Status:
COMPLETED
Clinical Trial of Idebenone in Primary Progressive Multiple Sclerosis (IPPoMS)
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Primary Progressive Multiple Sclerosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
Background: * Multiple sclerosis (MS) is an inflammatory disorder of the central nervous system that progressively weakens and destroys the pathways of the nervous system. About 10 percent to 15 perc...
Detailed Description
Objective: The goal of this study is to assess the safety, therapeutic efficacy and mechanism of action of idebenone in primary-progressive multiple sclerosis (PP-MS) patients. Study Population: Adul...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- PP-MS as determined by the 2005 modification of McDonald s diagnostic criteria
- Age from 18-65 years (inclusive)
- Expanded Disability Status Scale (EDSS) measure of neurological disability from 1 (no disability, clinical signs only) to 7 (ambulatory with bilateral support)
- Able to provide informed consent
- 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 in a partner)) for the duration of treatment arm of the study
- Not receiving any immunomodulatory/immunosuppressive therapies for a period of at least 3 months before enrollment in the study
- No exposure to idebenone, coenzyme-Q(10) or other dietary supplements (such as antioxidants, mitochondrial-function promoting supplements or vitamins in excess of 3 times recommended daily doses) for a period of at least 1 month before enrollment in the study
- EXCLUSION CRITERIA:
- Alternative diagnoses that can explain neurological disability and MRI findings
- Clinically significant medical disorders that, in the judgment of the investigators, could cause CNS tissue damage or limit its repair, or might expose the patient to undue risk of harm or prevent the patient from completing the study
- History of hypersensitivity reaction to idebenone or coenzyme-Q (10)
- Pregnant or lactating women. All women of child-bearing potential must have a negative pregnancy test prior to the medication phase of the study.
- Abnormal screening/baseline blood tests exceeding any of the limits defined below:
- i. Serum alanine transaminase or aspartate transaminase levels greater than 3 times the upper limit of normal values
- ii. Total white blood cell count \< 3,000/mm(3)
- iii. Platelet count \< 85,000/mm(3)
- iv. Serum creatinine level \> 2.0 mg/dl or eGFR (estimated glomerular filtration rate) \<30
- v. Positive pregnancy test
- Patients who are receiving any immunosuppressive therapies (including cytostatic agents) due to the concern that these drugs may contribute to neurodegeneration or limit CNS repair
Exclusion
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 6 2018
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT00950248
Start Date
November 1 2009
End Date
August 6 2018
Last Update
March 19 2019
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892