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Project

A three-arm, randomized, double-blind, placebo-controlled study of the efficacy and safety of two trough-ranges of everolimus as adjunctive therapy in

Center:

TX-LoneStar, LEND

Fiscal Year:

2015

Contact Information:

Deborah Pearson
[email protected]
713-486-2588

Project Description:

This study will evaluate the efficacy and safety of two trough-ranges of everolimus given as adjunctive therapy in patients with tuberous sclerosis complex (TSC) who have refractory partial-onset seizures. The study consists of 3 phases for each patient [Baseline phase: From Screening Week -8 (V1) to randomization visit at Week 0 (V2)], Core phase, from randomization at Week 0 (V2) to Week 18 (V11)], and Extension phase from Week 18 (V11) until up to 48 weeks after the last patient has completed the core phase.

Keyword(s):

Core Function(s):

Performing Research or Evaluation

Area of Emphasis

Quality Assurance, Education & Early Intervention, Child Care-Related Activities, Health-Related Activities

Target Audience:

Professionals and Para-Professionals, Family Members/Caregivers, Children/Adolescents with Disabilities/SHCN

Unserved or Under-served Populations:

None

Primary Target Audience Geographic Descriptor:

Single-County

Funding Source: