Phase 2
N=61
Idebenone for Primary Progressive Multiple Sclerosis
Multiple Sclerosis · Primary Progressive Multiple Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT01854359 ↗Enrolled (actual)
61
Serious AEs
13.1%
Results posted
May 2021
Primary outcome: Primary: Area Under the Curve (AUC) of the Combinatorial Weight-Adjusted Disability Score (CombiWISE) — 1.55; 0.80; 0.46; 0.89 units on a scale * year
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Idebenone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve (AUC) of the Combinatorial Weight-Adjusted Disability Score (CombiWISE) |
1.55; 0.80; 0.46; 0.89; 0.75; 1.30 | — |
| SECONDARY Slopes of 25 Foot Walk (25FW) Time |
0.04322; -0.00531; 0.04031; 0.03401 | — |
| SECONDARY Slopes of 9 Hole Peg Test (9HPT) Time |
0.000665; 0.000947; 0.000718; 0.001086 | — |
| SECONDARY Slopes of Expanded Disability Status Scale (EDSS) Score |
0.1447; 0.1435; 0.1107; 0.1584 | — |
| SECONDARY Change in Slopes of Scripps Neurological Rating Scale (SNRS) Score |
-1.8838; -2.1655; -2.009; -2.7263 | — |
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.
Eligibility Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01854359). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.