and signs of Parkinson's disease created by the Movement Disorder Society with high internal consistency. MDS-UPDRS retains the four-scale structure with a reorganization of the various subscales. The subscale used in this study is Part III, motor examination (18 items). The subscale now has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The total of the subscales has a maximum value of 132 and a minimum value of zero. Lower scores indicate better motor function. A negative change from baseline indicates improved motor function."}, {'measure': 'Subjective Time to "ON" as Evaluated by the Investigator', 'timeFrame': '4 hours', 'description': 'Investigators will evaluate subjects\' fluctuations in motor functions at 15, 30, 45, 60, 90, 120, and 240 minutes post-dose to determine if they are "ON".'}, {'measure': 'Assessment of Time to "ON" as Evaluated by Subject Self-assessment', 'timeFrame': '4 hours', 'description': 'Subjects were asked to provide self-assessments at 15, 30, 45, 60, 90, 120, and 240 minutes post-dose as to whether they considered themselves to be "ON".'}, {'measure': 'AUC0-2h for Carbidopa', 'timeFrame': 'Plasma samples were taken at pre-dose, 5, 10, 15, 30, 45, 60, 90 and 120 minutes post-dose and AUC calculated from these from time 0 to 120 minutes.', 'description': 'Area under the concentration time curve for carbidopa'}, {'measure': 'Cmax of Carbidopa', 'timeFrame': 'For L-dopa 70 mg/carbidopa 7 mg, plasma samples were taken at pre-dose, 5, 10, 15, 30, 45, 60, 90 and 120 minutes post-dose.', 'description': 'Maximum concentration of carbidopa'}, {'measure': 'Tmax of Carbidopa', 'timeFrame': 'For L-dopa 70 mg/carbidopa 7 mg, plasma samples were taken at pre-dose, 5, 10, 15, 30, 45, 60, 90 and 120 minutes post-dose.', 'description': 'Time to reach the maximum concentration of carbidopa'}, {'measure': 'Duration of Response, Where Response is Defined as an Improvement of 30% in MDS-UPDRS Part III Score From Baseline.', 'timeFrame': '2 hours', 'description': "MDS-UPDRS is a clinimetric assessment of subjective and objective symptoms and signs of Parkinson's disease created by the Movement Disorder Society with high internal consistency. MDS-UPDRS retains the four-scale structure with a reorganization of the various subscales. The subscale used in this study is Part III, motor examination (18 items). The subscale has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. Maximum score is 132, minimum is zero. High score means worse outcome."}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Parkinsons', 'L-dopa', 'levodopa', 'ON', 'OFF', 'PD', 'POD device', 'I231', 'benserazide', 'Precision olfactory delivery', 'MDS-UPDRS', 'Carbidopa', 'DCI', 'Decarboxylase Inhibitor'], 'conditions': ["Parkinson's Disease"]}, 'descriptionModule': {'briefSummary': "A Phase IIa, Randomized, Double Blind, Placebo Controlled, Single Dose, Safety and Pharmacokinetic/Pharmacodynamic Study of INP103 (POD L-dopa) Administered in the Presence of Decarboxylase Inhibitor to L-dopa Responsive Parkinson's Disease Patients", 'detailedDescription': 'This is a Phase IIa randomized, double-blind, placebo-controlled, single dose study to compare the safety, tolerability and PK/PDyn of intranasal L-dopa following administration of INP103 in the presence of L-dopa decarboxylase inhibitor (DCI) during an OFF episode.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Adult males and females, 40 to 80 years of age (inclusive) at the time of Screening (Visit1)\n2. Diagnosed with Idiopathic PD (by UK Brain Bank Criteria) with Modified Hoehn \\& Yahr (H\\&Y) Stage I-III during an ON period at Visit 1\n3. Subjects who are prone to (and recognize) OFF episodes (when their usual PD medication has worn off)\n4. Shown to be responsive to L-dopa medication (≥ 30% improvement in MDS-UPDRS Part III Motor Examination score) as assessed during the Screening period (Visit 2)\n5. On a stable dose of L-dopa containing medication for at least 2 weeks prior to Visit 1 (up to 1200 mg/day) with no single dose exceeding 250 mg. All other anti-PD medication (e.g. dopamine agonists \\[DAs\\], monoamine oxidase-B inhibitor (MAOB-I) or catechol-O-methyl transferase (COMT) inhibitors ARE allowed if the subject has been on a stable dose for at least 30 days prior to Visit 1.\n6. Willing to omit their (usual) PD drugs (e.g. usual regular anti-PD medication including any L-dopa containing medication, DAs and/or COMT inhibitors and any required anti-OFF treatment) from 22:00 pm the evening prior to study dosing until 120 minutes post study treatment dosing.\n\n Cohorts 1, 2 and 3 ONLY WILL take oral benserazide 25 mg on arrival at the research site (at 60 ± 5 minutes before dosing with INP103 or placebo).\n\n Cohort 4 will omit oral benserazide and subjects may be dosed once OFF episode has been confirmed and all baseline assessments have been completed.\n7. If female and of childbearing potential must agree to use adequate contraception (see Section 4.4) during the study\n8. Able and willing to attend the necessary visits at the study centre\n9. Willing to provide voluntary written informed consent signed prior to entry into the study\n\nExclusion Criteria:\n\n1. Severe dyskinesia (defined as per MDS-UPDRS) during a 'normal day' that would significantly interfere with the subject's ability to perform study assessments\n2. In receipt of L-dopa containing medication at \\> 1200 mg/day\n3. History of significant psychotic episode(s) within the previous 12 months in the opinion of the Investigator, or currently receiving anti-psychotic medication at a moderate dose (quetiapine \\>50 mg/day, risperidone \\>1 mg/day or olanzapine \\>2.5 mg/day)\n4. Mini Mental State Examination (MMSE) ≤ 25 as documented within the previous 36 months or as assessed by Investigator during Screening\n5. History of suicidal ideation or attempted suicide within previous 12 months\n6. Narrow-angle glaucoma\n7. Presence of skin lesions that, in the opinion of the Investigator, may be cancerous\n8. Females who are pregnant, planning a pregnancy or lactating\n9. Subjects with any underlying physical condition that, in the opinion of the Investigator, would make it unlikely that the subject will comply with or be able to complete the study requirements\n10. Use of any medication likely to interact with benserazide, carbidopa or INP103 (see Appendix 5)\n11. Laboratory test abnormalities at Screening (Visit 1) deemed clinically significant by the Investigator.\n12. History or presence of alcoholism or drug abuse within the 2 years prior to INP103 or placebo dosing\n13. Administration of an investigational product in another trial within 30 days or 5 half-lives (whichever is longer) prior to INP103 or placebo dosing\n14. Significant nasal congestion, physical blockage in either nostril, or significantly deviated nasal septum as evaluated by the PI or other suitably trained healthcare professional\n15. Subjects who have previously shown hypersensitivity to L-dopa or benserazide (for Cohorts 1, 2 and 3), or L-dopa or carbidopa (for Cohort 4) or any of their excipients"}, 'identificationModule': {'nctId': 'NCT03541356', 'acronym': 'THOR201', 'briefTitle': "Therapeutic Potential for Intranasal Levodopa in Parkinson's Disease -Off Reversal", 'organization': {'class': 'INDUSTRY', 'fullName': 'Impel Pharmaceuticals'}, 'officialTitle': "A Phase IIa, Randomized, Double Blind, Placebo Controlled, Single Ascending Dose, Safety and Pharmacokinetic/Pharmacodynamic Study of INP103 (POD L-dopa) Administered in the Presence of DCI to L-dopa Responsive Parkinson's Disease Patients", 'orgStudyIdInfo': {'id': 'INP103-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Combination Product: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'L-dopa 35 mg', 'interventionNames': ['Combination Product: L-dopa 35 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'L-dopa 70 mg', 'interventionNames': ['Combination Product: L-dopa 70mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'L-dopa 140 mg', 'interventionNames': ['Combination Product: L-dopa 140 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'L-dopa 70 mg/carbidopa 7 mg', 'interventionNames': ['Combination Product: L-dopa 70mg/carbidopa 7mg']}], 'interventions': [{'name': 'Placebo', 'type': 'COMBINATION_PRODUCT', 'description': 'Delivered via the I231 POD (Precision Olfactory Delivery) device', 'armGroupLabels': ['Placebo']}, {'name': 'L-dopa 35 mg', 'type': 'COMBINATION_PRODUCT', 'description': 'Delivered via the I231 POD (Precision Olfactory Delivery) device via one puff to one nostril', 'armGroupLabels': ['L-dopa 35 mg']}, {'name': 'L-dopa 70mg', 'type': 'COMBINATION_PRODUCT', 'description': 'Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril', 'armGroupLabels': ['L-dopa 70 mg']}, {'name': 'L-dopa 140 mg', 'type': 'COMBINATION_PRODUCT', 'description': 'Delivered via the I231 POD (Precision Olfactory Delivery) device with four puffs, two to each nostril', 'armGroupLabels': ['L-dopa 140 mg']}, {'name': 'L-dopa 70mg/carbidopa 7mg', 'type': 'COMBINATION_PRODUCT', 'description': 'Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril', 'armGroupLabels': ['L-dopa 70 mg/carbidopa 7 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2031', 'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'The Brain and Mind Centre / Scientia Clinical Research', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'city': 'Brisbane', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Q-Pharm', 'geoPoint': {'lat': -27.46794, 'lon': 153.02809}}, {'city': 'Brisbane', 'state': 'Queensland', 'country': 'Australia', 'facility': 'The Mater Hospital', 'geoPoint': {'lat': -27.46794, 'lon': 153.02809}}, {'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'The Alfred Hospital', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '6009', 'city': 'Perth', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Perron Institute', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}], 'overallOfficials': [{'name': 'Stephen B Shrewsbury, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Impel NeuroPharma, Seattle, WA (USA)'}, {'name': "Terry O'Brien, MD/Prof", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Alfred Hospital, Melbourne, VIC (AUS)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Impel Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}