|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT00004802 |
|
Date of registration:
|
24/02/2000 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Phase III Randomized, Double-Blind, Placebo-Controlled Study of Dichlorphenamide for Periodic Paralyses and Associated Sodium Channel Disorders
|
|
Scientific title:
|
|
|
Date of first enrolment:
|
June 1992 |
|
Target sample size:
|
64 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00004802 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
|
|
Phase:
|
Phase 3
|
|
|
Contacts
|
|
Name:
|
Jerry R. Mendell |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Ohio State University |
| | |
|
Key inclusion & 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
Age minimum:
10 Years
Age maximum:
75 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Hypokalemic Periodic Paralysis
|
|
Paramyotonia Congenita
|
|
Paralysis, Hyperkalemic Periodic
|
|
Intervention(s)
|
|
Drug: dichlorphenamide
|
|
Secondary ID(s)
|
|
OSU-92H0173
|
|
199/11958
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|