| 1 |
NCT03422367 |
Recruiting |
JASPER Early Intervention for Tuberous Sclerosis |
|
|
Interventional |
Not Applicable |
- University of California, Los Angeles
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Boston Children’s Hospital
- Massachusetts General Hospital
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- ESCS (Early Social Communication Scales) Assessment.
- Parent Caregiver Interaction assesses the amount of time the parent and child spend in engaged in the same play routine.
- Structured Play Assessment (SPA)
- (and 4 more...)
|
64 |
All |
6 Months to 40 Months (Child) |
NCT03422367 |
IRB #17-000262
1R01HD090138-01A1 |
JETS |
October 24, 2017 |
June 15, 2022 |
June 15, 2022 |
February 5, 2018 |
February 23, 2018 |
|
- University of California Los Angeles
Los Angeles, California, United States - Boston Children's Hospital
Boston, Massachusetts, United States
|
| 2 |
NCT01954693 |
Active, not recruiting |
A Study of Everolimus in the Treatment of Neurocognitive Problems in Tuberous Sclerosis |
|
- Drug: Placebo
- Drug: Everolimus (RAD001)
|
Interventional |
Phase 2 |
- Cardiff University
- Novartis
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- List Learning test (from the BIRT Memory and Information Processing Battery)
- Complex Figure test (from the BIRT Memory and Information Processing Battery)
- CANTAB - Stockings of Cambridge (SOC)
- (and 14 more...)
|
48 |
All |
16 Years to 60 Years (Child, Adult) |
NCT01954693 |
SPON803-10
2011-004854-25 |
TRON |
June 2012 |
August 6, 2018 |
August 6, 2018 |
October 7, 2013 |
January 30, 2018 |
|
- Cardiff University
Cardiff, United Kingdom
|
| 3 |
NCT00598455 |
Completed |
Tuberous Sclerosis Complex Natural History Study: Renal Manifestations |
- Tuberous Sclerosis Complex
|
|
Observational |
|
- Children's Hospital Medical Center, Cincinnati
- Loma Linda University
- Massachusetts General Hospital
- (and 5 more...)
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
|
450 |
All |
7 Years to 65 Years (Child, Adult) |
NCT00598455 |
TS0500008
W81XWH-06-1-0538 |
|
February 2008 |
September 2013 |
September 2013 |
January 22, 2008 |
May 4, 2017 |
|
- Cincinnati Children's
Cincinnati, Ohio, United States
|
| 4 |
NCT02687633 |
Unknown † |
Early Behavioral Intervention to Improve Social Communication Function in Infants With Tuberous Sclerosis Complex |
- Tuberous Sclerosis Complex
|
|
Interventional |
Not Applicable |
- University of California, Los Angeles
- Boston Children’s Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- change from baseline in Joint Engagement (shared engagement in a play routine) at 2 weeks into study participation, according to the parent caregiver interaction assessment.
- change from baseline in Joint Engagement (shared engagement in a play routine) at 3 months into study participation, according to the parent caregiver interaction assessment.
- change from baseline in Joint Engagement (shared engagement in a play routine) at 6 months into study participation, according to the parent caregiver interaction assessment.
- (and 11 more...)
|
32 |
All |
12 Months to 36 Months (Child) |
NCT02687633 |
15-000699 |
|
September 2015 |
August 2017 |
August 2017 |
February 22, 2016 |
February 22, 2016 |
|
- UCLA Semel Insitute
Los Angeles, California, United States
|
| 5 |
NCT01780441 |
Active, not recruiting |
Early Biomarkers of Autism in Infants With Tuberous Sclerosis Complex (TSC) |
- Tuberous Sclerosis Complex
|
|
Observational |
|
- Boston Children’s Hospital
- National Institute of Neurological Disorders and Stroke (NINDS)
- Tuberous Sclerosis Alliance
|
Other / NIH |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- ADOS evaluation score at the 36 month visit
- MRI biomarkers
- EEG biomarkers
|
166 |
All |
3 Months to 12 Months (Child) |
NCT01780441 |
IRB-P00005074
1U01NS082320-01 |
|
January 2013 |
February 2019 |
December 2019 |
January 31, 2013 |
February 7, 2018 |
|
- University of Alabama at Birmingham
Birmingham, Alabama, United States - University of California at Los Angeles
Los Angeles, California, United States - Boston Children's Hospital
Boston, Massachusetts, United States - (and 2 more...)
|
| 6 |
NCT03276195 |
Recruiting |
Studies in Patients With Tuberous Sclerosis Complex |
- Tuberous Sclerosis Complex
|
|
Observational |
|
- Translational Genomics Research Institute
- United States Department of Defense
|
Other / U.S. Fed |
- Observational Model: Family-Based
- Time Perspective: Prospective
|
- Next Generation Sequencing to Measure Phenotypic Variability
|
1000 |
All |
Child, Adult, Senior |
NCT03276195 |
vnarayanan15-016 |
|
May 2016 |
December 2019 |
December 2021 |
September 8, 2017 |
March 13, 2018 |
|
- Translational Genomics Research Institute (TGen)
Phoenix, Arizona, United States
|
| 7 |
NCT01289912 |
Completed
Has Results |
Trial of RAD001 and Neurocognition in Tuberous Sclerosis Complex (TSC) |
- Tuberous Sclerosis Complex
|
- Drug: RAD001
- Drug: Placebo
|
Interventional |
Phase 2 |
- Mustafa Sahin
- Tuberous Sclerosis Alliance
- Autism Speaks
- (and 3 more...)
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Evaluation of the Safety of RAD001 on Neurocognition in Patients With TSC Compared With Placebo in Patients With TSC.
- Evaluation of the Efficacy of RAD001 on Neurocognition in Patients With TSC Compared With Placebo.
- Evaluation of the Efficacy of RAD001 on Neurocognition (Cambridge Neuropsychological Test Automated Battery) in Patients With TSC Compared With Placebo.
- (and 5 more...)
|
52 |
All |
6 Years to 21 Years (Child, Adult) |
NCT01289912 |
10-06-0247 |
TSC |
January 2011 |
December 2014 |
December 2014 |
February 4, 2011 |
January 25, 2018 |
January 25, 2018 |
- Boston Children's Hospital
Boston, Massachusetts, United States - Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
|
| 8 |
NCT02849457 |
Recruiting |
Preventing Epilepsy Using Vigabatrin In Infants With Tuberous Sclerosis Complex |
- Tuberous Sclerosis Complex
|
- Drug: Vigabatrin
- Drug: Placebo
|
Interventional |
Phase 2 |
- Martina Bebin
- National Institute of Neurological Disorders and Stroke (NINDS)
- University of Alabama at Birmingham
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Prevention
|
- Cognitive Assessment Scores and Developmental Impact
- Number of subjects that develop seizures when treated with vigabatrin
- Time to the Subject's First Clinical Seizure
- (and 5 more...)
|
80 |
All |
up to 6 Months (Child) |
NCT02849457 |
PREVeNT
1U01NS092595-01A1 |
|
December 2016 |
May 2020 |
May 2021 |
July 29, 2016 |
May 30, 2017 |
|
- University of Alabama at Birmingham
Birmingham, Alabama, United States - University of California, Los Angeles
Los Angeles, California, United States - Stanford University
Palo Alto, California, United States - (and 4 more...)
|
| 9 |
NCT02887781 |
Recruiting |
Clinical Presentation and Renal Outcome of Patients With Tuberous Sclerosis Complex and/or Renal Angiomyolipoma in the Great West Region of France |
- Tuberous Sclerosis Complex
|
|
Observational |
|
- University Hospital, Brest
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Evolution of the renal function estimated by the MDRD GFR
|
150 |
All |
8 Years and older (Child, Adult, Senior) |
NCT02887781 |
TSAR (RB 14.055) |
TSAR |
August 13, 2015 |
December 31, 2020 |
December 31, 2020 |
September 2, 2016 |
November 29, 2017 |
|
- CHU Brest
Brest, France - CHU Rennes
Rennes, France
|
| 10 |
NCT02104011 |
Completed |
Treatment of Renal Angiomyolipomas in Tuberous Sclerosis by Beta-blockers |
- Renal Angiomyolipomas
- Tuberous Sclerosis
|
|
Interventional |
Phase 2 |
- University Hospital, Bordeaux
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Evolution of angiomyolipomas volume
- Renal function evolution
- Effect on the potential haemorraghic transformation
- (and 2 more...)
|
2 |
All |
18 Years and older (Adult, Senior) |
NCT02104011 |
CHUBX 2011/35 |
STBETA |
May 22, 2015 |
November 22, 2017 |
November 22, 2017 |
April 4, 2014 |
January 23, 2018 |
|
- Nephrology department
Bordeaux, France
|
| 11 |
NCT01713946 |
Completed |
A Placebo-controlled Study of Efficacy & Safety of 2 Trough-ranges of Everolimus as Adjunctive Therapy in Patients With Tuberous Sclerosis Complex (TSC) & Refractory Partial-onset Seizures |
- Tuberous Sclerosis Complex-associated Refractory Seizures
|
- Drug: RAD001
- Drug: Placebo
|
Interventional |
Phase 3 |
- Novartis Pharmaceuticals
- Novartis
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- European Medicine Agency (EMA): Response rate
- Food & Drug Administration (FDA): Percentage reduction in partial onset seizure frequency
- Seizure free rate
- (and 14 more...)
|
370 |
All |
2 Years to 65 Years (Child, Adult) |
NCT01713946 |
CRAD001M2304
2011-000860-90 |
EXIST-3 |
April 29, 2013 |
October 2, 2015 |
October 25, 2017 |
October 25, 2012 |
February 1, 2018 |
|
- University of Alabama at Birmingham SC
Birmingham, Alabama, United States - TGen/APNNA
Phoenix, Arizona, United States - University of California at Los Angeles SC
Los Angeles, California, United States - (and 100 more...)
|
| 12 |
NCT00457808 |
Completed |
Rapamycin Therapy for Patients With Tuberous Sclerosis Complex and Sporadic LAM |
- Tuberous Sclerosis
- Lymphangioleiomyomatosis
|
- Drug: Rapamycin, sirolimus
|
Interventional |
Phase 2 |
- Children's Hospital Medical Center, Cincinnati
- The LAM Foundation
- Tuberous Sclerosis Alliance
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Volume of Angiomyolipomata
|
25 |
All |
18 Years to 65 Years (Adult) |
NCT00457808 |
CCHMC IRB # 02-10-16
R21CA103486 |
|
December 2002 |
|
March 2006 |
April 9, 2007 |
April 9, 2007 |
|
- Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, United States
|
| 13 |
NCT00411619 |
Completed
Has Results |
Everolimus (RAD001) Therapy of Giant Cell Astrocytoma in Patients With Tuberous Sclerosis Complex |
- Tuberous Sclerosis
- Subependymal Giant Cell Astrocytoma
|
|
Interventional |
Phase 1
Phase 2 |
- Children's Hospital Medical Center, Cincinnati
- Novartis
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number With Observed Adverse Side Effects
- Overall Reduction in SEGA Tumor Volume.
|
28 |
All |
3 Years and older (Child, Adult, Senior) |
NCT00411619 |
CCHMC IRB# 06-07-50 |
|
January 2007 |
January 2014 |
January 2014 |
December 14, 2006 |
October 20, 2014 |
October 20, 2014 |
- Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
|
| 14 |
NCT01070316 |
Completed
Has Results |
Everolimus (RAD001) Therapy for Epilepsy in Patients With Tuberous Sclerosis Complex (TSC) |
- Epilepsy
- Tuberous Sclerosis Complex
|
|
Interventional |
Phase 1
Phase 2 |
- Children's Hospital Medical Center, Cincinnati
- Novartis
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Reduction in Seizure Frequency
- Number of Participants Continuing Study Medication Over Time
|
20 |
All |
2 Years and older (Child, Adult, Senior) |
NCT01070316 |
2009-0998 |
|
January 2010 |
April 2016 |
April 2016 |
February 18, 2010 |
March 13, 2017 |
September 23, 2016 |
- Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States - Baylor College of Medicine
Houston, Texas, United States
|
| 15 |
NCT03363763 |
Not yet recruiting |
Topical Sirolimus Ointment for Cutaneous Angiofibromas in Subjects With Tuberous Sclerosis Complex |
- Angiofibroma of Face
- Tuberous Sclerosis
|
- Drug: Sirolimus 0.2%
- Drug: Sirolimus 0.4%
- Drug: Placebo ointment
|
Interventional |
Phase 2 |
- Aucta Pharmaceuticals, Inc
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- The proportion of subjects with a clinical response of treatment success.
- The proportion of subjects with at least 30% improvement at Week 12 as compared to Baseline in the Facial Angiofibromas Severity Index (FASI) score.
- The time to reach at least 30% improvement from Baseline in the Facial Angiofibromas Severity Index (FASI) score
- (and 3 more...)
|
45 |
All |
2 Years to 18 Years (Child, Adult) |
NCT03363763 |
AUCTA-UAP006-PH2 |
|
December 2017 |
June 2018 |
September 2018 |
December 6, 2017 |
December 6, 2017 |
|
|
| 16 |
NCT02544763 |
Recruiting |
A Randomized Controlled Trial of Cannabidiol (GWP42003-P, CBD) for Seizures in Tuberous Sclerosis Complex (GWPCARE6) |
- Tuberous Sclerosis Complex
- Seizures
|
- Drug: GWP42003-P
- Drug: Placebo
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change in seizure frequency
- Number of treatment responders
- Number of participants with worsening, no change, or improvements in seizure frequency
- (and 18 more...)
|
210 |
All |
1 Year to 65 Years (Child, Adult) |
NCT02544763 |
GWEP1521 Blinded Phase
2015-002154-12 |
|
April 2016 |
September 2018 |
September 2018 |
September 9, 2015 |
October 24, 2017 |
|
- Massachusetts General Hospital
Boston, Massachusetts, United States
|
| 17 |
NCT02544750 |
Enrolling by invitation |
An Open-label Extension Trial of Cannabidiol (GWP42003-P, CBD) for Seizures in Tuberous Sclerosis Complex (GWPCARE6) |
- Tuberous Sclerosis Complex
- Seizures
|
|
Interventional |
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Incidence of adverse events
- Change in seizure frequency
- Number of treatment responders
- (and 18 more...)
|
210 |
All |
1 Year to 65 Years (Child, Adult) |
NCT02544750 |
GWEP1521 Open-Label Extension
2015-002154-12 |
|
August 2016 |
September 2020 |
September 2020 |
September 9, 2015 |
October 24, 2017 |
|
- Massachusetts General Hospital
Boston, Massachusetts, United States
|
| 18 |
NCT00490789 |
Unknown † |
Trial of Efficacy and Safety of Sirolimus in Tuberous Sclerosis and LAM |
- Tuberous Sclerosis
- Lymphangioleiomyomatosis
|
|
Interventional |
Phase 2 |
- Cardiff University
- University of Nottingham
- St Georges Hospital Medical School
- (and 3 more...)
|
Other / Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- longest diameter of renal angiomyolipomas assessed by MRI scan, toxicity graded by National Cancer Institute's Common Terminology Criteria for Adverse Events v3.0
- toxicity graded by National Cancer Institute's Common Terminology Criteria for Adverse Events
- respiratory function tests (FEV1, FVC, DLCO), cognitive function (memory, executive skills)
|
14 |
All |
18 Years to 65 Years (Adult) |
NCT00490789 |
TESSTAL |
TESSTAL |
October 2005 |
September 2009 |
September 2009 |
June 25, 2007 |
April 30, 2008 |
|
- University Hospital of Wales
Cardiff, Wales, United Kingdom - Royal Sussex County Hospital
Brighton, United Kingdom - City Hospital
Nottingham, United Kingdom
|
| 19 |
NCT00789828 |
Completed
Has Results |
Efficacy and Safety of Everolimus (RAD001) in Patients of All Ages With Subependymal Giant Cell Astrocytoma Associated With Tuberous Sclerosis Complex (TSC)(EXIST-1) |
- Tuberous Sclerosis
- Subependymal Giant Cell Astrocytoma
|
- Drug: Everolimus
- Drug: Placebo
|
Interventional |
Phase 3 |
- Novartis Pharmaceuticals
- Novartis
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Percentage of Participants With Best Overall Subependymal Giant Cell Astrocytomas (SEGA) Response
- Change From Baseline in Frequency of Total Seizure Events Per 24 Hours at Week 24 in Both Core and Extension Period
- Time to SEGA Progression
- (and 8 more...)
|
117 |
All |
Child, Adult, Senior |
NCT00789828 |
CRAD001M2301
2007-006997-27 |
EXIST-1 |
August 2009 |
March 2011 |
October 2014 |
November 13, 2008 |
February 3, 2016 |
May 1, 2012 |
- University of Alabama at Birmingham
Birmingham, Alabama, United States - Barrow Tuberous Sclerosis Center
Phoenix, Arizona, United States - University of California at Los Angeles
Los Angeles, California, United States - (and 21 more...)
|
| 20 |
NCT00792766 |
Completed |
Long Term Follow Up for RAD001 Therapy of Angiomyolipomata in Patients With Tuberous Sclerosis (TSC) and Sporadic Lymphangioleiomyomatosis (LAM) |
- Tuberous Sclerosis
- Angiolipoma
|
- Drug: everolimus (RAD001)
|
Interventional |
Phase 1
Phase 2 |
- Children's Hospital Medical Center, Cincinnati
- Novartis
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- RAD001 tolerance
- Angiomyolipoma volume reduction
|
20 |
All |
18 Years to 65 Years (Adult) |
NCT00792766 |
CCHMC IRB# 2008-0333 |
|
December 2008 |
September 2013 |
September 2013 |
November 18, 2008 |
September 18, 2013 |
|
- Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
|
| 21 |
NCT02962414 |
Recruiting |
Roll-over Study to Collect and Assess Long-term Safety of Everolimus in Patients With TSC and Refractory Seizures Who Have Completed the EXIST-3 Study [CRAD001M2304] and Who Are Benefitting From Continued Treatment |
- Tuberous Sclerosis Complex
|
|
Interventional |
Phase 3 |
- Novartis Pharmaceuticals
- Novartis
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Occurances of adverse events and serious adverse events
- Percentage of patients with clinical benefit
|
218 |
All |
2 Years to 65 Years (Child, Adult) |
NCT02962414 |
CRAD001M2X02B |
|
June 8, 2017 |
April 2, 2027 |
January 5, 2028 |
November 11, 2016 |
August 28, 2017 |
|
- TGen/APNNA SC
Phoenix, Arizona, United States - UCSF Benioff Children's Hospital
Oakland, California, United States - Connecticut Childrens Medical Center
Hartford, Connecticut, United States - (and 33 more...)
|
| 22 |
NCT02098759 |
Recruiting |
Long-term, Prospective Study Evaluating Clinical and Molecular Biomarkers of Epileptogenesis in a Genetic Model of Epilepsy - Tuberous Sclerosis Complex |
- TSC
- Tuberous Sclerosis Complex
- Epilepsy
|
- Device: epilepsy early diagnosis protocol
|
Interventional |
Not Applicable |
- Sergiusz Jozwiak
- University of Rome Tor Vergata
- Institut National de la Santé Et de la Recherche Médicale, France
- (and 8 more...)
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Diagnostic
|
- number of patients with epilepsy
|
100 |
All |
up to 4 Months (Child) |
NCT02098759 |
EPISTOP
602391 |
EPISTOP |
November 2013 |
October 2018 |
October 2018 |
March 28, 2014 |
April 4, 2014 |
|
- Medizinische Universitaet Wien
Vienna, Austria - Vrije Universiteit Brussel
Brussels, Belgium - Katholieke Universiteit Leuven
Leuven, Belgium - (and 6 more...)
|
| 23 |
NCT00001975 |
Recruiting |
Study of Skin Tumors in Tuberous Sclerosis |
- Hereditary Neoplastic Syndrome
- Tuberous Sclerosis
|
|
Observational |
|
- National Heart, Lung, and Blood Institute (NHLBI)
- Uniformed Services University of the Health Sciences
- National Institutes of Health Clinical Center (CC)
|
NIH / U.S. Fed |
|
|
130 |
All |
18 Years to 90 Years (Adult, Senior) |
NCT00001975 |
000051
00-H-0051 |
|
January 19, 2000 |
|
|
January 21, 2000 |
April 17, 2018 |
|
- United States Uniformed Health Service
Bethesda, Maryland, United States - National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
| 24 |
NCT00790400 |
Completed
Has Results |
Efficacy and Safety of RAD001 in Patients Aged 18 and Over With Angiomyolipoma Associated With Either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM) |
- Tuberous Sclerosis Complex (TSC)
- Lymphangioleiomyomatosis (LAM)
|
- Drug: Everolimus (RAD001)
- Drug: Everolimus Placebo
|
Interventional |
Phase 3 |
- Novartis Pharmaceuticals
- Novartis
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Angiomyolipoma Response Rate as Per Central Radiology Review
- Time to Angiomyolipoma Progression as Per Central Radiology Review
- Skin Lesion Response Rate as Per Investigator (Only Patients With at Least One Skin Lesion at Baseline)
- (and 7 more...)
|
118 |
All |
18 Years and older (Adult, Senior) |
NCT00790400 |
CRAD001M2302
2008-002113-48 |
EXIST-2 |
April 2009 |
June 2011 |
November 2015 |
November 13, 2008 |
February 17, 2017 |
August 28, 2012 |
- University of Alabama at Birmingham
Birmingham, Alabama, United States - Barrow Tuberous Sclerosis Center
Phoenix, Arizona, United States - Massachusetts General Hospital Massachussetts General Hospita
Boston, Massachusetts, United States - (and 22 more...)
|
| 25 |
NCT02325505 |
Recruiting |
Characterization of Patients With Tuberous Sclerosis Complex, Lymphangioleiomyomatosis and Angiomyolipoma |
- Tuberous Sclerosis
- Lymphangioleiomyomatosis
- Angiomyolipoma
|
|
Observational |
|
- InCor Heart Institute
- Novartis
|
Other / Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Pulmonary function tests
- Chest high resolution computed tomography findings
- Findings on computed tomography of the brain
- (and 13 more...)
|
200 |
All |
Child, Adult, Senior |
NCT02325505 |
4147/14/127 |
|
April 2016 |
April 2018 |
April 2018 |
December 25, 2014 |
August 22, 2017 |
|
- InCor Heart Institute
Sao Paulo, Brazil - InCor Heart Institute
Sao Paulo, Brazil
|
| 26 |
NCT02654340 |
Recruiting |
Genetic Heterogeneity and Genotype-phenotype Correlation of Children and Adults With Tuberous Sclerosis Complex |
- Sclerosis Tuberosa
- Tuberous Sclerosis Complex
- Cerebral Sclerosis
- Nervous System Disorders
|
|
Observational |
|
- University of Rostock
- Centogene AG Rostock
|
Other / Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Association of specific mutations after sequencing the TSC1 and TSC2 gene with the clinical manifestations of the tuberous sclerosis complex in cohort of clinically well characterized tuberous sclerosis complex patients.
- Classification of the clinical severity of the tuberous sclerosis complex Classification of the severity of accompanying symptoms
|
100 |
All |
2 Years and older (Child, Adult, Senior) |
NCT02654340 |
TSC 06-2015 |
TuScCom |
March 2015 |
March 2020 |
March 2020 |
January 13, 2016 |
July 5, 2017 |
|
- Albrecht-Kossel-Institute for Neuroregeneration (AKos) Centre for Mental Health Disease University of Rostock
Rostock, Germany
|
| 27 |
NCT02461459 |
Recruiting |
Autism Spectrum Disorder (ASD) and Intellectual Disability (ID) Determinants in Tuberous Sclerosis Complex (TSC) |
- Tuberous Sclerosis
- Autism Disorder
- Intellectual Disability
|
|
Observational |
|
- Boston Children’s Hospital
- National Institutes of Health (NIH)
- National Institute of Neurological Disorders and Stroke (NINDS)
- (and 3 more...)
|
Other / NIH |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Change in ADOS-2 at 12 months
- Change in SBIS-5 at 12 months
- Change in Fractional anisotropy (FA) at 12 months
- (and 9 more...)
|
100 |
All |
3 Years to 21 Years (Child, Adult) |
NCT02461459 |
IRB-P00013585
1U54NS092090 |
|
May 2015 |
December 2019 |
December 2019 |
June 3, 2015 |
July 19, 2017 |
|
- University of Alabama at Birmingham
Birmingham, Alabama, United States - University of California at Los Angeles
Los Angeles, California, United States - Boston Children's Hospital
Boston, Massachusetts, United States - (and 2 more...)
|
| 28 |
NCT02634931 |
Unknown † |
Long-term Trial of Topical Sirolimus to Angiofibroma in Patient With Tuberous Sclerosis Complex |
- Tuberous Sclerosis
- Angiofibroma
- Hypomelanotic Macule
- Plaque
|
|
Interventional |
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- The discontinuation rate due to adverse events
- Adverse events and adverse events related to the test drug
- Adverse events related to the test drug leading to the discontinuation permanently
- (and 12 more...)
|
80 |
All |
3 Years and older (Child, Adult, Senior) |
NCT02634931 |
NPC-12G-2 |
|
December 2015 |
October 2017 |
February 2018 |
December 18, 2015 |
December 23, 2015 |
|
- Graduate School of Medicine, Osaka University
Suita, Osaka, Japan
|
| 29 |
NCT02635789 |
Completed |
Phase III Trial of Topical Formulation of Sirolimus to Skin Lesions in Patients With Tuberous Sclerosis Complex (TSC) |
- Tuberous Sclerosis
- Angiofibroma
- Hypomelanotic Macule
- Plaque
|
- Drug: NPC-12G gel
- Drug: Placebo gel
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Improvements in angiofibroma
- Improvements in redness of angiofibroma
- Improvements in hypomelanotic macule and plaque of upper neck
- (and 7 more...)
|
62 |
All |
3 Years and older (Child, Adult, Senior) |
NCT02635789 |
NPC-12G-1 |
|
December 2015 |
October 2016 |
October 2016 |
December 21, 2015 |
February 2, 2017 |
|
- Graduate School of Medicine, Osaka University
Suita, Osaka, Japan
|
| 30 |
NCT01730209 |
Unknown † |
Efficacy of RAD001/Everolimus in Autism and NeuroPsychological Deficits in Children With Tuberous Sclerosis Complex |
- Tuberous Sclerosis Complex
- TSC Related Cognitive Disability
- TSC Related Autism
- TSC Related Learning Problems
|
- Drug: Everolimus
- Drug: Placebo
|
Interventional |
Phase 2
Phase 3 |
- Erasmus Medical Center
- Utrecht University
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Cognitive ability measured by IQ
- Autistic features
- Social and communicational skills
- (and 8 more...)
|
60 |
All |
4 Years to 15 Years (Child) |
NCT01730209 |
NL38619.078.11 |
RAPIT |
November 2012 |
November 2015 |
November 2016 |
November 21, 2012 |
May 5, 2015 |
|
- Erasmus Medical Center
Rotterdam, Netherlands
|
| 31 |
NCT02061397 |
Recruiting |
Safety of Simvastatin in LAM and TSC |
- Lymphangioleiomyomatosis
- Tuberous Sclerosis Complex
|
|
Interventional |
Phase 1
Phase 2 |
- University of Pennsylvania
- The LAM Foundation
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Safety of simvastatin in the treatment of LAM-S and LAM-TS patients on a stable (for at least 3 months) dose of sirolimus or everolimus.
- FEV1, FVC, DLCO, VEGF-D, and QOL; signs of clinical benefit.
|
10 |
Female |
18 Years and older (Adult, Senior) |
NCT02061397 |
The SOS Trial |
SOS |
March 2014 |
January 2018 |
January 2018 |
February 12, 2014 |
June 14, 2017 |
|
- University of Pennsylvania
Philadelphia, Pennsylvania, United States
|
| 32 |
NCT00457964 |
Completed |
RAD001 Therapy of Angiomyolipomata in Patients With TS Complex and Sporadic LAM |
- Tuberous Sclerosis
- Lymphangioleiomyomatosis
|
|
Interventional |
Phase 1
Phase 2 |
- Children's Hospital Medical Center, Cincinnati
- Novartis Pharmaceuticals
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Patients will be considered responders if their angiomyolipoma volume decreases by thirty percent or more from baseline
|
36 |
All |
18 Years to 65 Years (Adult) |
NCT00457964 |
CCHMC IRB #2008-0812(04-07-22) |
|
August 2005 |
July 2013 |
July 2013 |
April 9, 2007 |
September 25, 2013 |
|
- Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
|
| 33 |
NCT02436746 |
Unknown † |
The Cognitive Variability in NF1 and TSC Monozygotic Twins |
- Neurofibromatosis Type I
- Tuberous Sclerosis Complex
|
|
Observational |
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Cross-Sectional
|
- Correlation of full intelligence quotient
- Correlation of word reading ability
- Correlation of attention problems
- (and 4 more...)
|
116 |
All |
Child, Adult, Senior |
NCT02436746 |
MEC-2014-483 |
COVANTT |
April 2015 |
April 2017 |
April 2017 |
May 7, 2015 |
May 7, 2015 |
|
- Erasmus MC
Rotterdam, Netherlands
|
| 34 |
NCT01031901 |
Completed |
Topical Rapamycin Therapy to Alleviate Cutaneous Manifestations of Tuberous Sclerosis Complex (TSC) and Neurofibromatosis I (NF1) |
- Tuberous Sclerosis
- Neurofibromatoses
- Angiofibroma
- Neurofibroma
|
- Drug: Skincerity
- Drug: Skincerity plus sirolimus/rapamycin
- Drug: Skinercity plus sirolimus/rapamycin
|
Interventional |
Phase 1 |
- The University of Texas Health Science Center, Houston
- Society for Pediatric Dermatology
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Rapamycin level
- Complete blood count
- Total cholesterol
- (and 2 more...)
|
52 |
All |
13 Years and older (Child, Adult, Senior) |
NCT01031901 |
HSC-MS-09-0259 |
|
December 2009 |
February 2011 |
June 2011 |
December 15, 2009 |
February 27, 2012 |
|
- The University of Texas Health Science Center
Houston, Texas, United States
|
| 35 |
NCT01767779 |
Active, not recruiting |
Potential EEG Biomarkers and Antiepileptogenic Strategies for Epilepsy in TSC |
- Tuberous Sclerosis Complex
|
|
Observational |
|
- University of Alabama at Birmingham
- Children's Hospital Medical Center, Cincinnati
- The University of Texas Health Science Center, Houston
- (and 2 more...)
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Identification of EEG biomarkers as predictors of developing epilepsy in infants with Tuberous Sclerosis Complex
|
40 |
All |
up to 6 Months (Child) |
NCT01767779 |
1P20NS080199-01 |
|
September 2012 |
December 2016 |
December 2018 |
January 14, 2013 |
January 9, 2018 |
|
- University of Alabama at Birmingham
Birmingham, Alabama, United States - UCLA
Los Angeles, California, United States - Boston Children's Hospital
Boston, Massachusetts, United States - (and 2 more...)
|
| 36 |
NCT03356769 |
Recruiting |
Aspirin as an add-on Treatment of Refractory Epilepsy in Tuberous Sclerosis Complex |
- Tuberous Sclerosis Complex
- Aspirin
- Epilepsy
- (and 2 more...)
|
- Drug: Aspirin
- Drug: AED
- Drug: Placebo
|
Interventional |
Phase 2 |
- Peking Union Medical College Hospital
- Shijiazhuang Pharmaceutical Group Co. Ltd.
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Percentage of reduction in seizure frequency
- Total days of seizure free
- A mild reduction in seizure frequency
- (and 4 more...)
|
98 |
All |
6 Years to 30 Years (Child, Adult) |
NCT03356769 |
JS-1425 |
|
November 20, 2017 |
November 20, 2019 |
November 20, 2020 |
November 29, 2017 |
November 29, 2017 |
|
- Department of Neurology, Peking Union Medical College Hospital
Beijing, Beijing, China
|
| 37 |
NCT03140449 |
Completed |
Topical Rapamycin and Calcitriol for Angiofibroma of Tuberous Sclerosis |
|
- Drug: Rapamycin
- Drug: Calcitriol
- Drug: Rapamycin-calcitriol combination
|
Interventional |
Phase 3 |
- National Taiwan University Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- facial angiofibroma severity index (FASI)
|
52 |
All |
7 Years to 65 Years (Child, Adult) |
NCT03140449 |
201306009MINB |
|
September 5, 2013 |
November 7, 2016 |
April 25, 2017 |
May 4, 2017 |
May 4, 2017 |
|
|
| 38 |
NCT02860494 |
Not yet recruiting |
Topical Everolimus in Patients With Tuberous Sclerosis Complex |
|
- Drug: Everolimus
- Drug: Placebo
|
Interventional |
Phase 2
Phase 3 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Facial Angiofibroma Severity Index (FASI)
- FA size
- Dermatologist's global assessment of efficacy
- (and 6 more...)
|
96 |
All |
up to 2 Years (Child) |
NCT02860494 |
69HCL16_0062 |
EVEROST |
September 2018 |
September 2021 |
September 2022 |
August 9, 2016 |
February 26, 2018 |
|
- Hopital Femme Mère Enfant
Bron, France
|
| 39 |
NCT01092208 |
Terminated |
Studies of Autistic Patients: Gene Networks and Clinical Subtypes |
|
|
Observational |
|
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Time Perspective: Retrospective
|
|
11 |
Male |
4 Years to 18 Years (Child, Adult) |
NCT01092208 |
100084
10-CH-0084 |
|
March 17, 2010 |
|
September 24, 2013 |
March 24, 2010 |
April 19, 2018 |
|
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
| 40 |
NCT03326765 |
Not yet recruiting |
Characterizing Sleep Disorders in Children and Adults With Tuberous Sclerosis Complex (TSC) |
|
- Other: Questionnaires
- Procedure: electroencephalogram (EEG)
- Procedure: polysomnography
- Procedure: Actigraphy
|
Interventional |
Not Applicable |
- Universitair Ziekenhuis Brussel
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
|
- characterize the sleep phenotype of TSC in children and adults without epilepsy
|
60 |
All |
up to 70 Years (Child, Adult, Senior) |
NCT03326765 |
TSC v 1.0 |
|
November 1, 2017 |
November 1, 2019 |
November 30, 2019 |
October 31, 2017 |
October 31, 2017 |
|
|
| 41 |
NCT01853423 |
Completed |
Tuberous Sclerosis Complex: Facial Angiofibroma Skin Cream |
|
|
Interventional |
Phase 1 |
- Le Bonheur Children's Hospital
- Pfizer
- University of Tennessee Health Science Center
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Reduction of facial angiofibroma with use of rapamune facial skin cream
|
11 |
All |
3 Years to 45 Years (Child, Adult) |
NCT01853423 |
UTHSC TSC01
12-2008 |
|
October 2013 |
May 2016 |
July 2016 |
May 15, 2013 |
August 19, 2016 |
|
- LeBonheur Children's Hospital
Memphis, Tennessee, United States
|
| 42 |
NCT01217125 |
Completed |
Rapamycin In Angiomyolipomas In Patients With Tuberous Sclerosis |
|
|
Interventional |
Phase 4 |
- Fundacio Puigvert
- Ministry of Health, Spain
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Angiomyolipoma volume
- skin lesions, AML complications,
|
18 |
All |
10 Years and older (Child, Adult, Senior) |
NCT01217125 |
EudraCT 2007-005978-30 |
|
October 2008 |
May 2011 |
May 2011 |
October 8, 2010 |
March 8, 2012 |
|
|
| 43 |
NCT01526356 |
Completed |
Topical Rapamycin to Erase Angiofibromas in TSC |
- Angiofibromas
- Tuberous Sclerosis
|
- Drug: Placebo
- Drug: Rapamycin
|
Interventional |
Phase 2 |
- The University of Texas Health Science Center, Houston
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Reduction in lesion size and appearance
- Confirm the lack of systemic uptake of topically applied rapamycin.
- Dermatologic sensitivity at the site of application.
|
177 |
All |
Child, Adult, Senior |
NCT01526356 |
HSC-MS-11-0501
Department of Defense USAMRMC |
Treatment |
May 2012 |
August 2014 |
August 2014 |
February 3, 2012 |
June 11, 2015 |
|
- University of Alabama at Birmingham
Birminham, Alabama, United States - UCLA Mattel Children's Hospital
Los Angeles, California, United States - Jack & Julia Center for TSC at Oakland Children's Hospital & Research Center
Oakland, California, United States - (and 7 more...)
|
| 44 |
NCT00989742 |
Completed |
Doxycycline In Lymphangioleiomyomatosis (LAM) |
- Lymphangioleiomyomatosis
- Tuberous Sclerosis
|
- Drug: Doxycycline
- Drug: Placebo
|
Interventional |
Phase 4 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Mean rate of change of FEV1 over 24 months on doxycycline compared with placebo.
- Rate change FVC over 24 months Change DLCO at 12 & 24 mths Change in shuttle walk distance at 12 & 24 mths Change in QOL at 12 & 24 mths Time to composite safety endpoint Number complications Number respiratory infections Adverse effects
|
24 |
Female |
18 Years and older (Adult, Senior) |
NCT00989742 |
07061 |
|
July 2009 |
January 2013 |
January 2013 |
October 5, 2009 |
December 2, 2015 |
|
- Nottingham University Hospitals
Nottingham, United Kingdom
|
| 45 |
NCT01266291 |
Terminated
Has Results |
Sabril for Complex Partial Seizures in Adult Tolerability Study (TS) Patients |
|
|
Interventional |
Phase 4 |
- University of Pennsylvania
- H. Lundbeck A/S
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of Participants Safely Tolerating Sabril
- Number of Patients Who Become Seizure Free While Taking Sabril
|
1 |
All |
18 Years and older (Adult, Senior) |
NCT01266291 |
811542 |
STARS |
August 2010 |
February 2013 |
December 2013 |
December 24, 2010 |
July 12, 2017 |
July 12, 2017 |
- University of Pennsylvania
Philadelphia, Pennsylvania, United States
|
| 46 |
NCT02451696 |
Recruiting |
A Pilot Study To Evaluate The Effects of Everolimus on Brain mTOR Activity and Cortical Hyperexcitability in TSC and FCD |
- Epilepsy
- Tuberous Sclerosis Complex
- Focal Cortical Dysplasia
|
|
Interventional |
Phase 2 |
- New York University School of Medicine
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of patients with adverse events
- Number of participants with reduced mTOR signaling
|
30 |
All |
2 Years to 40 Years (Child, Adult) |
NCT02451696 |
14-00245 |
|
January 2014 |
June 2018 |
June 2018 |
May 22, 2015 |
April 13, 2018 |
|
- New York University Langone Medical Center
New York, New York, United States
|
| 47 |
NCT01929642 |
Completed |
Rapalogues for Autism Phenotype in TSC: A Feasibility Study |
- Tuberous Sclerosis Complex
- Self-injury
- Autism
|
- Drug: Sirolimus
- Drug: Everolimus
|
Interventional |
Phase 2 |
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Compliance
- Caregiver Burden
- Feasibility measurements of parental stress
- (and 9 more...)
|
3 |
All |
2 Years to 30 Years (Child, Adult) |
NCT01929642 |
AM00037881 |
RAPT |
July 2013 |
July 2016 |
August 2016 |
August 28, 2013 |
January 23, 2018 |
|
- Kennedy Krieger Institute
Baltimore, Maryland, United States
|
| 48 |
NCT02201212 |
Recruiting |
Everolimus for Cancer With TSC1 or TSC2 Mutation |
- TSC1
- TSC2
- Tuberous Sclerosis Complex
- MTOR
|
|
Interventional |
Phase 2 |
- Dana-Farber Cancer Institute
- Novartis Pharmaceuticals
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Objective Response Rate
- Duration of Response Rate
- Progression-free Survival Rate
- (and 2 more...)
|
30 |
All |
18 Years and older (Adult, Senior) |
NCT02201212 |
14-229
CRAD001MUS217T |
|
September 2014 |
December 2018 |
January 2022 |
July 28, 2014 |
March 1, 2018 |
|
- Dana Farber Cancer Institute
Boston, Massachusetts, United States - Memorial Sloan Kettering Cancer Center
New York, New York, United States
|
| 49 |
NCT00552955 |
Completed |
Effect of Fasting on the Size of Abdominal Lymphatic Tumors in Women |
- Lymphangioleiomyomas
- Tuberous Sclerosis
- Lymphangioleiomyomatosis
|
|
Observational |
|
- National Heart, Lung, and Blood Institute (NHLBI)
- National Institutes of Health Clinical Center (CC)
|
NIH |
|
|
35 |
Female |
18 Years to 80 Years (Adult, Senior) |
NCT00552955 |
080016
08-H-0016 |
|
October 26, 2007 |
|
March 21, 2016 |
November 2, 2007 |
February 14, 2018 |
|
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
| 50 |
NCT00001465 |
Recruiting |
Study of the Disease Process of Lymphangioleiomyomatosis |
- Lung Disease
- Pneumothorax
- Tuberous Sclerosis
|
|
Observational |
|
- National Heart, Lung, and Blood Institute (NHLBI)
- National Institutes of Health Clinical Center (CC)
|
NIH |
|
|
99999999 |
All |
16 Years to 80 Years (Child, Adult, Senior) |
NCT00001465 |
950186
95-H-0186 |
|
September 25, 1995 |
|
|
November 4, 1999 |
March 29, 2018 |
|
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
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