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

What is this study about?

This clinical trial is focused on studying a condition known as tardive dyskinesia, which involves involuntary movements that can be bothersome and affect daily life. The trial will test a treatment called (+)-α-dihydrotetrabenazine, also known by its code name ADE513. This medication is provided as an oral solution, meaning it is taken by mouth in liquid form. The purpose of the study is to evaluate how effective ADE513 is in reducing the abnormal movements associated with tardive dyskinesia.

The study is divided into two parts. In the first part, all participants will receive the medication openly, meaning everyone knows they are taking ADE513. In the second part, participants will be randomly assigned to receive either ADE513 or a placebo, without knowing which one they are taking. This is done to compare the effects of the medication against no active treatment. The study will last for a period of up to 18 weeks, during which participants will attend regular visits to monitor their progress and any changes in their symptoms.

Throughout the study, participants will be assessed on their involuntary movements using a scale called the AIMS (Abnormal Involuntary Movement Scale). This will help determine any improvements in their condition. The trial aims to find out if ADE513 can provide significant relief from the symptoms of tardive dyskinesia, potentially offering a new treatment option for those affected by this condition.

1 joining the study

Upon joining the study, the patient will be informed about the trial’s purpose and procedures. The patient must provide written consent to participate.

The patient will be assessed to ensure they meet the inclusion criteria, such as age, health status, and a clinical diagnosis of tardive dyskinesia.

2 part I: open-label phase

The patient will begin the open-label phase, where they will receive the medication (+)-α-dihydrotetrabenazine as an oral solution.

The dosage and frequency of administration will be determined by the study protocol and the investigator’s assessment.

The patient will be monitored for changes in involuntary movements using the Abnormal Involuntary Movement Scale (AIMS) over a period of 12 weeks.

3 assessment and monitoring

Throughout the trial, the patient’s involuntary movements will be assessed at various intervals, including baseline, week 6, week 9, and week 12.

The primary goal is to observe changes in the AIMS score from the start of the trial to week 12.

4 part II: randomized, double-blind phase

In this phase, the patient may be randomly assigned to receive either the active medication or a placebo.

Neither the patient nor the investigator will know which treatment the patient is receiving to ensure unbiased results.

The patient’s response to the treatment will be evaluated, focusing on the control of dyskinesia and overall improvement.

5 completion of the trial

At the end of the trial, the patient’s overall progress and any changes in symptoms will be reviewed.

The study aims to determine the effectiveness of the medication in reducing involuntary movements associated with tardive dyskinesia.

Who Can Join the Study?

Subject aged between 18 and 75 years, inclusive.
Subject in good general health with the expectation to attend all study visits and complete all study assessments as judged by the Investigator.
Subject able to read, comprehend, and provide the written informed consent.
Subject able to complete subject-facing rating scales.
Female subject of childbearing potential who agrees to use a highly effective form of contraception throughout the Study.
Subject with a clinical diagnosis of tardive dyskinesia (a condition with involuntary movements).
Subject with symptoms of tardive dyskinesia which are bothersome and/or cause functional impairment.
Subject with a total motor AIMS score of 6 or more, and with abnormal movements judged as moderate or severe by the Investigator. The AIMS score is a way to measure involuntary movements.
Subject with body weight of not less than 45 kg for females and 55 kg for males.
Subject in a psychiatrically stable condition with no change in psychoactive medications (such as neuroleptics, benzodiazepines, anticonvulsants, mood stabilizers) within the last 30 days before Screening, and with no anticipated changes to the subject’s treatment regimen in the next 3 months.
Subject living in a stable environment as judged by the Investigator, with adequate supervision when necessary.
Subject having a caregiver who is in regular personal contact with the subject (no less than 5 days a week), if locally required.
Subject compliant with the prescribed treatment regimen as judged by the Investigator.

Who Cannot Join the Study?

Patients who do not have tardive dyskinesia, which is a condition that causes involuntary movements, cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who belong to certain clinical trial groups that are not included in this study cannot participate.
Patients who are part of a vulnerable population that is not selected for this study cannot participate.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
INEP medical s.r.o.	Prague	Czechia
Clintrial s.r.o.	Prague	Czechia
A-Shine s.r.o.	Plzen	Czechia
Zarmed s.r.o.	Kosice	Slovakia
Vggshkht Vrnfffsxu Cbibvqaa Ffflth Knubqk	Sumeg	Hungary
Mzspnjgbgjh sfbtnd	Poruba	Czechia
Ssqomnmgevraxmr Pugelyum Lbafelcc Du Seoyzqgfx Ocxvpfb	Katowice	Poland
Byocfqtmfzx Visoixyab Oumaunodotno	Kecskemet	Hungary

Trial status

Country	Status	Recruitment Start
Czechia	Recruiting	13.11.2023
Hungary	Not yet recruiting	13.11.2023
Poland	Not yet recruiting	13.11.2023
Slovakia	Not yet recruiting	13.11.2023

Trial locations

(+)-α-Dihydrotetrabenazine is being studied for its potential to help reduce the involuntary movements associated with tardive dyskinesia. Tardive dyskinesia is a condition that causes repetitive and uncontrollable movements, often as a side effect of long-term use of certain medications. This trial aims to see if this medication can effectively lessen these movements and improve the quality of life for patients experiencing moderate to severe symptoms.

Tardive Dyskinesia – Tardive dyskinesia is a neurological disorder characterized by involuntary, repetitive body movements. These movements can include grimacing, tongue movements, lip smacking, and rapid eye blinking. The condition often arises as a side effect of long-term use of certain medications, particularly antipsychotics. Symptoms may vary in intensity and can affect different parts of the body, including the face, limbs, and trunk. The progression of tardive dyskinesia can be gradual, with symptoms sometimes appearing after months or years of medication use. The movements are typically persistent and may become more pronounced over time.

Trial ID:

2024-516852-17-00

Protocol code:

ADT-2022-003

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

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