Halted Therapeutic exploratory (Phase II) tardive dyskinesia

Evaluate the Efficacy, Safety and Tolerability of (+)-α-dihydrotetrabenazine for Treatment of Tardive Dyskinesia

EU CTIS ID: 2024-519105-35-00

What this study is testing

The objectives of this study are to evaluate the efficacy, safety, and tolerability of different ascending doses (10 to 20 mg) of (+)-αDHTBZ administered once daily (od) and 25 mg administered twice daily (bid) for the treatment of tardive dyskinesia in subjects with schizophrenia, schizoaffective disorder, mood disorder, gastrointestinal disorder or neuroleptic-induced TD.

Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

Male or female aged 18 to 85 years (inclusive).
Have adequate hearing, vision, and language skills to perform the procedures specified in the protocol.
Have a negative urine drug screen at screening and study start (negative for amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, opiates, or cannabinoids), except for any subject receiving a stable dose of benzodiazepine or opiates. Subjects with positive cannabinoid results may be allowed to participate in the study provided that the subject is given thorough counselling and agrees to refrain from using cannabinoids for the duration of his/her study participation. Subjects must also have a negative alcohol breath test at screening and study start.
Dated and signed informed consent.
Meet clinical diagnoses of schizophrenia, schizoaffective disorder, mood disorder, gastrointestinal disorder (e.g., gastroparesis, gastroesophageal reflux disease), and have a clinical diagnosis of neuroleptic-induced TD as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V) for at least 3 months prior to screening with TD assessed as moderate or severe by AIMS Item 8 (≥3)
Maintenance medication(s) for schizophrenia or schizoaffective disorder, mood disorders, or gastrointestinal disorders (except metoclopramide) must be at a stable dose for ≥30 days before screening.

You likely can't join if

Have an active, clinically significant unstable medical condition within 1 month (30 days) prior to screening.
Receiving medication for the treatment of tardive dyskinesia.
Have a positive human immunodeficiency virus antibody, (HIV-Ab), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody result at screening or have a history of positive result.
Have received an investigational drug within 30 days before screening or plan to use an investigational drug (other than (+)-α-DHTBZ) during the study
Have an allergy, hypersensitivity, or intolerance to tetrabenazine.
Have had previous exposure with (+)-α-DHTBZ

See the full eligibility criteria

Who can join

Male or female aged 18 to 85 years (inclusive).
Have adequate hearing, vision, and language skills to perform the procedures specified in the protocol.
Have a negative urine drug screen at screening and study start (negative for amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, opiates, or cannabinoids), except for any subject receiving a stable dose of benzodiazepine or opiates. Subjects with positive cannabinoid results may be allowed to participate in the study provided that the subject is given thorough counselling and agrees to refrain from using cannabinoids for the duration of his/her study participation. Subjects must also have a negative alcohol breath test at screening and study start.
Dated and signed informed consent.
Meet clinical diagnoses of schizophrenia, schizoaffective disorder, mood disorder, gastrointestinal disorder (e.g., gastroparesis, gastroesophageal reflux disease), and have a clinical diagnosis of neuroleptic-induced TD as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V) for at least 3 months prior to screening with TD assessed as moderate or severe by AIMS Item 8 (≥3)
Maintenance medication(s) for schizophrenia or schizoaffective disorder, mood disorders, or gastrointestinal disorders (except metoclopramide) must be at a stable dose for ≥30 days before screening.
Subjects who are not using an antipsychotic medication must have a stable psychiatric status as clinically determined by the investigator. Subjects with a diagnosis of bipolar disorder must be on stable dose of mood stabilizer(s) (e.g., lithium, valproate, olanzapine) for a minimum of 30 days before screening.
Have the doses of concurrent medications and the conditions being treated be stable for a minimum of 30 days before study start and be expected to remain stable during the study.
Subjects of childbearing potential must agree to use a highly effective contraception method during the study.
Be in good general health and expected to complete the clinical study as designed.
Have a body mass index (BMI) of 18 to 38 kg/m2.

What rules you out

Have an active, clinically significant unstable medical condition within 1 month (30 days) prior to screening.
Receiving medication for the treatment of tardive dyskinesia.
Have a positive human immunodeficiency virus antibody, (HIV-Ab), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody result at screening or have a history of positive result.
Have received an investigational drug within 30 days before screening or plan to use an investigational drug (other than (+)-α-DHTBZ) during the study
Have an allergy, hypersensitivity, or intolerance to tetrabenazine.
Have had previous exposure with (+)-α-DHTBZ
Have a history of substance dependence or substance (drug) or alcohol abuse within the 3 months before study start (nicotine and caffeine dependence are not exclusionary).
Have a significant risk of suicidal or violent behavior. Subjects with any suicidal behavior or suicidal ideation of type 4 (active suicidal ideation with some intent to act, without specific plan) or type 5 (active suicidal ideation with specific plan and intent), based on the C-SSRS in the 3 months prior to screening, will be excluded.
Have a known history of neuroleptic malignant syndrome.
Have a known history of long QT syndrome or cardiac tachyarrhythmia
Have a screening or Day -1 average triplicate ECG QT interval corrected for heart rate using QTcF of >450 ms (males) or >470 ms (females) or the presence of any clinically significant cardiac abnormality.
Subjects with clinical diagnoses of schizophrenia or schizoaffective disorder must not have a CDSS total score ≥10 at screening or Day -1 or PANSS total score ≥70 at Day -1.
Female pregnant women.
Receiving any excluded concomitant medication such as reserpine, metoclopramide, carbamazepine, stimulants, or tetrabenazine, or any other specified in the protocol.

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.