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Tuberous Sclerosis clinical trials

View clinical trials related to Tuberous Sclerosis.

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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: NCT04285346 Completed - Tuberous Sclerosis Clinical Trials

Adjunctive Ganaxolone Treatment (Part A) in TSC Followed by Long-term Treatment (Part B)

TSC
Start date: April 8, 2020
Phase: Phase 2
Study type: Interventional

To assess preliminary safety and efficacy of ganaxolone as adjunctive therapy for the treatment of primary seizure types in patients with genetically- or clinically-confirmed TSC-related epilepsy through the end of the 12 week treatment period.

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: NCT03826628 Completed - Tuberous Sclerosis Clinical Trials

Dose-Ranging Efficacy and Safety Study of Topical Rapamycin Cream for Facial Angiofibroma Associated With Tuberous Sclerosis Complex

Start date: July 28, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

The study aims to compare the safety and efficacy of two different strengths of Rapamycin cream, topical and placebo over 26 weeks in the treatment of facial angiofibroma (FA) associated with Tuberous Sclerosis Complex (TSC).

NCT ID: NCT03525834 Completed - Clinical trials for Renal Angiomyolipoma

Safety and Efficacy of Everolimus (Afinitor®) in Chinese Adult Patients With Angiomyolipoma Associated With Tuberous Sclerosis Complex.

Start date: November 9, 2018
Phase: Phase 4
Study type: Interventional

The purpose of this study was to assess the safety and efficacy of everolimus (Afinitor®) in Chinese patients with renal angiomyolipoma (AML) associated with tuberous sclerosis complex (TSC).

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: NCT03140449 Completed - Facial Angiofibroma Clinical Trials

Topical Rapamycin and Calcitriol for Angiofibroma of Tuberous Sclerosis

Start date: September 5, 2013
Phase: Phase 3
Study type: Interventional

The aim of the study is to determine the effect and safety of topical rapamycin or calcitriol and their combination for the treatment of TSC-associated facial angiofibroma. Methods: A total of 52 TSC patients including 20 male and 32 female subjects were recruited, and 50 of them completed the period 1 study. In period 1, topical rapamycin (0.1%) or calcitriol (3 mcg/g) single-agent therapy versus their combination were applied twice a day by a left-right randomized, split-face comparison for 12 weeks. The primary end point was the reduction of facial angiofibroma severity index (FASI) for the grade of erythema, papule size, elevation and extension of the lesions at week 12. In period 2, the patients entered an open-label study and were reassigned to use the more effective ointment on both cheeks for another 12 weeks (week 13-24). A follow-up FASI analysis for recurrence after drug discontinuance for 12 weeks was also performed (week 36). The secondary end point was the reduction of Visual Analysis Score (VAS) evaluated by the subjects themselves at week 12.

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.