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Safety Study of (+)-α-Dihydrotetrabenazine for Patients with Moderate to Severe Tardive Dyskinesia

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the safety of a treatment for tardive dyskinesia, a condition characterized by involuntary movements, often affecting the face and body. The treatment being tested is called (+)-α-dihydrotetrabenazine, also known by its code name ADE513. This medication is provided as an oral solution, which means it is taken by mouth in liquid form.

The purpose of the study is to evaluate how safe and tolerable this treatment is when used over a long period. Participants in the study will receive the medication and be monitored for any changes in their condition and any side effects they might experience. The study will last for up to 54 weeks, during which time participants will have regular check-ups to assess their health and the effects of the treatment.

Throughout the study, participants will be asked to complete certain assessments to help researchers understand the impact of the treatment on their symptoms. The study aims to provide valuable information on the long-term use of (+)-α-dihydrotetrabenazine for managing tardive dyskinesia, contributing to better treatment options for those affected by this condition.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Introduction to the trial

    Upon joining the clinical trial, the patient will receive an overview of the study's purpose, which is to evaluate the safety and tolerability of long-term maintenance therapy with (+)-α-dihydrotetrabenazine for tardive dyskinesia.

    The patient will be informed about the trial's duration, which is expected to last until February 2027.

  2. Step 2

    Baseline assessment

    The patient will undergo a baseline assessment to evaluate their current condition. This includes measuring the Abnormal Involuntary Movement Scale (AIMS) score, which assesses involuntary movements.

    Other assessments may include clinical laboratory tests, vital signs, and ECG parameters.

  3. Step 3

    Medication administration

    The patient will begin taking (+)-α-dihydrotetrabenazine as an oral solution. The dosage and frequency will be determined by the study protocol and adjusted as necessary during the trial.

    The medication is intended to be taken regularly as part of the long-term treatment plan.

  4. Step 4

    Titration period

    During the titration period, the dosage of the medication may be adjusted to find the most effective and tolerable dose for the patient.

    The patient will be monitored for any adverse effects or changes in their condition.

  5. Step 5

    Long-term treatment

    The patient will continue with the long-term treatment phase, which lasts until the end of the study period.

    Regular assessments will be conducted to monitor the patient's progress, including changes in the AIMS score and other health parameters.

  6. Step 6

    End of study assessment

    At the end of the study, the patient will undergo a final assessment to evaluate the overall effectiveness and safety of the treatment.

    The primary endpoint is the change in the AIMS score from the baseline to the end of the therapy.

Who can join the trial?

12 criteria

  • Men and women aged 18 to 75 years can participate.
  • The participant should be able to complete forms or questionnaires used in the study.
  • If required, the participant should have a caregiver who sees them regularly, at least 5 days a week.
  • Women who can have children must agree to use a very reliable form of birth control during the study.
  • The participant must have finished treatment in a previous study, with a break of at least one week if it was a specific type of study.
  • The participant must have a clinical diagnosis of Tardive Dyskinesia (TD), a condition that affects movement.
  • If the participant has mental health issues, their condition should be stable, with no changes in their mental health medications in the last 30 days.
  • No expected changes to the participant's treatment plan should be anticipated.
  • The participant should be following their treatment plan as determined by the study doctor.
  • The participant must weigh at least 45 kg if female and 55 kg if male.
  • The participant should live in a stable environment, with enough support to follow all study procedures and attend all study visits.
  • The participant must be able to read, understand, and sign a written consent form to join the study.

Who cannot join the trial?

3 criteria

  • Patients who are not diagnosed with Tardive dyskinesia cannot participate. Tardive dyskinesia is a condition that causes involuntary movements, often in the face and body.
  • Patients who are not within the specified age range cannot participate. The age range includes certain age groups, but the specific ages are not provided here.
  • Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups that may need special protection, but this study does not include such groups.
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Investigated drugs

ADE513 is being studied for its safety and tolerability in patients with moderate to severe tardive dyskinesia. Tardive dyskinesia is a condition characterized by involuntary, repetitive body movements. This medication aims to help manage these symptoms over a long-term period.

What is already known about the treatment

(+)-α-Dihydrotetrabenazine – This medication is administered orally and is currently being studied in clinical trials for its safety and tolerability in treating tardive dyskinesia, a movement disorder. It is not yet widely recognized in medical literature as a standard treatment, as it is still under investigation. The main therapeutic indication for this medication is to manage symptoms of tardive dyskinesia. At the molecular level, it works by modulating neurotransmitter activity in the brain, which helps reduce involuntary movements. It is classified pharmacologically as a vesicular monoamine transporter 2 (VMAT2) inhibitor.

Investigated diseases

Tardive Dyskinesia – Tardive dyskinesia is a neurological disorder characterized by involuntary, repetitive body movements. These movements can include grimacing, sticking out the tongue, or smacking the lips. The condition often develops after long-term use of certain medications, particularly antipsychotics. Symptoms may appear gradually and can vary in intensity. The disorder primarily affects the face and mouth, but it can also involve the limbs and trunk. Over time, the movements may become more pronounced and persistent.
Trial detailsLast updated 16 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-509518-12-01Protocol codeADT-2023-001Estimated enrolment70 patientsSponsorAdeptio Pharmaceuticals Limited

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