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Tuberous Sclerosis Complex clinical trials

View clinical trials related to Tuberous Sclerosis Complex.

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NCT ID: NCT06392009 Recruiting - Clinical trials for Tuberous Sclerosis Complex

A Study of Radiprodil on Safety, Tolerability, Pharmacokinetics, and Effect on Seizures and Behavioral Symptoms in Patients With TSC or FCD Type II

Start date: May 2024
Phase: Phase 1/Phase 2
Study type: Interventional

Study RAD-GRIN-201 is a phase 1B/2A trial to assess safety, tolerability, pharmacokinetics (PK), and potential efficacy of radiprodil in participants with Tuberous Sclerosis Complex (TSC) or Focal Cortical Dysplasia (FCD) type II. The study is open-label, so all participants will be treated with radiprodil. Subjects' participation in the study is expected to last up to six months in Part A and one year in Part B/long-term treatment period. The treatment period in Part B may be extended based on a favorable benefit/risk profile.

NCT ID: NCT06160310 Recruiting - Clinical trials for Tuberous Sclerosis Complex

Tuberous Sclerosis Complex and Lymphangioleiomyomatosis Pregnancy Registry (TSC-LAM Registry)

Start date: July 1, 2023
Phase:
Study type: Observational [Patient Registry]

This study is an observational registry designed to gather information about Tuberous Sclerosis Complex (TSC) and Lymphangioleiomyomatosis (LAM) in pregnant women and their child.

NCT ID: NCT05534672 Recruiting - Clinical trials for Tuberous Sclerosis Complex

Placebo Controlled Study to Assess the Efficacy and Safety of Rapamycin in Drug Resistant Epilepsy Associated With Tuberous Sclerosis Complex

RaRE-TS
Start date: January 23, 2023
Phase: Phase 3
Study type: Interventional

The purpose of the RaRE-TS study is to determine safety, tolerability and efficacy of rapamycin versus placebo in a drug resistant epilepsy associated with tuberous sclerosis complex (TSC).

NCT ID: NCT05467397 Recruiting - Clinical trials for Tuberous Sclerosis Complex

Feasibility of [11C]Acetate-PET in LAM and TSC

Start date: August 30, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This study aims to assess [11C]acetate positron emission tomography (PET)/computed tomography (CT) as a biomarker for renal angiomyolipomas and pulmonary lymphangioleiomyomatosis (LAM) and an early biomarker of response to rapamycin in LAM patients. [11C]Acetate is a radioactive form of acetate, a nutrient commonly processed in our body's cells to generate fat and energy. Preclinical studies support the hypothesis that TSC tumors enhance lipid synthesis compared to normal tissues, suggesting that quantification of [11C]acetate in these tumors by PET/CT may provide a metabolic biomarker of disease. Participants in the study will undergo 1 or 2 PET/CT scans over 3 to 6 months at the Massachusetts General Hospital (Boston, MA). [11C]acetate is administered through an intravenous catheter. This small amount of radioactivity is short-lived and eliminated from the body within a few hours.

NCT ID: NCT05104983 Recruiting - Epilepsy Clinical Trials

Stopping TSC Onset and Progression 2B: Sirolimus TSC Epilepsy Prevention Study

TSC-STEPS
Start date: October 13, 2021
Phase: Phase 2
Study type: Interventional

This trial is a Phase II randomized, double-blind, placebo controlled multi-site study to evaluate the safety and efficacy of early sirolimus to prevent or delay seizure onset in TSC infants. This study is supported by research funding from the Office of Orphan Products Division (OOPD) of the US Food and Drug Administration (FDA).

NCT ID: NCT05059327 Recruiting - Clinical trials for Tuberous Sclerosis Complex

Basimglurant in Children, Adolescents, and Young Adults With TSC

Start date: March 3, 2022
Phase: Phase 2
Study type: Interventional

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

NCT ID: NCT04987463 Recruiting - Clinical trials for Tuberous Sclerosis Complex

Efficacy and Safety of Rapamycin Versus Vigabatrin in the Prevention of Tuberous Sclerosis Complex Symptoms in Infants

ViRap
Start date: May 7, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of the study is to evaluate the efficacy, tolerability, and safety of vigabatrin versus rapamycin as a preventive treatment in infants with Tuberous Sclerosis Complex (TSC).

NCT ID: NCT04198207 Recruiting - Epilepsy Clinical Trials

The Effectiveness and Safety of Vagus Nerve Stimulation for TRE

Start date: December 10, 2019
Phase:
Study type: Observational [Patient Registry]

Prospective controlled studies to identify clinical epilepsy control, cognitive changes, and safety in VNS treatment of tuberculosis-related epilepsy.

NCT ID: NCT03356769 Recruiting - Epilepsy Clinical Trials

Aspirin as an add-on Treatment of Refractory Epilepsy in Tuberous Sclerosis Complex

Start date: November 20, 2017
Phase: Phase 2
Study type: Interventional

There had been much evidence in aspirin controlling tumorous conditions conducted by basic researches, especially through mammilian target of rapamycin (mTOR) pathway. The investigator observed efficacy of aspirin in the treatment of tuberous sclerosis complex (TSC) in one child who got Kawasaki disease and in the addition four TSC patients with epilepsy. The investigator intend to evaluate whether aspirin would be an effective add-on treatment in TSC patients with refractory seizures.

NCT ID: NCT02887781 Recruiting - Clinical trials for Tuberous Sclerosis Complex

Clinical Presentation and Renal Outcome of Patients With Tuberous Sclerosis Complex and/or Renal Angiomyolipoma in the Great West Region of France

TSAR
Start date: August 13, 2015
Phase:
Study type: Observational

This study aims to investigate the factors (clinical, care-related and genetic) affecting renal outcome in patients with TSC (Tuberous sclerosis complex)