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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
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.
Rush University Medical Center
Chicago, Illinois, United States
North Shore University Hospital, Dept. of Psychiatry
Manhasset, New York, United States
Improvement in total tic severity score on the Yale Global Tic Severity Scale at 4 weeks
Determine whether SNC-102 800 mg twice daily (BID) will decrease tic severity in adult patients with Tourette Syndrome (TS), as measured by changes from baseline to 4 weeks in the total tic severity score on the Yale Global Tic Severity Scale (Y-GTSS).
Time frame: 4 weeks
Improvement in total tic severity score on the Yale Global Tic Severity Scale at 8 weeks
Determine whether SNC-102 1600 mg in the morning and 800 mg in the evening will decrease tic severity in adult patients with Tourette Syndrome (TS) as measured by change from baseline to Day 57 in the total tic severity score on the Yale Global Tic Severity Scale (Y-GTSS).
Time frame: 8 weeks
Assess safety and tolerability
Assess the safety and tolerability of SNC-102 in the adult TS population, including assessing the effects, if any, of SNC-102 on symptoms of depression, anxiety, obsessive-compulsive disorder (OCD), and attention deficit-hyperactivity disorder (ADHD);
Time frame: 2, 4, 6, 8, 11 weeks
Evaluate clinical effects of SNC-102 on tic severity at 2 weeks and 6 weeks
Further evaluate the clinical effects of SNC-102 in this population as measured by changes from baseline in Y-GTSS total tic severity score at 2 weeks and 6 weeks
Time frame: 2, 6 weeks
Pharmacokinetic profile of SNC-102 in Tourette Syndrome subjects
Assess the pharmacokinetics (PK) of acamprosate administered as SNC-102, including measures of the plasma concentration at 3 hours post-dose (C3h) and the trough plasma concentration (Cmin). The pharmacokinetic analysis will be based on the pre-dose and 3 hour post-dose plasma concentrations of acamprosate on the first day of dosing (Baseline) and on the Day 15, Day 29, Day 43 and Day 57 visits.
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Time frame: 2, 4, 6, 8 weeks
Explore relationship between study drug plasma levels and the magnitude of clinical response
Explore the relationship between steady-state acamprosate plasma levels and the magnitude of clinical response to the drug.
Time frame: 2, 4, 6, 8 weeks
Evaluate clinical effects of SNC-102 on Global Clinical Impression
Evaluate the clinical effects of SNC-102 in this population as measured by changes from baseline in Clinical Global Impression (CGI) at all post-baseline visits
Time frame: 2, 4, 6, 8, 11 weeks
Evaluate clinical effects of SNC-102 on tic severity sub scales
Further evaluate the clinical effects of SNC-102 in this population as measured by changes from baseline in Y-GTSS sub scales at all visits
Time frame: 2, 4, 6, 8, 11 weeks