Drug-induced Tardive DyskinesiaPhase 2NCT02064010
A Phase 2 Trial Evaluating SNC-102 in Drug-Induced Tardive Dyskinesia
A Phase 2 study testing SNC-102 in people with Drug-induced Tardive Dyskinesia, run by Synchroneuron Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Drug-induced Tardive Dyskinesia
- What is being tested?
- SNC-102
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Dec 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA - Greater Los Angeles
Los Angeles, California, 90073
About this study
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
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
- Being tested
- SNC-102, Placebo
- Medical subject headings
- Tardive Dyskinesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SNC-102Drug
Also called Acamprosate calcium, Acamprosate calcium controlled-release tablet, calcium N-acetylhomotaurinate
Acamprosate calcium (SNC-102) tablet, administered orally for 4 weeks
PlaceboDrug
Placebo tablet, administered orally for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| SNC-102, low dose | Experimental | SNC-102 (Acamprosate calcium) tablet 4 week duration dosing Receives: Drug: SNC-102 |
| SNC-102, high dose | Experimental | SNC-102 (Acamprosate calcium) tablet 4 week duration dosing Receives: Drug: SNC-102 |
| Placebo | Placebo comparator | Placebo tablet 4 week duration dosing Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 4 weeks
Secondary outcomes (4)
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)
Measured: 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.
Measured: 4 weeks
Assess the pharmacokinetic (PK) profile in TD subjects
Measure and analyze the serum concentration of acamprosate.
Measured: 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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionJan 2015 (estimated)
- Study completionDec 2015 (estimated)
Why it stopped: Funding terminated; company closed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug-induced Tardive DyskinesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Synchroneuron Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02064010
- Sponsor's protocol ID
- SNC102-201
- Status last verified
- Nov 2016
- First submitted
- 6 Dec 2013
- Last updated
- 13 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02064010
- Acronym / sponsor ID
- SNC102-201
- Conditions
- Drug-induced Tardive Dyskinesia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding terminated; company closed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Synchroneuron Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 17 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SNC-102, low dose | Experimental | Drug: SNC-102SNC-102 (Acamprosate calcium) tablet 4 week duration dosing |
| SNC-102, high dose | Experimental | Drug: SNC-102SNC-102 (Acamprosate calcium) tablet 4 week duration dosing |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo tablet 4 week duration dosing |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Males and females 18-75 years of age.
- Diagnosis, at least 3 months prior to the Screening Visit, of drug-induced TD
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SNC-102Also: Acamprosate calcium, Acamprosate calcium controlled-release tablet, calcium N-acetylhomotaurinateAcamprosate calcium (SNC-102) tablet, administered orally for 4 weeks | Drug | SNC-102, high dose, SNC-102, low dose |
| PlaceboPlacebo tablet, administered orally for 4 weeks | Drug | Placebo |
Primary outcome
Efficacy as measured by changes from baseline in summary scores on the Abnormal Involuntary Movement Scale (AIMS)
Time frame: 4 weeks
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 secondary outcomes
Compare the effectiveness of low dose and high dose of SNC-102
Time frame: 4 weeks
Assess safety and tolerability of SNC-102 in the tardive dyskinesia population
Time frame: 4 weeks
Assess the pharmacokinetic (PK) profile in TD subjects
Time frame: 4 weeks
Determine the relationship between the PK profile and clinical effects of SNC-102
Time frame: 4 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SNC-102 in people with Drug-induced Tardive Dyskinesia, run by Synchroneuron Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy as measured by changes from baseline in summary scores on the Abnormal Involuntary Movement Scale (AIMS) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2021.