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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: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT01495260
Date of registration: 28/11/2011
Prospective Registration: Yes
Primary sponsor: Onofre, Aurora Pujol, M.D.
Public title: A Clinical Trial for AMN: Validation of Biomarkers of Oxidative Stress, Efficacy and Safety of a Mixture of Antioxidants
Scientific title: 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
Date of first enrolment: September 2011
Target sample size: 13
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01495260
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 2
Countries of recruitment
Spain
Contacts
Key inclusion & exclusion criteria

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
Health Condition(s) or Problem(s) studied
Adrenomyeloneuropathy
Intervention(s)
Drug: lipoic acid
Drug: N-acetylcysteine
Drug: vitamin E
Primary Outcome(s)
oxidative lesion biomarkers [Time Frame: 12 months]
Secondary Outcome(s)
clinical parameters [Time Frame: 2, 6 and 12 months]
Secondary ID(s)
XAMNANTIOXAP2010
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Fundacion Hesperia
Ministerio de Sanidad, Servicios Sociales e Igualdad
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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