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(2R,3R,11Br)-1,3,4,6,7,11B-Hexahydro-9,10-Dimethoxy-3-(2-Methylpropyl)-2H-Benzo[A]Quinolizin-2-Ol

This article discusses clinical trials investigating the use of (+)-α-dihydrotetrabenazine, also known as (2R,3R,11Br)-1,3,4,6,7,11B-Hexahydro-9,10-Dimethoxy-3-(2-Methylpropyl)-2H-Benzo[A]Quinolizin-2-Ol, for the treatment of moderate to severe tardive dyskinesia. These trials aim to evaluate the safety, tolerability, and efficacy of this drug in reducing abnormal involuntary movements associated with tardive dyskinesia. The studies include both open-label and randomized, double-blind, placebo-controlled designs to thoroughly assess the drug’s potential as a long-term treatment option for patients with this challenging condition.

Table of Contents

Introduction

A new medication is being studied for the treatment of tardive dyskinesia, a condition characterized by involuntary, repetitive body movements. This article will provide information about the drug, its potential benefits, and ongoing clinical trials.[1][2]

What is Tardive Dyskinesia?

Tardive dyskinesia is a neurological disorder that causes involuntary, repetitive body movements. These movements often affect the face, tongue, and limbs. The condition is usually a side effect of long-term use of certain medications, particularly antipsychotic drugs used to treat mental health conditions.[1][2]

About the Medication

The medication being studied is called (2R,3R,11BR)-1,3,4,6,7,11B-HEXAHYDRO-9,10-DIMETHOXY-3-(2-METHYLPROPYL)-2H-BENZO[A]QUINOLIZIN-2-OL. It’s a mouthful, so it’s also known by several other names:

  • (+)-α-Dihydrotetrabenazine
  • (+)-α-DHTBZ
  • (+)-DTBZ
  • NBI-98782
  • ADE513 (sponsor product code)

This medication is being developed as an oral solution, which means it’s a liquid that you drink.[1][2]

How It Works

The medication is classified as a VMAT2 inhibitor. VMAT2 stands for Vesicular Monoamine Transporter 2. This protein is responsible for packaging and transporting certain chemicals (neurotransmitters) in the brain. By inhibiting VMAT2, the medication aims to reduce the abnormal movements associated with tardive dyskinesia.[1][2]

Clinical Trials

The medication is currently being studied in clinical trials to evaluate its safety and effectiveness. Two main studies are underway:

  1. An open-label safety study for patients with moderate to severe tardive dyskinesia. This study aims to evaluate the safety and tolerability of long-term maintenance therapy with the medication.[1]
  2. A study with two parts: an open-label part followed by a randomized, double-blind, placebo-controlled part. This study aims to evaluate the efficacy of the medication in reducing abnormal involuntary movements of tardive dyskinesia.[2]

Potential Benefits

The main goal of this medication is to reduce the abnormal involuntary movements associated with tardive dyskinesia. Researchers are measuring this using a scale called the Abnormal Involuntary Movement Scale (AIMS). They’re looking to see if the medication can:

  • Reduce the AIMS score, indicating a decrease in abnormal movements
  • Improve the overall condition as assessed by doctors (Clinical Global Impression of Change – CGIC)
  • Improve the condition as perceived by patients themselves (Patient Global Impression of Change – PGIC)

If successful, this medication could significantly improve the quality of life for people living with tardive dyskinesia.[1][2]

Safety and Side Effects

As with any medication, safety is a crucial concern. The clinical trials are closely monitoring for any adverse effects. Some areas of focus include:

  • Changes in heart rhythm (monitored through ECG)
  • Liver function (monitored through blood tests)
  • Mental health status (monitored through scales like the Hospital Anxiety and Depression Scale)
  • Any other unexpected side effects

It’s important to note that the full safety profile of this medication is still being determined through these clinical trials.[1][2]

Who Can Take This Medication?

The medication is being studied in adults aged 18-75 with moderate to severe tardive dyskinesia. However, there are several factors that determine eligibility for the clinical trials. Some key points include:

  • Participants must have a clinical diagnosis of tardive dyskinesia
  • They must be in stable psychiatric condition
  • Certain medical conditions or medications may exclude participation
  • Pregnant or breastfeeding women are not eligible

It’s important to note that this medication is still in the testing phase and is not yet available for general use. If you think you might be eligible for one of the clinical trials, you should discuss this with your healthcare provider.[1][2]

Aspect Details
Drug Name (+)-α-dihydrotetrabenazine (ADE513)
Chemical Name (2R,3R,11Br)-1,3,4,6,7,11B-Hexahydro-9,10-Dimethoxy-3-(2-Methylpropyl)-2H-Benzo[A]Quinolizin-2-Ol
Condition Studied Moderate to severe tardive dyskinesia
Study Designs Open-label and randomized, double-blind, placebo-controlled
Primary Endpoint Change in AIMS score from baseline to Week 12
Key Secondary Endpoints Safety, tolerability, CGIC and PGIC scores
Dosage Form Oral solution
Maximum Daily Dose 25 mg
Treatment Duration Up to 54 weeks
Key Inclusion Criteria Adults 18-75 years, TD diagnosis, stable psychiatric condition
Key Exclusion Criteria Recent use of certain medications, significant cardiac or liver abnormalities, active substance abuse

FAQ

  • What is tardive dyskinesia? Tardive dyskinesia is a neurological disorder characterized by involuntary, repetitive body movements. It typically affects the face, mouth, and tongue, but can also involve other parts of the body. This condition is often a side effect of long-term use of certain medications, particularly antipsychotic drugs.
  • What is (+)-α-dihydrotetrabenazine? (+)-α-dihydrotetrabenazine, also known as ADE513 or (2R,3R,11Br)-1,3,4,6,7,11B-Hexahydro-9,10-Dimethoxy-3-(2-Methylpropyl)-2H-Benzo[A]Quinolizin-2-Ol, is an investigational drug being studied for the treatment of tardive dyskinesia. It belongs to a class of medications called VMAT2 inhibitors, which are thought to help reduce abnormal movements associated with tardive dyskinesia.
  • What are the main objectives of these clinical trials? The main objectives of these clinical trials are to evaluate the safety, tolerability, and efficacy of (+)-α-dihydrotetrabenazine in patients with moderate to severe tardive dyskinesia. The studies aim to assess the drug's ability to reduce abnormal involuntary movements and its long-term effects on patients with this condition.
  • How is the effectiveness of the drug measured in these trials? The effectiveness of (+)-α-dihydrotetrabenazine is primarily measured using the Abnormal Involuntary Movement Scale (AIMS). This scale assesses the severity of involuntary movements. The trials also use other measures such as the Clinical Global Impression of Change (CGIC) and Patient Global Impression of Change (PGIC) to evaluate overall improvement from both the clinician's and patient's perspectives.
  • Who can participate in these clinical trials? Participants in these trials must be adults aged 18-75 years with a clinical diagnosis of moderate to severe tardive dyskinesia. They must have stable psychiatric conditions and be in generally good health. Specific inclusion and exclusion criteria apply, including requirements for AIMS scores, body weight, and absence of certain medical conditions or medications that could interfere with the study results.

Ongoing Clinical Trials on (2R,3R,11Br)-1,3,4,6,7,11B-Hexahydro-9,10-Dimethoxy-3-(2-Methylpropyl)-2H-Benzo[A]Quinolizin-2-Ol

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

    Recruiting

    2 1
    Investigated diseases:
    Investigated drugs:
    Czechia Hungary Poland Slovakia

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

    Recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Czechia Poland

  • Study on the Effects of (+)-α-Dihydrotetrabenazine for Treating Tardive Dyskinesia in Patients with Schizophrenia, Mood, or Gastrointestinal Disorders

    Not yet recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Croatia

Glossary

  • Tardive dyskinesia (TD): A neurological disorder characterized by involuntary, repetitive body movements, typically affecting the face, mouth, and tongue. It is often a side effect of long-term use of certain medications, particularly antipsychotic drugs.
  • (+)-α-dihydrotetrabenazine (ADE513): An investigational drug being studied for the treatment of tardive dyskinesia. It is a VMAT2 inhibitor designed to reduce abnormal movements associated with TD.
  • VMAT2 inhibitor: A class of medications that work by blocking the vesicular monoamine transporter 2, which is involved in the storage and release of certain neurotransmitters in the brain.
  • Abnormal Involuntary Movement Scale (AIMS): A standardized assessment tool used to measure the severity of involuntary movements associated with tardive dyskinesia.
  • Clinical Global Impression of Change (CGIC): A scale used by healthcare professionals to evaluate a patient's overall clinical improvement during treatment.
  • Patient Global Impression of Change (PGIC): A scale that allows patients to rate their perception of improvement or worsening of their condition during treatment.
  • Open-label study: A type of clinical trial where both the researchers and participants know which treatment is being administered.
  • Double-blind, placebo-controlled study: A clinical trial design where neither the participants nor the researchers know who is receiving the active treatment or a placebo, used to minimize bias in assessing treatment effects.
  • QTcF interval: A measurement on an electrocardiogram (ECG) that represents the time it takes for the heart's electrical system to recharge between beats, corrected for heart rate using Fridericia's formula.

References

  1. http://clinicaltrials.eu/trial/safety-study-of-%ce%b1-dihydrotetrabenazine-for-patients-with-moderate-to-severe-tardive-dyskinesia/
  2. http://clinicaltrials.eu/trial/study-on-the-effects-of-%ce%b1-dihydrotetrabenazine-for-patients-with-moderate-to-severe-tardive-dyskinesia/