Ignite Creation Date:
2025-12-26 @ 12:18 PM
Ignite Modification Date:
2025-12-26 @ 12:18 PM
Study NCT ID:
NCT01294800
Status:
COMPLETED
Last Update Posted:
2018-11-08
First Post:
2011-02-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Dose Finding Study of Preladenant (SCH 420814) for the Treatment of Parkinson's Disease (PD) in Japanese Patients (P06402)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Japan']}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C539997', 'term': '2-(2-furanyl)-7-(2-(4-(4-(2-methoxyethoxy)phenyl)-1-piperazinyl)ethyl)-7H-pyrazolo(4,3-e)(1,2,4)triazolo(1,5-c)pyrimidine-5-amine'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'The investigator agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication (including, without limitation, slides and texts of oral or other public presentations and texts of any transmission through any electronic media, eg, any computer access system such as the Internet, World Wide Web, etc) that report any results of the trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 14 weeks', 'description': 'All Participants as Treated population, which included all participants who received at least one dose of study drug', 'eventGroups': [{'id': 'EG000', 'title': 'Preladenant 2 mg', 'description': 'Participants received preladenant 2 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.', 'otherNumAtRisk': 111, 'otherNumAffected': 19, 'seriousNumAtRisk': 111, 'seriousNumAffected': 9}, {'id': 'EG001', 'title': 'Preladenant 5 mg', 'description': 'Participants received preladenant 5 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.', 'otherNumAtRisk': 113, 'otherNumAffected': 23, 'seriousNumAtRisk': 113, 'seriousNumAffected': 5}, {'id': 'EG002', 'title': 'Preladenant 10 mg', 'description': 'Participants received preladenant 10 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.', 'otherNumAtRisk': 113, 'otherNumAffected': 25, 'seriousNumAtRisk': 113, 'seriousNumAffected': 7}, {'id': 'EG003', 'title': 'Placebo', 'description': 'Participants received a placebo to preladenant tablet taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.', 'otherNumAtRisk': 113, 'otherNumAffected': 14, 'seriousNumAtRisk': 113, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'CONSTIPATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 113, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 113, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 113, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 113, 'numEvents': 10, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'FALL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 113, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'DYSKINESIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 113, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 113, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'seriousEvents': [{'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'INGUINAL HERNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'LARGE INTESTINE POLYP', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'LOWER GASTROINTESTINAL HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'GAIT DISTURBANCE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'DRUG-INDUCED LIVER INJURY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'CELLULITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'PNEUMONIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'FEMUR FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'HEAT STROKE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'SPINAL COMPRESSION FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'ULNA FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'JAW CYST', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'PAIN IN EXTREMITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'COLON CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'METASTASES TO LYMPH NODES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': "PARKINSON'S DISEASE", 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'IMPULSE-CONTROL DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'CYSTITIS HAEMORRHAGIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'URINARY RETENTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'ACTIVITIES OF DAILY LIVING IMPAIRED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Mean "Off" Time (Hours Per Day) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}, {'value': '90', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Preladenant 2 mg', 'description': 'Participants received preladenant 2 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.'}, {'id': 'OG001', 'title': 'Preladenant 5 mg', 'description': 'Participants received preladenant 5 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.'}, {'id': 'OG002', 'title': 'Preladenant 10 mg', 'description': 'Participants received preladenant 10 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received a placebo to preladenant tablet taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.2', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '2.6', 'groupId': 'OG001'}, {'value': '-0.9', 'spread': '2.2', 'groupId': 'OG002'}, {'value': '-0.5', 'spread': '3.0', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.0564', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-1.37', 'ciUpperLimit': '0.02', 'statisticalMethod': 'Constrained longitudinal data analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.1844', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Difference in Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-1.16', 'ciUpperLimit': '0.22', 'statisticalMethod': 'Constrained longitudinal data analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.3386', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference in Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-1.04', 'ciUpperLimit': '0.36', 'statisticalMethod': 'Constrained longitudinal data analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'The "on" state is defined as the period of time during which a participant\'s symptoms of PD improve or disappear following treatment with levodopa (L-dopa) or dopamine agonists. The "off" state is defined as the period of time characterized by the return of symptoms (i..e. tremor, slowness, and rigidity) following treatment with L-dopa or dopamine agonists. Study participants reported their symptoms at half-hour intervals as "off", "on", or "asleep" on their daily diary for 3 days before randomization (baseline) and for the 3 days immediately before their Week-12 visit. The mean change from baseline in "off" time was based on a constrained longitudinal data analysis with treatment, time, and treatment-by-time interaction as fixed effects, and an unstructured covariance matrix was used to model the correlation among repeated measurements.', 'unitOfMeasure': 'Hours/Day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) population, which consisted of all randomized participants who received at least one dose of study treatment; had endpoint data subsequent to at least one dose of study treatment; and had baseline data for those analyses requiring baseline data.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With ≥30% Reduction in "Off" Time at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '112', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Preladenant 2 mg', 'description': 'Participants received preladenant 2 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.'}, {'id': 'OG001', 'title': 'Preladenant 5 mg', 'description': 'Participants received preladenant 5 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.'}, {'id': 'OG002', 'title': 'Preladenant 10 mg', 'description': 'Participants received preladenant 10 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received a placebo to preladenant tablet taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '34.5', 'groupId': 'OG000'}, {'value': '34.6', 'groupId': 'OG001'}, {'value': '24.6', 'groupId': 'OG002'}, {'value': '28.9', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.404', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in proportions of responders', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.7', 'ciLowerLimit': '-7.75', 'ciUpperLimit': '19.00', 'statisticalMethod': 'A generalized linear mixed model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.390', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Difference in proportions of responders', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.7', 'ciLowerLimit': '-7.73', 'ciUpperLimit': '18.81', 'statisticalMethod': 'A generalized linear mixed model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.508', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference in proportions of responders', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.9', 'ciLowerLimit': '-17.78', 'ciUpperLimit': '7.97', 'statisticalMethod': 'A generalized linear mixed model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 12 Weeks', 'description': 'The proportion of responders (≥30% Reduction in "Off" Time at Week 12) was analyzed using a generalized linear mixed model with baseline mean OFF time (hours/day) as a covariate and treatment-by-time interaction as a fixed effect, and an unstructured covariance matrix was used to model the correlation among repeated measurements. Responder rates for each treatment arm are presented as are differences from placebo with 95% confidence interval.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) population, which consisted of all randomized participants who received at least one dose of study treatment; had endpoint data subsequent to at least one dose of study treatment; and had baseline data for those analyses requiring baseline data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean "On" Time Without Troublesome Dyskinesias (Hours Per Day) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}, {'value': '90', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Preladenant 2 mg', 'description': 'Participants received preladenant 2 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.'}, {'id': 'OG001', 'title': 'Preladenant 5 mg', 'description': 'Participants received preladenant 5 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.'}, {'id': 'OG002', 'title': 'Preladenant 10 mg', 'description': 'Participants received preladenant 10 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received a placebo to preladenant tablet taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.3', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '2.9', 'groupId': 'OG001'}, {'value': '1.0', 'spread': '2.4', 'groupId': 'OG002'}, {'value': '0.5', 'spread': '2.9', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.0509', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.7', 'ciLowerLimit': '-0.00', 'ciUpperLimit': '1.43', 'statisticalMethod': 'Constrained longitudinal data analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.1847', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Difference in Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '-0.23', 'ciUpperLimit': '1.19', 'statisticalMethod': 'Constrained longitudinal data analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.2021', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference in Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '-0.25', 'ciUpperLimit': '1.19', 'statisticalMethod': 'Constrained longitudinal data analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'When a participant is "on" without dyskinesias, parkinsonian symptoms have dissipated and the participant is experiencing no uncontrollable extraneous movements. Study participants reported their parkinsonian symptoms at half-hour intervals as "off", "on without dyskinesia", "on with non-troublesome dyskinesia", "on with troublesome dyskinesia", or "asleep" on their daily diary for 3 days before randomization and for the 3 days immediately before their Week-12 visit. The mean change from baseline in "on without troublesome dyskinesia" time was based on a constrained longitudinal data analysis with treatment, time, and treatment-by-time interaction as fixed effects, and an unstructured covariance matrix was used to model the correlation among repeated measurements.', 'unitOfMeasure': 'Hours/Day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population, which consisted of all randomized participants who received at least one dose of study treatment; had endpoint data subsequent to at least one dose of study treatment; and had baseline data for those analyses requiring baseline data.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Experienced an Adverse Event (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}, {'value': '113', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Preladenant 2 mg', 'description': 'Participants received preladenant 2 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.'}, {'id': 'OG001', 'title': 'Preladenant 5 mg', 'description': 'Participants received preladenant 5 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.'}, {'id': 'OG002', 'title': 'Preladenant 10 mg', 'description': 'Participants received preladenant 10 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received a placebo to preladenant tablet taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 14 weeks', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Participants as Treated population, which included all participants who received at least one dose of study drug'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Discontinued Study Treatment Due to an AE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}, {'value': '113', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Preladenant 2 mg', 'description': 'Participants received preladenant 2 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.'}, {'id': 'OG001', 'title': 'Preladenant 5 mg', 'description': 'Participants received preladenant 5 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.'}, {'id': 'OG002', 'title': 'Preladenant 10 mg', 'description': 'Participants received preladenant 10 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received a placebo to preladenant tablet taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 12 Weeks', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Participants as Treated population, which included all participants who received at least one dose of study drug'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Preladenant 2 mg', 'description': 'Participants received preladenant 2 mg taken orally twice daily (BID), one tablet in the morning and one tablet in the evening, for 12 weeks.'}, {'id': 'FG001', 'title': 'Preladenant 5 mg', 'description': 'Participants received preladenant 5 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.'}, {'id': 'FG002', 'title': 'Preladenant 10 mg', 'description': 'Participants received preladenant 10 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.'}, {'id': 'FG003', 'title': 'Placebo', 'description': 'Participants received a placebo to preladenant tablet taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '111'}, {'groupId': 'FG001', 'numSubjects': '113'}, {'groupId': 'FG002', 'numSubjects': '113'}, {'groupId': 'FG003', 'numSubjects': '113'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}, {'groupId': 'FG001', 'numSubjects': '103'}, {'groupId': 'FG002', 'numSubjects': '96'}, {'groupId': 'FG003', 'numSubjects': '97'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '17'}, {'groupId': 'FG003', 'numSubjects': '16'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'Subject Withdrew Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '11'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Non-compliance With Protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Did Not Meet Protocol Eligibility', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '113', 'groupId': 'BG002'}, {'value': '113', 'groupId': 'BG003'}, {'value': '450', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Preladenant 2 mg', 'description': 'Participants received preladenant 2 mg taken orally twice daily (BID), one tablet in the morning and one tablet in the evening, for 12 weeks.'}, {'id': 'BG001', 'title': 'Preladenant 5 mg', 'description': 'Participants received preladenant 5 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.'}, {'id': 'BG002', 'title': 'Preladenant 10 mg', 'description': 'Participants received preladenant 10 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.'}, {'id': 'BG003', 'title': 'Placebo', 'description': 'Participants received a placebo to preladenant tablet taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.0', 'spread': '7.9', 'groupId': 'BG000'}, {'value': '67.6', 'spread': '8.3', 'groupId': 'BG001'}, {'value': '67.8', 'spread': '7.6', 'groupId': 'BG002'}, {'value': '65.8', 'spread': '9.1', 'groupId': 'BG003'}, {'value': '67.3', 'spread': '8.3', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}, {'value': '64', 'groupId': 'BG003'}, {'value': '253', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}, {'value': '197', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All Randomized Participants'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 450}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2013-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-08', 'studyFirstSubmitDate': '2011-02-10', 'resultsFirstSubmitDate': '2016-08-18', 'studyFirstSubmitQcDate': '2011-02-10', 'lastUpdatePostDateStruct': {'date': '2018-11-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-08-18', 'studyFirstPostDateStruct': {'date': '2011-02-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-10-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Mean "Off" Time (Hours Per Day) at Week 12', 'timeFrame': 'Baseline and Week 12', 'description': 'The "on" state is defined as the period of time during which a participant\'s symptoms of PD improve or disappear following treatment with levodopa (L-dopa) or dopamine agonists. The "off" state is defined as the period of time characterized by the return of symptoms (i..e. tremor, slowness, and rigidity) following treatment with L-dopa or dopamine agonists. Study participants reported their symptoms at half-hour intervals as "off", "on", or "asleep" on their daily diary for 3 days before randomization (baseline) and for the 3 days immediately before their Week-12 visit. The mean change from baseline in "off" time was based on a constrained longitudinal data analysis with treatment, time, and treatment-by-time interaction as fixed effects, and an unstructured covariance matrix was used to model the correlation among repeated measurements.'}, {'measure': 'Number of Participants Who Experienced an Adverse Event (AE)', 'timeFrame': 'Up to 14 weeks', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.'}, {'measure': 'Number of Participants Who Discontinued Study Treatment Due to an AE', 'timeFrame': 'Up to 12 Weeks', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With ≥30% Reduction in "Off" Time at Week 12', 'timeFrame': 'Up to 12 Weeks', 'description': 'The proportion of responders (≥30% Reduction in "Off" Time at Week 12) was analyzed using a generalized linear mixed model with baseline mean OFF time (hours/day) as a covariate and treatment-by-time interaction as a fixed effect, and an unstructured covariance matrix was used to model the correlation among repeated measurements. Responder rates for each treatment arm are presented as are differences from placebo with 95% confidence interval.'}, {'measure': 'Change From Baseline in Mean "On" Time Without Troublesome Dyskinesias (Hours Per Day) at Week 12', 'timeFrame': 'Baseline and Week 12', 'description': 'When a participant is "on" without dyskinesias, parkinsonian symptoms have dissipated and the participant is experiencing no uncontrollable extraneous movements. Study participants reported their parkinsonian symptoms at half-hour intervals as "off", "on without dyskinesia", "on with non-troublesome dyskinesia", "on with troublesome dyskinesia", or "asleep" on their daily diary for 3 days before randomization and for the 3 days immediately before their Week-12 visit. The mean change from baseline in "on without troublesome dyskinesia" time was based on a constrained longitudinal data analysis with treatment, time, and treatment-by-time interaction as fixed effects, and an unstructured covariance matrix was used to model the correlation among repeated measurements.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ["Parkinson's disease"], 'conditions': ["Parkinson's Disease"]}, 'referencesModule': {'references': [{'pmid': '27632893', 'type': 'RESULT', 'citation': "Hattori N, Kikuchi M, Adachi N, Hewitt D, Huyck S, Saito T. Adjunctive preladenant: A placebo-controlled, dose-finding study in Japanese patients with Parkinson's disease. Parkinsonism Relat Disord. 2016 Nov;32:73-79. doi: 10.1016/j.parkreldis.2016.08.020. Epub 2016 Aug 27."}]}, 'descriptionModule': {'briefSummary': 'This study is to evaluate the efficacy of a range of preladenant doses compared with placebo in participants with moderate to severe Parkinson\'s disease (PD) experiencing motor fluctuations and receiving a stable dose of levodopa (L-dopa), as measured by "off" time. Participants will continue to receive their stable regimen of L-dopa plus any adjunct medications during the study as prescribed by their physician. Several classes of adjunct medications may be used, including Amantadine, anticholinergics, dopa decarboxylase inhibitors, and dopamine agonists.\n\nPrimary Hypothesis: At least the 10 mg twice daily dose of preladenant is superior to placebo as measured by the change from Baseline to Week 12 in the mean "off" time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must have a diagnosis of idiopathic PD based on the United Kingdom Parkinson\'s Disease Society Brain Bank Criteria, judged to be moderate to severe\n* Must have received prior therapy with L-dopa for more than 1 year before Screening\n* Must have been on a stable, optimal dopaminergic treatment regimen, defined as maximum\n\ntherapeutic effect achieved with available anti-Parkinsonian treatment, for at least the 4 weeks immediately before randomization\n\n* If receiving one or more of the following adjunctive treatments: amantadine, anticholinergics, catechol-O-methyltransferase inhibitors, dopa decarboxylase inhibitors, dopamine agonists, entacapone, L-dopa, must have been on a stable regimen of treatment for at least the 4 weeks immediately before randomization\n* Hoehn and Yahr stage must be ≥ 2.5 and ≤ 4 following optimum titration of treatment medications at Screening\n* Must be experiencing motor fluctuations with or without dyskinesias following optimum titration of\n\ntreatment medications and within the 4 weeks immediately before Screening\n\n\\- Must be experiencing a minimum of 2 hours/day of "off" time as estimated by the investigator\n\nand supported by the symptom diary (Daily Diary) at the Diary Training Visit\n\n\\- With or without the help of a caregiver, must be capable of maintaining an accurate and\n\ncomplete symptom diary (Daily Diary) as assessed at the Diary Training Visit\n\n\\- Must have results of Screening clinical laboratory tests (complete blood count \\[CBC\\], blood\n\nchemistries, and urinalysis) within normal limits or clinically acceptable to the investigator at Screening\n\n\\- Must have results of a physical examination within normal limits or clinically acceptable limits\n\nto the investigator\n\n* Must be able to adhere to dose and visit schedules\n* Females of child-bearing potential must have a negative serum pregnancy test (human chorionic\n\ngonadotropin \\[hCG\\]) at Screening and must agree to use a medically accepted method of contraception while receiving protocol-specified medication and for 2 weeks after stopping the medication\n\nExclusion Criteria:\n\n* Must not have a form of drug-induced or atypical parkinsonism, cognitive impairment, bipolar disorder, schizophrenia, or other psychotic disorder\n* Must not have had surgery for PD\n* Must not have an untreated major depressive disorder meeting Diagnostic and Statistical Manual\n\nof Mental Disorders IV Text Revision (DSM-IV-TR) criteria\n\n\\- Must not be at imminent risk of self-harm or harm to others, in the investigator\'s opinion based on\n\nclinical interview\n\n* Must not have participated in any studies using preladenant\n* Must not have allergy/sensitivity to preladenant or any of its excipients\n* Must not have used any investigational drugs or participated in any other clinical trial within 90 days of Screening'}, 'identificationModule': {'nctId': 'NCT01294800', 'briefTitle': "A Dose Finding Study of Preladenant (SCH 420814) for the Treatment of Parkinson's Disease (PD) in Japanese Patients (P06402)", 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': "A Phase 2, 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Assess the Efficacy and Safety of Preladenant in Japanese Subjects With Moderate to Severe Parkinson's Disease. (Phase 2; Protocol No. P06402)", 'orgStudyIdInfo': {'id': 'P06402'}, 'secondaryIdInfos': [{'id': 'MK-3814-026', 'type': 'OTHER', 'domain': 'Merck'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Preladenant 2 mg', 'description': 'Participants will receive preladenant 2 mg taken orally twice daily (BID), one tablet in the morning and one tablet in the evening, for 12 weeks.', 'interventionNames': ['Drug: Preladenant']}, {'type': 'EXPERIMENTAL', 'label': 'Preladenant 5 mg', 'description': 'Participants will receive preladenant 5 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.', 'interventionNames': ['Drug: Preladenant']}, {'type': 'EXPERIMENTAL', 'label': 'Preladenant 10 mg', 'description': 'Participants will receive preladenant 10 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.', 'interventionNames': ['Drug: Preladenant']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive a placebo to preladenant tablet taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.', 'interventionNames': ['Drug: Placebo tablet to match Preladenant']}], 'interventions': [{'name': 'Preladenant', 'type': 'DRUG', 'otherNames': ['SCH 420814', 'MK-3814'], 'description': '2, 5, or 10 mg tablets taken orally twice daily (BID)', 'armGroupLabels': ['Preladenant 10 mg', 'Preladenant 2 mg', 'Preladenant 5 mg']}, {'name': 'Placebo tablet to match Preladenant', 'type': 'DRUG', 'description': 'tablets taken orally BID', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'url': 'http://engagezone.msd.com/ds_documentation.php', 'ipdSharing': 'YES', 'description': 'https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}