EUCTR2004-000622-67-GB进行中（未招募）1 期
A Double-Blind, Placebo-Controlled, Randomized, Multiple Ascending Dose, Safety Study of MYO-029 Administered to Adult Patients with Becker, Facioscapulohumeral and Limb-Girdle Muscular Dystrophy.
Wyeth Research Division of Wyeth Pharmaceuticals Inc.0 个研究点目标入组 136 人开始时间: 2005年2月10日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 136
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
入选标准
- •1. Age >=18 years.
- •2. Confirmed clinical and molecular diagnosis of BMD, FSHD, or LGMD 2A, 2B, 2C, 2D, 2E, or 2I using the specific diagnostic criteria listed in Section 19, Muscular Dystrophy History
- •3. Independent ambulation as assessed by completion of a 9-meter walking test. The use of an ankle foot orthosis is permitted if needed.
- •4. Screening period- first strength evaluation: at least 8 of the following 16 muscle groups must have a MMT muscle grade >= 3- and <= 4+ on the modified Medical Research Council Scale:
- •Shoulder flexors, Shoulder abductors, Shoulder external rotators, Shoulder internal rotators, Biceps, Elbow extensors, Brachioradialis (all bilateral), Neck Flexors, Neck Extensors.
- •5. Screening period- second strength evaluation: at least 10 of the following 16 muscle groups must have an MMT grade that is within 2 steps of the grade assigned at the first screening evaluation:
- •Shoulder flexors, Shoulder abductors, Shoulder external rotators, Shoulder internal rotators, Biceps, Elbow extensors, Brachioradialis (all bilateral), Neck flexors, Neck Extensors.
- •6. Forced vital capacity (FVC) >= 60% of predicted (performed while seated) at Visit 1
- •7. Ejection fraction > 40% as measured by echocardiogram at Visit 1.
- •8. Male subjects who are not surgically sterile agree and commit to the use of 2 reliable methods of birth control for the duration of the study and for 12 weeks after the last dose of test article.
- •9. Female subjects who are surgically sterile or postmenopausal.
- •10. Able to comply with all study evaluations and return for all study visits.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Known history of congestive heart failure.
- •2. Diagnosis of atherosclerotic heart disease.
- •3. Use of anti-arrhythmic treatment during the 12 weeks before randomization.
- •4. Use of chronic anti-coagulant treatment during the 12 weeks before randomization.
- •5. Use of steroids such as, but not limited to, prednisone, prednisolone, deflazacort, and oxandrolone, during the 6 months before randomization and for the duration of the study with the exception of topical, inhaled and/or intranasal steroids used for a condition other than muscular dystrophy.
- •6. Use of any other pharmacologic treatment with the potential to affect muscle function such as, but not limited to, albuterol and creatine during the 4 weeks before randomization and for the duration of the study.
- •7. Initiation of, or significant change in, endurance and/or strengthening exercises with the potential to affect muscle function during the 8 weeks before randomization and for the duration of the study.
- •8. Surgery performed during the 12 weeks before randomization or planned for the duration of the study.
- •9. Concomitant co-morbidity that functionally limits the ability to perform required study procedures (eg, MMT, MRI, etc.).
- •10. Any contraindication to MRI per site standard of care, including the presence of any metal implants.
- •11. Significant concomitant intercurrent illness.
- •12. History of sensitivity to monoclonal antibodies or protein pharmaceuticals.
- •13. Lactating women.
- •14. Women of childbearing potential
- •15. Use of any experimental treatments or participation in a clinical trial during the 4 weeks before randomization and for the duration of the study.
- •16. Any other major illness or reason that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in this study.
- •17. Diagnosis of LGMD other than LGMD 2A, 2B, 2C, 2D, 2E, and 2I.
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