Hyper- and Hypokalemic Periodic Paralysis Study

2010-07-15 17:00:00 | BioPortfolio


The purpose of this study is to compare Dichlorphenamide with placebo (an inactive substance) for prevention of episodes and for improvement of strength in periodic paralysis. This study will also look at the long-term effects of Dichlorphenamide in periodic paralysis.


Periodic paralysis is a relatively rare, life-long disorder characterized by intermittent bouts of paralysis, progressive weakness, and diminished quality of life. Two drugs, acetazolamide and dichlorphenamide, have been prescribed to treat the disorder, however, dichlorphenamide is no longer available.

In this multi-center, parallel, randomized trial researchers will compare the effects of dichlorphenamide vs. placebo in patients with hyperkalemic (HYP) and hypokalemic (HOP) periodic paralysis.

The trial consists of two 9-week studies—one study will enroll persons with hyperkalemic periodic paralysis and the other study will enroll persons with hypokalemic periodic paralysis. Participants will be randomly assigned to one of two treatment groups: dichlorphenamide or placebo (an inactive substance). During the studies, participants will be asked to keep a daily computer diary to record the time, length, and severity of each episode of weakness. The study coordinator will contact participants weekly to review the diary information.

The 9-week phase will be followed by a 1-year open-label dichlorphenamide extension without placebo to determine the long-term effects of dichlorphenamide on the course of the disease and on inter-attack weakness.

Duration of the trial for participants is approximately 65 weeks, including a screening phase to determine eligibility, the first 9-week treatment phase, and the one-year open-label extension phase.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Periodic Paralysis


Dichlorphenamide, Placebo


University of California-San Francisco
San Francisco
United States




University of Rochester

Results (where available)

View Results


Published on BioPortfolio: 2010-07-15T17:00:00-0400

Clinical Trials [139 Associated Clinical Trials listed on BioPortfolio]

Phase III Randomized, Double-Blind, Placebo-Controlled Study of Dichlorphenamide for Periodic Paralyses and Associated Sodium Channel Disorders

OBJECTIVES: I. Assess the efficacy of dichlorphenamide in the treatment of episodic weakness attacks in patients with hyperkalemic periodic paralysis, paramyotonia congenita with periodi...

Bumetanide in Hypokalaemic Periodic Paralysis

This is a randomised, double-blind, placebo-controlled phase II clinical trial with a cross-over design to investigate the efficacy of bumetanide in patients with hypokalemic periodic para...

Genetic Analysis of Thyrotoxic Periodic Paralysis

Thyrotoxic periodic paralysis (TPP) is characterized by episodes of reversible hypokalemia and weakness in thyrotoxic patients. It is commonly found in males of Asian descent and is also s...

Multislice Computed Tomography in Cases With Facial Nerve Paralysis Due to Temporal Bone Trauma

Facial nerve paralysis is a disfiguring complication which occurs in 7-10 % of temporal bone fractures. The onset of paralysis may be immediate, delayed or undetermined, the latter of whi...

Effects of Mindfulness Meditation on Facial Paralysis Patients

Currently, physicians have several options in addressing the anatomic and physiologic sequela of facial paralysis. However, strategies to address the psychologic and coping ability for pat...

PubMed Articles [1540 Associated PubMed Articles listed on BioPortfolio]

Increased promoter activity as a mechanism in atypical normokalemic periodic paralysis.

To identify the genetic basis of a patient with symptoms of normokalemic sporadic periodic paralysis (PP) and to study the effect of mutations.

A novel ATP1A2 mutation in a patient with hypokalaemic periodic paralysis and CNS symptoms.

Hypokalaemic periodic paralysis is a rare genetic neuromuscular disease characterized by episodes of skeletal muscle paralysis associated with low serum potassium. Muscle fibre inexcitability during a...

The Long Exercise Test in Periodic Paralysis: A Bayesian Analysis.

The long exercise test (LET) is used to assess the diagnosis of periodic paralysis (PP), but LET methodology and normal "cut-off" values vary.

Looking for periodic paralysis: Optimizing the long exercise test.

Thyrotoxic hypokalemic periodic paralysis.

Medical and Biotech [MESH] Definitions

A heterogenous group of inherited disorders characterized by recurring attacks of rapidly progressive flaccid paralysis or myotonia. These conditions have in common a mutation of the gene encoding the alpha subunit of the sodium channel in skeletal muscle. They are frequently associated with fluctuations in serum potassium levels. Periodic paralysis may also occur as a non-familial process secondary to THYROTOXICOSIS and other conditions. (From Adams et al., Principles of Neurology, 6th ed, p1481)

An autosomal dominant familial disorder which presents in infancy or childhood and is characterized by episodes of weakness associated with hyperkalemia. During attacks, muscles of the lower extremities are initially affected, followed by the lower trunk and arms. Episodes last from 15-60 minutes and typically occur after a period of rest following exercise. A defect in skeletal muscle sodium channels has been identified as the cause of this condition. Normokalemic periodic paralysis is a closely related disorder marked by a lack of alterations in potassium levels during attacks of weakness. (Adams et al., Principles of Neurology, 6th ed, p1481)

A carbonic anhydrase inhibitor that is used in the treatment of glaucoma.

A form of inherited long QT syndrome (or LQT7) that is characterized by a triad of potassium-sensitive periodic paralysis, VENTRICULAR ECTOPIC BEATS, and abnormal features such as short stature, low-set ears, and SCOLIOSIS. It results from mutations of KCNJ2 gene which encodes a channel protein (INWARD RECTIFIER POTASSIUM CHANNELS) that regulates resting membrane potential.

Paralysis of an infant resulting from injury received at birth. (From Dorland, 27th ed)

More From BioPortfolio on "Hyper- and Hypokalemic Periodic Paralysis Study"

Quick Search


Searches Linking to this Trial