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
Sites (27)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario Germans Trias i Pujol (Site # 194) Coordinator of this site? Confirm its status | Badalona | Spain | Unknown status |
| Hospital Sant Joan de Deu - PIN (Site # 192) Coordinator of this site? Confirm its status | Esplugues de Llobregat | Spain | Unknown status |
| Hospital Regional Universitario de Malaga - Hospital General (Site # 193) Coordinator of this site? Confirm its status | Málaga | Spain | Unknown status |
| Centro de Neurología Avanzada (Site # 191) Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
| Noahs Ark Children's Hospital (Site # 306) Coordinator of this site? Confirm its status | Cardiff | United Kingdom | Unknown status |
| Salford Royal Hospital - PPDS (Site # 304) Coordinator of this site? Confirm its status | Salford | United Kingdom | Unknown status |
| Hadassah Medical Center - PPDS (Site #: 503) Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Rainbow Childrens Hospital (Site # 803) Coordinator of this site? Confirm its status | Hyderabad | India | Unknown status |
| Citi Neuro Centre (Site # 806) Coordinator of this site? Confirm its status | Hyderabad | India | Unknown status |
| Jaslok Hospital and Research Centre (Site # 801) Coordinator of this site? Confirm its status | Mumbai | India | Unknown status |
| All India Institute of Medical Sciences (Site # 804) Coordinator of this site? Confirm its status | New Delhi | India | Unknown status |
| Deenanath Mangeshkar Hospital and Research Centre (Site # 805) Coordinator of this site? Confirm its status | Pune | India | Unknown status |
| Christian Medical College (Site # 807) Coordinator of this site? Confirm its status | Vellore | India | Unknown status |
| ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda (Site # 183) Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Instytut Pomnik Centrum Zdrowia Dziecka (Site # 262) Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
| Kennedy Krieger Institute (Site #: 110) Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Boston Children's Hospital (Site #: 102) Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| University Hospitals Cleveland Medical Center, Rainbow Babies and Childrens Hospital (Site #: 107) Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Duke Children's Hospital and Health Center (Site #: 106) Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| Boston Children's Health Physicians (BCHP) (Site #: 111) Coordinator of this site? Confirm its status | Hawthorne | United States | Unknown status |
| The University of Texas Medical School at Houston (Site #: 103) Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| David Geffen School of Medicine at UCLA (Site #: 101) Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Minnesota Epilepsy Group PA (Site #: 105) Coordinator of this site? Confirm its status | Roseville | United States | Unknown status |
| William Beaumont Hospital - Royal Oak (Site #: 104) Coordinator of this site? Confirm its status | Royal Oak | United States | Unknown status |
| Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi (Site #: 905) Coordinator of this site? Confirm its status | Fatih | Turkey (Türkiye) | Unknown status |
| Yeditepe University Kosuyolu Hospital (Site #: 904) Coordinator of this site? Confirm its status | Kadıköy | Turkey (Türkiye) | Unknown status |
| Istanbul Egitim ve Arastirma Hastanesi (Site #: 901) Coordinator of this site? Confirm its status | Sultangazi | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.