Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2025-12-27 @ 11:09 PM
Study NCT ID:
NCT01283594
Status:
COMPLETED
Last Update Posted:
2019-01-17
First Post:
2011-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Study of SYN115 in Parkinson's Patients Using Levodopa to Treat End of Dose Wearing Off
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': 'C000593256', 'term': 'tozadenant'}, {'id': 'C494814', 'term': 'BID protein, human'}, {'id': 'D007980', 'term': 'Levodopa'}], 'ancestors': [{'id': 'D004295', 'term': 'Dihydroxyphenylalanine'}, {'id': 'D002395', 'term': 'Catecholamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 420}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'dispFirstSubmitDate': '2014-01-21', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-14', 'studyFirstSubmitDate': '2011-01-24', 'dispFirstSubmitQcDate': '2014-01-21', 'studyFirstSubmitQcDate': '2011-01-24', 'dispFirstPostDateStruct': {'date': '2014-02-14', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2019-01-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess efficacy of different doses of SYN115 for reducing the mean total hours of awake time per day spent in the off state', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'To assess the effect of SYN115 on dyskinesia', 'timeFrame': '12 weeks'}, {'measure': 'To assess the effect of SYN115 on UPDRS scores', 'timeFrame': '12 weeks'}, {'measure': 'To assess investigator and patient impressions of PD severity and change', 'timeFrame': '12 weeks'}, {'measure': 'To assess the effect of SYN115 on non motor symptoms of PD', 'timeFrame': '12 weeks'}, {'measure': 'To assess the safety and tolerability of SYN115', 'timeFrame': '12 weeks'}, {'measure': 'To assess the effects of SYN115 on daytime drowsiness, impulsive behavior, development of melanoma and suicidal ideation', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ["Parkinson's Disease"]}, 'referencesModule': {'references': [{'pmid': '25008546', 'type': 'DERIVED', 'citation': "Hauser RA, Olanow CW, Kieburtz KD, Pourcher E, Docu-Axelerad A, Lew M, Kozyolkin O, Neale A, Resburg C, Meya U, Kenney C, Bandak S. Tozadenant (SYN115) in patients with Parkinson's disease who have motor fluctuations on levodopa: a phase 2b, double-blind, randomised trial. Lancet Neurol. 2014 Aug;13(8):767-76. doi: 10.1016/S1474-4422(14)70148-6. Epub 2014 Jul 6."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to test the effect of SYN115 compared to placebo (a "sugar pill" that looks like SYN115 but does not include active drug) on movement during the "on" and "off" states as well as other symptoms that some patients with Parkinson\'s disease experience. This study will also look at whether or not patients with Parkinson\'s disease experience "side-effects" with SYN115.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Meet Parkinson's Disease (PD) diagnosis consistent with UK PD diagnostic criteria\n* Meet Hoehn and Yahr PD stage\n* Good response to levodopa\n* Stable regimen of anti-parkinson medications\n* Are able to complete a Parkinson's disease diary\n* If of childbearing potential(male and female), use an acceptable method of birth control\n* Able and willing to sign an IRB/IEC approved informed consent\n* Able and willing to understand study requirements, follow study instructions, attend all visits and undergo all planned tests.\n\nExclusion Criteria:\n\n* Secondary or atypical Parkinson's\n* Neurosurgical intervention for Parkinson's disease\n* Treatment with apomorphine\n* Treatment with anti-psychotic drugs\n* Other abnormal findings on physical or neuro exam or history that in the opinion of the investigator would make subject unsuitable for the study or prejudice safety and efficacy evaluation\n* MMSE less than 26\n* Subjects with untreated or uncontrolled current episode of major depression\n* Receipt of any anti-psychotic drugs greater than 1 month in the past 5 years or any exposure in past year (except for quetiapine at doses \\<100mg per day)\n* Women pregnant or lactating\n* History of hepatitis, cholangitis\n* Untreated or uncontrolled hypothyroidism or hyperthyroidism\n* Drops in blood pressure requiring medication to maintain blood pressure\n* Any clinically significant out of range laboratory evaluations\n* Known sensitivity to the study medication or its components\n* Suicide ideation or type 4 or type 5 on the Columbia suicide severity rating scale\n* Finding of malignant melanoma on full body skin exam\n* Impulse disorder conditions"}, 'identificationModule': {'nctId': 'NCT01283594', 'briefTitle': "Safety and Efficacy Study of SYN115 in Parkinson's Patients Using Levodopa to Treat End of Dose Wearing Off", 'organization': {'class': 'INDUSTRY', 'fullName': 'Biotie Therapies Inc.'}, 'officialTitle': "A Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of SYN115 as Adjunctive Therapy in Levodopa-treated Parkinson's Subjects With End of Dose Wearing Off", 'orgStudyIdInfo': {'id': 'SYN115-CL02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tozadenant (SYN115) 60 mg BID', 'description': 'Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths.', 'interventionNames': ['Drug: Tozadenant (SYN115) 60 mg BID', 'Drug: Levodopa (L-dopa)']}, {'type': 'EXPERIMENTAL', 'label': 'Tozadenant (SYN115) 120 mg BID', 'description': 'Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths.', 'interventionNames': ['Drug: Levodopa (L-dopa)', 'Drug: Tozadenant (SYN115) 120 mg BID']}, {'type': 'EXPERIMENTAL', 'label': 'Tozadenant (SYN115) 180 mg BID', 'description': 'Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths.', 'interventionNames': ['Drug: Levodopa (L-dopa)', 'Drug: Tozadenant (SYN115) 180 mg BID']}, {'type': 'EXPERIMENTAL', 'label': 'Tozadenant (SYN115) 240 mg BID', 'description': 'Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths.', 'interventionNames': ['Drug: Levodopa (L-dopa)', 'Drug: Tozadenant (SYN115) 240 mg BID']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Sugar Pill', 'description': 'White-coated, modified-oval placebo tablets.', 'interventionNames': ['Drug: Placebo', 'Drug: Levodopa (L-dopa)']}], 'interventions': [{'name': 'Tozadenant (SYN115) 60 mg BID', 'type': 'DRUG', 'description': 'Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths.\n\nTotal daily doses include 60 mg BID.', 'armGroupLabels': ['Tozadenant (SYN115) 60 mg BID']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'White-coated, modified-oval placebo tablets.', 'armGroupLabels': ['Sugar Pill']}, {'name': 'Levodopa (L-dopa)', 'type': 'DRUG', 'otherNames': ['L-dopa'], 'description': 'One intravenous infusion of L-dopa to reach approximately 600 ng/ ml plasma concentration.', 'armGroupLabels': ['Sugar Pill', 'Tozadenant (SYN115) 120 mg BID', 'Tozadenant (SYN115) 180 mg BID', 'Tozadenant (SYN115) 240 mg BID', 'Tozadenant (SYN115) 60 mg BID']}, {'name': 'Tozadenant (SYN115) 120 mg BID', 'type': 'DRUG', 'description': 'Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths.\n\nTotal daily doses include 120 mg BID.', 'armGroupLabels': ['Tozadenant (SYN115) 120 mg BID']}, {'name': 'Tozadenant (SYN115) 180 mg BID', 'type': 'DRUG', 'description': 'Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths.\n\nTotal daily doses include 180 mg BID.', 'armGroupLabels': ['Tozadenant (SYN115) 180 mg BID']}, {'name': 'Tozadenant (SYN115) 240 mg BID', 'type': 'DRUG', 'description': 'Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths.\n\nTotal daily doses include 240 mg BID.', 'armGroupLabels': ['Tozadenant (SYN115) 240 mg BID']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35005', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '92318', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}, {'zip': '90001', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 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'overallOfficials': [{'name': 'Steve Bandak, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Biotie Therapies Inc.'}, {'name': 'Ann Neale, RN', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Biotie Therapies Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biotie Therapies Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}