Clinical Trials Logo

Tuberous Sclerosis Complex clinical trials

View clinical trials related to Tuberous Sclerosis Complex.

Filter by:

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: NCT05867576 Active, not recruiting - Clinical trials for Tuberous Sclerosis Complex

Acceptance and Commitment Therapy in Tuberous Sclerosis Complex

ACT in TSC
Start date: August 12, 2021
Phase: N/A
Study type: Interventional

The study will assess the acceptability and feasibility of a randomised controlled trial of 6-12 sessions of remotely-delivered Acceptance and Commitment Therapy (ACT) versus waitlist control. Waitlist control will involve a delay in the offer of ACT sessions for 12 weeks. Participants may access all services as usual in this time. Follow-up assessments will be conducted at 12-, 24 and 48 weeks post-randomisation to measure effectiveness.

NCT ID: NCT05604170 Enrolling by invitation - Clinical trials for Tuberous Sclerosis Complex

Open-label Study of Adjunctive GNX Treatment in Children and Adults With TSC-related Epilepsy

Start date: May 16, 2022
Phase: Phase 3
Study type: Interventional

This is a Phase 3, global, open-label extension (OLE) study of adjunctive GNX treatment in children and adults with TSC who previously participated in either Study 1042-TSC-3001 or Study 1042-TSC-2001

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: NCT05495425 Active, not recruiting - Clinical trials for Tuberous Sclerosis Complex

Clinical Study of NPC-12Y Gel in Patients With Skin Lesions Associated With TSC

Start date: June 1, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to investigate the efficacy and safety of NPC-12Y gel compared with placebo for skin lesions associated with tuberous sclerosis.

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: NCT05323734 Active, not recruiting - Clinical trials for Tuberous Sclerosis Complex

Adjunctive GNX Treatment Compared With Placebo in Children and Adults With TSC-related Epilepsy

Start date: April 1, 2022
Phase: Phase 3
Study type: Interventional

This is a Phase 3, global, double-blind, randomized, placebo-controlled study of adjunctive GNX treatment in children and adults with TSC-related epilepsy. The study consists of a 4-week prospective Baseline phase, defined as the first 28 days following screening, followed by a double-blind phase consisting of a 4-week titration period (Day 1 to Day 28) and a 12-week maintenance period (Day 29 to Week 16).

NCT ID: NCT05323370 Completed - Clinical trials for Tuberous Sclerosis Complex

Lymphangioleiomyomatosis, a Study on Cathepsin K

LAM-CAK
Start date: May 31, 2022
Phase:
Study type: Observational

This is a physiopathological case-control, non-interventional, monocentric study of adult patients with lymphangioleiomyomatosis. The controls are patients followed in neurology at the CHU of Tours for a tuberous sclerosis complex without lymphangioleiomyomatosis, the healthy volunteers are women with neither pulmonary nor renal pathology and recruited at the clinical investigation centre of the CHU of Tours.

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).