An Open label, Safety Clinical trial of (+)-a-dihydrotetrabenazine in patients with moderate to severe tardive dyskinesia

Phase 1

Recruiting

• Conditions: Tardive dyskinesia; MedDRA version: 21.1Level: PTClassification code: 10043118Term: Tardive dyskinesia Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: CTIS2023-509518-12-01
• Lead Sponsor: Adeptio Pharmaceuticals Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-24
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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: oSubject 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.

Exclusion Criteria

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, a-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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified