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

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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