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Modafinil

Phase 3

Narcolepsy | Small molecule | Other |Teva Pharmaceutical Industries Limited|Last Updated: May 9, 2014

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindUNCONTROLLEDBiomarker
Total Trials2
Total Enrollment420
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00107796Study of PROVIGIL ® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With NarcolepsyPHASE3 COMPLETED 140 — — Oct 1, 2004Sep 1, 2005Aug 24, 201273 United States, Canada
NCT00107848PROVIGIL® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy or Obstructive Sleep Apnea/Hypopnea SyndromePHASE3 COMPLETED 280 — — Oct 1, 2004Sep 1, 2005May 9, 201461 United States, Canada
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Study Endpoints
Primary Endpoints
Mean sleep latency from the Multiple Sleep Latency Test (MSLT) (average of 4 naps performed at 0900, 1100, 1300, and 1500) at the last post baseline observation (week 6 or early termination)
The Clinical Global Impression of Change (CGI-C) ratings for ES, at the last post baseline observation (week 6 or early termination)
The primary objective of the study is to evaluate the safety and tolerability of treatment with PROVIGIL in children and adolescents with excessive sleepiness (ES) associated with narcolepsy or OSAHS, when administered for up to 12 months.
Secondary Endpoints
Clinical Global Impression of Change (CGI-C) ratings for ES at weeks 3 and 6
Total score from the Pediatric Daytime Sleepiness Scale (PDSS) at weeks 3 and 6, and last postbaseline observation
Mean sleep latency from the MSLT (average of 4 naps performed at 0900, 1100, 1300, and 1500) at week 6
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
ModafinilDRUG -
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Eligibility Criteria
Age Range6 Years — 16 Years
SexALL
Healthy VolunteersYes
Study Sites73

Inclusion Criteria: Diagnosis and Main Criteria for Inclusion (Patients are included in the study if all of the following criteria are met): * Written informed consent/assent is obtained * A boy or girl aged 6 through 16 years, inclusive * Meet the minimal criteria established by the International...

Countries:United StatesCanada
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