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NCT05059327CompletedPhase 2

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

A Phase 2B, Multicenter, 30-week, Prospective, Cross-over, Double-blind, Randomized, Placebo-controlled Study Followed by a 52-Week Open-label Extension Study to Evaluate the Efficacy and Safety of Basimglurant Adjunctive to Ongoing Anticonvulsive Therapy in Children, Adolescents, and Young Adults With Uncontrolled Seizures Associated With Tuberous Sclerosis Complex

Source: ClinicalTrials.gov · Last updated 4 Jun 2025

Brief summary (registry, in English)

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

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
61 (actual)
First submitted
20 Aug 2021
Start date
3 Mar 2022
Primary completion date
6 Feb 2025
Lead sponsor
Noema Pharma AG
NCT number
NCT05059327

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 61
  • From 3 Mar 2022 to the primary completion date, 6 Feb 2025
  • 27 sites in 8 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Neurologic disease other than TSC
  • Clinically significant unstable medical condition(s)

Other

  • Recent anoxic episode
  • Patient weight below 15kg
  • Pregnancy or lactation

Who the study is looking for

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

Age in the registry: 5 years to 30 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (27)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hospital Universitario Germans Trias i Pujol (Site # 194)
Coordinator of this site? Confirm its status
BadalonaSpainUnknown status
Hospital Sant Joan de Deu - PIN (Site # 192)
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Esplugues de LlobregatSpainUnknown status
Hospital Regional Universitario de Malaga - Hospital General (Site # 193)
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MálagaSpainUnknown status
Centro de Neurología Avanzada (Site # 191)
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SevilleSpainUnknown status
Noahs Ark Children's Hospital (Site # 306)
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CardiffUnited KingdomUnknown status
Salford Royal Hospital - PPDS (Site # 304)
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SalfordUnited KingdomUnknown status
Hadassah Medical Center - PPDS (Site #: 503)
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JerusalemIsraelUnknown status
Rainbow Childrens Hospital (Site # 803)
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HyderabadIndiaUnknown status
Citi Neuro Centre (Site # 806)
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HyderabadIndiaUnknown status
Jaslok Hospital and Research Centre (Site # 801)
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MumbaiIndiaUnknown status
All India Institute of Medical Sciences (Site # 804)
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New DelhiIndiaUnknown status
Deenanath Mangeshkar Hospital and Research Centre (Site # 805)
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PuneIndiaUnknown status
Christian Medical College (Site # 807)
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VelloreIndiaUnknown status
ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda (Site # 183)
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MilanItalyUnknown status
Instytut Pomnik Centrum Zdrowia Dziecka (Site # 262)
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WarsawPolandUnknown status
Kennedy Krieger Institute (Site #: 110)
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BaltimoreUnited StatesUnknown status
Boston Children's Hospital (Site #: 102)
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BostonUnited StatesUnknown status
University Hospitals Cleveland Medical Center, Rainbow Babies and Childrens Hospital (Site #: 107)
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ClevelandUnited StatesUnknown status
Duke Children's Hospital and Health Center (Site #: 106)
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DurhamUnited StatesUnknown status
Boston Children's Health Physicians (BCHP) (Site #: 111)
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HawthorneUnited StatesUnknown status
The University of Texas Medical School at Houston (Site #: 103)
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HoustonUnited StatesUnknown status
David Geffen School of Medicine at UCLA (Site #: 101)
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Los AngelesUnited StatesUnknown status
Minnesota Epilepsy Group PA (Site #: 105)
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RosevilleUnited StatesUnknown status
William Beaumont Hospital - Royal Oak (Site #: 104)
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Royal OakUnited StatesUnknown status
Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi (Site #: 905)
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FatihTurkey (Türkiye)Unknown status
Yeditepe University Kosuyolu Hospital (Site #: 904)
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KadıköyTurkey (Türkiye)Unknown status
Istanbul Egitim ve Arastirma Hastanesi (Site #: 901)
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SultangaziTurkey (Türkiye)Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.