EUCTR2014-001890-15-CZ进行中（未招募）1 期
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF SD-809 (DEUTETRABENAZINE) FOR THE TREATMENT OF MODERATE TO SEVERE TARDIVE DYSKINESIA - Aim to Reduce Movements in Tardive Dyskinesia (ARM-TD)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 92
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Subject is between 18 and 75 years of age, inclusive.
- •2. Subject has a history of using a dopamine receptor antagonist for at least 3 months (or 1 month in subjects 60 years of age and older).
- •3. Subject has a clinical diagnosis of TD and has had symptoms for at least 3 months prior to Screening.
- •4. The subject's TD symptoms are bothersome to the subject or cause functional impairment.
- •5. At the Screening and Baseline visits, the subject has:
- •Moderate or severe abnormal movements as judged by the Investigator based on Item 8 of the AIMS, AND
- •A total motor AIMS score of = 6 (based on Items 1 through 7) as assessed by the Investigator.
- •Note: A video recording of the AIMS at Screening will also be reviewed by a blinded central rater to confirm eligibility prior to randomization.
- •6. For subjects with underlying psychiatric illness:
- •Subject is psychiatrically stable and has had no change in psychoactive medications (including, but not limited to, neuroleptics, benzodiazepines, anticonvulsants, and mood stabilizers) for = 30 days before Screening (45 days for antidepressants).
- •Subjects on long-acting (depot) medications been on stable therapy (dose, frequency) for =3 months before Screening.
- •Subject has a mental health provider who is aware of the subject's participation in the trial, and does not anticipate any changes to the subject's treatment regimen (drug, dose, frequency) in the next 3 months.
- •7. Subject has a history of being compliant with medications.
- •8. Subject is able to swallow study drug whole.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 73
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 19
排除标准
- •1. Subject has received any of the following medications within 30 days of Screening or
- •Tetrabenazine, reserpine, a-methyl-p-tyrosine (AMPT), botulinum toxin (within 3 months of Screening), and medications with strong anticholinergic activity (trihexyphenidyl, benztropine, orphenadrine, procyclidine, and biperiden)
- •Metoclopramide, promethazine, and prochlorperazine
- •Stimulants (i.e., methylphenidate, amphetamine/dextroamphetamine, lisdexamphetamine, etc.), or monoamine oxidase inhibitors (MAOIs)
- •Levodopa or dopamine agonists
- •2. Subject has participated in any previous study of SD-809 in which they received SD-809.
- •3. Subject has a neurological condition other than TD that may interfere with assessing the severity of dyskinesias.
- •4. Subject has a serious untreated or undertreated psychiatric illness at Screening or Baseline.
- •5. Subject has active suicidal ideation at Screening or Baseline.
- •6. Subject has history of any of the following within the last 6 months of Screening:
- •Previous intent to act on suicidal ideation with a specific plan (positive answer to question 5 on C-SSRS), irrespective of level of ambivalence at the time of suicidal thought
- •Previous preparatory acts to commit suicide or suicidal behavior
- •A previous actual, interrupted or aborted suicide attempt
- •7. Subject has a score =11 on the depression subscale of the Hospital Anxiety and Depression Scale (HADS) at Screening or Baseline.
- •8. Subject is developmentally disabled or has evidence of dementia.
- •9. Subject has an unstable or serious medical illness at Screening or Baseline.
- •10. Subject has history (within 3 months) or presence of violent behavior.
研究者
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