Skip secondary menu

Trial of Idebenone in People with Primary Progressive Multiple Sclerosis



Eligibility Criteria:

Inclusion:

  1. PP-MS as determined by the 2005 modification of McDonald Diagnostic Criteria
  2. Age from 18-65 years (inclusive)
  3. EDSS measure of neurological disability from 1 (no disability, clinical signs only) to 7 (ambulatory with bilateral support)
  4. Able to provide informed consent
  5. Willing to participate in all aspects of trial design and followup
  6. 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))
  7. Not receiving any immunomodulatory/immunosuppressive therapies for a period of at least 3 months before enrollment in the study
  8. 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:

  1. Alternative diagnoses that can explain neurological disability and MRI findings
  2. 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
  3. History of hypersensitivity reaction to idebenone or coenzyme Q10
  4. Pregnant or lactating women. All women of child-bearing potential must have a negative pregnancy test prior to the medication phase of the study.
  5. Abnormal screening/baseline blood tests exceeding any of the limits defined below:
    1. Serum alanine transaminase or aspartate transaminase levels greater than 3 times the upper limit of normal values
    2. Total white blood cell count < 3,000/mm(3)
    3. Platelet count < 85,000/mm(3)
    4. Serum creatinine level > 2.0 mg/dl or eGFR (glomerular filtration rate) < 60
    5. Positive pregnancy test
  6. 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

Last updated July 17, 2012