Effect of Glycerol Trierucate on Clinical Course of Adrenoleukodystrophy
| Status: | Suspended |
|---|---|
| Conditions: | Endocrine |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | Any - 6 |
| Updated: | 10/14/2017 |
| Start Date: | April 1998 |
| End Date: | November 2014 |
Study of Glyceryl Trierucate and Glyceryl Trioleate (Lorenzo's Oil) Therapy in Male Children With Adrenoleukodystrophy
OBJECTIVES: I. Evaluate the clinical efficacy of combination glyceryl trierucate and glyceryl
trioleate (Lorenzo's Oil) therapy in boys with X-linked adrenoleukodystrophy.
II. Compare the frequency and severity of neurological disability of study patients with
untreated historical controls.
trioleate (Lorenzo's Oil) therapy in boys with X-linked adrenoleukodystrophy.
II. Compare the frequency and severity of neurological disability of study patients with
untreated historical controls.
PROTOCOL OUTLINE: This is an open label study. Patients must follow dietary instructions as
provided by the investigator. Patients receive 2-4 tablespoons of a mixture of glyceryl
trierucate and glyceryl trioleate oil once daily. Patients complete a neuropsychological
scoring scale questionnaire to measure neurological disability. Patients undergo physical
examinations including magnetic resonance imaging and magnetic resonance spectroscopy of the
head.
Patients are followed monthly for 6 months, then every 3 months until death.
provided by the investigator. Patients receive 2-4 tablespoons of a mixture of glyceryl
trierucate and glyceryl trioleate oil once daily. Patients complete a neuropsychological
scoring scale questionnaire to measure neurological disability. Patients undergo physical
examinations including magnetic resonance imaging and magnetic resonance spectroscopy of the
head.
Patients are followed monthly for 6 months, then every 3 months until death.
- Biochemically proven asymptomatic X-linked adrenoleukodystrophy
- Platelet count in normal range
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Kennedy Krieger Institute While not officially part of Johns Hopkins Medicine, Kennedy Krieger Institute is...
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