Efficacy and Safety of RAD001 in Patients of All Ages With Subependymal Giant Cell Astrocytoma Associated With Tuberous Sclerosis Complex (TSC) (EXIST-1)
Tracking Information
Start Date ICMJE | April 2009 |
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Estimated Primary Completion Date | February 2014 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: November 12, 2008) | • Subependymal Giant Cell Astrocytoma response rate through MRIs at screening, 12, 24 and 48 weeks and annually thereafter [ Time Frame: Screening, 12, 24, 48 weeks and annually for 4-5 years ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00789828 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: November 12, 2008) |
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Original Secondary Outcome Measures ICMJE | Same as current |
Descriptive Information
Brief Title ICMJE | Efficacy and Safety of RAD001 in Patients of All Ages With Subependymal Giant Cell Astrocytoma Associated With Tuberous Sclerosis Complex (TSC) |
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Official Title ICMJE | 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) |
Brief Summary | This study will evaluate the safety and efficacy of RAD001 in treating patients with Subependymal Giant Cell Astrocytomas associated with Tuberous Sclerosis Complex. |
Detailed Description | |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Condition ICMJE | Tuberous Sclerosis |
Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 99 | ||||
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Completion Date | |||||
Estimated Primary Completion Date | February 2014 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply | ||||
Gender | Both | ||||
Ages | |||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | United States, Australia, Belgium, Canada, Italy, Netherlands, Poland, Russian Federation, United Kingdom |
Administrative Information
NCT ID ICMJE | NCT00789828 | ||||
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Responsible Party | External Affairs, Novartis | ||||
Study ID Numbers ICMJE | CRAD001M2301 | ||||
Study Sponsor ICMJE | Novartis Pharmaceuticals | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Novartis |
Source: http://clinicaltrials.gov/