Multiple Sclerosis Clinical Trials


CLICK-MS

Cladribine tablets: Observational evaluation of effectiveness and patient-reported outcomes (PROs) in suboptimally Controlled patients previously taking injectable disease-modifying drugs (DMDs) for relapsing forms of Multiple Sclerosis (RMS)

Description
The MS Center at EvergreenHealth is conducting a study is to evaluate the effectiveness and safety of cladribine tablets in participants with relapsing form of multiple sclerosis (RMS) and active secondary progressive multiple sclerosis (SPMS) who transition to cladribine tablets after suboptimal response to any injectable DMD approved in the United States for RMS in a real-world setting.

Currently enrolling

Who may be eligible to participate?
Male or female patients, age 18 years or older who have been diagnosed with RMS, including RRMS and active SPMS, and satisfy the approved indication for cladribine tablets; must have experienced suboptimal response (lack of effectiveness, intolerability, poor adherence) to injectable DMD treatment. Other inclusion/exclusion criteria apply.

What does participation involve?
Patients will attend study visits as per routine clinical practice, which are expected to happen approximately at the end of Month 2, Month 6 and Month 12 during Year 1, and at the end of Month 14, 18, and 24 (during Year 2), as clinically indicated. Detailed clinical data about MS disease relapses, MRI findings, hematologic and other laboratory assessments, medications received, and adverse events, as well as Patient-Reported Outcomes, will be prospectively collected.

Investigator: Theodore Brown, MD, MPH

For more information: contact EvergreenHealth Research Services at 425.899.5385 or email EvergreenResearch@evergreenhealth.com


MASTER-2

Cladribine tablets: Observational evaluation of effectiveness and patient-reported outcomes (PROs) in suboptimally controlled patients previously taking oral disease-modifying drugs (DMDs) for relapsing forms of multiple sclerosis (RMS)

Description
The MS Center at EvergreenHealth is conducting a study is to evaluate the effectiveness and safety of cladribine tablets in participants with relapsing form of multiple sclerosis (RMS) and active secondary progressive multiple sclerosis (SPMS) who transition to cladribine tablets after suboptimal response to any oral DMD approved in the United States for RMS in a real-world setting.

Currently enrolling

Who may be eligible to participate?
Male or female patients, age 18 years or older who have been diagnosed with RMS, including RRMS and active SPMS, and satisfy the approved indication for cladribine tablets; must have experienced suboptimal response (lack of effectiveness, intolerability, poor adherence) to oral DMD treatment other than cladribine tablets. Other inclusion/exclusion criteria apply.

What does participation involve?
Patients will attend study visits as per routine clinical practice, which are expected to happen approximately at the end of Month 2, Month 6 and Month 12 during Year 1, and at the end of Month 14, 18, and 24 (during Year 2), as clinically indicated. Detailed clinical data about MS disease relapses, MRI findings, hematologic and other laboratory assessments, medications received, and adverse events, as well as Patient-Reported Outcomes, will be prospectively collected.

Investigator: Theodore Brown, MD, MPH

For more information: contact EvergreenHealth Research Services at 425.899.5385 or email EvergreenResearch@evergreenhealth.com


M18-918

A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Assess the Safety and Efficacy of Elezanumab when Added to Standard of Care in Relapsing Forms of Multiple Sclerosis

Description
The MS Center at EvergreenHealth is conducting a study is to see if a study drug, elezanumab, is safe and works when added to the current treatment in adult subjects with relapsing forms of multiple sclerosis (RMS).

Currently enrolling

Who may be eligible to participate?
Patients 18-55 years of age with a confirmed diagnosis of relapsing remitting multiple sclerosis (RRMS) or secondary-progressive multiple sclerosis (SPMS). Other inclusion/exclusion criteria apply.

What does participation involve?
Participation in this study will last approximately 532 days (around 18-19 months), plus time for screening (up to 4 weeks, if needed). Subjects will be required to participate in 17 in-clinic study visits to receive study drug or placebo, blood draws and/or follow-up assessments/questionnaires.

Investigator: Theodore Brown, MD, MPH

For more information: contact EvergreenHealth Research Services at 425.899.5385 or email EvergreenResearch@evergreenhealth.com


M14-397

A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Assess the Safety and Efficacy of Elezanumab when Added to Standard of Care in Progressive Forms of Multiple Sclerosis

Description
The MS Center at EvergreenHealth is conducting a study is to see if a study drug, elezanumab, is safe and works when added to the current treatment in adult subjects with progressive forms of multiple sclerosis (PMS).

Currently enrolling

Who may be eligible to participate?
Patients 18-55 years of age with a confirmed diagnosis of primary-progressive multiple sclerosis (PPMS) or secondary-progressive multiple sclerosis (SPMS). Other inclusion/exclusion criteria apply.

What does participation involve?
Participation in this study will last approximately 532 days (around 18-19 months), plus time for screening (up to 4 weeks, if needed). Subjects will be required to participate in 17 in-clinic study visits to receive study drug or placebo, blood draws and/or follow-up assessments/questionnaires.

Investigator: Theodore Brown, MD, MPH

For more information: contact EvergreenHealth Research Services at 425.899.5385 or email EvergreenResearch@evergreenhealth.com


EXCHANGE

The EXCHANGE study is looking at an investigational medication for people with advancing relapsing multiple sclerosis (RMS). You, or someone you care for, may be able to take part if you/they:

  • are a man or woman, 18–65 years of age
  • have advancing RMS (where symptoms are getting worse over time)
  • have been treated with an MS therapy (beta-interferons, glatiramer acetate, fingolimod, dimethyl fumarate, or teriflunomide) for at least 3 months.

The EXCHANGE study will involve 6 study visits over a period of up to 6 months.

For more information: contact EvergreenHealth Research Services at 425.899.5385 or email EvergreenResearch@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 EvergreenHealth Research Services at 425.899.5385 or email EvergreenResearch@evergreenhealth.com

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