EUCTR2014-001891-73-HU进行中（未招募）1 期
AN OPEN-LABEL, LONG-TERM SAFETY STUDY OF SD-809 (DEUTETRABENAZINE) FOR THE TREATMENT OF MODERATE TO SEVERE TARDIVE DYSKINESIA
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 337
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 at least 18 years of age at Screening.
- •2. Subject has successfully completed Study SD-809-C-18 or any other controlled study of SD-809 for treatment of moderate to severe TD.
- •3. 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).
- •4. Subject has a clinical diagnosis of TD and has had symptoms for at least 3 months prior to Screening.
- •5. 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.
- •6. Subject has a history of being compliant with medications.
- •7. 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 64
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 16
排除标准
- •1. Subject has received tetrabenazine within 7 days of Baseline.
- •2. Subject has received any of the following medications within 30 days of Baseline:
- •Reserpine, a-methyl-p-tyrosine (AMPT), botulinum toxin (within 3 months of
- •Baseline), 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
- •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 Baseline.
- •5. Subject has active suicidal ideation at Baseline.
- •6. Subject has history of any of the following within the last 6 months of Baseline:
- •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 Baseline.
- •8. Subject is developmentally disabled or has evidence of dementia.
- •9. Subject has an unstable or serious medical illness at Baseline.
- •10. Subject has history (within 3 months) or presence of violent behavior.
研究者
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