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NCT00950248 · ClinicalTrials.gov registry record · Phase 1
Clinical Trial of Idebenone in Primary Progressive Multiple Sclerosis (IPPoMS)
A Phase 1 study of Primary Progressive Multiple Sclerosis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 85
- Enrollment target
- 1
- Study location
NCT00950248 is a Phase 1 study of Primary Progressive Multiple Sclerosis that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 85 participants. The trial reports 1 study location across 1 state.
The verdict
NCT00950248, a Phase 1 study of Primary Progressive Multiple Sclerosis, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 85 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: * Multiple sclerosis (MS) is an inflammatory disorder of the central nervous system that progressively weakens and destroys the pathways of the nervous system. About 10 percent to 15 percent of patients develop primary-progressive MS (PP-MS), characterized by progressive accumulation of disability from the disease onset, without any marked improvements or relapses. There are currently no effective treatments for PP-MS. * Idebenone is a manmade drug that is similar to a naturally occurring compound known as coenzyme Q10, a common dietary supplement. Research data suggest that idebenone may be able to limit demyelination and death of brain cells and thereby slow or halt the progression of neurological dysfunction such as that occurring in MS. Objectives: \- To evaluate the safety and effectiveness of using idebenone to treat primary progressive MS. Eligibility: \- Individuals between 18 and 65 years of age who have been diagnosed with primary progressive multiple sclerosis. Design: * The study will last 3 years and will be divided into two parts: a 1-year pretreatment baseline and 2 years of treatment with either idebenone or a placebo. * Pre-treatment study: approximately 5 clinic visits over 1 year. * Visit 1: Comprehensive medical history and neurological examination, with brain scans and neurological tests. * Visit 2: Magnetic resonance imaging (MRI) scan of the spine and lymphocytapheresis (withdrawal of white blood cells for testing). * Visit 3: Lumbar puncture. * Visit 4: Skin biopsy. * Visit 5: Repeat MRI of the brain and spinal cord, as well as neurological tests; these tests will be scheduled over 2 days. * After the five pretreatment visits, patients will receive a 6-month supply of study medication (either idebenone or a placebo) to take three times a day with food * Patients will continue to have regular followup clinic visits with brain MRI scans, blood tests, and other evaluations of brain and nervous system function. Randomly selecte
Conditions Studied
Interventions
- OTHER placebo
- DRUG Idebenone
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 85 participants |
| Start Date | 2009-11-01 |
| Est. Completion | 2018-08-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00950248
The ClinicalTrials.gov registry entry for NCT00950248 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 85 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Primary Progressive Multiple Sclerosis appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.
NCT00950248 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00950248 about?
NCT00950248 is a clinical study titled "Clinical Trial of Idebenone in Primary Progressive Multiple Sclerosis (IPPoMS)". Background: * Multiple sclerosis (MS) is an inflammatory disorder of the central nervous system that progressively weakens and destroys the pathways of the nervous system. About 10 percent to 15 percent of patients develop primary-progressive MS (PP-MS), characterized by progressive accumulation of...
What is the current status of trial NCT00950248?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 85 participants. The study started on 2009-11-01. Estimated completion is 2018-08-06.
What conditions does trial NCT00950248 study?
This clinical trial studies the following conditions: Primary Progressive Multiple Sclerosis.
What interventions are being tested in trial NCT00950248?
The interventions under investigation include: placebo (OTHER), Idebenone (DRUG).
Who is sponsoring clinical trial NCT00950248?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00950248 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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