Ignite Creation Date:
2025-12-24 @ 10:16 PM
Ignite Modification Date:
2025-12-31 @ 7:51 AM
Study NCT ID:
NCT01617135
Status:
COMPLETED
Last Update Posted:
2017-07-27
First Post:
2012-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Pharmacokinetics and Efficacy Study of CVT-301 Inpatients With Parkinson's Disease and "Off" Episodes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'C009265', 'term': 'carbidopa, levodopa drug combination'}, {'id': 'D002230', 'term': 'Carbidopa'}, {'id': 'D007980', 'term': 'Levodopa'}], 'ancestors': [{'id': 'D008750', 'term': 'Methyldopa'}, {'id': 'D004295', 'term': 'Dihydroxyphenylalanine'}, {'id': 'D002395', 'term': 'Catecholamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006834', 'term': 'Hydrazines'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-25', 'studyFirstSubmitDate': '2012-05-07', 'studyFirstSubmitQcDate': '2012-06-08', 'lastUpdatePostDateStruct': {'date': '2017-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-06-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety', 'timeFrame': 'change from baseline up to 13 weeks', 'description': 'Adverse experiences, ECGs, clinical laboratory evaluation, pulmonary function'}], 'secondaryOutcomes': [{'measure': 'Pharmacodynamics', 'timeFrame': '3 hours post-dose', 'description': 'Time to onset of meaningful "on" and "off" states (patient- and examiner-assessed) UPDRS III motor score Tapping test Dyskinesia'}, {'measure': 'Pharmacokinetics', 'timeFrame': '3 hours post-dose', 'description': 'Serial blood draw for determination of plasma concentration-time profile'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ["Parkinson's disease", 'Motor fluctuations', 'levodopa', 'inhaled drugs', 'Motor fluctuation ("off episodes")'], 'conditions': ["Idiopathic Parkinson's Disease"]}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://foxtrialfinder.michaeljfox.org/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the safety, efficacy and pharmacokinetics following administration of CVT-301 in treatment of "off" episodes in Parkinson\'s Disease patients.', 'detailedDescription': 'Treatment options for patients with motor response fluctuations are limited. Most commonly, "off" episodes are managed by adjusting the dose interval of their standard oral medications or by self-administration of unscheduled doses of oral Parkinson\'s medication. Due to the variability in levodopa absorption following oral dosing, resumption of motor function is unreliable and may be delayed for an hour or more. CVT-301 delivers levodopa using a simple inhaler, resulting in rapid increases in levodopa blood levels and is expected to result in rapid restoration in motor function for patients experiencing "off" episodes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Idiopathic Parkinson\'s Disease (PD) diagnosed between the ages of 30 and 80 years;\n* Hoehn and Yahr Stage 1-3 in an "on" state;\n* Require levodopa-containing medication regimen at least 4 times during the waking day;\n* Experience motor fluctuations with a minimum of 2 hours of average daily "off" time per waking day (excluding early morning "off" time) and demonstrate levodopa responsiveness;\n* Are on stable PD medication regimen.\n\nExclusion Criteria:\n\n* Pregnant or lactating females;\n* Previous surgery for PD or plan to have stereotactic surgery during the study period;\n* History of psychotic symptoms requiring treatment, or suicide ideation or attempt within last year;\n* Adequate lung function as measured by spirometry;\n* Any significant condition, severe concurrent disease, abnormality or finding that would make patients unsuitable or may compromise patient safety.'}, 'identificationModule': {'nctId': 'NCT01617135', 'briefTitle': 'Safety, Pharmacokinetics and Efficacy Study of CVT-301 Inpatients With Parkinson\'s Disease and "Off" Episodes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Acorda Therapeutics'}, 'officialTitle': 'A Randomized, Placebo-Controlled, Phase 2 Study of the Safety, Pharmacokinetics and Pharmacodynamics of CVT-310 (Levodopa Inhalation Powder) in Patients With Parkinson\'s Disease and Motor Response Fluctuations ("Off Episodes")', 'orgStudyIdInfo': {'id': 'CVT-301-002'}, 'secondaryIdInfos': [{'id': '2012-000181-37', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CVT-301 Low Dose', 'description': 'CVT-Low; levodopa inhalation powder (LIP)', 'interventionNames': ['Drug: CVT-301']}, {'type': 'EXPERIMENTAL', 'label': 'CVT-301 High Dose', 'description': 'CVT-High; levodopa inhalation powder (LIP)', 'interventionNames': ['Drug: CVT-301']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Inhaled Placebo', 'description': 'Inhaled placebo powder', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Oral Sinemet (carbidopa/levodopa)', 'description': 'Open-label oral carbidopa/levodopa (CD/LD)', 'interventionNames': ['Drug: Sinemet (carbidopa/levodopa)']}], 'interventions': [{'name': 'CVT-301', 'type': 'DRUG', 'armGroupLabels': ['CVT-301 Low Dose']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Inhaled Placebo']}, {'name': 'Sinemet (carbidopa/levodopa)', 'type': 'DRUG', 'armGroupLabels': ['Oral Sinemet (carbidopa/levodopa)']}, {'name': 'CVT-301', 'type': 'DRUG', 'armGroupLabels': ['CVT-301 High Dose']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Petah Tikva', 'country': 'Israel', 'facility': 'Civitas Clinical Site #6', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}, {'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Civitas Clinical Site #5', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}, {'city': 'Belgrade', 'country': 'Serbia', 'facility': 'Civitas Clinical Site #4', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'city': 'Belgrade', 'country': 'Serbia', 'facility': 'Civitas Clinical Site #7', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'city': 'Glasgow', 'country': 'United Kingdom', 'facility': 'Civitas Clinical Site #1', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'city': 'Newcastle', 'country': 'United Kingdom', 'facility': 'Civitas Clinical Site #3', 'geoPoint': {'lat': 54.21804, 'lon': -5.88979}}, {'city': 'Norwich', 'country': 'United Kingdom', 'facility': 'Civitas Clinical Site #2', 'geoPoint': {'lat': 52.62783, 'lon': 1.29834}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Acorda Therapeutics', 'class': 'INDUSTRY'}, 'collaborators': [{'name': "Michael J. Fox Foundation for Parkinson's Research", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}