NCT02064010

A Phase 2 Trial Evaluating SNC-102 in Drug-Induced Tardive Dyskinesia

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Efficacy, Safety, and Pharmacokinetic Behavior of Orally Administered SNC-102 in Subjects With Drug-Induced Tardive Dyskinesia

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Synchroneuron Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This Phase 2 study was designed to evaluate the efficacy and safety of SNC-102 in subjects with drug-induced Tardive Dyskinesia (TD). To ensure an adequate evaluation of SNC-102, a randomized, double-blind, parallel-group, placebo-controlled trial was designed. Two dosing levels of SNC-102 are employed to evaluate the proposed dosing range. A target enrollment of 90 subjects with drug-induced TD will provide sufficient data to assess the efficacy and safety profiles of SNC-102 in the target population.

Conditions

• Drug-induced Tardive Dyskinesia

Interventions

Type	Name	Description
DRUG	SNC-102	Acamprosate calcium (SNC-102) tablet, administered orally for 4 weeks
DRUG	Placebo	Placebo tablet, administered orally for 4 weeks

Timeline

• Start date: 2014-02-01
• Primary completion: 2015-01-01
• Completion: 2015-12-01
• First posted: 2014-02-17
• Last updated: 2021-04-13

Locations

1 site across 1 country: United States