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Clinical trials are studies to determine if a treatment is safe and effective for MS. These studies can offer people with MS an opportunity to actively participate in the effort to mobilize people and resources to drive research for a cure - but these studies must be conducted carefully to ensure the validity of the results. Here we provide resources for participating in studies, the latest news/results, and information about clinical research funded by the National MS Society. There are currently a variety of research studies being conducted in our chapter area.

Individuals who are interested in participating in a clinical trial are encouraged to discuss the possibility with their personal physician.

Are you a researcher who needs help with recruiting?

Research Programs Recruiting Subjects in Washington

Below is a listing of other clinical trials that we are aware of that are recruiting subjects in our community:

• Take Charge Study, Seattle
• MS Center of Excellence, VA Puget Sound
• A Randomized Trial of Two Formal Group Programs for Multiple Sclerosis
• Dignity 2 Study
• Viriginia Mason Tysabri Study
• Viriginia Mason PREFERM§ Study
• Viriginia Mason Fingolimod Study
• Viriginia Mason ACCLAIM Study
• Hypnotherapy for pain management study
• ASCEND
• AVP-923
• Fingolimod
• MEDI-551
• Tcelna®
• Physical Therapy
• MS-BMD (Gilenya)
• Hand Held Dynamometer
• Synera

Surveys and Other Research StudiesSurveys and Other Research Studies

The National MS Society is committed to delivering accurate and reliable information to everyone affected by MS, and subsequently reviews many requests for participation in MS surveys. Following is a list of surveys (mostly online) and other research studies seeking to recruit people with multiple sclerosis that has been reviewed by the Society and offered as information only, not an endorsement or recommendation. The surveys/studies are being conducted either by investigators seeking to answer scientific or health policy questions about MS, or by pharmaceutical or medical device companies conducting market research efforts to develop or improve products for people with MS. For further details about each survey/study, as well as contact information, please click here.

Take Charge Study

Description of Trial/Study

We are interested in learning if self-management treatments can be effectively delivered by telephone to persons with an MS diagnosis. We are also interested in comparing two different approaches to self-management delivered by phone.

The purpose of this study is to see if these treatments, when delivered by telephone, can help reduce pain, depressed mood, or fatigue in persons with MS. We also want to determine if these treatments can help reduce the negative consequences that these problems often causes in terms of a person’s mood, daily activities, and enjoyment of life.

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MS Center of Excellence, VA Puget Sound - Cognition Study

The VA is currently recruiting veteran and non-veteran patients with Multiple Sclerosis (MS) (relapsing remitting or secondary progressive types only) for a cognition study. We are evaluating the effectiveness of an herbal supplement, Ginkgo bilboa, on cognitive impairment.

We are looking for people between 18-60 years old who are native English speakers, have not used Ginkgo bilboa for the past 30 days, and who have no significant medical problems. You cannot have had a MS relapse within 6 months of entering the program. Participants will need to be willing to come to the Seattle VA three times for assessments during the 6 months of the study.

For further information, please contact Jim Hunziker, ARNP, Study Coordinator at 206-277-5519, or 1-800-329-8387 x65519.

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A Randomized Trial of Two Formal Group Programs for Multiple Sclerosis

Description of Study/Trial

This is multi-site study with 4 VA sites: Seattle; Portland, OR; Gainesville, FL; and Baltimore, MD. It is a randomized single blind controlled parallel treatment trial with two arms. The purpose of this study is to compare two different group education programs for people with MS. We want to determine which program may be better at helping improve quality of life and MS symptoms. Both programs use materials from the National Multiple Sclerosis Society (NMSS). One of the programs is called Fatigue: Take Control. The other program is called MS: Take Control. Participants will be randomized to one of the groups.

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Investigators Recruiting People with MS for Study of New Investigational Dosage of Approved Medication for Urinary Incontinence

Description of Study/Trial: Investigators at sites worldwide are recruiting 184 people for a study of a new investigational dosage of an approved medication, which is injected into the bladder muscle to treat urinary incontinence in people with MS.

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A Multicenter, Observational, Open-Label, Single-Arm Study of Tysabri in Early Relapsing-Remitting Multiple Sclerosis in Anti-JCV Antibody Negative Patients

Description of Study/Trial: The purpose of the study is to find out if there are any assessments that might predict whether or not patients receiving Tysabri will remain free of disease (that is, without relapses, worsened disability, and/or lesions on brain magnetic imaging [MRI] scans) and how effective Tysabri is at keeping patients who are in the early stages of RRMS free of disease. We are looking for newly diagnosed RRMS patients who are already being prescribed Tysabri as a treatment for MS then this study will provide additional testing for patients.

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12-month, Prospective, Randomized, active-controlled, open-label study to Evaluate the patient retention of Fingolimod vs. approved first-line disease modifying therapies in adults who are in Early stages of treatment for Relapsing remitting Multiple Sclerosis (PREFERM§.)

Description of Study/Trial: The purpose of this study is to evaluate the effectiveness of fingolimod 0.5 mg/day versus approved first line disease modifying therapies (DMT) as measured by patient retention on randomized treatment over 12 months. The study will include adult patients with relapsing remitting MS who are in early stages of treatment. For the purpose of this study, early stages of treatment includes patients who are either treatment naive or who have been treated with no more than one class of approved first line DMT (interferon B preparation or glatiramer acetate) for less than or equal to a total of five years of lifetime exposure.

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A 12-month, randomized, rater- and dose-blinded study to compare the efficacy and safety of fingolimod 0.25 mg and 0.5 mg administered orally once daily with glatiramer acetate 20 mg administered subcutaneously once daily in patients with relapsing-remitting multiple sclerosis.

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A Phase II, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Abatacept in Adults with Relapsing-Remitting Multiple Sclerosis

Description of Study/Trial: The ACCLAIM study is testing whether the medication “abatacept” can be of benefit to patients with relapsing-remitting multiple sclerosis. Although abatacept is an investigational medication for MS, it is not a new drug: It has been approved by the FDA to treat rheumatoid arthritis.

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Exploring the efficacy of hypnotherapy for pain management in persons with multiple sclerosis

Description of Study/Trial: This study is designed to explore alternative treatment options for MS pain and discomfort; specifically whether self-hypnosis is an effective pain-management tool for those diagnosed with this challenging disease.

Sixty adult (18-65 years of age) participants who have been formally diagnosed with MS and who are presently self-administering treatment of an interferon beta product (Avonex®, Betaseron®, Extavia®, or Rebif®) and have been for at least 12 months, are invited to participate in this study. Participants will meet at the Northwest University graduate campus in Kirkland, WA at the commencement of the study to complete consent paperwork, a pencil-paper self-evaluated health assessment, and receive their study materials (e.g. orientation DVD, CDs, and trial questionnaires). All participants will be educated and prepared for hypnosis prior to being asked to engage in self-hypnosis. Participants will administer self-hypnosis via pre-recorded CDs in the comfort of their homes, 0-3 times per week (as assigned) for 6 weeks. Each week, all participants will fill out a brief pain questionnaire (approx. 5 min) for a total of 6. At the conclusion of the study, all participants will meet once more at the university to complete one final paper-pencil self-evaluated health assessment and turn in their 6 completed brief pain questionnaires. They will also receive a small package with additional hypnotherapy CD recordings, a gift certificate, and discount specials in appreciation and as compensation for their participation in the study at this time.

Currently, there is no cure for MS, and standard treatments have many side-effects and involve many risks. While scientists worldwide are searching for improved treatments and possible cures, the estimated over 2.5 million people in the world currently battling MS are in immediate need of assistance to manage their symptoms. This study aims to provide an alternate form of treatment to meet these needs and fill in this gap!

... Because Quality of Life is Invaluable!

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ASCEND

Description of Study/Trial: Phase 3b, multicenter, international, randomized, double-blind, placebo-controlled study to assess the efficacy of natalizumab in approximately 856 SPMS subjects who are exhibiting disease progression independent of relapses. Subjects will be randomized to receive either natalizumab 300 mg or placebo intravenously (IV) every 4 weeks (q4wk) for 96 weeks. This study will be conducted in subjects between the ages of 18 and 58, inclusive, with a diagnosis of SPMS for at least 2 years, an EDSS score between 3.0 and 6.5, inclusive, and documented evidence of disease progression independent of clinical relapses over the 1 year prior to enrollment, and who are naïve to natalizumab.

Natalizumab is a recombinant humanized anti-α4 integrin antibody. Natalizumab is produced in a murine myeloma cell line (NS0) and binds to the α4 subunit of human integrin, which is expressed at high levels on all circulating human leukocytes except polymorphonuclear leukocytes. IMP code and names: L04AA23 / natalizumab The proposed natalizumab dose regimen for this study is the current marketed regimen for the treatment of relapsing multiple sclerosis (MS).

Subjects will be randomized in a 1:1 ratio, stratified by site, to one of the following double-blind treatment regimens:

• Natalizumab 300 mg q4wk IV
• Placebo q4wk IV Natalizumab will be administered intravenously.

Treatment duration: Approximately 114 weeks, including up to a 6 week screening period, a 96-week treatment period, and follow up approximately 12 weeks after the last dose of study treatment. The primary objective for this study is: To investigate whether treatment with natalizumab slows the accumulation of disability not related to relapses in subjects with SPMS. The secondary objectives for this study are: To determine whether treatment with natalizumab improves the condition of subjects in this study population, including measurements such as walking speed and ability, MRI, EDSS and subject-reported quality of life.

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A Phase 2, Double-blind, Randomized, Placebo-controlled, Four-arm, Multicenter, Dose-finding Study to Assess the Safety and Efficacy of Three Dose Levels of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Central Neuropathic Pain in Patients with Multiple Sclerosis.

Description of Study/Trial: The objectives of the study are to evaluate the safety, tolerability, and efficacy of 3 doses of AVP-923 capsules containing either 45 mg DM and 10 mg Q (AVP-923-45) or 30 mg DM and 10 mg Q (AVP-923-30) or 20 mg DM and 10 mg Q (AVP-923-20) compared to placebo, for the treatment of central neuropathic pain in a population of patients with multiple sclerosis (MS) over a 12-week period. The MS patient population eligible for enrollment includes patients with relapsing-remitting multiple sclerosis (RRMS) or patients with secondary progressive multiple sclerosis (SPMS) over a 12-week period.

A 12-month, randomized, rater- and dose-blinded study to compare the efficacy and safety of fingolimod 0.25 mg and 0.5 mg administered orally once daily with glatiramer acetate 20 mg administered subcutaneously once daily in patients with relapsing-remitting multiple sclerosis.

Description of Study/Trial: The purpose of this study is to evaluate the efficacy and safety of two doses of fingolimod (0.25 mg and 0.5 mg) compared to 20 mg glatiramer acetate. Patients will be randomized to one of the three treatments in a ratio of 1:1:1. The study will last about 15 months with study visits every three months.

A Phase 1 Randomized, Dose-finding Study of MEDI-551 in Subjects with Relapsing-Remitting Multiple Sclerosis.

Description of Study/Trial: MEDI-551 is B cell depleting monoclonal antibody.

This is a Phase 1, multicenter, multinational, randomized, blinded, placebo-controlled, dose-escalation study to evaluate the safety and tolerability of MEDI-551 in adult subjects with RRMS.

The aim of the Phase 1, adaptive design study is to evaluate the safety, tolerability, and efficacy of MEDI-551 in adult subjects with RRMS. The study consists of a dose escalation phase which will evaluate a single course of MEDI-551 (30, 100, 300, or 900 mg) or placebo administered twice as a fixed IV dose on Days 1 and 15 (eg, 30 mg on Day 1 and 30 mg on Day 15) over a 24-week period (Days 1-169) with long-term follow-up (LTFU) of subjects for B-cell recovery starting after Day 169. In addition, subjects will continue to be followed for long-term clinical outcomes (ie, Kurtzke Expanded Disability Status Scale [EDSS] and vital status) on an annual basis.

A Phase 2 Double-Blind, Placebo Controlled Multi-Center Study to Evaluate the Efficacy and Safety of Tcelna® in Subjects with Secondary Progressive Multiple Sclerosis.

Description of Study/Trial: The study will assess the efficacy and safety of Tcelna (autologous T-Cell Immunotherapy) compared to placebo in subjects with Secondary Progressive Multiple Sclerosis. Primary end point will be percentage of whole brain volume change at two years.

Physical Therapy in Acute Motor MS Exacerbations.

Description of Study/Trial: The purpose of this study is to determine whether physical therapy early in the course of a motor MS relapse (within 7 days of the first motor symptom) improves the functional recovery from relapse. Currently, the standard treatment for an MS motor relapse is 5 days of intravenous steroids followed by six weeks of physical therapy. This study will investigate whether physical therapy concurrent with IV steroids is superior to IV steroids alone.

MS-BMD (Gilenya)

Description of Study/Trial: The purpose of the study is to assess the effect of Gilenya (fingolimod) on the rate of decline in bone mass density and expression of selected bone turnover biomarkers over 2 years in ambulatory subjects with a relapsing form of MS.

HHD - Hand Held Dynamometer

Description of Study/Trial: The purpose of the study is to demonstrate the method of testing the strength of five key lower limb muscle groups using a hand held strength device compared to an examiners manual rating of strength.

Synera

Description of Study/Trial: The purpose of the study is to reduce injection pain in 30 patients with relapsing forms of MS taking interferon beta or glatiramer acetate and to determine the optimal duration of application of the anesthetic patch.