EUCTR2014-003135-19-SK进行中（未招募）1 期
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, FIXED-DOSE STUDY OF SD-809 (DEUTETRABENAZINE) FOR THE TREATMENT OF MODERATE TO SEVERE TARDIVE DYSKINESIA - AIM-TD (Addressing Involuntary Movements in 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
- 288
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 80 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 assessment at Screening will be reviewed by a blinded central rater to confirm eligibility based on Items 1 through 7 of the AIMS 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 have 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 prescribed medications.
- •8. Subject is able to swallow study drug whole.
- •9. Subject has provided written, informed consent or, if subject lacks the capacity to provide informed consent, a legally authorized representative (LAR) has provided written informed consent and the subject has provided written assent.
- •10. In the opinion of the Investigator, the subject lives in a stable environment, and has adequate supervision when necessary to comply with all study procedures, attend all study visits and safely participate in the trial.
- •11. Subject is in good general health, is expected to attend all study visits and is expected to complete all study assessments, in the opinion of the Investigator.
- •12. Subject has sufficient reading skills to comprehend the
- •subjectcompleted rating scales.
- •13. Female subjects of childbearing potential a agree to use one of the following acceptable methods of contraception from Screening through study completion if sexually active:
- •IUD or intrauterine system in place for at least 3 months prior to screening;
- •Subject or partner using barrier method (e.g., condom, diaphragm, or cervical cap) with spermicide from Screening through study completion;
- •Partner has a documented vasectomy >6 months prior to enrollment.
- •Stable hormonal contraception (with approved oral, transdermal, or depot regimen) for at least 3 months prior to Screening.
- •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 201
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 87
排除标准
- •1. Subject has received any of the following medications within 30 days of Screening or Baseline:
- •Tetrabenazine, reserpine, a-methyl-p-tyrosine (AMPT), botulinum toxin (within 3 months of Screening), medications with strong anticholinergic activity (trihexyphenidyl, benztropine, orphenadrine, procyclidine, and biperiden)
- •Metoclopramide, prochlorperazine, or promethazine
- •Stimulants(i.e., methylphenidate, amphetamine/dextroamphetamine, lisdexamphetamine, etc.), or monoamine oxidase inhibitors (MAOIs)
- •Levodopa or dopamine agonists
- •2. Subject has previously participated in a study with 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 a Baseline.
- •5. Subject has active suicidal ideation at Screening or Baseline.
- •6. Subject has history of any of the following within 6 months of Screening:
- •Previous intent to act on suicidal ideation with a specific plan (positive answer to question 5 on C-SSRS)
- •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 has 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.
- •11. Subject has a QTcF value >450 ms (males) or >460 ms (females), or >480 ms (with right bundle branch block [RBBB]) on 12-lead ECG at Screening.
- •12. Subject has evidence of hepatic impairment at Screening, as indicated by:
- •Aspartate transaminase (AST) or alanine aminotransferase (ALT) >2.5 times the upper limit of normal (ULN).
- •Alkaline phosphatase (ALP) or total bilirubin (TBil) >2 times the ULN
- •o Note: Subjects with Gilbert's Syndrome are eligible to participate if approved by the Medical Monitor.
- •o Note: Subjects with abnormalities in two or more of these analytes (AST, ALT, ALP, TBil) must be approved by the Medical Monitor to be enrolled.
- •Prothrombin time >4 seconds prolonged.
- •Positive Hepatitis B surface antigen (HBsAg).
- •13. Subject has evidence of significant renal impairment at Screening, indicated by a creatinine clearance <50 mL/min, as estimated by the Cockroft-Gault formula.
- •14. Subject has known allergy to tetrabenazine or to any of the excipients of SD-809.
- •15. Subject has participated in an investigational drug or device trial and received study drug within 30 days (or 5 drug half-lives) of Screening, whichever is longer.
- •16. Subject is pregnant or breast-feeding at Screening or Baseline.
- •17. Subject acknowledges present use of illicit drugs at Screening.
- •18. Subject has a history of alcohol or substance abuse in the previous 12 months, as defined in the DSM-V, or subject is unable to refrain from substance abuse throughout the study.
- •19. Subject has a positive urine drug screen (for amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, or opiates) at Screening or Baseline, except if subject is receiving a stable dose of a benzodiazepine.
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