Phase III Randomized, Double-Blind, Placebo-Controlled Study of Dichlorphenamide for Periodic Paralyses and Associated Sodium Channel Disorders
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 64
研究概览
简要总结
OBJECTIVES:
I. Assess the efficacy of dichlorphenamide in the treatment of episodic weakness attacks in patients with hyperkalemic periodic paralysis, paramyotonia congenita with periodic paralysis, and hypokalemic periodic paralysis.
详细描述
PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by participating institution and diagnosis.
The weekly attack rate is determined during an 8-week assessment prior to therapy initiation and at crossover.
Patients are randomly assigned to oral dichlorphenamide (DCP) or placebo for 9 weeks and then cross to the alternate treatment. Patients on DCP at baseline continue on the same dose; those on acetazolamide (ACZ) at baseline receive a DCP dose equivalent to one fifth of the ACZ dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 10 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PROTOCOL ENTRY CRITERIA:
- •-Disease Characteristics--
- •Hypokalemic periodic paralysis Typical clinical profile Normal serum thyroxine Hypokalemia during spontaneous or glucose-induced paralytic attack in subject or affected family member
- •Periodic paralysis associated with sodium channel 17q alpha-subunit, e.g.:
- •Hyperkalemic periodic paralysis with or without myotonia
- •Paramyotonia congenita with periodic paralysis
- •Distinct, regular episodes of weakness at least once a week and no more than 3 times a day
- •No history of worsening symptoms with carbonic anhydrase inhibitor
- •No history of life-threatening weakness episodes prior to treatment
- •No atypical periodic paralysis without demonstrable 17q alpha-subunit defect
- •-Prior/Concurrent Therapy--
- •No requirement for the following agents, unless for periodic paralysis:
- •Diuretics
- •Antiepileptics
- •Antiarrhythmics
- •Magnesium supplements
- •Calcium supplements
- •Beta-blockers
- •Potassium supplements
- •Calcium channel blockers
- •-Patient Characteristics--
- •Hepatic: No hepatic disease
- •No renal failure
- •No nephrolithiasis
- •Cardiovascular:
- •No heart disease
- •No cardiac arrhythmia
- •Pulmonary: No restrictive or obstructive lung disease
- •No active thyroid disease
- •No pregnant women
排除标准
- 未提供