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

April 8, 2021 updated by: Synchroneuron Inc.

A Phase 2a, Open-Label Trial Evaluating the Efficacy, Safety, and Pharmacokinetics of Orally Administered SNC-102 in Subjects With Tourette Syndrome

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
    • New York
      • Manhasset, New York, United States, 11030
        • North Shore University Hospital, Dept. of Psychiatry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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
Drug: 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.
Other Names:
  • SNC-102
  • acamprosate calcium sustained release tablet
  • acamprosate calcium
  • acamprosate

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Improvement in total tic severity score on the Yale Global Tic Severity Scale at 4 weeks
Time Frame: 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
Time Frame: 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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assess safety and tolerability
Time Frame: 2, 4, 6, 8, 11 weeks
Assess the safety and tolerability of SNC-102 in the adult TS population, including assessing the effects, if any, of SNC-102 on symptoms of depression, anxiety, obsessive-compulsive disorder (OCD), and attention deficit-hyperactivity disorder (ADHD);
2, 4, 6, 8, 11 weeks
Evaluate clinical effects of SNC-102 on tic severity at 2 weeks and 6 weeks
Time Frame: 2, 6 weeks
Further evaluate the clinical effects of SNC-102 in this population as measured by changes from baseline in Y-GTSS total tic severity score at 2 weeks and 6 weeks
2, 6 weeks
Pharmacokinetic profile of SNC-102 in Tourette Syndrome subjects
Time Frame: 2, 4, 6, 8 weeks
Assess the pharmacokinetics (PK) of acamprosate administered as SNC-102, including measures of the plasma concentration at 3 hours post-dose (C3h) and the trough plasma concentration (Cmin). The pharmacokinetic analysis will be based on the pre-dose and 3 hour post-dose plasma concentrations of acamprosate on the first day of dosing (Baseline) and on the Day 15, Day 29, Day 43 and Day 57 visits.
2, 4, 6, 8 weeks
Explore relationship between study drug plasma levels and the magnitude of clinical response
Time Frame: 2, 4, 6, 8 weeks
Explore the relationship between steady-state acamprosate plasma levels and the magnitude of clinical response to the drug.
2, 4, 6, 8 weeks
Evaluate clinical effects of SNC-102 on Global Clinical Impression
Time Frame: 2, 4, 6, 8, 11 weeks
Evaluate the clinical effects of SNC-102 in this population as measured by changes from baseline in Clinical Global Impression (CGI) at all post-baseline visits
2, 4, 6, 8, 11 weeks
Evaluate clinical effects of SNC-102 on tic severity sub scales
Time Frame: 2, 4, 6, 8, 11 weeks
Further evaluate the clinical effects of SNC-102 in this population as measured by changes from baseline in Y-GTSS sub scales at all visits
2, 4, 6, 8, 11 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Synchroneuron Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Barry S Fogel, MD, Synchroneuron Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2016

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 23, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 15, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SNC-102-211 TS

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