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Clinical trials for (((tuberous OR cerebral OR brain OR tuberosa OR tuberose) AND sclerosis) OR TSC OR bourneville OR bournevilles OR epiloia OR epiloya OR (adenoma sebaceum)) AND (everolimus OR votubia OR rad001 OR rad001a OR (rad 001) OR (rad 001a) OR afinitor OR affinitor OR certican OR zortress OR (sdz rad))

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
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43862   clinical trials with a EudraCT protocol, of which   7285   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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    11 result(s) found for: (((tuberous OR cerebral OR brain OR tuberosa OR tuberose) AND sclerosis) OR TSC OR bourneville OR bournevilles OR epiloia OR epiloya OR (adenoma sebaceum)) AND (everolimus OR votubia OR rad001 OR rad001a OR (rad 001) OR (rad 001a) OR afinitor OR affinitor OR certican OR zortress OR (sdz rad)). Displaying page 1 of 1.
    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 (Ongoing) ES (Completed) BE (Completed) FR (Completed) PL (Ongoing) IT (Ongoing)
    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: (No results available)
    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: 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: 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: 2018-002531-18 Sponsor Protocol Number: 69HCL16_0062 Start Date*: 2018-10-31
    Sponsor Name:Hospices Civils de Lyon
    Full Title: Topical Everolimus versus placebo for the treatment of facial angiofibromas in patients with tuberous sclerosis complex. A phase II/III, multicentre, randomized, double-blind, placebo-controlled st...
    Medical condition: angiofibromas
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10002429 Angiofibroma PT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing)
    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: 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
    EudraCT Number: 2010-019519-39 Sponsor Protocol Number: RAPIT Start Date*: 2012-03-14
    Sponsor Name:Erasmus MC - Department of Neurology
    Full Title: Efficacy of RAD001/everolimus in Autism and NeuroPsychological deficits in children with TSC (RAPIT-trial)
    Medical condition: Tuberous Sclerosis Complex
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing)
    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: 2010-019825-32 Sponsor Protocol Number: CRAD001X2201 Start Date*: 2010-07-28
    Sponsor Name:NOVARTIS FARMA
    Full Title: An exploratory, open label, non-randomized, within-patient multiple dose-escalation safety, tolerability, PK and efficacy trial of RAD001 (everolimus) in patients with Lymphangioleiomyomatosis.
    Medical condition: Lymphangioleiomyomatosis
    Disease: Version SOC Term Classification Code Term Level
    12.1 10049459 Lymphangioleiomyomatosis LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: IT (Completed) FR (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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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