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Tuberous Sclerosis Complex clinical trials

View clinical trials related to Tuberous Sclerosis Complex.

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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: NCT04595513 Completed - Epilepsy Clinical Trials

Stopping TSC Onset and Progression 2: Epilepsy Prevention in TSC Infants

STOP2
Start date: September 8, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

This phase I/II clinical trial is an open-label clinical trial design to verify safety and dosing for TAVT-18 (sirolimus) powder for oral solution in TSC infants (N=5).

NCT ID: NCT04198181 Completed - Epilepsy Clinical Trials

The Effectiveness and Safety of Resective Epilepsy Surgery for TRE

Start date: December 12, 2019
Phase:
Study type: Observational

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

NCT ID: NCT03276195 Completed - Clinical trials for Tuberous Sclerosis Complex

Studies in Patients With Tuberous Sclerosis Complex

Start date: May 1, 2016
Phase:
Study type: Observational

This study is aimed to carry out a systematic study to examine the effects of genetic variants (genetic modifiers) other than TSC genes on phenotypic variability in familial TSC patients (affected parent, child and unaffected siblings) and sporadic TSC.

NCT ID: NCT02849457 Completed - Clinical trials for Tuberous Sclerosis Complex

Preventing Epilepsy Using Vigabatrin In Infants With Tuberous Sclerosis Complex

Start date: December 2016
Phase: Phase 2
Study type: Interventional

Study design is a Phase IIb prospective multi-center, randomized, placebo-controlled, double-blind clinical trial. The goal will be to enroll 80 infants with Tuberous Sclerosis Complex who are less than 6 months of age prior to the onset of their first seizure

NCT ID: NCT02687633 Completed - Clinical trials for Tuberous Sclerosis Complex

Early Behavioral Intervention to Improve Social Communication Function in Infants With Tuberous Sclerosis Complex

Start date: September 2015
Phase: N/A
Study type: Interventional

The investigators are running an intervention study for young children with Tuberous Sclerosis Complex (TSC). The study will include free play-based behavioral intervention that may improve social and communication skills in children with TSC. Eligible families will have a child in the age range of 12-36 months, with a diagnosis of TSC. A parent must also be available to attend the weekly intervention sessions at UCLA. The intervention will focus on teaching caregivers skills to improve the social and communication outcomes of their children. The content of the intervention will be individually tailored to the child's developmental level. The intervention involves pre-assessments, an intervention period of daily 60 minute sessions for 10 days, followed by weekly 60 minute sessions for 10 weeks, and post-assessments. The classroom can have up to 3 parent-child dyad and the curriculum focuses on improving social-communication and play skills.

NCT ID: NCT02544763 Completed - Seizures Clinical Trials

A Randomized Controlled Trial of Cannabidiol (GWP42003-P, CBD) for Seizures in Tuberous Sclerosis Complex (GWPCARE6)

Start date: April 6, 2016
Phase: Phase 3
Study type: Interventional

This trial consists of 2 parts: a double-blinded phase and an open-label extension phase. The blinded phase only will be described in this record. Participants will receive 1 of 2 doses of GWP42003-P or matching placebo. The primary clinical hypothesis is that there will be a difference between GWP42003-P and placebo in their effect on seizure frequency.

NCT ID: NCT02544750 Completed - Seizures Clinical Trials

An Open-label Extension Trial of Cannabidiol (GWP42003-P, CBD) for Seizures in Tuberous Sclerosis Complex (GWPCARE6)

Start date: August 31, 2016
Phase: Phase 3
Study type: Interventional

This trial consists of 2 parts: a double-blinded phase and an open-label extension phase. The open-label extension phase only will be described in this record. All participants will receive the same dose of GWP42003-P. However, investigators may subsequently decrease or increase the participant's dose until the optimal dose is found.

NCT ID: NCT02451696 Completed - Epilepsy Clinical Trials

A Pilot Study To Evaluate The Effects of Everolimus on Brain mTOR Activity and Cortical Hyperexcitability in TSC and FCD

Start date: January 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study is to measure if the drug called Everolimus effects mTOR signaling (an electrical activity signal in the brain) in patients with Tuberous Sclerosis Complex (TSC) and Focal Cortical Dysplasia (FCD) with treatment resistant epilepsy (TRE) who will be undergoing brain surgery. One group of patients will be treated with Everolimus, and another will not. Researchers will determine if there is a difference in mTOR signaling between the patients who were treated with Everolimus and those who were not. Previous studies have suggested that Everolimus may reduce seizure activity in TSC patients by decreasing mTOR signaling. Since patients with FCD may also have excess mTOR signaling brain activity, Everolimus may also reduce seizure activity in these patients. The drug Everolimus is approved by the Food and Drug Administration to treat specific types of breast, pancreatic, and kidney cancer, a kidney tumor called an angiomyolipoma (common in patients with TSC), and TSC patients who have a brain tumor called a subependymal giant cell astrocytoma (SEGA). However, in this research it is considered to be an investigational since it is not approved for reduction in mTOR signaling and a decrease in seizure frequency. Researchers believe that Everolimus may be useful in reducing something called cortical hyperexcitability, which is the excess brain activity that can contribute to seizures.

NCT ID: NCT02201212 Completed - Clinical trials for Tuberous Sclerosis Complex

Everolimus for Cancer With TSC1 or TSC2 Mutation

Start date: September 2014
Phase: Phase 2
Study type: Interventional

In this research study, the investigators are evaluating the clinical benefit of everolimus in cancer patients with inactivating TSC1 or TSC2 mutations or activating MTOR mutations. This research study is a Phase II clinical trial, which tests the safety and effectiveness of an investigational drug called everolimus to learn whether the drug works in treating a specific cancer. "Investigational" means that the drug is being studied. It also means that the FDA (the U.S. Food and Drug Administration) has not yet approved everolimus for your type of cancer. Everolimus is a drug that may stop cancer cells from growing by blocking an important factor (mTOR) involved in the growth of cells. This drug has been used in treatment for other cancers and is approved by the Food and Drug Administration for treatment of several types of cancer, including renal cell carcinoma. Treatment with this drug has been associated with responses in some patients whose cancers had mutations in TSC1 or TSC2. The investigators think that patients whose tumors have mutations in TSC1 or TSC2 may have a good chance of responding to treatment with drugs like everolimus.