Multiple Sclerosis Clinical Trials

FLUENT

A 12-Month, prospective, multicenter, two-cohort, nonrandomized, open-label study in adult patients with Relapsing Multiple Sclerosis (RMS), to investigate changes in immune phenotype biomarkers after treatment with 0.5 mg fingolimod (FTY720) [FLUENT]

Description
The EvergreenHealth Multiple Sclerosis Center is conducting a study of immune phenotype biomarkers in patients with Relapsing Multiple Sclerosis (RMS) after treatment with 0.5mg fingolimod.

Currently enrolling

Who may be eligible to participate?
Patients 18 years of age and older with a confirmed diagnosis of relapsing forms of Multiple Sclerosis. Patients must be planning to start commercially prescribed fingolimod therapy 0.5mg per day OR must already be on commercially prescribed fingolimod 0.5mg per day continuously for 2 years or more. Other inclusion and exclusion criteria may apply.

What does participation involve?
This study uses a two-cohort, nonrandomized, open-label, multicenter design. The study consists of two periods: screening (up to 4 Weeks) and fingolimod treatment period (Baseline to 12 Months). The total study duration is up to 13 Months. Follow-up Visits will be conducted at 3, 6 and 12 Months.

Investigator: Theodore Brown, MD, MPH

For More Information, contact the EvergreenHealth Research Department hotline at 425.899.5385 and ask about the FLUENT study.


MIRROR

ClinicalTrials.gov Identifier: NCT02086188

Pilot Study of Mirabegron and Behavioral Modification Including Pelvic Floor Exercise for Overactive Bladder in Multiple Sclerosis

Description
The purpose of this research trial is to find out if treatment with the drug Mirabegron will improve urinary urgency control better than behavioral changes alone. We will enroll 40 patients with MS who have bladder problems. All participants will receive educational material about managing overactive bladder, including pelvic floor exercises. They will be randomized to receive Mirabegron treatment or a placebo (“sugar pill”). The duration of the study will be about 12 weeks (1-2 weeks of baseline observation followed by about 10 weeks of on-drug observation). There will be 4 scheduled visits during the 12 weeks of participation.

Who Can Participate? Patients aged 18 and older with overactive bladder complaints and a confirmed diagnosis of Multiple Sclerosis. Must be willing to complete diaries regarding bladder activity.

Investigator: Theodore Brown, MD, MPH

For More Information: Shalom Kilcup - 425.899.5369 SEKilcup@evergreenhealth.com


PEG-Thermal IIT

ClinicalTrials.gov Identifier: NCT02490943

A pilot study of warm and cold compress to reduce injection site erythema due to peginterferon-beta-1a in multiple sclerosis.

Phase IV

The MS Center is enrolling research volunteers for a drug study in MS. A research trial using thermal methods to reduce redness and pain caused by peginterferon-beta-1a (Plegridy) injections.

Description
Study involvement up to 18 weeks, consisting of two in-clinic visits and 2 phone visits. Subjects who are enrolled will use a hot and cold compress to see if it relieves redness and pain.

Currently enrolling

Who may be eligible to participate?
Patients with a confirmed diagnosis of Multiple Sclerosis who are receiving Plegridy for treatment.

Investigator: Theodore Brown, MD, MPH

For More Information: Carey Gonzales – 425.899.5374 or CLGonzales@evergreenhealth.com


Tecfidera IIT

Measuring the Impact of Tecfidera on the Gut Microbiota: Does a Change in the Gut Flora Correlate with Gastrointestinal Disturbances Following Therapy Initiation?

Description
The primary objective of this pilot study is to determine whether a measureable change in bacteria represented in the gut takes place following the initiation of dimethyl fumarate, also known as Tecfidera. This study will assess whether a measured change in gut bacterial flora corresponds to the risk of developing gastrointestinal disturbances and of changes in mood state. There are 2 in-clinic study visits and 3 telephone-only study visits required, taking place over a 24-week period.

Currently enrolling

Who may be eligible to participate?
Individuals with a confirmed diagnosis of a relapsing form of MS. No prior treatment with Tecfidera, or prior clinical trial related dimethyl fumarate therapy. Age 18 and over.

Investigator: Virginia Simnad, MD, MSc

For More Information: Shalom Kilcup 425.899.5369 SEKilcup@evergreenhealth.com


DREAM

A Double-blind, CrossoveR, placebo-controlled Study to compare the Effects of Nighttime Administration of suvorexant in Patients with Multiple Sclerosis fatigue and insomnia

Description
The EvergreenHealth Multiple Sclerosis Center is conducting a randomized, double-blind, placebo-controlled, cross-over trial to assess the safety, tolerability, and efficacy of suvorexant (Belsomra®) in treating insomnia in adults with multiple sclerosis (MS) and fatigue.

Currently enrolling

Who may be eligible to participate?
Patients 18-75 years of age with a confirmed diagnosis of Multiple Sclerosis and Insomnia Disorder. Patients must be on a stable regimen of disease modifying therapy with no MS exacerbations for 60 days prior to screening.

What does participation involve?
This study will assess whether suvorexant (Belsomra®) is more effective than placebo in treating insomnia and fatigue in people with MS. Enrolled patients will come to the study site for 4 visits (45-90 minutes each) during the study. Patients will also have 3 or more phone conversations with a study coordinator.

Investigator: Theodore Brown, MD, MPH

For More Information: contact the EvergreenHealth Research Department hotline at 425.899.5385 and ask about the DREAM study.

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