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.
- 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:
- 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 at www.newportbeachresearch.com.
- 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.
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Elan Pharmaceuticals (ELND002)
Summary
Elan Pharmaceuticals is continuing to develop ELND002, a PEGylated small molecule alpha4 integrin inhibitor delivered subcutaneously for the treatment of MS. Currently, MS Center of Southern California, Newport Beach Clinical Research Associates, Inc. (NBCRA) and Elan Pharmaceuticals are enrolling for a trial examining the safety and tolerability of ELND002 in patients with relapsing forms of secondary progressive multiple sclerosis (SPMS) or relapsing-remitting multiple sclerosis (RRMS). In Southern California, Dr. Daniel S. Bandari is a principal investigator.Eligibility and Details
This study consists of a 12-week, placebo-controlled phase followed by a 1 year open-label phase.To enroll in this study, people must be between 18 and 65 years of age and have a diagnosis of relapsing forms of MS for at least 2 years. Patients must have a documented medical history of relapse in the past year or MRI-documented evidence of MS activity in the last year. If the patient has ever received treatment with recombinant humanized monoclonal antibodies he/she is not eligible to participate.
All qualified participants will undergo study-related tests and procedures including an MRI of the Brain. All medication and study-related testing are provided at no cost to patients in the study.
Contact Information
Ricky Cortes, 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
ricky@nbneuro.comClinicaltrials.gov link:
http://clinicaltrials.gov/ct2/show/NCT01144351
Summary
MS Center of Southern California, NBCRA and Novartis are evaluating patient outcomes, safety and tolerability of Fingolimod in patients with Relapsing Forms of Multiple Sclerosis who are candidates for MS therapy change from previous Disease Modifying Therapy (DMT). In Southern California, Dr. Daniel S. Bandari is a principal investigator.Eligibility and Details
This study consists of a 6-month open label phase in which patients will be randomly assigned to Fingolimod 0.5 mg/day oral capsule or a standard of care DMT.To enroll in this study, people must be between 18 and 65 years of age and have a diagnosis of relapsing remitting MS (RRMS). Patients must be on a DMT for at least 6 months before the first clinical trial visit. If a patient has ever received treatment with Fingolimod he/she is not eligible to participate.
All qualified participants will undergo study-related tests and procedures including an Ophthalmology Exam. All medication and study-related testing are provided at no cost to patients in the study.
Contact Information
Ricky Cortes, 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
ricky@nbneuro.comClinicaltrials.gov link:
http://clinicaltrials.gov/ct2/show/NCT01216072
Summary
MS Center of Southern California and NBCRA, together with ELAN Pharmaceuticals and Biogen Idec, are working together to enroll patients in the STRATIFY-2 research study, a program for patients with Relapsing Multiple Sclerosis receiving or considering treatment with Tysabri. The purpose is to define the sero prevalence of JCV Antibody in the MS population and potentially stratify patients into lower or higher risk for developing PML based on antibody status. In Southern California, Dr. Daniel S. Bandari is a principal investigator.Eligibility and Details
This study is an observational study and requires one office visit per year for up to two years.To enroll in this study, patients must be receiving or considering treatment with Tysabri. If a patient is currently participating in another clinical trial he/she is not eligible for enrollment.
This study requires a blood collection at the first clinic visit and annually thereafter for up to two years.
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/NCT01070836
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.comClinicaltrials.gov link:
http://clinicaltrials.gov/ct2/show/NCT01013350