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. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 February 2015 |
Main ID: |
NCT00070993 |
Date of registration:
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09/10/2003 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Creatine for the Treatment of Amyotrophic Lateral Sclerosis
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Scientific title:
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Clinical Trial of Creatine in Amyotrophic Lateral Sclerosis |
Date of first enrolment:
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December 2002 |
Target sample size:
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110 |
Recruitment status: |
Completed |
URL:
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http://clinicaltrials.gov/show/NCT00070993 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Phase:
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Phase 2
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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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Jeffrey Rosenfeld, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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Carolinas Medical Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria
- Diagnosis of probable or definite ALS
- At least 5 of 10 testable upper extremity muscle groups (shoulder and elbow
extensors/flexors and grip) of Medical Research Council (MRC) grade 4 or better
- At least 5 years from onset of symptoms
Exclusion Criteria
- Requires tracheostomy ventilation
- History of renal disease
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
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Intervention(s)
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Drug: creatine monohydrate
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Secondary ID(s)
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R01 AT000967-01
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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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