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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Drug-induced Tardive Dyskinesia
• Intervention / Treatment: Drug: SNC-102; Drug: Placebo

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90073
      • UCLA - Greater Los Angeles

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	4 weeks
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.	4 weeks
Assess the pharmacokinetic (PK) profile in TD subjects	Measure and analyze the serum concentration of acamprosate.	4 weeks
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.	4 weeks

Collaborators and Investigators

• Sponsor: Synchroneuron Inc.

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (ANTICIPATED): January 1, 2015
• Study Completion (ANTICIPATED): December 1, 2015

Study Registration Dates

• First Submitted: December 6, 2013
• First Submitted That Met QC Criteria: February 13, 2014
• First Posted (ESTIMATE): February 17, 2014

Study Record Updates

• Last Update Posted (ACTUAL): April 13, 2021
• Last Update Submitted That Met QC Criteria: April 8, 2021
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Movement Disorders; Dyskinesia, Drug-Induced; Dyskinesias; Tardive Dyskinesia; Physiological Effects of Drugs; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Alcohol Deterrents; Calcium; Calcium, Dietary; Acamprosate
• Other Study ID Numbers: SNC102-201