Amyotrophic Lateral Sclerosis (ALS) Clinical Trial
Official title:
A Phase III, Multi-Center, Double-Blind, Placebo Controlled, Randomized Study of Creatine Monohydrate in Patients With Amyotrophic Lateral Sclerosis
Verified date | April 2005 |
Source | The Avicena Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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).
Status | Active, not recruiting |
Enrollment | 107 |
Est. completion date | April 2005 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 21 Years to 80 Years |
Eligibility |
- A clinical diagnosis of probable or definite lab-supported ALS, either SALS or FALS,
according to modified El Escorial criteria. - Males or females, 21 to 80 years of age. - Patients receiving treatment with RilutekĀ® (riluzole) must be on a stable dose for at least 30 days immediately prior to enrollment. - Women of childbearing potential must be non-lactating and surgically sterile or using an effective method of birth control (double barrier or oral contraception) and have a negative pregnancy test. Women will be considered menopausal if they have not had a menstrual cycle (period) for two years. - Disease duration less than five years since symptom onset. - At least 5 of 10 testable upper extremity muscle groups of MRC grade 4 or better. - The patient must have given informed consent that has been approved by the appropriate Institutional Review Board (IRB). |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of New Mexico | Albuquerque | New Mexico |
United States | Carolinas Medical Center | Charlotte | North Carolina |
United States | University of Virginia Health System | Charlottesville | Virginia |
United States | Duke University Medical Center | Durham | North Carolina |
United States | University of Kansas | Kansas City | Kansas |
United States | Oregon Health Sciences University | Portland | Oregon |
United States | University of Texas Health Science Center | San Antonio | Texas |
United States | University of California, San Francisco | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
The Avicena Group |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in upper extremity motor function after 3 weeks | |||
Primary | Change in upper extremity motor function after 9 months | |||
Secondary | Acute changes in muscle strength | |||
Secondary | Chronic changes in muscle strength | |||
Secondary | ALS functioning | |||
Secondary | Quality of life | |||
Secondary | Pulmonary function | |||
Secondary | Muscle fatigue. |
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