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:
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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.
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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.
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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.
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Following FDA approval, post-marketing studies (phase IV) might be conducted to assess long-term safety and effectiveness.
A selection of local trials (approved by the National MS Society) are detailed on this page:
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General Inquiries
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Scripps Clinic is participating in a new clinical research program, called Orchestra, which comprises of three studies. The Opera 1 and the Opera II Study is for patients with relapsing MS, whereas the third study is for patients with progressive MS. Each study is looking at whether patients treated with an investigational drug, called ocrelizumab, experience fewer relapses compared with patients who take a treatment that is already approved for MS, called Rebif®. To learn more about the program, please review the patient letter.
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Newport Beach Clinical Research Associates are currently enrolling for several Multiple Sclerosis Clinical Studies. If you are interested in hearing about a new injectable medicine for RFMS, or an oral medication for RFMS or PPMS, please contact us at 949-631-2917. All evaluations, tests, care and medication are free. More information atwww.newportbeachresearch.com.
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The Research Center of Southern California in conjunction with The MS Center of Southern California is engaged in three MS research studies at this time. If you would like to learn more about opportunities to participate in meaningful MS research, call (760) 732-0557 ext 2147. More details to follow.
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FTY PREFER (MS)
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NOVARTIS ASSESS FTY (2312): Fingolimod vs. Glatiramer Acetate
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Cladibrine Study
Summary
MS Center of Southern California and NBCRA are preparing to enroll patients in an observational long-term safety registry of Multiple Sclerosis patients who have previously participated in Cladribine Clinical Trials. In Southern California, Dr. Daniel S. Bandari is a principal investigator.
Contact Information
Cecil Sta. Ana, CRC
MS Center of Southern California & Newport Beach Clinical Research Associates, Inc.
3900 West Coast Hwy, Suite 330
Newport Beach, CA 92663
949-631-2917
cecil@nbneuro.com
Clinicaltrials.gov link:
http://clinicaltrials.gov/ct2/show/NCT01013350
UCI Medical Center Clinical Trial
The purpose of this study is to demonstrate the effectiveness of an investigational drug named GTR compared to Copaxone® in patients with relapsing remitting multiple sclerosis (RRMS) and to evaluate the safety and tolerability of GTR injections in comparison to Copaxone®. GTR, glatiramer acetate, is a generic form of Copaxone®. In addition to GTR and Copaxone®, participants may also receive placebo (injection fluid without the active study drug), to help show that both study drugs are working as desired. Learn how you can be part of the trial.
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UCSD Generation of Patient Specific Neural Cells to Study Multiple Sclerosis
Dr. Jody Corey-Bloom at UCSD and Dr. Fred Gage at the Salk Institute want to convert skin cells from MS patients and relatives into a stem cell-like stage to study MS pathology, the process of myelination, and potential novel therapies for MS.View document for information. If you are interested in participating, please contact Dr. Corey-Bloom at 858-246-1288.
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CSD Guided Imagery and Guided Journaling for Multiple Sclerosis
Dr. Ramachandran, Paula Jackson, Laura Case, M.A., and their colleagues are conducting a research study to find out more about the effects of guided imagery and guided journaling on the wellbeing of patients with MS. The study is accepting participants that have relapsing-remitting MS. View the clinical document and the approval letter for more information. To participate, contact Laura Case by calling (781) 223-1213 or by email.