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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: |
NCT00107770 |
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Date of registration:
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07/04/2005 |
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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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Safety Study of Oral Sodium Phenylbutyrate in Subjects With ALS (Amyotrophic Lateral Sclerosis)
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Scientific title:
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Safety and Dose Escalating Study of Oral Sodium Phenylbutyrate in Subjects With Amyotrophic Lateral Sclerosis |
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Date of first enrolment:
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April 2005 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00107770 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1/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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Robert Ferrante, PhD MSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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Edith Nourse Rogers Memorial Veterans Hospital, Bedford |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosed with ALS
- At least 18 years of age
- Women, who can become pregnant, must actively use effective birth control measures
Exclusion Criteria:
- Must not have any other neurological (nervous system) disease
Veterans only are eligible to participate at VA sites.
Age minimum:
18 Years
Age maximum:
N/A
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: sodium phenylbutyrate
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Primary Outcome(s)
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safety and tolerability
[Time Frame: 20 weeks]
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Secondary Outcome(s)
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Relationship between blood levels and sodium phenylbutyrate dosage
[Time Frame: No]
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The number of side effects at each dosage, including abnormalities in vital signs, physical examination, blood tests and EKGs, change in vital capacity (breathing function) and ALS functional rating scale
[Time Frame: No]
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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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