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Study of Glyceryl Trierucate and Glyceryl Trioleate (Lorenzo's Oil) Therapy in Male Children with Adrenoleukodystrophy Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Study of Glyceryl Trierucate and Glyceryl Trioleate (Lorenzo's Oil) Therapy in Male Children with Adrenoleukodystrophy conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Study of Glyceryl Trierucate and Glyceryl Trioleate (Lorenzo's Oil) Therapy in Male Children with Adrenoleukodystrophy Clinical research trials and Study of Glyceryl Trierucate and Glyceryl Trioleate (Lorenzo's Oil) Therapy in Male Children with Adrenoleukodystrophy healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Study of Glyceryl Trierucate and Glyceryl Trioleate (Lorenzo's Oil) Therapy in Male Children with Adrenoleukodystrophy. Study of Glyceryl Trierucate and Glyceryl Trioleate (Lorenzo's Oil) Therapy in Male Children with Adrenoleukodystrophy Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Study of Glyceryl Trierucate and Glyceryl Trioleate (Lorenzo's Oil) Therapy in Male Children with Adrenoleukodystrophy clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Study of Glyceryl Trierucate and Glyceryl Trioleate (Lorenzo's Oil) Therapy in Male Children with Adrenoleukodystrophy condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.

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Study of Glyceryl Trierucate and Glyceryl Trioleate (Lorenzo's Oil) Therapy in Male Children with Adrenoleukodystrophy



Study of Glyceryl Trierucate and Glyceryl Trioleate (Lorenzo's Oil) Therapy in Male Children with Adrenoleukodystrophy

For Condition: Adrenoleukodystrophy
Status: Recruiting
Sponsor(s): FDA Office of Orphan Products Development , Kennedy Krieger Institute
Synopsis: 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.
Details: 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.
Eligibility:
Study Type:
  Interventional, Treatment, Open Label
Minimum Age/Maximum Age: 18 Months/6 Years
Genders: Male
Protocol Entry Criteria: - Biochemically proven asymptomatic X-linked adrenoleukodystrophy - Platelet count in normal range
Total Enrollment: 30

Location and Contact Information:

Overall Study Official:
HugoMoser,  Study Chair,  Kennedy Krieger Institute

Johns Hopkins Hospital *Recruiting*
Baltimore,  Maryland,  21287-6681
United States
Recruiting Hugo  Moser 410-502-9405

Kennedy Krieger Institute *Recruiting*
Baltimore,  Maryland,  21205
United States
Recruiting Hugo  Moser 410-502-9405


Additional Information:
Study ID Numbers:
  199/13312;  KKI-88-11-22-01,KKI-FDR000685
Study Start Date: April 1998
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004418

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