EUCTR2014-001891-73-PL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 - Reducing 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
- 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 completeda Study SD-809-C-18, Study SD-809-C-23, or any other controlled study of SD-809 for treatment of moderate to severe TD
- •3. Subject has a history of using a DRA 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 have been on stable therapy (dose, frequency) for =3 months before Screening.
- •Subject has a health care 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 prescribed medications.
- •7. Subject is able to swallow study drug whole.
- •8. 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 assent.
- •9. 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.
- •10. Subject has sufficient reading skills to comprehend the subject-completed rating scales.
- •11. Female subjects of childbearing potentialb 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 264
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 66
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 a history of any of the following within 6 months of Baseline:
- •Previous intent to act on suicidal ideation with a specific plan, 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.
- •11. Subject has a Fridericia-corrected QT interval (QTcF) value >450 ms (males) or >460 ms (females), or >480 ms (with right bundle branch block [RBBB]) on 12-lead electrocardiogram (ECG) at Baseline.
- •12. Subject has evidence of hepatic impairment at Screening of the parent study, 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 >17 seconds (i.e. prothrombin time prolonged >4 seconds over the ULN)
- •Positive Hepatitis B surface antigen (HBsAg).
- •13. Subject has evidence of significant renal impairment at Screening of the parent study,, 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 components of SD-809.
- •15. Subject has participated in an investigational drug or device trial (other than Study SD-809-C-18, Study SD-809-C-23 or any other eligible SD-809 parent study) and received study drug within 30 days (or 5 drug half-lives) of Baseline, whichever is longer.
- •16. Subject is pregnant or breast-feeding at Baseline.
- •17. Subject acknowledges present use of illicit drugs at Baseline.
- •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.
研究者
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