Status:
RECRUITING
Disease Progression in Women With X-linked Adrenoleukodystrophy
Lead Sponsor:
Minoryx Therapeutics, S.L.
Conditions:
X-linked Adrenoleukodystrophy
Eligibility:
FEMALE
18+ years
Brief Summary
Observational, single-site prospective and minimally interventional study in women with X-linked adrenoleukodystrophy (ALD), conducted in France.
Detailed Description
Patients accepting participation (after signing ICF) will be followed up to at least 2 years or until they started treatment for X-linked adrenoleukodystrophy (ALD) or withdraw consent, whichever occu...
Eligibility Criteria
Inclusion
- Women aged 18 years old or older.
- Diagnosis of X-linked ALD based on genetic testing, altered VLCFA levels, or family history.
- Willing to undergo annual follow-up visits, including brain and spinal cord MRI scans.
- Provision of written informed consent.
- Affiliation or beneficiary of a French social security system or of such a regime.
Exclusion
- Any condition that in the opinion of the investigator are likely to adversely affect the study participation, interfere with study compliance, or confound the study results.
- Under treatment or previous treatment with leriglitazone.
- Pregnant or lactating women.
- Subjects benefiting from laws aimed at protecting vulnerable adults: subjects being deprived of liberty by judicial or administrative decision, subjects under guardianship.
- Participation in an interventional clinical trial.
Key Trial Info
Start Date :
January 2 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06178120
Start Date
January 2 2024
End Date
June 1 2027
Last Update
January 31 2024
Active Locations (1)
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1
Paris Brain Institute (ICM) Centre Hospitalier Universitaire Pitié Salpêtrière
Paris, France, 75013