Effect of pioglitazone in patienst with Adrenomyeloneuropathy.

• Conditions: X-linked adrenoleukodystrophy; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2011-006113-34-ES
• Lead Sponsor: AURORA PUJOL ONOFRE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09-12
• Last Update Posted: 26 November 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Men and women of 18 to 65 years old, inclusive.Clinical signs of AMN with at least pyramidal signs in the lower limbs and difficulties to run.Presence of motor deficit according to the EDSS scale. Ability to perform the 6MWT
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Gadolinium enhancement on T1 sequence of any abnormal hypersignal of white matter, including myelinated pyramidal tracts, visible at brain MRI on FLAIR sequences.History of heart failure or cardiac disease.Prior or current bladder cancer. Women with history of osteoporosis. Gross hematuria of unknown origin.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified