Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||5 Years - 18 Years|
Inclusion Criteria (summary):
- - Ability and willingness to provide informed assent or written consent or consent from their legal representative.
- - Fluency in the language of the study staff.
- - Age 5 to 18 years.
- - A documented history of TSC, - Refractory seizure treatment status.
- - Currently receiving one or more anti-epileptic drugs (AEDs) - Stable medications or interventions for epilepsy.
- - Willingness to complete Patient Reported Outcome.
- - For female patients of childbearing potential: 1.
- - Neurologic disease other than TSC.
- - Recent anoxic episode.
- - Patient weight below 15kg.
- - Clinically significant unstable medical condition(s).
- - Pregnancy or lactation.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Noema Pharma AG|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Renata Lazarova, MD|
|Principal Investigator Affiliation||Noema Pharma AG|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Tuberous Sclerosis Complex|
The study drug (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 and adolescents 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.
Experimental: Arm A (Basimglurant to Placebo)
Basimglurant to Placebo
Placebo Comparator: Arm B (Placebo to Basimglurant)
Placebo to Basimglurant
Drug: - Basimglurant with crossover to Placebo
Basimglurant with crossover to Placebo
Drug: - Placebo with crossover to Basimglurant
Placebo with crossover to Basimglurant
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.