Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004418
Status:
TERMINATED
Last Update Posted:
2020-10-23
First Post:
1999-10-18
Brief Title:
Effect of Glycerol Trierucate on Clinical Course of Adrenoleukodystrophy
Sponsor:
Hugo W Moser Research Institute at Kennedy Krieger Inc
Organization:
Hugo W Moser Research Institute at Kennedy Krieger Inc
Study Overview
Official Title:
Study of Glyceryl Trierucate and Glyceryl Trioleate Lorenzos Oil Therapy in Male Children With Adrenoleukodystrophy
Status:
TERMINATED
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No funding move to expanded access
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
OBJECTIVES I Evaluate the clinical efficacy of combination glyceryl trierucate and glyceryl trioleate Lorenzos Oil therapy in boys with X-linked adrenoleukodystrophy
II Compare the frequency and severity of neurological disability of study patients with untreated historical controls
II Compare the frequency and severity of neurological disability of study patients with untreated historical controls
Detailed Description:
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 they reach the age of 13 years or death
Patients are followed monthly for 6 months then every 3 months until they reach the age of 13 years or death
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| KKI-FDR000685 | OTHER | FDA | None |
| Nutricia-Loma Linda | OTHER_GRANT | None | None |