NCT01950234终止2 期
Treatment of Progressive Forms of Multiple Sclerosis With Pulsed ACTH (Acthar Gel)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 59
- 试验地点
- 3
- 主要终点
- Proportion of Patients Exhibiting a 20% Worsening in T25FW at 36 Months
研究概览
简要总结
This is a phase II, randomized, double-blind, placebo-controlled, multi-center study to evaluate the safety, tolerability, and efficacy of adrenocorticotropic hormone (ACTH, Acthar gel) administered as a pulsed regimen consisting of injections on three consecutive days per month in patients with progressive forms of Multiple Sclerosis (MS). Patients will be randomly assigned to either an ACTH arm or a placebo arm. The main hypotheses are that 1) pulsed ACTH will be safe and well-tolerated, and 2) pulsed ACTH will slow progression of clinical and paraclinical measures of MS progression compared to placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients with a confirmed diagnosis of MS by McDonald criteria
- •Age >/= 18 years
- •SPMS, PPMS, or PRMS phenotype, according to Lublin and Reingold criteria
- •EDSS 2.0 - 6.0, inclusive
- •Able to understand the consent process
排除标准
- •Known intolerance of ACTH or corticosteroids
- •Diabetes mellitus, defined as pre-existing diagnosis, fasting blood glucose > 125 mg/dl, or glycosylated hemoglobin >/= 6.5%
- •Osteoporosis, defined as pre-existing diagnosis or T-score on dual-energy x-ray absorptiometry (DEXA) scan of </= -2.
- •Current serious medical condition which may interfere with subject's ability to complete the study, or for which pulsed ACTH therapy is contraindicated or might complicate current therapy (e.g., cancer, severe psychiatric illness, chronic infections, autoimmune disorders)
- •Treatment with cytotoxic agents (including but not necessarily limited to mitoxantrone, cyclophosphamide, alemtuzumab, or rituximab) within 3 years prior to randomization
- •Treatment with non-cytotoxic immunosuppressive agents (including but not necessarily limited to corticosteroids, ACTH, azathioprine, mycophenolate mofetil, methotrexate or natalizumab) within 3 months prior to randomization
- •Treatment with FDA-approved first-line MS disease-modifying therapies (B-interferon, glatiramer acetate, fingolimod, teriflunomide or dimethyl fumarate) will be permitted, as long as treatment has been ongoing and stable for at least 3 months prior to randomization
- •Treatment with dalfampridine or compounded 4-aminopyridine (4-AP) will be permitted as long as treatment has been ongoing and stable for at least 3 months prior to randomization
- •Stimulant medications for fatigue (such as methylphenidate, modafinil, armodafinil, amantadine or dextroamphetamine) will be permitted, but subjects will be asked to not take these medications on study visit days until all study procedures/assessments are completed.
研究组 & 干预措施
ACTH
Experimental
ACTH administered subcutaneously as a pulsed regimen of 3 consecutive days per month
干预措施: ACTH (Drug)
Placebo
Placebo Comparator
Placebo subcutaneous injections administered on 3 consecutive days per month
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of Patients Exhibiting a 20% Worsening in T25FW at 36 Months
时间窗: Month 36
次要结局
- Safety and Tolerability of ACTH: Bruising(Month 36)
- Safety and Tolerability of ACTH: Menstrual Changes [Female](Month 36)
- Safety and Tolerability of ACTH: Swelling Ankles(Month 36)
- Safety and Tolerability of ACTH: Hair Loss(Month 36)
- Safety and Tolerability of ACTH: Acne(Month 36)
- Safety and Tolerability of ACTH: Insomnia(Month 36)
- Safety and Tolerability of ACTH: Mood Change(Month 36)
- Safety and Tolerability of ACTH: GI Upset(Month 36)
- Safety and Tolerability of ACTH: Fatigue(Month 36)
- Safety and Tolerability of ACTH: Unpleasant Taste(Month 36)
- Safety and Tolerability of ACTH: Blurred Vision(Month 36)
- Safety and Tolerability of ACTH: Moon Facies(Month 36)
- Safety and Tolerability of ACTH: Skin Thinning(Month 36)
- Safety and Tolerability of ACTH: Cataracts(Month 36)
- Safety and Tolerability of ACTH: Myopathy(Month 36)
- Safety and Tolerability of ACTH: Change in Hemoglobin A1c(Month 36)
- Safety and Tolerability of ACTH: DEXA Scans(Month 36)
- Safety and Tolerability of ACTH: Hirsuitism(Month 36)
- Safety and Tolerability of ACTH: Ankle Swelling(Month 36)
研究者
研究点 (3)
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