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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 82 weeks
Awards & highlights

Study 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 below
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I am between 5 and 30 years old.
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My seizures do not respond to treatment.
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I am currently taking medication for epilepsy.
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My epilepsy treatment has been consistent without changes.
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I have been diagnosed with Tuberous Sclerosis Complex (TSC).

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~82 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 82 weeks for reporting.

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 more
Other 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

Find a Location

Who is running the clinical trial?

Noema Pharma AGLead Sponsor
4 Previous Clinical Trials
485 Total Patients Enrolled
Clinical Director, MDStudy DirectorNoema Pharma AG
1 Previous Clinical Trials
180 Total Patients Enrolled
Renata Lazarova, MDStudy DirectorNoema Pharma AG

Media Library

Basimglurant (Glutamate Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05059327 — Phase 2
Tuberous Sclerosis Research Study Groups: Arm A (Basimglurant to Placebo), Arm B (Placebo to Basimglurant)
Tuberous Sclerosis Clinical Trial 2023: Basimglurant Highlights & Side Effects. Trial Name: NCT05059327 — Phase 2
Basimglurant (Glutamate Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05059327 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

At how many locations is this trial being conducted?

"Presently, this trial is being conducted in 25 hospitals, with locations in large cities such as Roseville, Houston and Baltimore. If you are considering participating in this study, know that it might be helpful to select a site nearer to your home to reduce travel costs."

Answered by AI

Will this experiment be testing subjects who are over 25 years old?

"This clinical trial's requirements for patient participation state that prospective enrollees must be between 5 and 30 years old."

Answered by AI

How many people can participate in this experiment at most?

"That is correct, the online clinicaltrials.gov database shows that this research is looking for volunteers right now. The listing went up on March 3rd, 2021 and was updated October 13th, 2022. So far, 54 people have signed up at 25 different hospitals or clinics."

Answered by AI

Has Arm A (Basimglurant to Placebo) received FDA clearance?

"While Phase 2 trials are not as reliable in terms of efficacy, the data collected suggests that Arm A is safe. Therefore, it was given a score of 2."

Answered by AI

Are there any current vacancies for participants in this trial?

"This clinical trial, which was originally posted on March 3rd 2021 according to information from clinicaltrials.gov, is currently looking for patients."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Basimglurant in Children, Adolescents, and Young Adults With TSC
2021. "Basimglurant in Children, Adolescents, and Young Adults With TSC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05059327.
~9 spots leftby Nov 2024
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