Ignite Creation Date:
2024-05-05 @ 10:18 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004802
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-02-24
Brief Title:
Phase III Randomized Double-Blind Placebo-Controlled Study of Dichlorphenamide for Periodic Paralyses and Associated Sodium Channel Disorders
Sponsor:
National Center for Research Resources NCRR
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
1998-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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:
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
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| OSU-92H0173 | None | None | None |