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Clinical trials for Tuberous Sclerosis

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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    The EU Clinical Trials Register currently displays   44336   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    30 result(s) found for: Tuberous Sclerosis. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2016-002408-13 Sponsor Protocol Number: NL58183.041.16 Start Date*: 2017-02-07
    Sponsor Name:UMC Utrecht
    Full Title: Bumetanide to Ameliorate Tuberous Sclerosis Complex Hyperexcitable Behaviors
    Medical condition: Tuberous Sclerosis Complex
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10045138 Tuberous sclerosis PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-002977-37 Sponsor Protocol Number: CRAD001M2X02B Start Date*: 2017-08-25
    Sponsor Name:Novartis Pharma AG
    Full Title: An open-label, multi-center long-term safety roll-over study in patients with tuberous sclerosis complex (TSC) and refractory seizures who are judged by the Investigator to benefit from continued t...
    Medical condition: Refractory seizures associated with tuberous sclerosis complex
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10045138 Tuberous sclerosis PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) HU (Completed) ES (Completed) BE (Completed) FR (Completed) PL (Trial now transitioned) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-001319-30 Sponsor Protocol Number: CH/2011/3670 Start Date*: 2012-04-04
    Sponsor Name:University Hospitals Bristol NHS Foundation Trust
    Full Title: A randomized, double-blind, parallel group, placebo-controlled trial of metformin in tuberous sclerosis complex.
    Medical condition: Tuberous Sclerosis Complex
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10045138 Tuberous sclerosis PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2007-005978-30 Sponsor Protocol Number: FP2007/02 Start Date*: 2008-01-22
    Sponsor Name:FUNDACIÓ PUIGVERT
    Full Title: Ensayo clínico para evaluar la eficacia y seguridad de la rapamicina en los angiomiolipomas en pacientes con esclerosis tuberosa Clinical Trial to Determine the Efficacy and Safety of Rapamycin in ...
    Medical condition: Angiomiolipomas en pacientes con esclerosis tuberosa (angiomyolipoma of tuberous sclerosis patients)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10045138 Tuberous sclerosis LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-000838-34 Sponsor Protocol Number: NOE-TCS-201 Start Date*: 2023-04-04
    Sponsor Name:Noema Pharma AG
    Full Title: A Phase 2B, Multicenter, 30-week, Prospective, Cross-over, Doubleblind, Randomized, Placebo-controlled Study Followed by a 52-Week Open-label Extension Study to Evaluate the Efficacy and Safety of ...
    Medical condition: Tuberous Sclerosis Complex
    Disease: Version SOC Term Classification Code Term Level
    21.0 10010331 - Congenital, familial and genetic disorders 10080584 Tuberous sclerosis complex PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: IT (Trial now transitioned) ES (Ongoing) PL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2015-002154-12 Sponsor Protocol Number: GWEP1521 Start Date*: 2016-09-30
    Sponsor Name:GW Research Ltd.
    Full Title: A double-blind, randomized, placebo-controlled study to investigate the efficacy and safety of cannabidiol (GWP42003-P, CBD) as add-on therapy in patients with tuberous sclerosis complex who experi...
    Medical condition: Tuberous Sclerosis Complex (TSC)
    Disease: Version SOC Term Classification Code Term Level
    19.0 10010331 - Congenital, familial and genetic disorders 10045138 Tuberous sclerosis PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: ES (Completed) GB (GB - no longer in EU/EEA) PL (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2011-000860-90 Sponsor Protocol Number: CRAD001M2304 Start Date*: 2013-02-14
    Sponsor Name:Novartis Farmacéutica, S.A.
    Full Title: A three-arm, randomized, double-blind, placebo-controlled study of the efficacy and safety of two trough-ranges of everolimus as adjunctive therapy in patients with tuberous sclerosis complex (TSC)...
    Medical condition: Refractory partial-onset seizures associated with tuberous sclerosis complex (TSC)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10045138 Tuberous sclerosis PT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) IT (Completed) NL (Completed) DE (Completed) HU (Completed) GB (Completed) BE (Completed) GR (Completed) DK (Completed) IE (Completed)
    Trial results: View results
    EudraCT Number: 2020-002132-67 Sponsor Protocol Number: GWEP17005 Start Date*: 2021-10-22
    Sponsor Name:GW Research Ltd
    Full Title: An Open-Label, Randomized Trial to Assess the Safety, Pharmacokinetics, and Exploratory Efficacy of Adjunctive Cannabidiol Oral Solution (GWP42003-P) Compared with Standard of Care Antiseizure Medi...
    Medical condition: Tuberous Sclerosis Complex (TSC)
    Disease: Version SOC Term Classification Code Term Level
    21.0 10010331 - Congenital, familial and genetic disorders 10045138 Tuberous sclerosis LLT
    21.0 10010331 - Congenital, familial and genetic disorders 10080584 Tuberous sclerosis complex PT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2013-003795-13 Sponsor Protocol Number: CRAD001M2305 Start Date*: 2014-12-10
    Sponsor Name:Novartis Pharma Services AG
    Full Title: Long-term follow-up study to monitor the growth and development of pediatric patients previously treated with everolimus in study CRAD001M2301
    Medical condition: Subependymal Giant Cell Astrocytoma (SEGA) associated with Tuberous Sclerosis Complex (TSC)
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004850 10045138 Tuberous sclerosis LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2010-022583-13 Sponsor Protocol Number: CRAD001MIC02 Start Date*: Information not available in EudraCT
    Sponsor Name:Novartis Pharma Services AG
    Full Title: An open-label, multi-center, expanded access study of RAD001 in patients with subependymal giant cell astrocytomas (SEGA) associated with tuberous sclerosis complex (TSC). The EFFECTS STUDY: Everol...
    Medical condition: The study will evaluate the safety of RAD001 in patients with subependymal giant cell astrocytomas (SEGA) associated with Tuberous Sclerosis Complex (TSC).
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) HU (Completed) CZ (Completed) FR (Ongoing) BE (Completed) GR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2010-022655-29 Sponsor Protocol Number: RATE-trial Start Date*: 2011-05-30
    Sponsor Name:Erasmus MC
    Full Title: Randomised open label cross-over study into the efficacy of RApamycin in children with Tuberous sclerosis complex with intractable Epilepsy (RATE-trial)
    Medical condition: Epilepsy in children with Tuberous Sclerosis Complex
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-005397-63 Sponsor Protocol Number: CRAD001MES12 Start Date*: 2013-04-19
    Sponsor Name:Novartis Farmacéutica, S.A,
    Full Title: An open-label, multi-center, expanded access study of RAD001 in patients with angiomyolipoma associated with tuberous sclerosis complex (TSC)
    Medical condition: Angiomyolipoma associated with either Tuberous Sclerosis Complex (TSC)
    Disease: Version SOC Term Classification Code Term Level
    16.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10051810 Angiomyolipoma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2020-003231-19 Sponsor Protocol Number: ViRap Start Date*: Information not available in EudraCT
    Sponsor Name:The Children's Memorial Health Institute
    Full Title: Randomized, placebo-controlled, double-blind and double-dummy clinical trial comparing the safety, tolerability, and efficacy of vigabatrin and rapamycin in a preventive treatment of infants with T...
    Medical condition: Tuberous Sclerosis Complex Epilepsy Tumors associated with Tuberous Sclerosis Complex
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: PL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-004548-64 Sponsor Protocol Number: RaRETS Start Date*: Information not available in EudraCT
    Sponsor Name:The Children's Memorial Health Institute
    Full Title: Multicenter, randomized, double-blind, placebo controlled study to assess the efficacy and safety of Rapamycin in drug Resistant Epilepsy associated with TSC (RaRE-TS)
    Medical condition: tuberous sclerosis complex, epilepsy, organ tumors associated with tuberous sclerosis
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: PL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2007-006997-27 Sponsor Protocol Number: CRAD001M2301 Start Date*: 2011-06-01
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A randomized, double-blind, placebo-controlled study of RAD001 in the treatment of patients with subependymal giant cell astrocytomas (SEGA) associated with Tuberous Sclerosis Complex (TSC)
    Medical condition: This study will evaluate the antitumor activity of RAD001 versus placebo in patients with subependymal giant cell astrocytomas (SEGA) associated with Tuberous Sclerosis Complex (TSC).
    Disease:
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) IT (Completed) GB (Completed) DE (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2022-000490-13 Sponsor Protocol Number: EstuEla2022 Start Date*: 2023-01-09
    Sponsor Name:OILS4CURE S.L
    Full Title: Treatment, with a full spectrum extract of cannabis, in refractory epilepsy associated with tuberous sclerosis complex (TSC)
    Medical condition: Refractory epilepsy in tuberous sclerosis complex
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-000752-34 Sponsor Protocol Number: DSLP-01 Start Date*: 2019-11-15
    Sponsor Name:DSLP
    Full Title: A Phase 2/3, multi-center, double-blind, placebo-controlled, randomized, parallel-group, dose-response comparison of the efficacy and safety of a topical rapamycin cream for the treatment of facial...
    Medical condition: Facial Angiofibromas Associated with Tuberous Sclerosis Complex
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10002429 Angiofibroma PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10073678 Juvenile angiofibroma PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: SK (Completed) HU (Completed) CZ (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-005528-40 Sponsor Protocol Number: EPISTOP Start Date*: 2014-12-05
    Sponsor Name:The Children's Memorial Health Institute
    Full Title: Long-term, prospective study evaluating clinical and molecular biomarkers of epileptogenesis in a genetic model of epilepsy – Tuberous Sclerosis Complex.
    Medical condition: Epilepsy in tuberous sclerosis complex (TSC)
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004852 10032061 Other forms of epilepsy LLT
    Population Age: Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: NL (Completed) BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-004854-25 Sponsor Protocol Number: SPON803-10 Start Date*: 2012-01-10
    Sponsor Name:Cardiff University
    Full Title: TRON: A randomised, double blind, placebo-controlled study of RAD001 (Everolimus) in the treatment of neurocognitive problems in tuberous sclerosis.
    Medical condition: Tuberous Sclerosis Complex (TSC)
    Disease: Version SOC Term Classification Code Term Level
    14.0 10037175 - Psychiatric disorders 10002649 Anorexia nervosa PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2008-002113-48 Sponsor Protocol Number: CRAD001M2302 Start Date*: Information not available in EudraCT
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A randomized double-blind, placebo-controlled study of RAD001 in the treatment of Angiomyolipoma in patients with either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM)
    Medical condition: Angiomyolipoma in patients with either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM)
    Disease: Version SOC Term Classification Code Term Level
    16.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10051810 Angiomyolipoma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) FR (Completed) NL (Completed) GB (Completed) IT (Completed) ES (Completed)
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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