Ongoing Clinical Trials for Tardive Dyskinesia
Currently, there are 3 clinical trials testing treatments for tardive dyskinesia. These studies are taking place across several European countries and focus on evaluating a medication called (+)-α-dihydrotetrabenazine for managing involuntary movements associated with this condition. The trials assess both the safety and effectiveness of this investigational treatment in different patient groups.
Clinical trial locations
- Croatia
- Czechia
- Hungary
- Poland
- Slovakia
Safety Study of (+)-α-Dihydrotetrabenazine for Patients with Moderate to Severe Tardive Dyskinesia
This trial focuses on evaluating the long-term safety of a treatment for people experiencing moderate to severe involuntary movements. The study lasts up to 54 weeks and takes place in Czechia and Poland.
Main inclusion criteria: Adults aged 18 to 75 years with a confirmed diagnosis of the condition can participate. Participants must have stable mental health if they have psychiatric conditions, with no changes to their mental health medications in the past 30 days. Women who can become pregnant must use highly effective contraception. Participants should weigh at least 45 kg for females and 55 kg for males, live in a stable environment with adequate support, and be able to complete study forms and attend all visits.
Main exclusion criteria: People without a diagnosis of the condition or those outside the specified age range cannot participate. Vulnerable populations that are not included in the study design are also excluded.
Focus and goals: The trial evaluates how safe and well-tolerated the treatment is when used over an extended period. Participants undergo baseline assessments measuring involuntary movements using the Abnormal Involuntary Movement Scale (AIMS). Throughout the study, the medication dosage may be adjusted during a titration period to find the most effective and tolerable dose. Regular monitoring includes clinical laboratory tests, vital signs, and ECG parameters to track any changes in health status.
Investigational treatment: The medication being tested is (+)-α-dihydrotetrabenazine, also known as ADE513. It is provided as an oral solution taken by mouth. This medication works by modulating neurotransmitter activity in the brain and is classified as a vesicular monoamine transporter 2 (VMAT2) inhibitor.
Study on the Effects of (+)-α-Dihydrotetrabenazine for Patients with Moderate to Severe Tardive Dyskinesia
This study evaluates how effective a specific medication is in reducing involuntary movements in people with moderate to severe symptoms. The trial is conducted in Czechia, Hungary, Poland, and Slovakia and lasts up to 18 weeks.
Main inclusion criteria: Men and women between 18 and 75 years old can participate if they have a clinical diagnosis and experience symptoms that are bothersome or cause functional impairment. Participants must have a total motor AIMS score of 6 or more, with movements judged as moderate or severe. They should be in good general health, able to complete rating scales, and provide written consent. Those with mental health conditions must be psychiatrically stable with no changes to psychoactive medications in the past 30 days. Participants need to weigh at least 45 kg for females and 55 kg for males and live in a stable environment.
Main exclusion criteria: People without the condition, those outside the specified age range, and individuals from vulnerable populations not selected for this study cannot participate.
Focus and goals: The trial is divided into two parts. In the first part, all participants openly receive the medication for 12 weeks while their involuntary movements are monitored using the AIMS scale at baseline, week 6, week 9, and week 12. In the second part, participants are randomly assigned to receive either the active medication or a placebo in a double-blind manner, meaning neither they nor the researchers know which treatment they are receiving. This design helps determine if the medication provides significant relief compared to no active treatment.
Investigational treatment: The medication tested is (+)-α-dihydrotetrabenazine, also known as ADE513. It is administered as an oral solution and works by modulating neurotransmitter activity in the brain to help reduce abnormal movements.
Study on the Effects of (+)-α-Dihydrotetrabenazine for Treating Tardive Dyskinesia in Patients with Schizophrenia, Mood, or Gastrointestinal Disorders
This trial examines the effectiveness, safety, and tolerability of treatment for people who have developed involuntary movements while taking medications for mental health or gastrointestinal conditions. The study takes place in Croatia and lasts eight weeks.
Main inclusion criteria: Adults aged 18 to 85 years with a clinical diagnosis of schizophrenia, schizoaffective disorder, mood disorder, gastrointestinal disorder (such as gastroparesis or gastroesophageal reflux disease), and neuroleptic-induced condition for at least 3 months can participate. The condition must be moderate or severe. Any medications for these underlying conditions must be at a stable dose for at least 30 days before the study. Participants must have good hearing, vision, and language skills, a negative urine drug test and alcohol breath test at screening, and provide informed consent. Those with bipolar disorder must be on stable doses of mood stabilizers. Body mass index must be between 18 to 38 kg/m2.
Main exclusion criteria: People without the condition, those outside the age range, individuals who do not have the specified underlying conditions (schizophrenia, mood disorders, or gastrointestinal disorders), those unable to follow study procedures, and vulnerable populations not included in the study cannot participate.
Focus and goals: The study explores different dosing schedules, with participants receiving doses ranging from 10 to 20 mg once daily or 25 mg twice daily. The medication dose is adjusted over time through a titration process to find the most effective and tolerable amount for each person. Throughout the study, regular assessments monitor the severity of symptoms using the AIMS Dyskinesia Total Score and Clinical Global Impression of Tardive Dyskinesia (CGI-TD), along with evaluations of mental health and cognitive function. Safety monitoring includes clinical evaluations, laboratory tests, and vital sign checks.
Investigational treatment: The medication being studied is (+)-α-dihydrotetrabenazine, also known as (+)-α-DHTBZ. It is taken as an oral solution and works as a vesicular monoamine transporter 2 (VMAT2) inhibitor to modulate brain neurotransmitter activity and reduce involuntary movements.
Summary
All three clinical trials focus on testing the same investigational medication, (+)-α-dihydrotetrabenazine, for managing involuntary movements in people with moderate to severe symptoms. The trials are concentrated in Central and Eastern European countries, with studies taking place in Czechia, Poland, Hungary, Slovakia, and Croatia.
The trials vary in their specific focus: one emphasizes long-term safety over 54 weeks, another evaluates effectiveness through an 18-week design that includes both open-label and placebo-controlled phases, and the third examines dosing strategies over eight weeks in patients with specific underlying conditions such as schizophrenia, mood disorders, or gastrointestinal problems.
All studies use the AIMS scale to measure changes in involuntary movements and require participants to be in stable condition regarding their underlying health issues and medications. The medication being tested works by modulating brain neurotransmitter activity and belongs to a class of drugs known as VMAT2 inhibitors.
