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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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19 February 2015 |
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Main ID: |
NCT01787578 |
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Date of registration:
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06/02/2013 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Safety and Pharmacodynamic Study of Sobetirome in X-Linked Adrenoleukodystrophy (X-ALD)
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Scientific title:
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A Prospective Safety, Tolerance, Pharmacodynamics and Pharmacokinetics Study of Sobetirome in Male Subjects Diagnosed With X-linked Adrenoleukodystrophy (X-ALD) |
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Date of first enrolment:
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April 2013 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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http://clinicaltrials.gov/show/NCT01787578 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1
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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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David Koeller, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Oregon Health and Science University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- males 18-65 years old
- X-ALD diagnosis by either elevated VLCFAs or DNA testing
- must sign informed consent and agree to complete required clinic visits.
Exclusion Criteria:
- female gender
- abnormal laboratory test results (except VLCFA) at screening visit
- history of coronary artery disease
- use of triiodothyronine therapy
- abnormal thyroid function test at screening visit
- untreated adrenal insufficiency
- currently taking Lorenzo's Oil or other VLCFA lowering agent
- participation in investigational drug study within 30 days
Age minimum:
18 Years
Age maximum:
64 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Adrenomyeloneuropathy
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X-Linked Adrenoleukodystrophy
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Intervention(s)
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Drug: Sobetirome
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Primary Outcome(s)
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Change from Baseline in very long chain fatty acid (VLCFA) levels
[Time Frame: Day 14 and Day 28 of sobetirome dosing]
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Secondary Outcome(s)
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Evidence of changes in thyroid function from baseline confirmed by measured changes in TSH and/or free T4
[Time Frame: Day 14 and 28 of sobetirome dosing]
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Number of participants with adverse events from baseline
[Time Frame: Every 7 days to outcome visit day and again at end of study visit day]
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Peak Plasma Concentration (Cmax) of Sobetirome
[Time Frame: Day 1]
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Secondary ID(s)
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Sobetirome-CLIN-006
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CTSA grant (UL1TR000128)
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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