NCT02217007

A Trial Evaluating the Efficacy, Safety, and Pharmacokinetics of SNC-102 in Subjects With Tourette Syndrome

A Phase 2a, Open-Label Trial Evaluating the Efficacy, Safety, and Pharmacokinetics of Orally Administered SNC-102 in Subjects With Tourette Syndrome

• Status: Withdrawn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 is an open-label study of SNC-102 (acamprosate calcium sustained release tablet) in adult subjects with Tourette Syndrome. Subjects will be treated with oral doses of SNC-102 800 mg on a BID basis - before breakfast and at bedtime - for 4 weeks and the same subjects will be treated with SNC-102 1600mg in the morning and 800mg in the evening for an additional 4 weeks. Subjects will be assessed for changes in tic severity, safety, and pharmacokinetics. The study hypothesis is that treatment with SNC-102 will improve the tic severity in adult subjects with Tourette Syndrome.

Conditions

• Tourette Syndrome

Interventions

Type	Name	Description
DRUG	SNC-102 sustained release tablet	SNC-102 is an 800 mg tablet. It will be administered twice daily (morning and evening) for a total of 8 weeks: the initial 4 weeks will be 1 tablet in the morning and 1 tablet in the evening; the next 4 weeks will be 2 tablets in the morning and 1 tablet in the evening.

Timeline

• Start date: 2015-04-01
• Primary completion: 2016-01-01
• Completion: 2016-02-01
• First posted: 2014-08-15
• Last updated: 2021-04-13

Locations

2 sites across 1 country: United States