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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00069186 |
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Date of registration:
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17/09/2003 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Study of Creatine Monohydrate in Patients With Amyotrophic Lateral Sclerosis
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Scientific title:
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A Phase III, Multi-Center, Double-Blind, Placebo Controlled, Randomized Study of Creatine Monohydrate in Patients With Amyotrophic Lateral Sclerosis |
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Date of first enrolment:
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June 2003 |
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Target sample size:
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107 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00069186 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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United States
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Contacts
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Name:
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Rosenfeld Jeffrey, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Carolinas ALS Center |
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Key inclusion & exclusion criteria
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- 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 Rilutek® (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).
Age minimum:
21 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Amyotrophic Lateral Sclerosis (ALS)
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Intervention(s)
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Drug: Creatine Monohydrate
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Primary Outcome(s)
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Change in upper extremity motor function after 9 months
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Change in upper extremity motor function after 3 weeks
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Secondary Outcome(s)
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Quality of life
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ALS functioning
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Acute changes in muscle strength
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Chronic changes in muscle strength
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Muscle fatigue.
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Pulmonary function
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Secondary ID(s)
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AGI-ALS-III-01
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Orphan Drug:01-1527
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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