Clinical trials help to determine if a drug is safe and effective for people with MS. People with MS who are willing to volunteer in these studies make it possible for all of us to look forward to new and better therapies.
Clinical Trial Basics
The process is complicated. Many factors are involved in making sure that a study is conducted properly and that the results are valid. The U.S. Food and Drug Administration requires therapies to undergo three phases of clinical trials before they can be approved to treat people with MS:
- Phase I – The first step is to determine safety. In a small number of healthy volunteers or persons with MS, the investigators determine how the human body reacts to the therapy.
- Phase II – If the therapy proves to be safe, studies begin to determine the effectiveness of the drug in people with MS. These studies may last several months or several years, and involve larger numbers of people. The study is "controlled"—that is, the drug is compared with the standard treatment, or an inactive placebo.
- Phase III – If an MS drug shows effectiveness, an even larger study is conducted in hundreds of people to gain a better understanding of the drug’s effectiveness and possible side effects. These multi-center studies can span several years and several countries.
University of Colorado, John Corboy, M.D.
Aurora Colorado
Female MS Volunteers Needed for Oral Estriol Research Study
Looking for women with relapsing-remitting MS for a 24 -month study to see if there are less relapses with the treatment of Copaxone injections plus oral estriol as compared to the treatment of Copaxone injections plus oral placebo. Criteria: women 18-50 years old, diagnosed with definite RRMS, able to walk without any aids such as cane or walker, and have had at least one relapse within the last 2 years. Not Eligible: women who are pregnant, breast-feeding, smoke, or have other serious medical conditions.
If you are interested, call Caitlin Walker, the study coordinator, at (303)724-2198 or email (caitlin.walker@ucdenver.edu) for further information.
This trial is funded by the National Multiple Sclerosis Society and the National Institutes of Health.
Website: http://www.clinicaltrials.gov/ct2/show/NCT00451204?term=estriol+AND+multiple+sclerosis&rank=1
Rocky Mountain MS Center @ Anshutz Medical Campus
University of Colorado Denver
12631 E 17th Ave
Aurora CO 80045
Contact: e-mail – neurology.msresearch @ucdenver.edu
Or call Carl Hale at 303-724-3736
Click on this link for more detailed information on the following studies:
- Open-label, flexible dose titrations study of the safety and tolerability of ONO-4641 in patients with a Relapsing form of multiple sclerosis
- Duloxetine in patients with central neuropathic pain due to multiple sclerosis
- BRAVO (Benefit-Risk Assessment of Avonex and Laquinimod) (Relapsing remitting MS)
- Randomized, Double-blind, Placebo=Controlled, Escalating Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CS-0777, administered for 12 Weeks in Patients with Multiple Sclerosis (Relapsing form of MS)
- A Phase 3, Randomized, Rater-and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low-and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a(Rebif) in Patients with Relapsing-Remitting Multiple Sclerosis Who Have Relapsed on Therapy
- A two-arm, randomized, double-blind, placebo-controlled, multicenter phase II study to evaluate the safety and tolerability and explore the neuroprotective effect of atacicept as assessed by Optical Coherence Tomography (OCT) in subjects with Optic Neuritis (ON) as Clinically Isolated Syndrome (CIS) over a 36 week treatment course to determine if an oral drug can protect the eye from damage caused by optic neuritis. (Not diagnosed with MS)
Neurological Consultants, P.C.
4545 E. 9th Ave (Corner of 9th Ave. & Clermont St. adjacent to Rose Medical Ctr.)
Suite # 510
Denver, CO 80220
Phone: 303-321-0700
Contact: Kristin Johnson, research coordinator, directly at (720) 941-9363.
Click on this link for more detailed information on the following studies:
- Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis, Study Two (CARE-MS II) to establish the efficacy and safety of two different doses of alemtuzumab as a treatment for relapsing-remitting multiple sclerosis (MS), in comparison with Rebif® (interferon beta-1a).
- 12-Week Safety Evaluation of Oral CS-0777 in Multiple Sclerosis Patients to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of oral CS-0777 in patients with Multiple Sclerosis (Relapsing Form of MS)
Advanced Neurology of Colorado
2121 East Harmony Road, Suite 180, Ft. Collins, CO 80528
Ph: (970) 226-6111 Fax: (970) 226-6707
Click on this link for more detailed information on the following studies:
- Rebif new formulation and Add on Cladribine/placebo for subject on Rebif with active disease
- Treatment with Alemtuzumab for Treatment Naïve MS patients with active disease diagnosed within the last 5 years
- Treatment with Alemtuzumab for Treatment experienced patients who have relapsed on therapy, diagnosed within the last 5 years
- Oral Laquinimod study for Relapsing Remitting MS patients
- Biogen Sponsored study for patients with Relapsing Remitting MS patients
Alpine Clinical Research Center
1000 Alpine Ave.
Suite 200
Boulder, Colorado 80304
Phone: 303/443-7229
Fax: 303/443-7748
E-Mail: peg@alpineresearch.com
Click on this link for more detailed information on the following studies:
- Cymbalta in Patients with Central Neuropathic Pain Due to Multiple Sclerosis (All types of MS)
- Add-on Therapy of an oral medication for patients with Multiple Sclerosis, currently using Avonex, Betaseron, or Rebif.
- Efficacy and Safety Study of Oral BG00012 With Active Reference in Relapsing-Remitting Multiple Sclerosis (CONFIRM)
Dr. Patricia Fodor
7606 North Union Blvd
Suite G
Colorado Springs CO 80920
Contact: Debbie Debaun (719) 598-4189
Please call for more information on this study
- Efficacy and Safety Study of Oral BG00012 With Active Reference in Relapsing-Remitting Multiple Sclerosis (CONFIRM)
For more information on clinical trials by listing of drug or treatment being studied go to, http://www.nationalmssociety.org/news/news-detail/index.aspx?nid=1481