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Basimglurant in Children and Adolescents With TSC

Study Purpose

The study intends to show that basimglurant provides effective seizure control in children and adolescents 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 - 18 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 18 years.
  • - A documented history of TSC, - Refractory seizure treatment status.
  • - Currently receiving one or more anti-epileptic drugs (AEDs) - Stable medications or interventions for epilepsy.
  • - Willingness to complete Patient Reported Outcome.
  • - 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.

Renata Lazarova, 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 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 and adolescents 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

Recruiting

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

Grand Rapids, Michigan

Status

Not yet recruiting

Address

Helen DeVos Children Hospital (Site #: 112)

Grand Rapids, Michigan, 49503-2560

Royal Oak, Michigan

Status

Recruiting

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

Recruiting

Address

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

Hawthorne, New York, 10532

Durham, North Carolina

Status

Recruiting

Address

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

Durham, North Carolina, 27705-4699

Cleveland, Ohio

Status

Recruiting

Address

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

Cleveland, Ohio, 44106-1716

Dallas, Texas

Status

Not yet recruiting

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

Recruiting

Address

Multicare Health System (Site#: 109)

Tacoma, Washington, 98405-4048

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