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(904) 244-0411

A Phase 3, Multi-Center, Double-Blind, Randomized, Placebo-Controlled Trial To Evaluate The Efficacy And Safety Of Reldesemtiv in Patients With Amyotrophic Lateral Sclerosis (ALS)

  • Status
    Accepting Candidates
  • Age
    N/A
  • Sexes
    All
  • Healthy Volunteers
I'm interested
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Description

This is a Phase 3, double-blind, randomized, placebo-controlled trial of Reldesemtiv in patients aged 18 to 80 with ALS.

A drug named "Reldesemtiv" is being investigated as a potential new therapy for the improvement of skeletal muscle function in conditions associated with muscle weakness or fatigue such as Amyotrophic Lateral Sclerosis (“ALS”).

The main purpose of this research study is to evaluate the efficacy and safety of Reldesemtiv.

If you agree to participate, your participation in the study will be for about 52 weeks. There will be up to eight clinic visits, accompanied by a Forced Vital Capacity (FVC) pulmonary function test done at home. Nine remote assessment visits with home laboratory/blood draw, most of which will also include a phone call/video appointment with clinic staff.

In-clinic visits can be converted to remote visits in the event the clinic is closed to patient care, or if the study doctor believes your health would be best served by replacing the in-clinic visit with a remote one.

Screening and Day 1 visits can only be done in the clinic and cannot be done remotely.

This study has two parts:

  1. A double-blind, placebo-controlled part, where patients are randomized (2:1) to receive the following dose of Reldesemtiv or placebo (no drug) for the first 24 weeks (double-blind, placebo-controlled part):

• 300 mg Reldesemtiv twice a day for a 600 mg total daily dose (2 tablets twice a day)

• Placebo twice daily (2 tablets twice a day)

  1. An active drug period, where at the end of the 24-week double-blind, placebo-controlled part, all study participants who completed the first 24-week period (this includes participants who were assigned either Reldesemtiv or placebo) will receive Reldesemtiv for the next 24 weeks. You will not know what you received during the first 24 weeks until the entire study is over. If for any reason you were down-titrated to 1 tablet twice a day of study drug during the first 24 weeks of the study, you will take Reldesemtiv 150 mg twice a day for a 300 mg total daily dose during the active drug period.

You will take the study drug twice daily, morning and afternoon (at least 8 hours apart). All doses of the study drug should be taken with food or within 2 hours following eating.

You will be reimbursed for certain expenses related to your participation in this research study (for example, parking and mileage expenses), and your study doctor can provide more information. Study staff will be available via phone or email to answer any questions you may have if you are interested in participating in the trial or would like to learn more about the study.

Details

Protocol number WIRB20211633

Lead researchers

  • Shannon M LaBoy, MD, MS
    Neurologist, Neuromuscular Medicine Physician
  • Michael T Pulley, MD, PhD
    Neurologist, Clinical Neurophysiologist, Neuromuscular Medicine Physician

Participate in a study

Here are some general steps to consider when participating in a research study:

  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step
    4

    Participate

    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.