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

Last updated: April 16, 2025
Sponsor: Noema Pharma AG
Overall Status: Active - Not Recruiting

Phase

2

Condition

Precancerous Condition

Neurofibromatosis

Scar Tissue

Treatment

Basimglurant with crossover to Placebo

Placebo with crossover to Basimglurant

Clinical Study ID

NCT05059327
NOE-TSC-201
  • Ages 5-30
  • All Genders

Study Summary

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 Criteria

Inclusion

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

Study Design

Total Participants: 61
Treatment Group(s): 2
Primary Treatment: Basimglurant with crossover to Placebo
Phase: 2
Study Start date:
March 03, 2022
Estimated Completion Date:
January 31, 2026

Study 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.

Connect with a study center

  • Sydney Children's Hospital (Site #401)

    Randwick, New South Wales 2031
    Australia

    Site Not Available

  • Sydney Children's Hospital (Site #: 401)

    Randwick, New South Wales 2031
    Australia

    Site Not Available

  • Royal Brisbane & Women's Hospital (Site # 405)

    Herston, Queensland 4029
    Australia

    Site Not Available

  • Queensland Children's Hospital (Site #: 402)

    South Brisbane, Queensland 4101
    Australia

    Site Not Available

  • Queensland Children's Hospital (site #402)

    South Brisbane, Queensland 4101
    Australia

    Site Not Available

  • Alfred Health (Site # 403)

    Melbourne, Victoria 3004
    Australia

    Site Not Available

  • Perth Children's Hospital (Site # 404)

    Nedlands, Western Australia 6009
    Australia

    Site Not Available

  • Citi Neuro Centre (Site # 806)

    Hyderabad, Andhra Pradesh 500034
    India

    Site Not Available

  • Rainbow Children's Hospital (Site # 803)

    Hyderabad, Andhra Pradesh 500034
    India

    Site Not Available

  • Rainbow Children's Hospital (Site # 803)

    Hyderabad, Andhra Pradesh 500034
    India

    Site Not Available

  • All India Institute of Medical Sciences (Site # 804)

    New Delhi, Delhi 110029
    India

    Site Not Available

  • Jaslok Hospital and Research Centre (Site # 801)

    Mumbai, Maharashtra 400026
    India

    Site Not Available

  • Deenanath Mangeshkar Hospital and Research Centre (Site # 805)

    Pune, Maharashtra 411006
    India

    Site Not Available

  • Gleneagles Global Health City (Site # 802)

    Chennai, Tamil Nadu 600100
    India

    Site Not Available

  • Christian Medical College (Site # 807)

    Vellore, Tamil Nadu 632004
    India

    Site Not Available

  • Schneider Children's Medical Center of Israel - Petah Tikvah - PIN (Site #: 502)

    Petah Tikva, HaMerkaz 49202
    Israel

    Site Not Available

  • The Edmond and Lily Safra Children's Hospital (Site #: 501)

    Ramat Gan, Tel-Aviv 52621
    Israel

    Site Not Available

  • Dana Children's Hospital (Site #: 504)

    Tel Aviv-Yafo, Tel-Aviv 64239
    Israel

    Site Not Available

  • Hadassah Medical Center - PPDS (Site #: 503)

    Jerusalem, 91120
    Israel

    Site Not Available

  • ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda (Site # 183)

    Milano, Lombardia 20162
    Italy

    Site Not Available

  • ASST Santi Paolo e Carlo - Azienda Universitaria-Polo Universitario San Paolo (Site # 181)

    Milano, Lombardia 20142
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele (Site # 182)

    Catania, Sicilia 20142
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN (Site # 184)

    Firenze, Toscana 50139
    Italy

    Site Not Available

  • Instytut Pomnik Centrum Zdrowia Dziecka (Site # 262)

    Warsaw, Mazowieckie 04-730
    Poland

    Site Not Available

  • Centrum Medyczne Plejady (Site # 263)

    Kraków, 30-363
    Poland

    Site Not Available

  • AmiCare Centrum Medyczne (Site # 261)

    Łódź, 91-495
    Poland

    Site Not Available

  • Hospital Universitario Germans Trias i Pujol (Site # 194)

    Badalona, Barcelona 08916
    Spain

    Site Not Available

  • Hospital Sant Joan de Deu - PIN (Site # 192)

    Esplugues De Llobregat, Barcelona 08950
    Spain

    Site Not Available

  • Hospital Regional Universitario de Malaga - Hospital General (Site # 193)

    Málaga, 29010
    Spain

    Site Not Available

  • Centro de Neurología Avanzada (Site # 191)

    Sevilla, 41013
    Spain

    Site Not Available

  • Ankara Etlik Şehir Hastanesi (Site #: 903)

    Yenimahalle, Ankara 06170
    Turkey

    Site Not Available

  • Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi (Site #: 905)

    Fatih, Istanbul 34093
    Turkey

    Site Not Available

  • Yeditepe University Kosuyolu Hospital (Site #: 904)

    Kadıköy, Istanbul 34718
    Turkey

    Site Not Available

  • Istanbul Egitim ve Arastirma Hastanesi (Site #: 901)

    Sultangazi, Istanbul 34096
    Turkey

    Site Not Available

  • Dr. Sami Ulus Kadin Dogum, Cocuk Sagligi ve Hastaliklari Egitim ve Arastirma Hastanesi (Site #: 903)

    Ankara, 6560
    Turkey

    Site Not Available

  • Yeditepe University Kozyatagi Hospital (Site #: 904)

    Ataşehir, 34752
    Turkey

    Site Not Available

  • Acibadem Altunizade Hospital (Site #: 902)

    Üsküdar, 34662
    Turkey

    Site Not Available

  • Salford Royal Hospital - PPDS (Site # 304)

    Salford, Lancashire M6 8HD
    United Kingdom

    Site Not Available

  • St George Hospital (Site # 303)

    London, London, City Of SW17 0QT
    United Kingdom

    Site Not Available

  • The Royal London Hospital (Site # 302)

    London, London, City Of E1 1BB
    United Kingdom

    Site Not Available

  • Cardiff University (Site # 305)

    Cardiff, South Glamorgan CF10 3AT
    United Kingdom

    Site Not Available

  • Noahs Ark Children's Hospital (Site # 306)

    Cardiff, South Glamorgan CF14 4XW
    United Kingdom

    Site Not Available

  • Queen Elizabeth Hospital Birmingham (Site # 301)

    Birmingham, West Midlands B15 2TH
    United Kingdom

    Site Not Available

  • Translational Genomics Research Institute (TGen) (Site # 114)

    Phoenix, Arizona 85004-2157
    United States

    Site Not Available

  • David Geffen School of Medicine at UCLA (Site #: 101)

    Los Angeles, California 90095
    United States

    Site Not Available

  • Nicklaus Children's Hospital (Site # 116)

    Miami, Florida 33155-3009
    United States

    Site Not Available

  • Kennedy Krieger Institute (Site #: 110)

    Baltimore, Maryland 21205
    United States

    Site Not Available

  • Boston Children's Hospital (Site #: 102)

    Boston, Massachusetts 02115-5724
    United States

    Site Not Available

  • Helen DeVos Children Hospital (Site #: 112)

    Grand Rapids, Michigan 49503-2560
    United States

    Site Not Available

  • William Beaumont Hospital - Royal Oak (Site #: 104)

    Royal Oak, Michigan 48073-6712
    United States

    Site Not Available

  • Minnesota Epilepsy Group PA (Site #: 105)

    Roseville, Minnesota 55113-1306
    United States

    Site Not Available

  • Boston Children's Health Physicians (BCHP) (Site #: 111)

    Hawthorne, New York 10532
    United States

    Site Not Available

  • Duke Children's Hospital and Health Center (Site #: 106)

    Durham, North Carolina 27705-4699
    United States

    Site Not Available

  • Cincinnati Children's Hospital Medical Center - PIN (Site # 115)

    Cincinnati, Ohio 45229-3026
    United States

    Site Not Available

  • University Hospitals Cleveland Medical Center, Rainbow Babies and Childrens Hospital (Site #: 107)

    Cleveland, Ohio 44106-1716
    United States

    Site Not Available

  • Texas Scottish Rite Hospital For Children (Site #: 113)

    Dallas, Texas 75219-3924
    United States

    Site Not Available

  • The University of Texas Medical School at Houston (Site #: 103)

    Houston, Texas 77030-3000
    United States

    Site Not Available

  • Multicare Health System (Site #: 109)

    Tacoma, Washington 98405-4048
    United States

    Site Not Available

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