CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 82 enrolled
Drug / intervention
SYN120 +1 moredrug
Likely dose
SYN120 20 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02258152
NCT02258152Phase 2Completed
CompareCT.gov

SYN120 a Dual 5-HT6/5-HT2A Antagonist Proof of Concept Study to Evaluate Its Safety, Tolerability and Efficacy in Parkinson's Disease Dementia (SYNAPSE)

Biotie Therapies Inc.·interventional·Posted Oct 7, 2014·Updated Apr 19, 2019

In Brief

A Phase 2 clinical trial evaluating SYN120 and Placebo for Parkinson's Disease Dementia (PDD). Completed, enrolled 82 participants across 20 sites.

Detailed Summary

The purpose of this study placebo-controlled, randomized, double-blind study is to assess the safety and efficacy of SYN120 in patients with Parkinson's disease dementia (PDD) already treated with a stable dose of a cholinesterase inhibitor.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParkinson's Disease Dementia (PDD)
CountriesUnited States
CollaboratorsMichael J. Fox Foundation for Parkinson's Research, Massachusetts General Hospital, Acorda Therapeutics

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 7, 2014
Enrollment StartDec 22, 2014
Primary CompletionOct 3, 2017
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 11.7 years ago

Interventions

SYN120drug

SYN120 Doses to be Administered: 20 mg QD (1 week titration), 50 mg QD (1 week titration), 100 mg QD (14 weeks of maintenance).

Placebodrug

Placebo QD