Skip to navigation Skip to content
Menu

Navigation

National Multiple Sclerosis Society

Sign In
In Your Area
DonateDonate
v
  • What Is MS?

    • Definition of MS
    • What Causes MS?
    • Who Gets MS?
    • Multiple Sclerosis FAQs
    • Types of MS
    • Related Conditions
  • Symptoms & Diagnosis

    • MS Symptoms
    • Diagnosing MS
    • Magnetic Resonance Imaging (MRI)
    • Cerebrospinal Fluid (CSF)
    • Possible MS
    • Clinically Isolated Syndrome (CIS)
    • Newly Diagnosed
    • Other Conditions to Rule Out
    • For Clinicians
  • Treating MS

    • Comprehensive Care
    • Find Doctors & Resources
    • Medications
    • Managing Relapses
    • Rehabilitation
    • Complementary & Alternative Medicines
    • For Clinicians
  • Resources & Support

    • Library & Education Programs
    • Find Support
    • Advanced Care Needs
    • Resources for Specific Populations
    • Find Programs & Services in Your Area
    • Calendar of Programs and Events
    • Find Doctors & Resources
  • Living Well with MS

    • Diet, Exercise & Healthy Behaviors
    • Emotional Well-Being
    • Spiritual Well-Being
    • Cognitive Health
    • Work, Home & Leisure
    • Relationships
  • Research

    • Participate in Research Studies
    • Research News & Progress
    • Research We Fund
    • For Researchers
  • Get Involved

    • Fundraising Events
    • Volunteer
    • Advocate for Change
    • Raise Awareness
    • Join the Community
    • Stay Informed
    • Corporate Support
    • Personal Stories
  • d What Is MS?
    • d Definition of MS
      • Myelin
      • Immune-Mediated Disease
    • d What Causes MS?
      • Viruses
      • Clusters
    • d Who Gets MS?
      • Pediatric MS
      • African Americans
      • Hispanics & Latinos
    • d Multiple Sclerosis FAQs
    • d Types of MS
      • Clinically Isolated Syndrome (CIS)
      • Relapsing-remitting MS (RRMS)
      • Secondary progressive MS (SPMS)
      • Primary progressive MS (PPMS)
    • d Related Conditions
      • Acute Disseminated Encephalomyelitis (ADEM)
      • Balo’s Disease
      • HTLV-I Associated Myelopathy (HAM)
      • Neuromyelitis Optica (NMO)
      • Schilder's Disease
      • Transverse Myelitis
  • d Symptoms & Diagnosis
    • d Diagnosing MS
    • d Magnetic Resonance Imaging (MRI)
    • d Cerebrospinal Fluid (CSF)
    • d Possible MS
    • d Clinically Isolated Syndrome (CIS)
    • d Newly Diagnosed
    • d Other Conditions to Rule Out
      • Lyme Disease
      • Lupus
      • Neuromyelitis Optica
      • Acute Disseminated Encephalomyelitis (ADEM)
    • d For Clinicians
  • d Treating MS
    • d Comprehensive Care
      • Developing a Healthcare Team
      • Make the Most of Your Healthcare Provider Visits
      • Advance Medical Directives
    • d Find Doctors & Resources
    • d Medications
      • Adherence
      • Patient Assistance Programs
      • Meds Used Off Label
      • Make Medications Accessible
      • Generic and Biosimilar - Medications
    • d Managing Relapses
      • Plasmapheresis
    • d Rehabilitation
      • Functional Electrical Stimulation (FES)
    • d Complementary & Alternative Medicines
      • Chiropractic Therapy
      • Marijuana
      • Massage and Bodywork
      • Acupuncture
      • Low-Dose Naltrexone
    • d For Clinicians
  • d Resources & Support
    • d Library & Education Programs
      • Webinar Series
      • Momentum Magazine
      • Educational Videos
      • Knowledge Is Power
      • Pathways to a Cure
      • Live Fully, Live Well
      • Everyday Matters
      • Free From Falls
      • Relationship Matters
      • Resilience: Addressing the Challenges of MS
      • Webcasts
      • DVDs
      • Books
      • For Kids: Keep S'myelin
      • Información en Español
      • Brochures
    • d Find Support
      • Ask an MS Navigator
      • Community at MSconnection.org
      • Join a Local Support Group
      • Peer Connections: One-on-One
      • Edward M. Dowd Personal Advocate Program
    • d Advanced Care Needs
      • Pressure Sores
      • Osteoporosis
      • Seeking Services: Questions to Ask
    • d Resources for Specific Populations
      • Pediatric MS Support
      • Veterans with Multiple Sclerosis
    • d Find Programs & Services in Your Area
    • d Calendar of Programs and Events
    • d Find Doctors & Resources
  • d Living Well with MS
    • d Diet, Exercise & Healthy Behaviors
      • Diet & Nutrition
      • Exercise
      • Heat & Temperature Sensitivity
      • Sleep
      • Vaccinations
      • Women's Health
      • Unhealthy Habits
      • Managing MS and Another Condition
      • Aging with MS
      • Anesthesia and Surgery
      • Managing Your MS
    • d Emotional Well-Being
      • Mood Changes
    • d Spiritual Well-Being
      • Building Spirituality into Your Life
    • d Cognitive Health
    • d Work, Home & Leisure
      • Employment
      • Insurance & Financial Information
      • Staying Mobile
      • Reclaiming Control
      • Accessibility
      • Technology
      • Recreation
      • Travel
      • Emergencies & Disasters
    • d Relationships
      • Disclosure
      • Family Matters
      • Parenting
      • Intimacy
      • Preventing Abuse
  • d Research
    • d Participate in Research Studies
      • Participate in a Clinical Trial
      • Surveys and Other Research Studies
      • Participate in Genetic Studies
      • Donate to Tissue Banks
    • d Research News & Progress
      • Research News
      • Stem Cells in MS
      • Progressive MS Research
      • Clinical Trials in MS
      • Wellness and Lifestyle Research
      • Diet
      • Vitamin D
      • How and Why Do Scientists Share Results
    • d Research We Fund
      • Stopping MS In Its Tracks
      • Restoring What's Been Lost
      • Ending the Disease Forever
      • How We Fund Research
      • FAQs about Society Research
      • Past Research Efforts
      • Driving Solutions
    • d For Researchers
  • d Get Involved
    • d Volunteer
      • Volunteer Information
      • Volunteer Recognition
    • d Advocate for Change
      • Become an MS Activist
      • Take Action
      • Current Advocacy Issues
      • Advocacy Results
      • Advocacy News
    • d Raise Awareness
    • d Join the Community
    • d Stay Informed
    • d Corporate Support
      • Corporate Partners
      • National Teams
      • Partnership Opportunities
    • d Personal Stories
      • Life with MS
      • Givers
      • Shakers
      • Families with MS
      • Seekers
      • Movers
      • Tributes
  • d Donate
    • d Support an Event Participant
    • d Donate Online
    • d Give in Honor or Memory
    • d Workplace Giving
    • d Employer Matching Gifts
    • d Gifts of Stock or Securities
    • d Giving Circles
      • Golden Circle
      • Circle of Distinction
      • Lawry Circle
      • Circle of Influence
    • d Planned Giving
    • d Other Ways to Give
      • Donate by Mail or Phone
  • d About the Society
    • d Vision
      • Strategic Plan
      • Independent Review of Society's Research Programs
    • d Careers
    • d Leadership
      • Board of Directors
      • Senior Leadership Team
      • Founder Sylvia Lawry
    • d Cultural Values
    • d Financials
      • Annual Reports
      • Sources of Support
    • d News
    • d Press Room
      • Events at a Glance
      • MS the Disease
      • Public Service Announcements
      • In the News Archives
    • d MS Prevalence
      • MS Prevalence FAQs
    • d Charitable Ratings
    • d Corporate Support and Programs
  • d Helpful Links
    • d Información en Español
    • d Site Map
    • d Site Tour
    • d Contact Us
  • d For Professionals
    • d Researchers
      • Society Funding
      • Deadlines
      • Apply Online
      • Funding Policies and Procedures
      • Scientific Peer Reviewers
      • Resources for Researchers
    • d Professional Resource Center
      • About MS
      • Diagnosing MS
      • Managing MS
      • Resources for You and Your Practice
      • Publications for Clinicians
      • Publications for Your Patients
      • MS Navigator Program
      • Programs and Services for Your Patients
      • Contact Us
      • Clinical Fellows
    • d Careers in MS
      • Clinical Care
      • Research
      • Have you met?
  • d Our Healthcare Voice
HomeResearch   Participate in Research Studies   Participate in a Clinical Trial

Share this page

FacebookTwitterEmail

Participate in a Clinical Trial

Without the participation of people with MS, it would be impossible to develop new and better therapies and other interventions.

Clinical Trial Finder

Search Results

Study to Evaluate the Safety and Efficacy of PIPE-307 in Subjects With Relapsing-Remitting Multiple Sclerosis

Study Purpose

This is a randomized, double-blind study of PIPE-307 or placebo in subjects with relapsing-remitting multiple sclerosis. Subjects will be randomized into 1 of 3 separate cohorts (1:1:1 randomization ratio, PIPE-307 Dose A:PIPE-307 Dose B: Placebo) for a total duration of approximately 30 weeks.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 50 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Subject is fluent in English.
  • - Male or female 18 to 50 years of age, inclusive, at the first Screening visit.
  • - A diagnosis of relapsing-remitting multiple sclerosis (RRMS) according to the 2017 Revised McDonald Criteria.
  • - Expanded Disability Status Scale (EDSS) and retinal nerve fiber layer within protocol requirements.
  • - Stable immunomodulatory treatment on no more than a single DMT for RRMS over the 6 months prior to Screening, as determined by the PI.
  • - Male or female subjects with reproductive potential agree to comply with a highly effective contraceptive method as per protocol through 1 month after last study drug administration as per protocol.
  • - General good medical health with no clinically significant or relevant abnormalities except those attributed to the underlying multiple sclerosis (MS), including medical history, physical exam, vital signs, ECG and laboratory evaluations, as assessed by the Investigator.
If enrolled in the visual evoked potential (VEP) sub-study, an additional inclusion criterion includes:
  • - Screening VEP P100 latency greater than the upper limit of normal (as defined in the protocol) in at least one eye, OR a protocol-defined difference in VEP P100 latency between eyes.

Exclusion Criteria:

  • - Diagnosis or history of symptoms of optic neuritis within 9 months prior to Screening in either eye.
  • - Diagnosis of MS more than 10 years prior to Screening.
  • - History of severe myopia, ophthalmologic or retinal disorder that would interfere with measurements of low contrast letter acuity (LCLA) or exam by optical coherence tomography (OCT), as determined by Investigator.
  • - Concurrent use of dalfampridine or other 4-aminopyridine or diamino-4-aminopyridine drugs.
  • - Clinical MS relapse or MS related treatment with corticosteroids within 6 months prior to or during Screening.
  • - History of treatment with bone marrow transplantation, mitoxantrone, cyclophosphamide, atacicept, or irradiation.
  • - Use of any daily or routine anticholinergic medications within 30 days of Screening or concurrent during the study.
  • - The presence of gadolinium enhancing lesions by MRI.
  • - Use of any drugs known to strongly or moderately induce or inhibit Cytochrome P450 3A4 (CYP3A4) enzyme activity within 30 days prior to Screening or concurrent during the study.
  • - Use of an investigational product, vaccine or intervention other than a non-interventional registry study within the greater of 30 days or 5 half-lives (if known) prior to Screening or expected during the study.
  • - History of malignancy under current active treatment or considered at substantial risk for progression or recurrence during the study interval, and/or significant cardiac disorder or dysrhythmia, as determined by the Investigator.
  • - History of a suicide attempt or suicidal behavior or considered at risk for suicide as judged by the PI using the Columbia-Suicide Severity Rating Scale (C-SSRS) as Screening.
If enrolled in the visual evoked potential (VEP) sub-study, an additional exclusion criterion includes:
  • - History of an ophthalmologic or retinal disorder that would interfere with measurements of VEP, as determined by the Investigator.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06083753
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Contineum Therapeutics
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Stephen Huhn, MD
Principal Investigator Affiliation Contineum Therapeutics
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Relapsing Remitting Multiple Sclerosis
Additional Details

This is a randomized, double-blind study of PIPE-307 or placebo given to 168 subjects randomized into one of 3 separate cohorts. They will be randomized 1:1:1 (PIPE-307 Dose A:Pipe 307 Dose B: Placebo). There will be a 28-day screening period followed by a 26-week treatment period. Safety will be assessed by periodic measurements of vital signs (VS), physical (PE) and neurological examinations, electrocardiograms (ECG), blood laboratory analyses and occurrence of adverse events (AE).

Arms & Interventions

Arms

Experimental: PIPE-307 Dose A

Experimental: PIPE-307 Dose B

Placebo Comparator: Placebo

Interventions

Drug: - PIPE-307 Dose A

Subjects will receive daily oral doses of PIPE-307

Drug: - PIPE-307 Dose B

Subjects will receive daily oral doses of PIPE-307

Drug: - Placebo

Subjects will receive daily oral matching dose of Placebo

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Xenosciences, Phoenix, Arizona

Status

Recruiting

Address

Xenosciences

Phoenix, Arizona, 85004

Site Contact

[email protected]

Arizona Neuroscience Research, LLC, Phoenix, Arizona

Status

Recruiting

Address

Arizona Neuroscience Research, LLC

Phoenix, Arizona, 85032

Site Contact

[email protected]

Sutter East Bay Medical Foundation, Berkeley, California

Status

Recruiting

Address

Sutter East Bay Medical Foundation

Berkeley, California, 94705

Site Contact

[email protected]

Colorado Springs Neurological Associates, Colorado Springs, Colorado

Status

Recruiting

Address

Colorado Springs Neurological Associates

Colorado Springs, Colorado, 80907

Site Contact

[email protected]

Clearwater, Florida

Status

Recruiting

Address

MS and Neuromuscular Center of Excellence

Clearwater, Florida, 33761

Site Contact

[email protected]

Aqualane Clinical Research, Naples, Florida

Status

Recruiting

Address

Aqualane Clinical Research

Naples, Florida, 34105

Site Contact

[email protected]

Port Orange, Florida

Status

Recruiting

Address

Accel Research Sites Network - Brain & Spine Institute

Port Orange, Florida, 32127

Site Contact

[email protected]

Vero Beach, Florida

Status

Recruiting

Address

Vero Beach Neurology And Research Institute

Vero Beach, Florida, 32960

Site Contact

[email protected]

Shepherd Center, Atlanta, Georgia

Status

Recruiting

Address

Shepherd Center

Atlanta, Georgia, 30309

Site Contact

[email protected]

Savannah, Georgia

Status

Recruiting

Address

Velocity Clinical Research, Savannah Neurology Specialists

Savannah, Georgia, 31406

Site Contact

[email protected]

Indianapolis, Indiana

Status

Recruiting

Address

Indiana University Health Neuroscience Center, Adult Neurology Center

Indianapolis, Indiana, 46202

Site Contact

[email protected]

University of Kansas Medical Center, Kansas City, Kansas

Status

Recruiting

Address

University of Kansas Medical Center

Kansas City, Kansas, 66160

Site Contact

[email protected]

Neurology Center of New England P.C., Foxboro, Massachusetts

Status

Recruiting

Address

Neurology Center of New England P.C.

Foxboro, Massachusetts, 02035

Site Contact

[email protected]

Farmington Hills, Michigan

Status

Recruiting

Address

Michigan Institute for Neurological Disorders (MIND)

Farmington Hills, Michigan, 48334

Site Contact

[email protected]

Washington University School of Medicine, Saint Louis, Missouri

Status

Recruiting

Address

Washington University School of Medicine

Saint Louis, Missouri, 63110

Site Contact

[email protected]

Albuquerque, New Mexico

Status

Recruiting

Address

University of New Mexico/Health Science Center/MIND Imaging Center/MS Specialty Clinic

Albuquerque, New Mexico, 87106

Site Contact

[email protected]

Dent Neurologic Institute, Amherst, New York

Status

Recruiting

Address

Dent Neurologic Institute

Amherst, New York, 14226

Site Contact

[email protected]

Raleigh, North Carolina

Status

Recruiting

Address

Velocity Clinical Research, Raleigh Neurology

Raleigh, North Carolina, 27607

Site Contact

[email protected]

Oklahoma City, Oklahoma

Status

Recruiting

Address

Oklahoma Research Foundation - MS Center of Excellence

Oklahoma City, Oklahoma, 73104

Site Contact

[email protected]

Sibyl Wray Neurology PC, Knoxville, Tennessee

Status

Recruiting

Address

Sibyl Wray Neurology PC

Knoxville, Tennessee, 37922

Site Contact

[email protected]

Clinical Trial Network, Houston, Texas

Status

Recruiting

Address

Clinical Trial Network

Houston, Texas, 77074

Site Contact

[email protected]

Bhupesh Dihenia, MD, PA, Lubbock, Texas

Status

Recruiting

Address

Bhupesh Dihenia, MD, PA

Lubbock, Texas, 79410

Site Contact

[email protected]

Virginia Mason Medical Center, Seattle, Washington

Status

Recruiting

Address

Virginia Mason Medical Center

Seattle, Washington, 98101

Site Contact

[email protected]

UW Medicine MS Center, Seattle, Washington

Status

Recruiting

Address

UW Medicine MS Center

Seattle, Washington, 98133

Site Contact

[email protected]

Tacoma, Washington

Status

Recruiting

Address

Multicare Neuroscience Center of Washington

Tacoma, Washington, 98405

Site Contact

[email protected]

Resources

Clinical Trials in MS


The latest clinical research in MS, including trials funded by the Society and trials in progressive MS.

Read more

Read more

NARCOMS Patient Registry

Register as a willing MS research participant to facilitate multicenter studies. Initiated by the Consortium of MS Centers.

Visit NARCOMS

Visit NARCOMS

Posting a Trial

If you would like us to post a study on these pages, please email [email protected] to find out what information you need to submit for review.

Powered By

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

Colophon

 

Stay Informed

Join Us

Facebook Twitter Instagram LinkedIn YouTube MS Connection
  • About the Society
    • Vision
    • Careers
    • Leadership
    • Cultural Values
    • Financials
    • News
    • Press Room
    • MS Prevalence
    • Charitable Ratings
    • Corporate Support
  • Helpful Links
    • Donate
    • MSConnection Blog
    • Información en Español
    • Glossary
    • Legal Notice/Privacy Policy
    • Site Map
    • Site Tour
    • Contact Us
  • For Professionals
    • Researchers
    • Physicians
    • Nurses
    • Rehabilitation Professionals
    • Mental Health Professionals
    • Health and Wellness Professionals
  • What Is MS?
  • Symptoms & Diagnosis
  • Treating MS
  • Resources & Support
  • Living Well with MS
  • Research
  • Get Involved
Hidden Link