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

N

National Center for Research Resources (NCRR)

Status and phase

Completed
Phase 3

Conditions

Paralysis, Hyperkalemic Periodic
Hypokalemic Periodic Paralysis
Paramyotonia Congenita

Treatments

Drug: dichlorphenamide

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00004802
199/11958
OSU-92H0173

Details and patient eligibility

About

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.

Full description

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.

Sex

All

Ages

10 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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
  • Steroids
  • Calcium supplements
  • Beta-blockers
  • Potassium supplements
  • Calcium channel blockers

--Patient Characteristics--

Hepatic: No hepatic disease

Renal:

  • No renal failure
  • No nephrolithiasis

Cardiovascular:

  • No heart disease
  • No cardiac arrhythmia

Pulmonary: No restrictive or obstructive lung disease

Other:

  • No active thyroid disease
  • No pregnant women

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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