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Glutamate Receptor Antagonist
Basimglurant for Tuberous Sclerosis
Phase 2
Recruiting
Research Sponsored by Noema Pharma AG
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 5 to 30 years at study entry
Refractory seizure history
Must not have
Neurologic disease other than TSC
Patient weight below 15kg
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 82 weeks
Awards & highlights
Summary
This trial will test whether basimglurant is an effective seizure control medication for children and adolescents with Tuberous Sclerosis Complex.
Who is the study for?
This trial is for children, adolescents, and young adults aged 5 to 30 with Tuberous Sclerosis Complex (TSC) who have seizures not controlled by current medications. Participants must be fluent in the study staff's language, on stable epilepsy treatments, and willing to undergo pregnancy tests if applicable. Those under 15kg or with other significant medical conditions are excluded.Check my eligibility
What is being tested?
The trial is testing Basimglurant's ability to control seizures in TSC patients. It involves a crossover design where participants receive either Basimglurant or a placebo first and then switch to the other after a certain period.See study design
What are the potential side effects?
While specific side effects of Basimglurant aren't listed here, similar medications often cause drowsiness, dizziness, gastrointestinal issues like nausea or vomiting, mood changes, and potential allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 5 and 30 years old.
Select...
My seizures do not respond to treatment.
Select...
I am currently taking medication for epilepsy.
Select...
My epilepsy treatment has been consistent without changes.
Select...
I have been diagnosed with Tuberous Sclerosis Complex (TSC).
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a neurological condition that is not tuberous sclerosis complex.
Select...
I weigh less than 15kg.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 82 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~82 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean percentage in monthly seizure frequency during the maintenance dosing in Period 2 (Weeks 13 to 16) and Period 4 (Weeks 27-30).
Secondary outcome measures
Change in the Sheehan Disability Scale during maintenance dosing in Period 2 (Weeks 13 to 16) and Period 4 (Weeks 27-30) compared to baseline.
Change in the severity of symptoms of TSC as measured by Caregiver Global Impression of Change (CGIC) score during maintenance dosing in Period 2 (Weeks 13 to 16) and Period 4 (Weeks 27-30) compared to Baseline.
Longest seizure free interval (i.e., seizure free days).
+2 moreOther outcome measures
Change in seriousness of disease as assessed by Most Impactful Symptoms Scale in Periods 2 (weeks 13 to 16) and Period 4 (weeks 27 to 30) compared to baseline.
Frequency of seizures detected by the wearable device evaluated as the change from Baseline compared to study treatment in Period 1 (weeks 13 to 16) and Period 4 (weeks 27 to 30).
Intensity of seizures detected by the wearable device evaluated as the change from Baseline compared to study treatment Periods 1 and 4.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm A (Basimglurant to Placebo)Experimental Treatment1 Intervention
Basimglurant to Placebo
Group II: Arm B (Placebo to Basimglurant)Placebo Group1 Intervention
Placebo to Basimglurant
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Tuberous Sclerosis Complex (TSC) include mTOR inhibitors like rapamycin and everolimus, which work by inhibiting the mTOR pathway, a key regulator of cell growth and proliferation that is often overactive in TSC. Basimglurant, a Negative Allosteric Modulator of the mGluR5 receptor, is being studied for its potential to control seizures in TSC patients by modulating glutamate signaling, which is implicated in neuronal excitability and seizure activity.
These treatments are crucial for TSC patients as they target the underlying molecular pathways responsible for the growth of benign tumors and neurological symptoms, thereby improving quality of life and reducing disease burden.
Inhibition of mTOR Pathway by Rapamycin Decreases P-glycoprotein Expression and Spontaneous Seizures in Pharmacoresistant Epilepsy.
Inhibition of mTOR Pathway by Rapamycin Decreases P-glycoprotein Expression and Spontaneous Seizures in Pharmacoresistant Epilepsy.
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Who is running the clinical trial?
Noema Pharma AGLead Sponsor
5 Previous Clinical Trials
509 Total Patients Enrolled
Clinical Director, MDStudy DirectorNoema Pharma AG
2 Previous Clinical Trials
204 Total Patients Enrolled
Renata Lazarova, MDStudy DirectorNoema Pharma AG
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing to take pregnancy tests if I can have children.I am between 5 and 30 years old.I have a neurological condition that is not tuberous sclerosis complex.My seizures do not respond to treatment.I am currently taking medication for epilepsy.I weigh less than 15kg.I do not have any unstable health conditions.I am willing to fill out surveys about my health condition.My epilepsy treatment has been consistent without changes.I have been diagnosed with Tuberous Sclerosis Complex (TSC).
Research Study Groups:
This trial has the following groups:- Group 1: Arm A (Basimglurant to Placebo)
- Group 2: Arm B (Placebo to Basimglurant)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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