A Phase 2 interventional study of Basimglurant with crossover to Placebo and Placebo with crossover to Basimglurant in Tuberous Sclerosis Complex, sponsored by Noema Pharma AG. Completed at 27 sites in 8 countries. Open to participants aged 5 Years to 30 Years. Per ClinicalTrials.gov, last updated 2025-06-04.
Sponsored by Noema Pharma AG · Phase 2, Interventional, and Treatment
Among 63 studies in Tuberous Sclerosis with a site in United States — 9 open to participants now, 16 under way, 1 of them phase 3. Tuberous Sclerosis · United States.
Among the 63 studies in Tuberous Sclerosis with a site in United States, this one is the 21st largest by enrollment of the 47 interventional ones that give a count, is one of 7 that started in 2022, is one of 14 in phase 2, and was the 48th registered.
115 studies on the registry are indexed under Tuberous Sclerosis; 27 are open to participants now.
This study's enrollment of 61 is above the median of 52 across 73 interventional studies indexed under Tuberous Sclerosis.
Browse Tuberous Sclerosis studies →9 of the 63 studies in Tuberous Sclerosis with a site in United States are open now, in 3 countries. Each count lists the studies.
Of the 21 Tuberous Sclerosis studies recruiting now, 10 (48%) set no upper age limit and 8 (38%) stop at 75 or younger; 15 take children under 18; 2 take healthy volunteers.
This study: 5 Years to 30 Years · all sexes · no healthy volunteers.
The full table on the hub →63 studies; the count open now beside each. This study's row is marked.
First in 1995; this study’s year is marked. 7 started in 2022.
Median enrollment 52 across the 47 interventional studies, 300 across the 15 observational. Of the 44 that completed or were terminated, 25 (57%) have results posted.
20 of 63 have an industry lead sponsor. The 10 most frequent:
Noema Pharma AG is the lead sponsor of 6 studies on the registry; none are open to participants now.
Noema Pharma AG has 1 study filed under Tuberous Sclerosis — fewer than ten, so there is no comparison to draw.
5 of the studies in Tuberous Sclerosis with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT02962414Phase 3Novartis PharmaceuticalsRoll-over Study to Collect and Assess Long-term Safety of Everolimus in Patients With TSC and Refractory Seizures Who Have Completed the EXIST-3 Study [CRAD001M2304] and Who Are Benefitting From Continued Treatment | 2026-12-30 |
| NCT06139172Rush University Medical CenterWeb Intervention for Parents of Youth With Genetic Syndromes (WINGS) | 2026-12 |
| NCT06879665Vrije Universiteit BrusselTANDem-2: Closing the Gap to Interventions for TAND | 2026-12-31 |
| NCT05104983Darcy KruegerStopping TSC Onset and Progression 2B: Sirolimus TSC Epilepsy Prevention Study | 2027-06-30 |
| NCT05044819Jazz PharmaceuticalsAssessment of Potential for Chronic Liver Injury in Participants Treated With Epidiolex (Cannabidiol) Oral Solution | 2027-08-01 |
Among the 63 studies in Tuberous Sclerosis with a site in United States, from their registry updates:
The study intends to show that basimglurant (NOE-101) provides effective seizure control in children, adolescents and young adults with Tuberous Sclerosis Complex (TSC).
The study drug (NOE-101, basimglurant) is a potent inhibitor of metabotropic glutamate receptor 5 (mGluR5) which controls a wide range of processes in the brain, spinal cord, retina, and peripheral nervous system. In animal studies, the inhibition of this receptor has shown therapeutic potential for the treatment of Tuberous Sclerosis Complex (TSC). This receptor's inhibition decreases the frequency of seizures. In previous clinical trials, the study drug has shown an advantageous safety profile in children and adolescents.
The objective of this study is to find an optimal dose at which the study drug will lead to a decrease in the duration, frequency and intensity of seizures in children, adolescents and young adults with TSC, while being well tolerated. All patients who positively respond and tolerate the medicine will be offered the possibility to continue in an open label extension.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
For female patients of :
Exclusion Criteria (summary):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Basimglurant to Placebo
Drug: Basimglurant with crossover to Placebo
Placebo to Basimglurant
Drug: Placebo with crossover to Basimglurant
Basimglurant with crossover to Placebo
Placebo with crossover to Basimglurant
Mean percentage in monthly seizure frequency during the maintenance dosing in Period 2 (Weeks 13 to 16) and Period 4 (Weeks 27-30).
Time frame: 30 weeks
Number of patients considered treatment responders.
Time frame: 30 weeks
Longest seizure free interval (i.e., seizure free days).
Time frame: 30 weeks
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.
Time frame: 30 weeks
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.
Time frame: 30 weeks
Safety of the study drug in children, adolescents and young adults with seizures associated with TSC.
Measured in terms of incidence, nature, and severity of adverse events, vital signs, physical examination, clinical chemistry, hematology, electrocardiograms, and urinalysis, as well as treatment delays, dose reductions, and dose discontinuations. In addition, suicidal ideation will be assessed using S-STS.
Time frame: 82 weeks
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.
Time frame: 30 weeks
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).
Time frame: 30 weeks
Intensity of seizures detected by the wearable device evaluated as the change from Baseline compared to study treatment Periods 1 and 4.
Time frame: 30 weeks
Ran from Mar 2022 to primary completion in Feb 2025, 35 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Noema Pharma AG