MedTrace Logo

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

NCT02258152 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2019-04-19

Study results available
· View outcomes & findings →

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.

Conditions

  • Parkinson's Disease Dementia (PDD)

Interventions

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

Sponsors & Collaborators

  • Michael J. Fox Foundation for Parkinson's Research

    collaborator OTHER

  • Massachusetts General Hospital

    collaborator OTHER

  • Acorda Therapeutics

    collaborator INDUSTRY

  • Biotie Therapies Inc.

    lead INDUSTRY

Principal Investigators

  • Christopher Kenney · Acorda Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-22
Primary Completion
2017-10-03
Completion
2017-10-03

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02258152 on ClinicalTrials.gov