Tourette SyndromePhase 2NCT02217007
A Trial Evaluating the Efficacy, Safety, and Pharmacokinetics of SNC-102 in Subjects With Tourette Syndrome
A Phase 2 study testing SNC-102 sustained release tablet in people with Tourette Syndrome, run by Synchroneuron Inc. at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Tourette Syndrome
- What is being tested?
- SNC-102 sustained release tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2015to Feb 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Rush University Medical Center
Chicago, Illinois, 60612
North Shore University Hospital, Dept. of Psychiatry
Manhasset, New York, 11030
About this study
Official title: 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.
- Conditions
- Tourette Syndrome
- Being tested
- SNC-102 sustained release tablet
- Keywords
- Tourette, Tourette's, tic
- Medical subject headings
- Tourette Syndrome, Tics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SNC-102 sustained release tabletDrug
Also called SNC-102, acamprosate calcium sustained release tablet, acamprosate calcium, acamprosate
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: SNC-102 sustained release tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 8 weeks
Secondary outcomes (6)
Assess safety and tolerability
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);
Measured: 2, 4, 6, 8, 11 weeks
Evaluate clinical effects of SNC-102 on tic severity at 2 weeks and 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
Measured: 2, 6 weeks
Pharmacokinetic profile of SNC-102 in Tourette Syndrome subjects
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.
Measured: 2, 4, 6, 8 weeks
Explore relationship between study drug plasma levels and the magnitude of clinical response
Explore the relationship between steady-state acamprosate plasma levels and the magnitude of clinical response to the drug.
Measured: 2, 4, 6, 8 weeks
Evaluate clinical effects of SNC-102 on Global Clinical Impression
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
Measured: 2, 4, 6, 8, 11 weeks
Evaluate clinical effects of SNC-102 on tic severity sub scales
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
Measured: 2, 4, 6, 8, 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2014 (estimated)
- Study startApr 2015
- Primary completionJan 2016 (estimated)
- Study completionFeb 2016 (estimated)
Why it stopped: Funding stopped, company closed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tourette SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Synchroneuron Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Barry S Fogel, MD, Study director, Synchroneuron Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02217007
- Sponsor's protocol ID
- SNC-102-211 TS
- Status last verified
- Apr 2021
- First submitted
- 23 Jul 2014
- Last updated
- 13 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Open-Label Trial Evaluating the Efficacy, Safety, and Pharmacokinetics of Orally Administered SNC-102 in Subjects With Tourette Syndrome
- ClinicalTrials.gov ID
- NCT02217007
- Acronym / sponsor ID
- SNC-102-211 TS
- Conditions
- Tourette Syndrome
- Keywords
- Tourette, Tourette's, tic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding stopped, company closed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Synchroneuron Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 15 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SNC-102 sustained release tablet | Experimental | Drug: SNC-102 sustained release tabletSNC-102 oral tablet 4 weeks at 800mg BID plus 4 weeks at 1600mg in the morning and 800mg in the evening |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SNC-102 sustained release tabletAlso: SNC-102, acamprosate calcium sustained release tablet, acamprosate calcium, acamprosateSNC-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. | Drug | SNC-102 sustained release tablet |
Primary outcome
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).
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).
6 secondary outcomes
Assess safety and tolerability
Time frame: 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
Pharmacokinetic profile of SNC-102 in Tourette Syndrome subjects
Time frame: 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
Evaluate clinical effects of SNC-102 on Global Clinical Impression
Time frame: 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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barry S Fogel, MD study director
Synchroneuron Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SNC-102 sustained release tablet in people with Tourette Syndrome, run by Synchroneuron Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in total tic severity score on the Yale Global Tic Severity Scale at 4 weeks (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2021.