Brief Title
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
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Improvement in total tic severity score on the Yale Global Tic Severity Scale at 4 weeks
Secondary Outcome
Assess safety and tolerability
Condition
Tourette Syndrome
Intervention
SNC-102 sustained release tablet
Study Arms / Comparison Groups
SNC-102 sustained release tablet
Description: SNC-102 oral tablet 4 weeks at 800mg BID plus 4 weeks at 1600mg in the morning and 800mg in the evening
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
0
Start Date
April 2015
Completion Date
February 2016
Primary Completion Date
January 2016
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.
Gender
All
Ages
18 Years - 75 Years
Accepts Healthy Volunteers
No
Contacts
Barry S Fogel, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02217007
Organization ID
SNC-102-211 TS
Responsible Party
Sponsor
Study Sponsor
Synchroneuron Inc.
Study Sponsor
Barry S Fogel, MD, Study Director, Synchroneuron Inc.
Verification Date
April 2021