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

NCT02064010 | Withdrawn Phase 2

• 1 other identifier: SNC102-201
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Drug-induced Tardive Dyskinesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Compare the effectiveness of low dose and high dose of SNC-102

  4 weeks

• Assess safety and tolerability of SNC-102 in the tardive dyskinesia population

  4 weeks

• Assess the pharmacokinetic (PK) profile in TD subjects

  4 weeks

• Determine the relationship between the PK profile and clinical effects of SNC-102

  4 weeks

Study Arms (3)

SNC-102, low dose

EXPERIMENTAL

SNC-102 (Acamprosate calcium) tablet 4 week duration dosing

Drug: SNC-102

SNC-102, high dose

EXPERIMENTAL

SNC-102 (Acamprosate calcium) tablet 4 week duration dosing

Drug: SNC-102

Placebo

PLACEBO COMPARATOR

Placebo tablet 4 week duration dosing

Drug: Placebo

Interventions

SNC-102 DRUG

Acamprosate calcium (SNC-102) tablet, administered orally for 4 weeks

Also known as: Acamprosate calcium, Acamprosate calcium controlled-release tablet, calcium N-acetylhomotaurinate

SNC-102, high dose; SNC-102, low dose

Placebo DRUG

Placebo tablet, administered orally for 4 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Synchroneuron Inc.: lead

Study Sites (1)

UCLA - Greater Los Angeles

Los Angeles, California, 90073, United States

Location

MeSH Terms

Conditions

Tardive Dyskinesia

Interventions

Acamprosate

Condition Hierarchy (Ancestors)

Dyskinesia, Drug-Induced; Dyskinesias; Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Taurine; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2013
• First Posted: February 17, 2014
• Study Start: February 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 13, 2021

Record last verified: 2016-11

Locations

US (1)