Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00372879
Status:
COMPLETED
Last Update Posted:
2016-03-03
First Post:
2006-09-05
Brief Title:
Clinical Trial of Vitamin E to Treat Muscular Cramps in Patients With ALS
Sponsor:
Lawson Health Research Institute
Organization:
Lawson Health Research Institute
Study Overview
Official Title:
Randomized Crossover Design Trial of Vitamin E vs Placebo for Treatment of Cramps in Amyotrophic Lateral Sclerosis
Status:
COMPLETED
Status Verified Date:
2016-03
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:
Muscular cramps are a common and uncomfortable symptom of amyotrophic lateral sclerosis ALS This clinical trial will compare the response of high dose vitamin E supplementation to placebo for treatment of muscular cramps in patients with ALS We hypothesize that vitamin E will be more effective than placebo in treating cramps
Detailed Description:
This will be a single centre randomized placebo controlled crossover design trial Participants will be randomized at study entry to protocol A vitamin E first or protocol B placebo first The first 2 weeks of the study will be a baseline assessment of the frequency severity and duration of cramps Patients will be blinded for the remainder of the duration of the study For weeks 3-6 of the study group A will receive vitamin E 800 IU bid and group B will receive placebo For weeks 7-10 of the study group A will receive placebo and group B will receive vitamin E Participants will record cramp frequency and characteristics via a daily journal for the duration of the study however the data analysis will focus on cramp frequency only during weeks 5-6 and 9-10 Weeks 3-4 and 7-8 will be used as time periods to allow the new drug to come to steady state and allow for washout of the previous drug Data analysis will focus on the difference in cramp frequency in individual patients in each treatment period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ALSClin-001 | None | None | None |