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Completed Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT05059327

Public ClinicalTrials.gov record NCT05059327. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 21, 2026, 5:29 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 2B, Multicenter, 30-week, Prospective, Cross-over, Double-blind, Randomized, Placebo-controlled Study Followed by a 52-Week Open-label Extension Study to Evaluate the Efficacy and Safety of Basimglurant Adjunctive to Ongoing Anticonvulsive Therapy in Children, Adolescents, and Young Adults With Uncontrolled Seizures Associated With Tuberous Sclerosis Complex

Study identification

NCT ID
NCT05059327
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Noema Pharma AG
Industry
Enrollment
61 participants

Conditions and interventions

Interventions

  • Basimglurant with crossover to Placebo Drug
  • Placebo with crossover to Basimglurant Drug

Drug

Eligibility (public fields only)

Age range
5 Years to 30 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 2, 2022
Primary completion
Feb 5, 2025
Completion
Apr 27, 2025
Last update posted
Jun 3, 2025

2022 – 2025

United States locations

U.S. sites
9
U.S. states
9
U.S. cities
9
Facility City State ZIP Site status
David Geffen School of Medicine at UCLA (Site #: 101) Los Angeles California 90095
Kennedy Krieger Institute (Site #: 110) Baltimore Maryland 21205
Boston Children's Hospital (Site #: 102) Boston Massachusetts 02115-5724
William Beaumont Hospital - Royal Oak (Site #: 104) Royal Oak Michigan 48073-6712
Minnesota Epilepsy Group PA (Site #: 105) Roseville Minnesota 55113-1306
Boston Children's Health Physicians (BCHP) (Site #: 111) Hawthorne New York 10532
Duke Children's Hospital and Health Center (Site #: 106) Durham North Carolina 27705-4699
University Hospitals Cleveland Medical Center, Rainbow Babies and Childrens Hospital (Site #: 107) Cleveland Ohio 44106-1716
The University of Texas Medical School at Houston (Site #: 103) Houston Texas 77030-3000

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 18 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05059327, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 3, 2025 · Synced Jul 21, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05059327 live on ClinicalTrials.gov.

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