A Trial Evaluating the Efficacy, Safety, and Pharmacokinetics of SNC-102 in Subjects With Tourette Syndrome
Status: | Completed |
---|---|
Conditions: | Neurology |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 18 - 75 |
Updated: | 4/21/2016 |
Start Date: | April 2015 |
End Date: | February 2016 |
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.
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.
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.
We found this trial at
2
sites
1653 W. Congress Parkway
Chicago, Illinois 60612
Chicago, Illinois 60612
(312) 942-5000
Principal Investigator: Katie Kompoliti, MD
Phone: 312-563-2900
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Manhasset, New York 11030
Principal Investigator: Cathy Budman, MD
Phone: 516-562-1012
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