Idebenone for Primary Progressive Multiple Sclerosis
Status:
Completed
Trial end date:
2018-10-31
Target enrollment:
Participant gender:
Summary
Background:
- The Idebenone in Patients With Primary Progressive Multiple Sclerosis (IPPoMS) trial tested
a new drug for multiple sclerosis. In the IPPoMS trial, participants took either idebenone or
placebo. Researchers want to give idebenone to all participants for 1 year. It is still not
certain whether idebenone can slow the progression of multiple sclerosis, but this study may
help answer that question.
Objectives:
- To provide idebenone to all participants on the IPPoMS trial.
- To collect data on the safety and effectiveness of idebenone for primary progressive
multiple sclerosis.
Eligibility:
- Individuals at least 18 years of age who have completed 3 years in the IPPoMS trial.
Design:
- The first study visit for this trial will happen on the same day as the last visit for
the IPPoMS trial.
- Participants will provide a blood samples and will have a lumbar puncture. They will
also receive a new supply of idebenone to take three times a day with food. They will
keep a diary to report on any side effects.
- After this first treatment visit, participants will have two follow-up visits to the NIH
6 months apart. These visits may be scheduled over multiple days. Participants will
provide blood and urine samples. They will also have imaging studies of the brain and
spine.
- Participants will have phone calls with the study researchers to provide updates on
their condition and any side effects.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID) National Institute of Neurological Disorders and Stroke (NINDS)