Phase III Randomized, Double-Blind, Placebo-Controlled Study of Dichlorphenamide for Periodic Paralyses and Associated Sodium Channel Disorders
NCT ID: NCT00004802
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
64 participants
INTERVENTIONAL
1992-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
TREATMENT
DOUBLE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
dichlorphenamide
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion 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
10 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ohio State University
OTHER
National Center for Research Resources (NCRR)
NIH
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jerry R. Mendell
Role: STUDY_CHAIR
Ohio State University
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
OSU-92H0173
Identifier Type: -
Identifier Source: secondary_id
199/11958
Identifier Type: -
Identifier Source: org_study_id