A Phase III Trial of Lorenzo's Oil in Adrenomyeloneuropathy
Stopped early · Phase 3
Conditions studied: Adrenomyeloneuropathy, Adrenoleukodystrophy
In brief
Study of the use of Lorenzo's oil in adults with adrenomyeloneuropathy, the adult form of Lorenzo's oil.
Key facts
- Study ID
- NCT00545597
- Run by
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- People needed
- 240
- Starts
- 2005-03-01
- Expected to finish
- 2007-10-01
- Last updated by the study team
- 2012-03-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Males or females age 18 years or older in whom the diagnosis of X-ALD has been confirmed by VLCFA assay and/or mutation analysis.
- Clinical evidence of spinal cord involvement with EDSS score between 1 and 6.5. Patients with an EDSS score of 6.5 are severely affected but have retained the capacity to walk 20 meters with the aid of a walker, crutch, or two canes.
- Either a normal brain MRI, or a type 3 pattern of MRI abnormality in which the abnormality is considered to represent the centripetal extension of the distal axonopathy.
- Adrenal function assessed by measurement of plasma ACTH and appropriate steroid replacement if adrenal insufficiency is present.
You may not qualify if…
- Kurtzke EDSS score of >6.5.
- Cognitive or behavioral abnormalities that impair capacity to give informed consent or carry out procedures that form part of the protocol.
- Current use, or use within 3 months, of Lorenzo's oil or other therapies that may alter the course of X-ALD. Bone marrow transplant will be a permanent exclusion criterion.
- Contraindications for MRI procedure such as subjects with paramagnetic materials in the body, such as aneurysm clips, pacemakers, intraocular metal or cochlear implants.
- Subjects who are pregnant.
- Allergies to peppermint
- Presence of non-specific conditions that may interfere with clinical assessment or participation in the protocol.
Where it is running
- Kennedy Krieger Institute — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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