Basimglurant (NOE-101) in Children, Adolescents, and Young Adults With TSC
NCT ID: NCT05059327
Last Updated: 2025-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
61 participants
INTERVENTIONAL
2022-03-03
2025-04-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Arm A (Basimglurant/NOE-101 to Placebo)
Basimglurant to Placebo
Basimglurant with crossover to Placebo
Basimglurant with crossover to Placebo
Arm B (Placebo to Basimglurant/NOE-101)
Placebo to Basimglurant
Placebo with crossover to Basimglurant
Placebo with crossover to Basimglurant
Interventions
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Basimglurant with crossover to Placebo
Basimglurant with crossover to Placebo
Placebo with crossover to Basimglurant
Placebo with crossover to Basimglurant
Eligibility Criteria
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Inclusion Criteria
* 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
* Recent anoxic episode
* Patient weight below 15kg
* Clinically significant unstable medical condition(s)
* Pregnancy or lactation
5 Years
30 Years
ALL
No
Sponsors
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Noema Pharma AG
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Director, MD
Role: STUDY_DIRECTOR
Noema Pharma AG
Locations
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David Geffen School of Medicine at UCLA (Site #: 101)
Los Angeles, California, United States
Kennedy Krieger Institute (Site #: 110)
Baltimore, Maryland, United States
Boston Children's Hospital (Site #: 102)
Boston, Massachusetts, United States
William Beaumont Hospital - Royal Oak (Site #: 104)
Royal Oak, Michigan, United States
Minnesota Epilepsy Group PA (Site #: 105)
Roseville, Minnesota, United States
Boston Children's Health Physicians (BCHP) (Site #: 111)
Hawthorne, New York, United States
Duke Children's Hospital and Health Center (Site #: 106)
Durham, North Carolina, United States
University Hospitals Cleveland Medical Center, Rainbow Babies and Childrens Hospital (Site #: 107)
Cleveland, Ohio, United States
The University of Texas Medical School at Houston (Site #: 103)
Houston, Texas, United States
Citi Neuro Centre (Site # 806)
Hyderabad, Andhra Pradesh, India
Rainbow Childrens Hospital (Site # 803)
Hyderabad, Andhra Pradesh, India
Jaslok Hospital and Research Centre (Site # 801)
Mumbai, Maharashtra, India
Deenanath Mangeshkar Hospital and Research Centre (Site # 805)
Pune, Maharashtra, India
All India Institute of Medical Sciences (Site # 804)
New Delhi, National Capital Territory of Delhi, India
Christian Medical College (Site # 807)
Vellore, Tamil Nadu, India
Hadassah Medical Center - PPDS (Site #: 503)
Jerusalem, , Israel
ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda (Site # 183)
Milan, Lombardy, Italy
Instytut Pomnik Centrum Zdrowia Dziecka (Site # 262)
Warsaw, Masovian Voivodeship, Poland
Hospital Universitario Germans Trias i Pujol (Site # 194)
Badalona, Barcelona, Spain
Hospital Sant Joan de Deu - PIN (Site # 192)
Esplugues de Llobregat, Barcelona, Spain
Hospital Regional Universitario de Malaga - Hospital General (Site # 193)
Málaga, , Spain
Centro de Neurología Avanzada (Site # 191)
Seville, , Spain
Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi (Site #: 905)
Fatih, Istanbul, Turkey (Türkiye)
Yeditepe University Kosuyolu Hospital (Site #: 904)
Kadıköy, Istanbul, Turkey (Türkiye)
Istanbul Egitim ve Arastirma Hastanesi (Site #: 901)
Sultangazi, Istanbul, Turkey (Türkiye)
Salford Royal Hospital - PPDS (Site # 304)
Salford, Lancashire, United Kingdom
Noahs Ark Children's Hospital (Site # 306)
Cardiff, South Glamorgan, United Kingdom
Countries
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Other Identifiers
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NOE-TSC-201
Identifier Type: -
Identifier Source: org_study_id
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