Idebenone for Primary Progressive Multiple Sclerosis

CompletedPhase 1Phase 2Progressive MSNCT01854359

What it found

Results posted, no main test reported

Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.

What was tested

Treatment tested

Idebenone
Antioxidant and mitochondrial electron carrier

Results by group

Area Under the Curve (AUC) of the Combinatorial Weight-Adjusted Disability Score (CombiWISE)

1-year pre-treatment baseline vs 2-year randomized double-blind phased vs 1-year treatment period

Group	Value	Interval	Number analysed
Pre-treatment Baseline (Placebo Group)	1.55 units on a scale * year	2.02 (Standard Deviation)	30
Double-blind Phase (Placebo Group)	0.80 units on a scale * year	1.96 (Standard Deviation)	30
Extension Phase (Placebo Group)	0.46 units on a scale * year	1.93 (Standard Deviation)	22
Pre-treatment Baseline (Active Treatment Group)	0.89 units on a scale * year	1.81 (Standard Deviation)	31
Double-blind Phase (Active Treatment Group)	0.75 units on a scale * year	1.82 (Standard Deviation)	31
Extension Phase (Active Treatment Group)	1.30 units on a scale * year	2.3 (Standard Deviation)	26

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

Group	Participants at risk	Serious adverse events	Deaths
Active Treatment in 09-I-0197	31	4 (12.9%)	0
Placebo in 09-I-0197	30	4 (13.3%)	0

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

Area Under the Curve (AUC) of the Combinatorial Weight-Adjusted Disability Score (CombiWISE)
1-year pre-treatment baseline vs 2-year randomized double-blind phased vs 1-year treatment period
Disability progressionWalking and mobilityHow the body handles the medicine

Other measures (4)

Slopes of 25 Foot Walk (25FW) Time
3-years double-blind phase and 1-year extension phase
Disability progressionWalking and mobility
Slopes of 9 Hole Peg Test (9HPT) Time
3-years double-blind phase and 1-year extension phase
Disability progressionArm and hand function
Slopes of Expanded Disability Status Scale (EDSS) Score
3-years double-blind phase and 1-year extension phase
Disability progression
Change in Slopes of Scripps Neurological Rating Scale (SNRS) Score
3-years double-blind phase and 1-year extension phase

Who could take part

Progressive MS · 18 and over

* 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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

Loading reviews and guidelines…

Related trials

MACSiMiSE-BRAIN_v1.0
Phase 2 · Running, not recruiting
Still running
OCTOPUS (PLATYPUS in Australia)
Phase 3 · Ongoing (inferred)
Still running
Metformin Treatment in Progressive Multiple Sclerosis
Early phase 1 · Completed
Result in a paper, not read yet
NACPMS
Phase 2 · Running, not recruiting
Still running
LAPMS
Phase 2 · Completed
Missed its main goal
A Trial of Bile Acid Supplementation in Patients With Mul…
Phase 1 / Phase 2 · Completed
Results posted, no main test reported

History

Started
Mar 2013
Main results due
Oct 2018
Finished
Oct 2018
Results posted
May 2021

Assembled by software from public sources and not checked by people. Each record links to its source. Report an error