Basimglurant in Children, Adolescents, and Young Adults With TSC

RECRUITING

I'm interested ...!!

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

Conditions:

🦠 Tuberous Sclerosis Complex

🗓️ Study Start (Actual) 3 March 2022

🗓️ Primary Completion (Estimated) 30 November 2024

✅ Study Completion (Estimated) 31 January 2026

👥 Enrollment (Estimated) 54

🔬 Study Type INTERVENTIONAL

📊 Phase PHASE2

Locations:

📍 Los Angeles, California, United States

📍 Baltimore, Maryland, United States

📍 Boston, Massachusetts, United States

📍 Royal Oak, Michigan, United States

📍 Roseville, Minnesota, United States

📍 Hawthorne, New York, United States

📍 Durham, North Carolina, United States

📍 Cleveland, Ohio, United States

📍 Dallas, Texas, United States

📍 Houston, Texas, United States

📍 Tacoma, Washington, United States

📍 Randwick, New South Wales, Australia

📍 South Brisbane, Queensland, Australia

📍 Hyderabad, Andhra Pradesh, India

📍 New Delhi, Delhi, India

📍 Mumbai, Maharashtra, India

📍 Pune, Maharashtra, India

📍 Chennai, Tamil Nadu, India

📍 Vellore, Tamil Nadu, India

📍 Jerusalem, Israel

📍 Milano, Lombardia, Italy

📍 Catania, Sicilia, Italy

📍 Firenze, Toscana, Italy

📍 Warsaw, Mazowieckie, Poland

📍 Kraków, Poland

📍 Łódź, Poland

📍 Badalona, Barcelona, Spain

📍 Esplugues De Llobregat, Barcelona, Spain

📍 Málaga, Spain

📍 Sevilla, Spain

📍 Yenimahalle, Ankara, Turkey

📍 Fatih, Istanbul, Turkey

📍 Kadıköy, Istanbul, Turkey

📍 Sultangazi, Istanbul, Turkey

📍 Salford, Lancashire, United Kingdom

📍 London, London, City Of, United Kingdom

📍 Cardiff, South Glamorgan, United Kingdom

📍 Birmingham, West Midlands, United Kingdom

More locations available...

📋 Eligibility Criteria

Description

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

Ages Eligible for Study: 5 Years to 30 Years (CHILD, ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 20 August 2021
First Submitted that Met QC Criteria 20 September 2021
First Posted 28 September 2021

Study Record Updates