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

NCT ID: NCT02217007

Last Updated: 2021-04-13

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2016-02-29

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.

Conditions

Tourette Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SNC-102 sustained release tablet

SNC-102 oral tablet 4 weeks at 800mg BID plus 4 weeks at 1600mg in the morning and 800mg in the evening

Group Type: EXPERIMENTAL

SNC-102 sustained release tablet

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

SNC-102; acamprosate calcium sustained release tablet; acamprosate calcium; acamprosate

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Synchroneuron Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Barry S Fogel, MD

Role: STUDY_DIRECTOR

Synchroneuron Inc.

Locations

Rush University Medical Center

Chicago, Illinois, United States

North Shore University Hospital, Dept. of Psychiatry

Manhasset, New York, United States

Countries

United States

Other Identifiers

SNC-102-211 TS

Identifier Type: -

Identifier Source: org_study_id