Lennox Gastaut Syndrome (LGS)NCT07555171
EEG Dynamics in Lennox-Gastaut Syndrome Patients Undergoing Fenfluramine Treatment
An observational study of Lennox Gastaut Syndrome (LGS), run by University of Chicago at 1 site in United States.
Trial summary
This study plans to learn if certain markers found during electroencephalogram (EEG) analysis could predict fenfluramine responsiveness to give clinicians greater insight into the effectiveness of fenfluramine in people with Lennox Gastaut Syndrome (LGS). Read more about this study
- Who is it for?
- Ages 2 to 35 years
- Conditions the study is for
- Lennox Gastaut Syndrome (LGS)
- What is being tested?
- fenfluramine HCl
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2026to Apr 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients at University of Chicago who have been diagnosed with Lennox-Gastaut Syndrome (LGS)
Who may be able to join
- Children and adults aged 2 to 35 years
- Have a confirmed diagnosis of Lennox-Gastaut Syndrome (LGS), validated by the Epilepsy Study Consortium
- Documented seizure onset at age 11 years or younger, accompanied by multiple seizure types, specifically including tonic seizures and atonic or tonicatonic seizures.
- Participants must exhibit a stable seizure baseline for at least 4 weeks prior to enrollment, with documented frequency of two or more drop seizures per week, characterized as generalized tonic-clonic (GTC), secondary GTC (focal to bilateral tonic-clonic seizures), tonic, atonic, or combined tonic-atonic seizures.
- Participants must exhibit abnormal cognitive development and a medical history consistent with electroencephalographic (EEG) findings demonstrating abnormal background activity characterized by a slow spike-andwave pattern at a frequency of less than 2.5 Hz.
- Participants must have a clearly documented etiology of LGS falling into one of the following categories: structural, genetic, metabolic, infectious, immune or unknown.
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- Participants must have had a valid baseline EEG that reflects their clinical state during a stable seizure period and must have been conducted within 6 months prior to study enrollment.
- Participants must be currently receiving fenfluramine as part of their clinical management regimen. Fenfluramine dosing must follow established LGS-specific dosing guidelines, initiated at 0.1 mg/kg administered orally twice daily, with weekly dose titration based on tolerability and clinical response until reaching the recommended maintenance dose of 0.35 mg/kg orally twice daily, not exceeding a total daily dose of 26 mg.
- At the time of enrollment, participants must have been on a stable antiseizure medication (ASM) regimen for at least 30 days, defined as receiving between one and four concomitant ASMs without any recent medication changes, aside from the addition of fenfluramine. To ensure accurate baseline EEG assessments, participants must have a documented EEG recorded within 6 months (±2 months) prior to initiation of fenfluramine treatment.
- Caregivers or legal guardians must provide informed consent, and participant assent will be obtained when developmentally appropriate according to ethical standards.
Who cannot join
- Patients have been diagnosed with any progressive neurodegenerative disorders, as these conditions could confound the interpretation of fenfluramine's clinical efficacy and safety profile.
- Individuals with a documented history of fenfluramine use prior to obtaining baseline EEG will be excluded to ensure the baseline EEG data accurately represent the pre-treatment neurophysiological state.
- Participants who have incomplete medical records, inadequate EEG documentation, or insufficient diagnostic workup confirming LGS diagnosis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This study plans to learn if certain markers found during electroencephalogram (EEG) analysis could predict fenfluramine responsiveness to give clinicians greater insight into the effectiveness of fenfluramine in people with Lennox Gastaut Syndrome (LGS).
- Conditions
- Lennox Gastaut Syndrome (LGS)
- Being tested
- fenfluramine HCl
- Keywords
- Lennox Gastaut Syndrome (LGS), fenfluramine
- Medical subject headings
- Lennox Gastaut Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fenfluramine HClDrug
Patients who receive fenfluramine will be enrolled in this non-interventional study.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who have concordance between electroencephalogram (EEG) changes and clinical responsiveness in patients diagnosed with Lennox-Gastaut Syndrome (LGS) undergoing treatment with fenfluramine after 6 months.
Measured: from EEG prior to fenfluarmine initiation to follow up EEG 6 months after
Secondary outcomes (4)
Number of participants whose specific EEG biomarkers are predicative of clinical responsiveness to fenfluramine treatment before, during, and after fenfluramine treatment
Measured: from EEG prior to fenfluarmine initiation to follow up EEG 6 months after
Change from baseline differences of longitudinal EEG dynamics before and during fenfluramine therapy, including changes in background activity, paroxysmal fast activity, epileptiform discharges, and sleep architecture.
Measured: from EEG prior to fenfluarmine initiation to follow up EEG 6 months after
Number of clinical responders and non-responders to fenfluramine treatment measured by differences in quantitative EEG variables after 6 months
Measured: from EEG prior to fenfluramine initiation to follow up EEG 6 months after
Change from baseline in quality of life scores on the Ped-QL epilepsy or QL-Epilepsy after 6 months
Measured: from prior to EEG initiation to 6 months after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start1 May 2026
- Primary completionDec 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lennox Gastaut Syndrome (LGS)Studies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- UCB Pharma
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07555171
- Sponsor's protocol ID
- IRB25-1092
- Status last verified
- Aug 2026
- First submitted
- 21 Apr 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study will be conducted at a single site and data sharing is not necessary.