NCT02258152

SYN120 Study to Evaluate Its Safety, Tolerability and Efficacy in Parkinson's Disease Dementia (SYNAPSE)

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Biotie Therapies Inc. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study includes a Screening Period of up to 6 weeks, a 16 week Treatment Period, and a 2 week Safety Follow Up Period. 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

• Parkinson's Disease Dementia (PDD)

Interventions

Type	Name	Description
DRUG	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).
DRUG	Placebo	Placebo QD

Timeline

• Start date: 2014-12-22
• Primary completion: 2017-10-03
• Completion: 2017-10-03
• First posted: 2014-10-07
• Last updated: 2019-04-19
• Results posted: 2019-04-19

Locations

20 sites across 1 country: United States