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Can a drug calm uncontrollable movements? new trial tests tetrabenazine

NCT ID NCT01543321

Disease control Sponsor: Centre Hospitalier Universitaire, Amiens Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 3 trial tested whether tetrabenazine (Xenazine) can reduce involuntary movements in people with tardive dyskinesia, a condition caused by long-term use of antipsychotic medications. Fifty-four adults with persistent symptoms were randomly assigned to receive either tetrabenazine or a placebo for 10 weeks. The study measured changes in movement severity using a standard rating scale.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Tetrabenazine (Xenazine)
What this could lead to
If successful, this could provide a proven treatment option to reduce involuntary movements in people with tardive dyskinesia, improving their quality of life.
What could go wrong
This is a small Phase 3 trial with only 54 participants, so results may not apply to everyone. Tetrabenazine can cause side effects like drowsiness or parkinsonism, and the benefit may be modest.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

54 people

The number who actually took part.

Started

May 2012

Finished

Aug 2017

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Adult (age over 18) or adult under judicial protection (tutor or curator). 2. Patient with late dyskinetic syndrome with neuroleptics yielding functional disability and/or impact in every day's life, according to the investigator, and/or the patient and/or the patient's family. 3. Patient with persistent late dyskinetic syndrome, even if the neuroleptic has been stopped for more than 6 months or patient with late dyskinetic syndrome under neuroleptic treatment unchanged for at least 3 months and which would a priori not need any dose variation during the study time. 4. MADRS \< 18 5. QTc \< 450 ms for men and \< 470 for women. Exclusion Criteria: 1. Lack of social insurance 2. Neuroleptic treatment less than 3 months 3. Insanity according to the DSM IV and MMS \< 24 4. Predominant akathisia 5. Psychiatric disease not stabilized for more than 6 months and/or which could require a neuroleptic treatment adaptation during study time. 6. Pregnancy and lactating 7. Women in genital activity without efficient contraception method (IUD or estrogen-progestin pill) 8. Hypersensitivity to tetrabenazine 9. Renal failure 10. Drugs: Non-selective MAOIs, dopaminergic (or other antiparkinsonian) 11. Other severe pathology 12. Patient non compliant to protocol, at the investigator's appreciation 13. Simultaneous participation to other clinical trial 14. Congenital galactosemia, glucose malabsorption or lactase deficiency

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Conditions

The condition(s) this trial relates to.

movement disorder tardive dyskinesia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Tardive dyskinesia

Contacts and locations

Locations

  • AP-HM Hopital de la Timone

    Marseille, 13385, France

  • CH Aix en Provence

    Aix-en-Provence, 13100, France

  • CH des Charpennes

    Lyon, 69100, France

  • CHRU Lille

    Lille, 59037, France

  • CHRU de Nimes

    Nîmes, 30900, France

  • CHU Amiens

    Amiens, Picardie, 80000, France

  • CHU Bordeaux

    Bordeaux, 33076, France

  • CHU Caen

    Caen, 14033, France

  • CHU Clermont-Ferrand

    Clermont-Ferrand, 63003, France

  • CHU Limoges

    Limoges, 87042, France

  • CHU Montpellier

    Montpellier, 34295, France

  • CHU Nantes

    Nantes, 44093, France

  • CHU Nice

    Nice, 06002, France

  • CHU Poitiers

    Poitiers, 86021, France

  • CHU Rouen

    Rouen, 76031, France

  • CHU Saint Antoine

    Paris, 75012, France

  • CHU Strasbourg

    Strasbourg, 67091, France

  • CHU Toulouse

    Toulouse, 31059, France

  • CHU de Rennes

    Rennes, 35033, France

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