Status:
COMPLETED
A Clinical Trial for AMN: Validation of Biomarkers of Oxidative Stress, Efficacy and Safety of a Mixture of Antioxidants
Lead Sponsor:
Pujol, Aurora, M.D.
Collaborating Sponsors:
Ministerio de Sanidad, Servicios Sociales e Igualdad
Fundacion Hesperia
Conditions:
Adrenomyeloneuropathy
Eligibility:
All Genders
18-64 years
Phase:
PHASE2
Brief Summary
X-linked adrenoleukodystrophy is a rare, demyelinating and neurodegenerative disorder, due to a loss of function of a fatty acid transporter, the peroxisomal ABCD1protein. Its more frequent phenotype,...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT01495260
Start Date
September 1 2011
End Date
November 1 2013
Last Update
March 11 2019
Active Locations (1)
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1
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain, 08907