Trial record 13 of 40 for:    Tardive Dyskinesia

A Phase 2 Trial Evaluating SNC-102 in Drug-Induced Tardive Dyskinesia

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Synchroneuron Inc.
Sponsor:
Information provided by (Responsible Party):
Synchroneuron Inc.
ClinicalTrials.gov Identifier:
NCT02064010
First received: December 6, 2013
Last updated: October 2, 2014
Last verified: October 2014
  Purpose

This Phase 2 study was designed to evaluate the efficacy and safety of SNC-102 in subjects with drug-induced Tardive Dyskinesia (TD). To ensure an adequate evaluation of SNC-102, a randomized, double-blind, parallel-group, placebo-controlled trial was designed. Two dosing levels of SNC-102 are employed to evaluate the proposed dosing range. A target enrollment of 90 subjects with drug-induced TD will provide sufficient data to assess the efficacy and safety profiles of SNC-102 in the target population.


Condition Intervention Phase
Drug-induced Tardive Dyskinesia
Drug: SNC-102
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Efficacy, Safety, and Pharmacokinetic Behavior of Orally Administered SNC-102 in Subjects With Drug-Induced Tardive Dyskinesia

Resource links provided by NLM:


Further study details as provided by Synchroneuron Inc.:

Primary Outcome Measures:
  • Efficacy as measured by changes from baseline in summary scores on the Abnormal Involuntary Movement Scale (AIMS) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Determine the efficacy relative to placebo of SNC-102 in subjects with drug-induced tardive dyskinesia (TD), as assessed by changes from baseline to four weeks in summary scores on the Abnormal Involuntary Movement Scale (AIMS)


Secondary Outcome Measures:
  • Compare the effectiveness of low dose and high dose of SNC-102 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Compare the effectiveness of low dose and high dose, as assessed by changes from baseline to four weeks in summary scores on the Abnormal Involuntary Movement Scale (AIMS)

  • Assess safety and tolerability of SNC-102 in the tardive dyskinesia population [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    Nature and frequency of adverse events; changes from baseline in tests of psychiatric symptoms and cognitive function.

  • Assess the pharmacokinetic (PK) profile in TD subjects [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Measure and analyze the serum concentration of acamprosate.

  • Determine the relationship between the PK profile and clinical effects of SNC-102 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Describe the correlation between change in AIMS score and serum levels of acamprosate.


Estimated Enrollment: 90
Study Start Date: February 2014
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SNC-102, low dose
SNC-102 (Acamprosate calcium) tablet 4 week duration dosing
Drug: SNC-102
Acamprosate calcium (SNC-102) tablet, administered orally for 4 weeks
Other Names:
  • Acamprosate calcium
  • Acamprosate calcium controlled-release tablet
  • calcium N-acetylhomotaurinate
Experimental: SNC-102, high dose
SNC-102 (Acamprosate calcium) tablet 4 week duration dosing
Drug: SNC-102
Acamprosate calcium (SNC-102) tablet, administered orally for 4 weeks
Other Names:
  • Acamprosate calcium
  • Acamprosate calcium controlled-release tablet
  • calcium N-acetylhomotaurinate
Placebo Comparator: Placebo
Placebo tablet 4 week duration dosing
Drug: Placebo
Placebo tablet, administered orally for 4 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males and females 18-75 years of age.
  2. Diagnosis, at least 3 months prior to the Screening Visit, of drug-induced TD

    1. AIMS ≥3 (moderate or worse) for ≥1 body area, or AIMS = 2 (mild) for ≥2 body areas; and
    2. >3 months exposure to antipsychotic drug or metoclopramide; and
    3. Other causes of dyskinesia have been ruled out.
  3. AIMS score is confirmed at the Screening Visit by the Principal Investigator and the Trial Reading Center, and at the Baseline Visit at least 1 week later by the Principal Investigator.
  4. If using antipsychotic medication or metoclopramide, dose has been stable for at least 60 days prior to the Baseline Visit and is expected to remain stable through the course of the trial.
  5. If using opioid medication, dose has been stable for at least 14 days prior to the Baseline Visit and is expected to remain stable through the course of the trial.
  6. If using vitamin or dietary supplements, dose and type has been stable for at least 14 days prior to the Baseline Visit and is expected to remain stable through the course of the trial.
  7. If using alcohol, willingness to limit intake to no more than 2 drinks/day through the course of participation in the trial, and to abstain for at least 12 hours prior to any assessment visit.

Exclusion Criteria:

  1. Unstable psychiatric status, as indicated by any change in psychotropic medication (unless approved by the Sponsor), or by hospitalization, within 60 days prior to the Screening Visit.
  2. Active drug or alcohol dependence or abuse.
  3. Current use of cocaine, amphetamine, phencyclidine (PCP), or ketamine, documented either by history or by urinary drug screening at Screening and Baseline Visits. Drugs used to treat attention deficit-hyperactivity disorder are allowed if stable for at least 14 days prior to the Baseline Visit and are expected to remain stable through the course of the trial.
  4. Risk of significant medication non-adherence, based on the judgment of the Principal Investigator.
  5. Neurologic or psychiatric disorder that could interfere with the attribution of observed involuntary movements to TD, such as a primary movement disorder unrelated to medication.
  6. History of neuroleptic malignant syndrome.
  7. Significant risk, in the judgment of the Principal Investigator, of suicidal or violent behavior.
  8. Receipt of new medication for the treatment of TD within 4 weeks prior to the Baseline Visit or anticipated while participating in the trial.
  9. Initiation of oral contraceptive medication, or change in dose, within 30 days prior to the Screening Visit, or anticipated while participating in the trial.
  10. Gastrointestinal disease such as short-bowel or other malabsorption syndrome which, in the judgment of the Principal Investigator, could interfere with absorption of orally-administered medication.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02064010

Contacts
Contact: Marc R. Cote info@synchroneuron.com

Locations
United States, California
UCLA - Greater Los Angeles Recruiting
Los Angeles, California, United States, 90073
Principal Investigator: Stephen Marder, M.D.         
Sponsors and Collaborators
Synchroneuron Inc.
  More Information

No publications provided

Responsible Party: Synchroneuron Inc.
ClinicalTrials.gov Identifier: NCT02064010     History of Changes
Other Study ID Numbers: SNC102-201
Study First Received: December 6, 2013
Last Updated: October 2, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Dyskinesias
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Calcium, Dietary
Acamprosate
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Alcohol Deterrents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014