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Sponsors and Collaborators: |
University of Texas Southwestern Medical Center Aspreva Pharmaceuticals |
Information provided by: | University of Texas Southwestern Medical Center |
ClinicalTrials.gov Identifier: | NCT00324506 |
The primary objective of this safety/mechanistic study is to determine the safety and tolerability of oral Cellcept when compared with weekly intramuscular Avonex in relapsing multiple sclerosis. Safety will be assessed by virtue of changes in size and number of lesions on MRI scans.
Condition | Intervention | Phase |
Multiple Sclerosis |
Drug: Mycophenolate Mofetil (CellCept) |
Phase II Phase III |
MedlinePlus related topics: | Multiple Sclerosis |
ChemIDplus related topics: | Mycophenolate Mofetil Mycophenolate mofetil hydrochloride Interferon alfa-2b Interferons Interferon beta Interferon-beta Interferon beta 1a |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Open-Label, Parallel-Group Multicenter Study to Determine the Safety/Efficacy of Mycophenolate Mofetil in Mono & Combination Therapy With Interferon Beta 1a in Patients With Relapsing Remitting Multiple Sclerosis |
Estimated Enrollment: | 60 |
Study Start Date: | May 2006 |
Estimated Study Completion Date: | May 2008 |
Sixty patients (20 patients at each recruiting center) with RR MS who satisfy both inclusion and exclusion criteria will be treated with CellCept® or Avonex® with added placebo therapy for the first 6 months of the study. Those patients will have a fifty-fifty chance of receiving either combination of therapy: active Avonex with Cellcept placebo OR Avonex placebo with active Cellcept. Baseline data will be collected before treatment begins including a MRI, chest x-ray, EKG, and standard labwork, along with a blood test for HIV and Hepatitis B. Once enrolled, study visits include an MRI scan every month for the first six months, a neurological exam by the examining neurologist every three months, frequent bloodwork, questionnaires, and eye-testing at month zero and six. Eye testing takes about one hour and requires dilation of pupils. All assessments are standard of care for ophthalmology with the exception of optical coherence tomography (OCT)-- a non-invasive procedural device that records graphical and numerical measurements of the optic nerve and macula.
All patients will begin active combination therapy on both CellCept® and Avonex® during the second 6 months of the study. During this second phase, MRI and clinical examinations will be performed at months 9, 10 and 12.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Gina M Remington, RN/BSN | 214-645-0560 | Gina.Remington@utsouthwestern.edu |
Contact: Elliot Frohman, MD/PhD | 214-645-0557 | Elliot.Frohman@utsouthwestern.edu |
United States, Michigan | |||||
Michigan Institute for Neurological Disorders (M.I.N.D.) | Recruiting | ||||
Farmington Hills, Michigan, United States, 48334 | |||||
Contact: Sonda Lawson, MA, LLPC 248-553-0010 Sondall@aol.com | |||||
Contact: Howard Rossman, MD 248-553-0010 hsrossman@aol.com | |||||
Sub-Investigator: Howard Rossman, MD | |||||
United States, New York | |||||
Buffalo Neuroimaging Analysis Center (BNAC) | Recruiting | ||||
Buffalo, New York, United States, 14203 | |||||
Contact: Kara Patrick, MS, CCRC KPatrick@KaleidaHealth.Org | |||||
Contact: Bianca Weinstock-Guttman, MD BWeinstock-Guttman@KaleidaHealth.Org | |||||
Sub-Investigator: Robert Zivadinov, MD | |||||
Sub-Investigator: Bianca Weinstock-Guttman, MD | |||||
United States, Texas | |||||
University of Texas Southwestern Medical Center at Dallas | Recruiting | ||||
Dallas, Texas, United States, 75390 | |||||
Contact: Gina M Remington, RN/BSN 214-645-0560 Gina.Remington@utsouthwestern.edu | |||||
Principal Investigator: Elliot Frohman, MD/PhD | |||||
Sub-Investigator: Anjali Shah, MD | |||||
Sub-Investigator: Olaf Stuve, MD, PhD |
University of Texas Southwestern Medical Center |
Aspreva Pharmaceuticals |
Principal Investigator: | Elliot M Frohman, MD/PhD | University of Texas Southwestern Medical Center at Dallas |
Study ID Numbers: | IIT 355349, IRB #012006-028 |
First Received: | May 9, 2006 |
Last Updated: | April 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00324506 |
Health Authority: | United States: Food and Drug Administration |
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