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

NCT02217007 | Withdrawn Phase 2

• 1 other identifier: SNC-102-211 TS
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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

Keywords

Tourette; Tourette's; tic

Outcome Measures

Primary Outcomes (2)

• 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).

  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).

  8 weeks

Secondary Outcomes (6)

• Assess safety and tolerability

  2, 4, 6, 8, 11 weeks

• Evaluate clinical effects of SNC-102 on tic severity at 2 weeks and 6 weeks

  2, 6 weeks

• Pharmacokinetic profile of SNC-102 in Tourette Syndrome subjects

  2, 4, 6, 8 weeks

• Explore relationship between study drug plasma levels and the magnitude of clinical response

  2, 4, 6, 8 weeks

• Evaluate clinical effects of SNC-102 on Global Clinical Impression

  2, 4, 6, 8, 11 weeks

Study Arms (1)

SNC-102 sustained release tablet

EXPERIMENTAL

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

Drug: SNC-102 sustained release tablet

Interventions

SNC-102 sustained release tablet 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.

Also known as: SNC-102, acamprosate calcium sustained release tablet, acamprosate calcium, acamprosate

SNC-102 sustained release tablet

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Synchroneuron Inc.: lead

Study Sites (2)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

North Shore University Hospital, Dept. of Psychiatry

Manhasset, New York, 11030, United States

Location

MeSH Terms

Conditions

Tourette Syndrome; Tics

Interventions

Acamprosate

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tic Disorders; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurodevelopmental Disorders; Mental Disorders; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Taurine; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Barry S Fogel, MD

  Synchroneuron Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2014
• First Posted: August 15, 2014
• Study Start: April 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: February 1, 2016
• Last Updated: April 13, 2021

Record last verified: 2021-04

Locations

US (2)