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 Criteria:

  1. Women aged 18 years old or older.
  2. Diagnosis of X-linked ALD based on genetic testing, altered VLCFA levels, or family history.
  3. Willing to undergo annual follow-up visits, including brain and spinal cord MRI scans.
  4. Provision of written informed consent.
  5. Affiliation or beneficiary of a French social security system or of such a regime.

Exclusion Criteria:

  1. 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.
  2. Under treatment or previous treatment with leriglitazone.
  3. Pregnant or lactating women.
  4. Subjects benefiting from laws aimed at protecting vulnerable adults: subjects being deprived of liberty by judicial or administrative decision, subjects under guardianship.
  5. 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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Page 1 of 1 (1 locations)

1

Paris Brain Institute (ICM) Centre Hospitalier Universitaire Pitié Salpêtrière

Paris, France, 75013