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Basimglurant (NOE-101) in Children, Adolescents, and Young Adults With TSC

CompletedPhase 2

Sponsor: Noema Pharma AG

Conditions: Tuberous Sclerosis Complex

Interventions: Basimglurant with crossover to Placebo, Placebo with crossover to Basimglurant

Countries: United States, India, Israel, Italy, Poland, Spain, Turkey (Türkiye), United Kingdom

The study intends to show that basimglurant (NOE-101) provides effective seizure control in children, adolescents and young adults with Tuberous Sclerosis Complex (TSC).

Eligibility overview

Sex: ALL

Age: 5 Years to 30 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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:

  1. Willingness to undergo serum or urinary pregnancy testing at screening and during the trial period.
  2. Willingness to use contraception.

Exclusion Criteria (summary):

* Neurologic disease other than TSC
* Recent anoxic episode
* Patient weight below 15kg
* Clinically significant unstable medical condition(s)
* Pregnancy or lactation

Locations (27)

Los Angeles, California, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Royal Oak, Michigan, United States
Roseville, Minnesota, United States
Hawthorne, New York, United States
Durham, North Carolina, United States
Cleveland, Ohio, United States
Houston, Texas, United States
Hyderabad, Andhra Pradesh, India
Hyderabad, Andhra Pradesh, India
Mumbai, Maharashtra, India
Pune, Maharashtra, India
New Delhi, National Capital Territory of Delhi, India
Vellore, Tamil Nadu, India
Jerusalem, Israel
Milan, Lombardy, Italy
Warsaw, Masovian Voivodeship, Poland
Badalona, Barcelona, Spain
Esplugues de Llobregat, Barcelona, Spain
Málaga, Spain
Seville, Spain
Fatih, Istanbul, Turkey (Türkiye)
Kadıköy, Istanbul, Turkey (Türkiye)
Sultangazi, Istanbul, Turkey (Türkiye)
Salford, Lancashire, United Kingdom
Cardiff, South Glamorgan, United Kingdom