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NCT01854359 · ClinicalTrials.gov registry record · Phase 1
Idebenone for Primary Progressive Multiple Sclerosis
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 61
- Enrollment target
NCT01854359: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT01854359 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 61 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01854359, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 61 participants
- Enrollment target
Study 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.
Primary Outcome
CombiWISE is a composite scale derived from Expanded Disability Status Scale (EDSS) , Scripps Neurological Disability Scale (SNRS), times 25 foot walk (25FW), and non-dominant hand of 9 hole peg test (9HPT) with a minimum value of 0 (no disability) and maximum value of 100 (maximum disability). The AUC values were calculated for both study groups (Active treatment group in the 09-I-0197 trial and Placebo group in the 09-I-0197) as follows: 1. pre-treatment baseline during the 09-I-0197 trial (
Interventions
- DRUG Idebenone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2013-03-12 |
| Est. Completion | 2018-10-31 |
| Phase | Phase 1 |
What the finished NCT01854359 record still lists
NCT01854359 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which Idebenone is the first listed.
NCT01854359 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01854359 about?
NCT01854359 is a clinical study titled "Idebenone for Primary Progressive Multiple Sclerosis". 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 certai...
What is the current status of trial NCT01854359?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 61 participants. The study started on 2013-03-12. Estimated completion is 2018-10-31.
What interventions are being tested in trial NCT01854359?
The interventions under investigation include: Idebenone (DRUG).
Who is sponsoring clinical trial NCT01854359?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01854359's enrollment target sits among peer trials
61 828th of 2000 higher than 1,170 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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