Clinical trial NCT02217007: A Trial Evaluating the Efficacy, Safety, and Pharmacokinetics of SNC-102 in Subjects With Tourette Syndrome
Official title: A Phase 2a, Open-Label Trial Evaluating the Efficacy, Safety, and Pharmacokinetics of Orally Administered SNC-102 in Subjects With Tourette Syndrome
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Tourette Syndrome
Keywords: Tourette
Tourette's
tic
Lead sponsor: Synchroneuron Inc.
Sponsor class: INDUSTRY
First posted: 2014-08-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Diagnosis by a Board-certified neurologist or psychiatrist of Tourette Syndrome according to Diagnostic and Statistical Manual (DSM)-V criteria for Tourette's Disorder, viz.
* Both multiple motor and one or more vocal tics have been present at some time during the illness, although not necessarily concurrently.
* The tics may wax and wane in frequency but have persisted for more than 1 year since first tic onset.
* Onset is before age 18 years.
* The disturbance is not attributable to the physiological effects of a substance (e.g., cocaine) or another medical condition (e.g., Huntington's disease, postviral encephalitis).
* Moderate to severe tics as indicated by a Clinical Global Impression (CGI) score of 4 or higher on both the Screening Visit and the Baseline Visit while on their usual drug therapy for Tourette Syndrome.
* If using a permitted medication (SSRI, Serotonin-norepinephrine reuptake inhibitors (SNRI), alpha-2 agonist, benzodiazepine, dopamine antagonist, or stimulant) the dose has been stable for at least 4 weeks prior to the Screening Visit and is expected to remain stable through the conclusion of the study.
* Ability to swallow investigational tablets whole and without chewing, as demonstrated by swallowing a placebo tablet at the Screening Visit.

Exclusion Criteria:

* Diagnosis of epilepsy.
* Treatment with an antiepileptic drug with the exception of a stable dose of clonazepam. Topiramate and lamotrigine are specifically excluded.
* Unstable psychiatric status, as indicated by any change in psychotropic medication (unless approved by the Sponsor), or by psychiatric hospitalization, within 30 days prior to the Screening Visit.
* Active drug or alcohol dependence or abuse.
* Current use of cocaine, amphetamine, phencyclidine, or ketamine, documented either by history or by urinary drug screening at Screening and Baseline Visits. Drugs used to treat attention deficit-hyperactivity disorder or obsessive-compulsive symptoms are allowed if stable for at least 4 weeks prior to the Screening Visit and are expected to remain stable through the course of the trial. Any other drugs identified on drug screening will warrant exclusion only if the Principal Investigator, in consultation with the Sponsor, judges that their presence could interfere with the objectives of the trial.
* Risk of significant medication non-adherence, based on the judgment of the Principal Investigator.
* History of neuroleptic malignant syndrome.
* Significant risk, in the judgment of the Principal Investigator, of suicidal or violent behavior.
* Female subjects with a history of pre-menstrual exacerbation of tics.
* Initiation of oral contraceptive medication, insertion of progestin contraceptive implant, or change in dose, within 30 days prior to the Screening Visit, or anticipated while participating in the trial.
* History of short-bowel or other malabsorption syndrome, gastrointestinal hypermotility of any cause, or any gastrointestinal disease or surgery that, in the judgment of the Principal Investigator, could interfere with absorption of orally-administered medication, reduce intestinal transit time or pre-dispose to gastric outlet obstruction.
* Allergy or intolerance to acamprosate.
* Prior treatment with acamprosate for any indication.
* Known human immunodeficiency virus or acquired immunodeficiency syndrome-related illness.
* Use of any investigational agents within 4 weeks of Baseline.
* Pregnant or lactating female.

Primary outcomes:
measure: Improvement in total tic severity score on the Yale Global Tic Severity Scale at 4 weeks
timeFrame: 4 weeks
measure: Improvement in total tic severity score on the Yale Global Tic Severity Scale at 8 weeks
timeFrame: 8 weeks
Secondary outcomes:
measure: Assess safety and tolerability
timeFrame: 2, 4, 6, 8, 11 weeks
measure: Evaluate clinical effects of SNC-102 on tic severity at 2 weeks and 6 weeks
timeFrame: 2, 6 weeks
measure: Pharmacokinetic profile of SNC-102 in Tourette Syndrome subjects
timeFrame: 2, 4, 6, 8 weeks
measure: Explore relationship between study drug plasma levels and the magnitude of clinical response
timeFrame: 2, 4, 6, 8 weeks
measure: Evaluate clinical effects of SNC-102 on Global Clinical Impression
timeFrame: 2, 4, 6, 8, 11 weeks
measure: Evaluate clinical effects of SNC-102 on tic severity sub scales
timeFrame: 2, 4, 6, 8, 11 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Manhasset
country: United States
facility: North Shore University Hospital, Dept. of Psychiatry
state: New York
Study officials:
affiliation: Synchroneuron Inc.
name: Barry S Fogel, MD
role: STUDY_DIRECTOR
References: