Clinical Research Study for Lennox-Gastaut Syndrome (LGS)

Sign up today for a Lennox-Gastaut Syndrome research study and help shape the future of LGS research — all from home.
Condition
Lennox-Gastaut Syndrome (LGS)
Study Treatment:
Investigational Drug
Age:
2 to 55 years old
Sex:
All
Duration:
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Key Criteria:
Confirmed LGS diagnosis with ongoing major motor seizures
Location:
Remote (from your home) — some at-home visits and assessments are part of the study
Travel
None, participation is from home
Compensation
Compensation may be available for completing study-related activities
What Participation may Involve?

  1. Screening & Observation (4 Weeks)
    • Seizure diary documentation
    • Medical history and medication review
    • Physical exams, blood tests, and ECGs
  2. Double-Blind Treatment Phase
    • Participants receive either the investigational medication or placebo.
  3. Optional Long-Term Extension (Up to 3 Years)
    • Participants who complete the double-blind phase may join the open-label extension, where all participants receive the investigational medication.
  4. Safety Taper Period
    • The study drug is tapered gradually over up to 4 weeks, followed by safety follow-up.

All study-related evaluations will be explained by the research team. You (or your child) may withdraw from the study at any time.

About the Study

This study is designed to evaluate the safety and potential effectiveness of clemizole hydrochloride, an investigational oral medication, in reducing major motor seizures in individuals with LGS. Participants who qualify will continue their current antiseizure medications while taking either the investigational medication or placebo during the initial study phase.

Who may qualify:

  • Are 2 to 55 years old
  • Have a confirmed diagnosis of Lennox–Gastaut Syndrome (LGS), including:
  • Major motor seizures that can be counted
  • EEG features consistent with LGS
  • Abnormal cognitive development
  • Seizure onset at age ≤11 years
  • Have had at least 4 countable seizures per month in the two months before screening, including tonic or tonic/atonic seizures
  • Experience at least 4 major motor seizures during the initial 28-day observation period
  • Have tried one or more antiseizure medications without adequate seizure control
  • Are taking 4 or fewer antiseizure medications, stable for ≥30 days
  • Can maintain a daily seizure diary with the help of a parent/caregiver/LAR
  • For females who can become pregnant:
    • Have negative pregnancy tests
    • Agree to nonhormonal contraception or abstinence during the study and for 15 days afterward
Enroll Today
Don't have the Lennox-Gastaut Syndrome but know someone who does?

Just two simple steps to see if you qualify.

Our dedicated team of patient experience coordinators is here to guide you through every step of the pre-screening process.

You Complete a
Short Questionnaire

Answer a few quick questions to see if you pre-qualify. You’ll receive a response within minutes.

Sign the Medical Records
Release Form

Once you sign our Medical Record Release Form, a Clinical Research Coordinator will contact you for an informed consent call.
Enroll Today
Sign up and complete a short questionnaire.
Find out if you (or your child) pre-qualify for the study.
You'll receive an immediate response if you qualify or not.
If you pre-qualify, we'll provide the next steps for medical records and the informed consent discussion.

What’s Involved in the Study?

See below for a summary of the timing and key activities.
Before
Complete the
Pre-Screening
Questionnaire
Fill out the
Medical Record
Request Form
Science37
Reviews Medical
Records
During
Treatment period
Fill Out
The Consent
Form
Complete video
call (telemed) study
visits from home
Compensation may be available for completing study-related activities.
After
Safety follow-up: up to 4 weeks
Compensation may be available for completing study-related activities.
Do you know someone interested in helping with our research?
Enroll Today
Don’t have for narcolepsy but know someone who does?

Have Questions?

We have an awesome team of doctors, researchers, and patient experience coordinators who are eager to help guide you through the research process.

Frequently Asked Questions

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Frequently Asked Questions (FAQ)

What does a typical research study look like?

There are different types of research studies, including those that are observational, where no investigational drug is given to the patient, and interventional, where an investigational drug/device/procedure is used. The government has established many rules to help ensure that research studies are conducted in the most ethical and safe way possible and that participants are protected throughout.

Why volunteer to take part in a research study?

Volunteers are part of the next wave of science and can influence the future of medicine. Advances in research have allowed people to get new treatments, new diagnostic tests, new procedures, etc. — and these breakthroughs wouldn’t be possible without volunteers.

Can I tell my doctor? Will my doctor get involved?

You can always share information about the research study with your primary doctor or healthcare provider. We encourage you to do so, especially if this is someone you know well and trust. Your doctor can be an additional resource when you are first learning about a research study and have any questions. You can continue to see your doctor throughout the research study for routine visits and tests. Our study team is available to talk to both you and your doctor if there are any concerns or questions. Working together helps to ensure that other medications or treatments you receive will not be a problem with the research study protocol. However, because these studies are investigational, the result of the study will not be available to individual patients.

Will taking part in a research study cost me anything?

There is no cost to participate, and many research studies offer reimbursement for your time and effort. Compensation depends on the research study and is discussed during the informed consent process.

How long is a research study?

Research studies are designed by a team of expert scientists, physicians, and statisticians. The duration of a research study varies depending on the protocol that this team develops. When you learn about a research study, you will be informed about the time commitment needed before you agree to participate.

Can I talk to other people about the research study?

Besides talking to the study staff, you should minimize sharing your experience in the research study with others. We understand that talking about your experience is an important part of feeling supported, but we ask that you not share information about the research study on social media or with other research study participants. This helps to ensure the most valid and highest-quality scientific results. Our study team is always available to address your questions and concerns.

What if I want to leave a research study?

You can leave the research study at any time and for any reason. You are under no obligation to complete a research study or give a reason why you’re leaving one. Although we do our best to make our research studies as easy as possible for you to take part in, we understand that there are many reasons why finishing may not be possible.

What happens to me after I complete the research study?

After you complete the research study, the study team will talk with you to answer your questions and get your feedback on your overall experience during the trial. As a Science 37 research study participant, you will have access to news and updates about medical discoveries, educational content, and future research opportunities. You will continue to see your local primary doctor or healthcare provider for routine medical care.
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