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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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12 December 2020 |
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Main ID: |
NCT01495260 |
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Date of registration:
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28/11/2011 |
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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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A Clinical Trial for AMN: Validation of Biomarkers of Oxidative Stress, Efficacy and Safety of a Mixture of Antioxidants
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Scientific title:
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A Clinical Trial for Adrenomyeloneuropathy (AMN): Validation of Biomarkers of Oxidative Stress, and Efficacy, Tolerance and Safety of a Mixture of the Antioxidants N-acetylcysteine, Lipoic Acid and Vitamin E |
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Date of first enrolment:
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September 2011 |
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Target sample size:
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13 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01495260 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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Spain
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Symptomatic AMN patients,
- 18-64 years old,
- male and female,
- clinically and biochemically diagnosed;
- females must be obligated heterozygotes or must have gene mutation identified.
Exclusion Criteria:
- Pregnant and lactation in females,
- Cerebral inflammatory disease with cognitive disorder, and/or
- need the help of two walking sticks,
- epilepsy,
- hypersensibility to cysteine related compounds,
- transaminases 2 fold up normal values.
Age minimum:
18 Years
Age maximum:
64 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Adrenomyeloneuropathy
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Intervention(s)
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Drug: vitamin E
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Drug: lipoic acid
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Drug: N-acetylcysteine
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Primary Outcome(s)
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oxidative lesion biomarkers
[Time Frame: 12 months]
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Secondary Outcome(s)
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clinical parameters
[Time Frame: 2, 6 and 12 months]
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Secondary ID(s)
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XAMNANTIOXAP2010
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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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