Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00069186
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2003-09-17
Brief Title:
Study of Creatine Monohydrate in Patients With Amyotrophic Lateral Sclerosis
Sponsor:
The Avicena Group
Organization:
The Avicena Group
Study Overview
Official Title:
A Phase III Multi-Center Double-Blind Placebo Controlled Randomized Study of Creatine Monohydrate in Patients With Amyotrophic Lateral Sclerosis
Status:
UNKNOWN
Status Verified Date:
2005-04
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether nine months of administration of creatine monohydrate results in an increase in muscle strength in patients with amyotrophic lateral sclerosis ALS
Detailed Description:
Introduction Twenty-one ALS patients were enrolled in a placebo controlled pilot study at the Carolinas NeuromuscularALS-MDA Center The University of Texas Health Science Center at San Antonio and The University of New Mexico at Albuquerque At all time points sampled over a nine month period patients taking creatine monohydrate had either a significantly greater improvement in their strength or a more modest decline compared to the patients taking placebo Overall analysis of variance is significant for both an effect of the drug p0002 and time p 0001The pilot study also showed that quality of life as measured by ALSFRS-R correlated significantly with the observed changes in muscle strength MVIC
Phase III Study The primary objective of this study is to determine whether treatment with creatine monohydrate results in an increase in muscle strength relative to placebo in patients with amyotrophic lateral sclerosis ALS after three months and at the end of a nine-month treatment period
The study is a Phase III eight-center double-blind placebo-controlled randomized clinical trial designed to evaluate the safety and efficacy of creatine monohydrate in patients fulfilling the eligibility criteria The subjects n156 will be randomized in a 11 ratio to receive treatment of highly purified creatine monohydrate or placebo Dextrose USP for nine months The subjects will be administered 10 grams of creatine monohydrate per day for the first five days and then 5 grams per day thereafter Each subject will be followed for the nine-month treatment period
The primary outcome measure for the study is change in upper extremity motor function after three weeks and at the end of a nine-month treatment period as tested by MVIC Strength in ten arm muscles will be measured bilateral shoulder and elbow flexionextension and grip
Patient safety will be assured by ongoing review of reports of adverse events clinical laboratory data and measurement of vital signs These tests include measurement of MVIC and muscle fatigue measurement of FVC completion of ALSFRS-R and SF-12 quality of life instruments review of potential adverse effects determination of vital signs and weight serum creatinine and BUN and urine dipstick for protein
Phase III Study The primary objective of this study is to determine whether treatment with creatine monohydrate results in an increase in muscle strength relative to placebo in patients with amyotrophic lateral sclerosis ALS after three months and at the end of a nine-month treatment period
The study is a Phase III eight-center double-blind placebo-controlled randomized clinical trial designed to evaluate the safety and efficacy of creatine monohydrate in patients fulfilling the eligibility criteria The subjects n156 will be randomized in a 11 ratio to receive treatment of highly purified creatine monohydrate or placebo Dextrose USP for nine months The subjects will be administered 10 grams of creatine monohydrate per day for the first five days and then 5 grams per day thereafter Each subject will be followed for the nine-month treatment period
The primary outcome measure for the study is change in upper extremity motor function after three weeks and at the end of a nine-month treatment period as tested by MVIC Strength in ten arm muscles will be measured bilateral shoulder and elbow flexionextension and grip
Patient safety will be assured by ongoing review of reports of adverse events clinical laboratory data and measurement of vital signs These tests include measurement of MVIC and muscle fatigue measurement of FVC completion of ALSFRS-R and SF-12 quality of life instruments review of potential adverse effects determination of vital signs and weight serum creatinine and BUN and urine dipstick for protein
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 |
|---|---|---|---|
| Orphan Drug01-1527 | None | None | None |