Christian Medical College | Pulmonary Medicine
Status and phase
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About
The study intends to show that basimglurant (NOE-101) provides effective seizure control in children, adolescents and young adults with Tuberous Sclerosis Complex (TSC).
Full description
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.
Enrollment
Sex
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Volunteers
Inclusion and exclusion criteria
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 30 years at study entry
A documented history of TSC
Refractory seizure history
Currently receiving one or more anti-epileptic drugs (AEDs)
Stable medications or interventions for epilepsy
Willingness to complete Patient Reported Outcome assessments
For female patients of childbearing potential:
Exclusion Criteria (summary):
Primary purpose
Allocation
Interventional model
Masking
61 participants in 2 patient groups, including a placebo group
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Central trial contact
Noema Pharma
Data sourced from clinicaltrials.gov
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