A Phase 2 Trial Evaluating SNC-102 in Drug-Induced Tardive Dyskinesia
Primary Purpose
Drug-induced Tardive Dyskinesia
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
SNC-102
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Drug-induced Tardive Dyskinesia
Eligibility Criteria
Inclusion Criteria:
- Males and females 18-75 years of age.
Diagnosis, at least 3 months prior to the Screening Visit, of drug-induced TD
- AIMS ≥3 (moderate or worse) for ≥1 body area, or AIMS = 2 (mild) for ≥2 body areas; and
- >3 months exposure to antipsychotic drug or metoclopramide; and
- Other causes of dyskinesia have been ruled out.
- 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.
- 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.
- 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.
- 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.
- 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:
- 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.
- Active drug or alcohol dependence or abuse.
- 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.
- Risk of significant medication non-adherence, based on the judgment of the Principal Investigator.
- 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.
- History of neuroleptic malignant syndrome.
- Significant risk, in the judgment of the Principal Investigator, of suicidal or violent behavior.
- Receipt of new medication for the treatment of TD within 4 weeks prior to the Baseline Visit or anticipated while participating in the trial.
- Initiation of oral contraceptive medication, or change in dose, within 30 days prior to the Screening Visit, or anticipated while participating in the trial.
- 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.
Sites / Locations
- UCLA - Greater Los Angeles
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
SNC-102, low dose
SNC-102, high dose
Placebo
Arm Description
SNC-102 (Acamprosate calcium) tablet 4 week duration dosing
SNC-102 (Acamprosate calcium) tablet 4 week duration dosing
Placebo tablet 4 week duration dosing
Outcomes
Primary Outcome Measures
Efficacy as measured by changes from baseline in summary scores on the Abnormal Involuntary Movement Scale (AIMS)
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
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
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
Measure and analyze the serum concentration of acamprosate.
Determine the relationship between the PK profile and clinical effects of SNC-102
Describe the correlation between change in AIMS score and serum levels of acamprosate.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02064010
Brief Title
A Phase 2 Trial Evaluating SNC-102 in Drug-Induced Tardive Dyskinesia
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Funding terminated; company closed
Study Start Date
February 2014 (undefined)
Primary Completion Date
January 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Synchroneuron Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug-induced Tardive Dyskinesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SNC-102, low dose
Arm Type
Experimental
Arm Description
SNC-102 (Acamprosate calcium) tablet 4 week duration dosing
Arm Title
SNC-102, high dose
Arm Type
Experimental
Arm Description
SNC-102 (Acamprosate calcium) tablet 4 week duration dosing
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablet 4 week duration dosing
Intervention Type
Drug
Intervention Name(s)
SNC-102
Other Intervention Name(s)
Acamprosate calcium, Acamprosate calcium controlled-release tablet, calcium N-acetylhomotaurinate
Intervention Description
Acamprosate calcium (SNC-102) tablet, administered orally for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablet, administered orally for 4 weeks
Primary Outcome Measure Information:
Title
Efficacy as measured by changes from baseline in summary scores on the Abnormal Involuntary Movement Scale (AIMS)
Description
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)
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Compare the effectiveness of low dose and high dose of SNC-102
Description
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)
Time Frame
4 weeks
Title
Assess safety and tolerability of SNC-102 in the tardive dyskinesia population
Description
Nature and frequency of adverse events; changes from baseline in tests of psychiatric symptoms and cognitive function.
Time Frame
4 weeks
Title
Assess the pharmacokinetic (PK) profile in TD subjects
Description
Measure and analyze the serum concentration of acamprosate.
Time Frame
4 weeks
Title
Determine the relationship between the PK profile and clinical effects of SNC-102
Description
Describe the correlation between change in AIMS score and serum levels of acamprosate.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males and females 18-75 years of age.
Diagnosis, at least 3 months prior to the Screening Visit, of drug-induced TD
AIMS ≥3 (moderate or worse) for ≥1 body area, or AIMS = 2 (mild) for ≥2 body areas; and
>3 months exposure to antipsychotic drug or metoclopramide; and
Other causes of dyskinesia have been ruled out.
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.
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.
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.
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.
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:
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.
Active drug or alcohol dependence or abuse.
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.
Risk of significant medication non-adherence, based on the judgment of the Principal Investigator.
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.
History of neuroleptic malignant syndrome.
Significant risk, in the judgment of the Principal Investigator, of suicidal or violent behavior.
Receipt of new medication for the treatment of TD within 4 weeks prior to the Baseline Visit or anticipated while participating in the trial.
Initiation of oral contraceptive medication, or change in dose, within 30 days prior to the Screening Visit, or anticipated while participating in the trial.
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.
Facility Information:
Facility Name
UCLA - Greater Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
12. IPD Sharing Statement
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A Phase 2 Trial Evaluating SNC-102 in Drug-Induced Tardive Dyskinesia
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