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An Open label, Safety Clinical trial of (+)-α-dihydrotetrabenazine in patients with moderate to severe tardive dyskinesia
EU CTIS ID: 2023-509518-12-01
What this study is testing
To evaluate the safety and tolerability of long-term maintenance therapy with ADE513 (+)-α-DHTBZ.
- 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 and female subjects aged 18-75 years, inclusive at the time of enrollment to parent study
- Subject able to complete subject-facing rating scales.
- Subject having a caregiver who is in regular personal contact with the subject (no less than 5 days a week) if locally required
- Female subject of childbearing potential who agrees to use highly effective form of contraception (as defined by the Protocol) throughout the study.
- Subject who has completed treatment within an open-label parent study or part thereof, or treatment within a double-blind, placebo controlled parent study or part thereof followed by at least 1-week washout.
- Subject with a clinical diagnosis of TD.
You likely can't join if
- Subject who has an allergy, hypersensitivity, or intolerance to any component of ADE513, or to a VMAT2 inhibitor e.g. tetrabenazine, deutetrabenazine, valbenazine.
- Subject with an unstable or serious medical condition at Baseline.
- Subject with a history of violent behavior in the past 3 months before Baseline.
- Subject with a clinically significant cardiac abnormality or QTcF >450 ms (males) or >470 ms (females), on 12-lead ECG at Baseline.
- Subject with any of the following abnormal values in laboratory test results at Baseline: • Aspartate transaminase (AST) or alanine aminotransferase (ALT) > 2.5 times the upper limit of normal (ULN) • Alkaline phosphatase (ALP) or total bilirubin >2 times the ULN • Serum creatinine >1.5 times the ULN. • Any other results outside of laboratory reference ranges judged as clinically significant by the Investigator.
- Subject who has participated in an investigational trial other than the parent study within 30 days of Baseline.
See the full eligibility criteria
Who can join
- Male and female subjects aged 18-75 years, inclusive at the time of enrollment to parent study
- Subject able to complete subject-facing rating scales.
- Subject having a caregiver who is in regular personal contact with the subject (no less than 5 days a week) if locally required
- Female subject of childbearing potential who agrees to use highly effective form of contraception (as defined by the Protocol) throughout the study.
- Subject who has completed treatment within an open-label parent study or part thereof, or treatment within a double-blind, placebo controlled parent study or part thereof followed by at least 1-week washout.
- Subject with a clinical diagnosis of TD.
- For subjects with underlying psychiatric disorders: o Subject in a stable psychiatric status with no change in psychoactive medications (e.g. neuroleptics, benzodiazepines, anticonvulsants, mood stabilizers, etc.) within the last 30 days before Baseline
- Subject with not anticipated changes to the subject’s treatment regimen.
- Subject compliant with prescribed treatment regimen as judged by the Investigator.
- Subject with a body weight of not less than 45 kg and 55 kg for females and males respectively.
- Subject living in a stable environment as judged by the Investigator, with adequate supervision when necessary to comply with all study procedures, attend all study visits, and safely participate in the trial.
- Subject able to read, comprehend and provide the written informed consent.
What rules you out
- Subject who has an allergy, hypersensitivity, or intolerance to any component of ADE513, or to a VMAT2 inhibitor e.g. tetrabenazine, deutetrabenazine, valbenazine.
- Subject with an unstable or serious medical condition at Baseline.
- Subject with a history of violent behavior in the past 3 months before Baseline.
- Subject with a clinically significant cardiac abnormality or QTcF >450 ms (males) or >470 ms (females), on 12-lead ECG at Baseline.
- Subject with any of the following abnormal values in laboratory test results at Baseline: • Aspartate transaminase (AST) or alanine aminotransferase (ALT) > 2.5 times the upper limit of normal (ULN) • Alkaline phosphatase (ALP) or total bilirubin >2 times the ULN • Serum creatinine >1.5 times the ULN. • Any other results outside of laboratory reference ranges judged as clinically significant by the Investigator.
- Subject who has participated in an investigational trial other than the parent study within 30 days of Baseline.
- Subject who acknowledges present use of illicit drugs at Baseline.
- Subject who has a history of alcohol or substance abuse within 12 months before Screening, or subject expected to be unable to refrain from substance abuse during the study.
- Subject who is pregnant or breastfeeding at Baseline.
- Subject who received any of the following medications within 30 days of Baseline: • Reserpine, α-methyl-p-tyrosine (AMPT) • Botulinum toxin within 3 months of Baseline • Trihexyphenidyl, orphenadrine, procyclidine, biperiden, or other strong anticholinergics • Metoclopramide, promethazine, and prochlorperazine • Methylphenidate, amphetamine/dextroamphetamine, or other stimulants • Monoamine oxidase inhibitors (MAOIs) • Levodopa or dopamine agonists • Botulinum toxin (within 3 months of Baseline)
- Subject with a neurological condition other than TD that may interfere with the assessment of dyskinesia severity.
- Subject with presence of parkinsonism, pheochromocytoma and prolactin dependent tumours, e.g. pituitary or breast cancer.
- Subject with an active clinically significant unstable psychiatry disorder that is untreated or undertreated at Baseline.
- Subject with active suicidal ideation at Baseline.
- Subject who has a history of any of the following within the last 6 months before Baseline: • History of previous intent to act on suicidal ideation with a specific plan (positive answer to question 5 on C-SSRS), regardless of level of ambivalence at the time of suicide. • Previous preparatory acts to commit suicide or suicidal behavior. • Previous actual, interrupted, or aborted suicide attempt.
- Subject with an abnormal (≥11) score on the depression subscale of the Hospital Anxiety and Depression Scale (HADS) at Baseline.
- Subject who is developmentally disabled or has evidence of dementia confirmed by Mini-Mental State Exam (MMSE) value ≤24.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
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.