EUCTR2016-001356-22-HU进行中（未招募）1 期
A PLACEBO-CONTROLLED RANDOMIZED WITHDRAWAL EVALUATION OF THE EFFICACY AND SAFETY OF BACLOFEN ER CAPSULES (GRS) IN SUBJECTS WITH SPASTICITY DUE TO MULTIPLE SCLEROSIS
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 300
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. Men and women age 18 years and older
- •2. Women of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s) [such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), oral or long acting injected contraceptives, bilateral tubal ligation or vasectomized partner] for at least 3 months prior to study entry OR postmenopausal for at least 1 year OR surgically sterile (bilateral oophorectomy or hysterectomy)
- •3. If female, negative pregnancy test
- •4. Known history of spasticity due to MS prior to starting baclofen
- •5. Clinically acceptable symptom control but with evidence of some residual spasticity associated with MS (meaning a modified Ashworth score of 1 on at least one lower extremity movement and no movement with a score of 4)
- •6. A stable daily dose of Baclofen IR, ranging from 30 to 60 mg/day (i.e., same dose given in the same schedule for last 30 days)
- •7. Has an ECG that is not clinically significantly, abnormal and a blood pressure <160/95 mmHg (systolic/diastolic) at screening, measured in the sitting position after approximately 5 minutes of quiet rest
- •8. If the subject has a history of or presence of clinically significant liver disease, diabetes mellitus, hypertension or heart disease, the subject must be on a stable treatment regimen for a minimum of 3 months prior to Screening Visit
- •9. Able and willing to comply with the protocol, including availability for all scheduled clinic visits
- •10. Willingness and giving of written informed consent
- •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 270
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1. History of hypersensitivity to baclofen
- •2. In relapse or history of unstable course over the prior 30 days prior to the Screening Visit
- •3. Concomitant neurologic conditions causing spasticity (e.g., stroke, cerebral palsy, traumatic brain injury) or rigidity (e.g., Parkinson?s disease, contractures that confound assessment of spasticity)
- •4. Advanced arthritis or any other cause of clinically significant limitation of passive range of motion around any of the joints being assessed in this study
- •5. Any medical condition, including psychiatric disease or epilepsy, which would interfere with the interpretation of the study results, the conduct of the study, or the safety of the subject
- •6. History or clinical evidence of achlorhydria, diabetic gastroparesis, severe gastrointestinal disease, particularly diarrhea or other conditions affecting gastrointestinal mobility or absorption
- •7. History of alcohol abuse or use of recreational drugs within 12 months prior to the Screening Visit
- •8. Receipt of systemic corticosteroid therapy within the 30 days prior to the Screening Visit
- •9. Use of medications that could influence muscle tone, such as benzodiazepines (within 21 days of Screening Visit), and the following medications within 3 days of Screening Visit: anti-spasticity medications, including tizanidine and fampridine/dalfampridine, and muscle relaxants, including cyclobenzaprine, metaxalone, dantrolene, mephenesin, carisoprodol, and methocarbamol, meprobamate, chlorzoxazone, and chlormezanone, and GABAergic drugs
- •10. Has received an investigational drug or device within 30 days that would interfere with the study goals prior to the Screening Visit
- •11. Unable to comply with study procedures in the opinion of the investigator
- •12. Treated with Botulinum Toxin Type A or B within the previous 6 months, or Phenol or therapeutic alcohol nerve block within 12 months prior to the Screening Visit in the muscle groups to be evaluated in the study
- •13. Has had major surgery within 3 months prior to Screening visit that may affect spasticity assessments such as abdominal surgery, back surgery, or lower leg or knee surgeries
研究者
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