Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruitingRare disease

Study on Basimglurant for Children, Adolescents, and Young Adults with Tuberous Sclerosis Complex-Related Seizures

Verified siteInvestigational
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as Tuberous Sclerosis Complex (TSC), which is a genetic disorder that causes non-cancerous tumors to form in many different organs, primarily the brain, eyes, heart, kidney, skin, and lungs. The study aims to evaluate the effectiveness and safety of a medication called Basimglurant, which is being tested as an additional treatment alongside ongoing anticonvulsive therapy for managing seizures associated with TSC. Basimglurant is taken in the form of a capsule and is known by the code name NOE-101.

The purpose of the study is to assess how well Basimglurant works in reducing seizures when used together with current seizure medications. Participants in the study will be randomly assigned to receive either Basimglurant or a placebo, which looks like the medication but does not contain the active ingredient. The study will be conducted over a period of 30 weeks, during which participants will not know whether they are receiving Basimglurant or the placebo. After this period, there will be an additional 52-week phase where all participants will receive Basimglurant.

Throughout the study, participants will continue their regular anticonvulsive therapy. The study will monitor the number of seizures, any changes in daily activities, and overall impressions of change from caregivers. Safety will also be closely observed, including any side effects or changes in health. This trial is designed to provide valuable information on whether Basimglurant can be a beneficial addition to existing treatments for those with Tuberous Sclerosis Complex.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial phase

    Upon joining the study, the participant will begin a 30-week trial period. This phase is designed to evaluate the effectiveness and safety of the medication basimglurant when used alongside existing seizure treatments.

    The participant will be randomly assigned to receive either basimglurant or a placebo. Both are administered in capsule form and taken orally.

  2. Step 2

    Treatment period 1

    During the first 12 weeks, the participant will take the assigned medication daily. The goal is to monitor seizure frequency and any changes in seizure patterns.

    The participant will continue their current anticonvulsive therapy throughout this period.

  3. Step 3

    Evaluation and crossover

    After the initial 12 weeks, the participant's response to the treatment will be evaluated. This includes assessing seizure counts and any side effects.

    The participant may then switch to the alternative treatment (from placebo to basimglurant or vice versa) for another 12-week period.

  4. Step 4

    Treatment period 2

    In this phase, the participant will continue with the new treatment regimen for another 12 weeks. The focus remains on monitoring seizure activity and overall health.

    Regular assessments will be conducted to track any changes in seizure frequency and to ensure the participant's safety.

  5. Step 5

    Open-label extension

    Following the 30-week double-blind phase, the participant may enter a 52-week open-label extension. During this time, all participants will receive basimglurant.

    The purpose of this phase is to gather long-term data on the medication's effectiveness and safety.

  6. Step 6

    Ongoing assessments

    Throughout the study, the participant will undergo regular health checks, including physical exams and laboratory tests, to monitor for any adverse effects.

    The participant's seizure activity will be closely tracked, and any changes in health or medication tolerance will be documented.

Who can join the trial?

10 criteria

  • Ability and willingness to provide informed assent or written consent, or consent from their legal representative. This means the patient or their guardian agrees to participate after understanding the study.
  • Fluency in the language of the study staff. The patient must be able to speak and understand the language used by the study team.
  • Age between 5 to 30 years at the start of the study.
  • A documented history of Tuberous Sclerosis Complex (TSC). This means the patient has medical records showing they have TSC.
  • Refractory seizure history. This means the patient has seizures that are difficult to control with medication.
  • Currently receiving one or more anti-epileptic drugs (AEDs). These are medications used to help control seizures.
  • Stable medications or interventions for epilepsy for 30 days before study entry. The patient's treatment for epilepsy should not have changed in the last 30 days.
  • Willingness to complete Patient Reported Outcome assessments. The patient agrees to provide feedback on their health and treatment during the study.
  • For female patients of childbearing potential: Willingness to undergo serum or urinary pregnancy testing at screening and during the trial period. This means they agree to take pregnancy tests before and during the study.
  • For female patients of childbearing potential: Willingness to use contraception. This means they agree to use birth control methods during the study.

Who cannot join the trial?

9 criteria

  • Patients who are not diagnosed with Tuberous Sclerosis Complex cannot participate. Tuberous Sclerosis Complex is a genetic disorder that causes non-cancerous growths in many parts of the body.
  • Patients who are not currently receiving anticonvulsive therapy cannot participate. Anticonvulsive therapy involves taking medication to help control seizures.
  • Patients who are unable to take the study medication as directed cannot participate.
  • Patients who have a medical condition that might interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have participated in another clinical trial recently may not be eligible.
  • Patients who have a history of drug or alcohol abuse may not be eligible.
  • Patients who have a known allergy to the study medication cannot participate.
  • Patients who are unable to comply with the study procedures cannot participate.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Basimglurant is being studied to see if it can help reduce seizures in children, adolescents, and young adults who have Tuberous Sclerosis Complex. It is given in addition to the anticonvulsive medications that patients are already taking. The study aims to find out if adding basimglurant to their current treatment can improve their condition.

What is already known about the treatment

Basimglurant – Basimglurant is administered orally and is currently being studied in clinical trials for its potential use in treating seizures associated with Tuberous Sclerosis Complex. It is not yet widely available in medical practice, as it is still under investigation. The main therapeutic indication for basimglurant is as an adjunctive treatment to existing anticonvulsive therapies in individuals with Tuberous Sclerosis Complex. At the molecular level, basimglurant works by modulating the activity of certain receptors in the brain, which may help reduce seizure frequency. It is classified pharmacologically as a negative allosteric modulator of the metabotropic glutamate receptor 5 (mGluR5).

Investigated diseases

Tuberous Sclerosis Complex – Tuberous Sclerosis Complex is a genetic disorder characterized by the growth of non-cancerous tumors in various parts of the body, including the brain, skin, kidneys, and heart. These tumors can lead to a range of symptoms, such as seizures, developmental delays, and skin abnormalities. The condition is caused by mutations in either the TSC1 or TSC2 genes, which are responsible for regulating cell growth. As the disease progresses, individuals may experience an increase in the number and size of tumors, potentially affecting organ function. The severity and specific symptoms can vary widely among individuals, even within the same family. Tuberous Sclerosis Complex is considered a rare disease, affecting a small percentage of the population.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-512611-53-00Protocol codeNOE-TSC-201Estimated enrolment67 patientsSponsorNoema Pharma AG

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.