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Basimglurant in Children, Adolescents, and Young Adults With TSC

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 5 Years - 30 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05059327
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Noema Pharma AG
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Clinical Director, MD
Principal Investigator Affiliation Noema Pharma AG
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries India, Israel, Italy, Poland, Spain, Turkey, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Tuberous Sclerosis Complex
Additional Details

The study drug (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.

Arms & Interventions

Arms

Experimental: Arm A (Basimglurant to Placebo)

Basimglurant to Placebo

Placebo Comparator: Arm B (Placebo to Basimglurant)

Placebo to Basimglurant

Interventions

Drug: - Basimglurant with crossover to Placebo

Basimglurant with crossover to Placebo

Drug: - Placebo with crossover to Basimglurant

Placebo with crossover to Basimglurant

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Los Angeles, California

Status

Recruiting

Address

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

Los Angeles, California, 90095

Kennedy Krieger Institute (Site #: 110), Baltimore, Maryland

Status

Completed

Address

Kennedy Krieger Institute (Site #: 110)

Baltimore, Maryland, 21205

Boston Children's Hospital (Site #: 102), Boston, Massachusetts

Status

Recruiting

Address

Boston Children's Hospital (Site #: 102)

Boston, Massachusetts, 02115-5724

Royal Oak, Michigan

Status

Completed

Address

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

Royal Oak, Michigan, 48073-6712

Roseville, Minnesota

Status

Recruiting

Address

Minnesota Epilepsy Group PA (Site #: 105)

Roseville, Minnesota, 55113-1306

Hawthorne, New York

Status

Completed

Address

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

Hawthorne, New York, 10532

Durham, North Carolina

Status

Completed

Address

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

Durham, North Carolina, 27705-4699

Cleveland, Ohio

Status

Completed

Address

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

Cleveland, Ohio, 44106-1716

Dallas, Texas

Status

Withdrawn

Address

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

Dallas, Texas, 75219-3924

Houston, Texas

Status

Recruiting

Address

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

Houston, Texas, 77030-3000

Multicare Health System (Site #: 109), Tacoma, Washington

Status

Withdrawn

Address

Multicare Health System (Site #: 109)

Tacoma, Washington, 98405-4048

International Sites

Citi Neuro Centre (Site # 806), Hyderabad, Andhra Pradesh, India

Status

Recruiting

Address

Citi Neuro Centre (Site # 806)

Hyderabad, Andhra Pradesh, 500034

Rainbow Children's Hospital (Site # 803), Hyderabad, Andhra Pradesh, India

Status

Recruiting

Address

Rainbow Children's Hospital (Site # 803)

Hyderabad, Andhra Pradesh, 500034

New Delhi, Delhi, India

Status

Recruiting

Address

All India Institute of Medical Sciences (Site # 804)

New Delhi, Delhi, 110029

Mumbai, Maharashtra, India

Status

Recruiting

Address

Jaslok Hospital and Research Centre (Site # 801)

Mumbai, Maharashtra, 400026

Pune, Maharashtra, India

Status

Recruiting

Address

Deenanath Mangeshkar Hospital and Research Centre (Site # 805)

Pune, Maharashtra, 411006

Chennai, Tamil Nadu, India

Status

Withdrawn

Address

Gleneagles Global Health City (Site # 802)

Chennai, Tamil Nadu, 600100

Christian Medical College (Site # 807), Vellore, Tamil Nadu, India

Status

Recruiting

Address

Christian Medical College (Site # 807)

Vellore, Tamil Nadu, 632004

Jerusalem, Israel

Status

Completed

Address

Hadassah Medical Center - PPDS (Site #: 503)

Jerusalem, , 91120

Milano, Lombardia, Italy

Status

Active, not recruiting

Address

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

Milano, Lombardia, 20142

Milano, Lombardia, Italy

Status

Recruiting

Address

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

Milano, Lombardia, 20162

Catania, Sicilia, Italy

Status

Active, not recruiting

Address

Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele (Site # 182)

Catania, Sicilia, 20142

Firenze, Toscana, Italy

Status

Active, not recruiting

Address

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

Firenze, Toscana, 50139

Warsaw, Mazowieckie, Poland

Status

Recruiting

Address

Instytut Pomnik Centrum Zdrowia Dziecka (Site # 262)

Warsaw, Mazowieckie, 04-730

Centrum Medyczne Plejady (Site # 263), Kraków, Poland

Status

Active, not recruiting

Address

Centrum Medyczne Plejady (Site # 263)

Kraków, , 30-363

AmiCare Centrum Medyczne (Site # 261), Łódź, Poland

Status

Active, not recruiting

Address

AmiCare Centrum Medyczne (Site # 261)

Łódź, , 91-495

Badalona, Barcelona, Spain

Status

Recruiting

Address

Hospital Universitario Germans Trias i Pujol (Site # 194)

Badalona, Barcelona, 08916

Esplugues De Llobregat, Barcelona, Spain

Status

Recruiting

Address

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

Esplugues De Llobregat, Barcelona, 08950

Málaga, Spain

Status

Recruiting

Address

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

Málaga, , 29010

Sevilla, Spain

Status

Recruiting

Address

Centro de Neurología Avanzada (Site # 191)

Sevilla, , 41013

Yenimahalle, Ankara, Turkey

Status

Active, not recruiting

Address

Ankara Etlik Şehir Hastanesi (Site #: 903)

Yenimahalle, Ankara, 06170

Fatih, Istanbul, Turkey

Status

Recruiting

Address

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

Fatih, Istanbul, 34093

Kadıköy, Istanbul, Turkey

Status

Recruiting

Address

Yeditepe University Kosuyolu Hospital (Site #: 904)

Kadıköy, Istanbul, 34718

Sultangazi, Istanbul, Turkey

Status

Recruiting

Address

Istanbul Egitim ve Arastirma Hastanesi (Site #: 901)

Sultangazi, Istanbul, 34096

Salford, Lancashire, United Kingdom

Status

Recruiting

Address

Salford Royal Hospital - PPDS (Site # 304)

Salford, Lancashire, M6 8HD

The Royal London Hospital (Site # 302), London, London, City Of, United Kingdom

Status

Active, not recruiting

Address

The Royal London Hospital (Site # 302)

London, London, City Of, E1 1BB

St George Hospital (Site # 303), London, London, City Of, United Kingdom

Status

Active, not recruiting

Address

St George Hospital (Site # 303)

London, London, City Of, SW17 0QT

Cardiff University (Site # 305), Cardiff, South Glamorgan, United Kingdom

Status

Active, not recruiting

Address

Cardiff University (Site # 305)

Cardiff, South Glamorgan, CF10 3AT

Cardiff, South Glamorgan, United Kingdom

Status

Recruiting

Address

Noahs Ark Children's Hospital (Site # 306)

Cardiff, South Glamorgan, CF14 4XW

Birmingham, West Midlands, United Kingdom

Status

Active, not recruiting

Address

Queen Elizabeth Hospital Birmingham (Site # 301)

Birmingham, West Midlands, B15 2TH

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