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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT00004418 |
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Date of registration:
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18/10/1999 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effect of Glycerol Trierucate on Clinical Course of Adrenoleukodystrophy
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Scientific title:
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Study of Glyceryl Trierucate and Glyceryl Trioleate (Lorenzo's Oil) Therapy in Male Children With Adrenoleukodystrophy |
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Date of first enrolment:
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April 1998 |
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Target sample size:
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126 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT00004418 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Gerald V Raymond, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hugo W. Moser Research Institute at Kennedy Krieger, Inc. |
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Key inclusion & exclusion criteria
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Inclusion criteria.
1. Boys between the age of 18 months and 8 years of age
2. Biochemically proven asymptomatic X-linked adrenoleukodystrophy determined by
elevation of very long chain fatty acids or DNA analysis.
3. Platelet count in normal range
Exclusion criteria.
1. Abnormal MRI consistent with childhood cerebral disease
2. Boys who have undergone bone marrow transplantation
3. Other medical condition which in the opinion of the investigator prevents evaluation
or treatment
Age minimum:
18 Months
Age maximum:
8 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Adrenoleukodystrophy
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Intervention(s)
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Drug: glyceryl trierucate/glyceryl trioleate
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Primary Outcome(s)
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Change From Baseline in Very Long Chain Fatty Acids (VLCFA) Blood Levels
[Time Frame: Baseline, an average of 10 years, up to age 13]
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Secondary Outcome(s)
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Number of Participants With T2 MRI Abnormality
[Time Frame: 10 years]
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Secondary ID(s)
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199/13312
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Nutricia-Loma Linda
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KKI-FDR000685
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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