Status:
COMPLETED
Idebenone for Primary Progressive Multiple Sclerosis
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Multiple Sclerosis
Primary Progressive Multiple Sclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 o...
Detailed Description
OBJECTIVE: A Phase I/II clinical trial is being conducted to investigate the safety, therapeutic efficacy and mechanism of action of idebenone in primary-progressive multiple sclerosis (PP-MS) patien...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Completion of 3 years in study IPPoMS (Protocol Number 09-N-0197)
- Able to provide informed consent
- Adults, at least 18 years of age
- Willing to participate in all aspects of trial design and follow-up
- If able to become pregnant or to father a child, agreeing to commit to the use of a reliable/accepted method of birth control (i.e. hormonal contraception (birth control pills, injected hormones, vaginal ring), intrauterine device, barrier methods with spermicide (diaphragm with spermicide, condom with spermicide) or surgical sterilization (hysterectomy, tubal ligation, or vasectomy)) for the duration of treatment arm of the study
- EXCLUSION CRITERIA:
- Pregnant or lactating women. All women of child-bearing potential must have a negative pregnancy test
- Patients dropping out of IPPoMS due to adverse events (AE) considered related to study medication
Exclusion
Key Trial Info
Start Date :
March 12 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2018
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT01854359
Start Date
March 12 2013
End Date
October 31 2018
Last Update
May 19 2021
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892