SYN120 Study to Evaluate Its Safety, Tolerability and Efficacy in Parkinson's Disease Dementia (SYNAPSE)
NCT ID: NCT02258152
Last Updated: 2019-04-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
82 participants
INTERVENTIONAL
2014-12-22
2017-10-03
Brief Summary
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Detailed Description
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Final eligibility will be determined at the Baseline Visit. Eligible patients will be randomized to receive placebo or SYN120 100 mg once a day (QD).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
Placebo
Placebo QD
SYN120
SYN120
SYN120 Doses to be Administered: 20 mg QD (1 week titration), 50 mg QD (1 week titration), 100 mg QD (14 weeks of maintenance).
Interventions
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SYN120
SYN120 Doses to be Administered: 20 mg QD (1 week titration), 50 mg QD (1 week titration), 100 mg QD (14 weeks of maintenance).
Placebo
Placebo QD
Eligibility Criteria
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Inclusion Criteria
* Patient has a routine caregiver
* Taking a stable cholinesterase inhibitor.
* Patient has a Montreal Cognitive Assessment (MoCA) 10-23 inclusive
Exclusion Criteria
* Any other condition or clinically significant abnormal findings that would make the patient unsuitable for the study
* Unpredictable motor fluctuations that would interfere with administering assessments
50 Years
ALL
No
Sponsors
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Michael J. Fox Foundation for Parkinson's Research
OTHER
Massachusetts General Hospital
OTHER
Acorda Therapeutics
INDUSTRY
Biotie Therapies Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Christopher Kenney
Role: STUDY_DIRECTOR
Acorda Therapeutics
Locations
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The University of Alabama at Birmingham
Birmingham, Alabama, United States
Banner Sun Health Research Institute
Sun City, Arizona, United States
UC San Diego
La Jolla, California, United States
Parkinson's Disease & Movement Disorder Center of Boca Raton
Boca Raton, Florida, United States
Augusta University
Augusta, Georgia, United States
Northwestern University, Feinberg School of Medicine
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Iowa, Carver College of Medicine
Iowa City, Iowa, United States
Parkinson's Disease & Movement Disorder Center, University of Kansas Medical Center
Kansas City, Kansas, United States
Department of Neurology, University of Maryland Parkinson's Disease & Movement Disorder Center
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Struthers Parkinson's Center
Golden Valley, Minnesota, United States
Atlantic Neuroscience Institute
Summit, New Jersey, United States
Duke University
Durham, North Carolina, United States
Wake Forest Baptist Health Sciences
Winston-Salem, North Carolina, United States
Parkinson's Disease Movement Disorder Center
Philadelphia, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Baylor Univeristy
Houston, Texas, United States
Houston Methodist Neurological Institute/Movement Disorders Clinic
Houston, Texas, United States
Countries
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References
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Fernandez HH, Weintraub D, Macklin E, Litvan I, Schwarzschild MA, Eberling J, Videnovic A, Kenney CJ; Parkinson Study Group SYNAPSE Investigators. Safety, tolerability, and preliminary efficacy of SYN120, a dual 5-HT6/5-HT2A antagonist, for the treatment of Parkinson disease dementia: A randomized, controlled, proof-of-concept trial. Parkinsonism Relat Disord. 2023 Sep;114:105511. doi: 10.1016/j.parkreldis.2023.105511. Epub 2023 Jul 13.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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SYN120-CL03
Identifier Type: -
Identifier Source: org_study_id
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