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Armodafinil

Phase 3

Narcolepsy | Small molecule | Other |Teva Pharmaceutical Industries Limited|Last Updated: Nov 9, 2021

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-BlindCONTROLLEDBiomarker
Total Trials2
Total Enrollment236
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00078377Safety and Efficacy Study of Armodafinil (CEP-10953) in the Treatment of Excessive Sleepiness Associated With NarcolepsyPHASE3 COMPLETED 196 — — Mar 1, 2004Jan 1, 2005Jul 19, 2013 - —
NCT01624480Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Armodafinil in Children and Adolescents With Excessive Sleepiness Associated With NarcolepsyPHASE1 COMPLETED 40 — — Jul 1, 2012Dec 1, 2015Nov 9, 202124 United States, Finland
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Study Endpoints
Primary Endpoints
Change From Baseline in Maintenance of Wakefullness Test (MWT) Score at 12 Weeks
change from baseline at 12 weeks

The Maintenance of Wakefulness Test (MWT) is an objective assessment of sleepiness that measures the ability of a subject to remain awake. Long latencies to sleep are indicative of a patient's ability to remain awake. The change from baseline in the mean sleep latency from the MWT (average of 4 tests at 0900, 1100, 1300, and 1500) was analyzed at weeks 4, 8, and 12. The primary efficacy variable was the mean change from the baseline assessment in MWT sleep latency as assessed at week 12 (or last post-baseline visit).

Change From Baseline in Clinical Global Impression of Change (CGI-C) Score at 12 Weeks
change from baseline at 12 weeks

Number of participants who had at least minimal improvement in CGI-C ratings at Week 12 or last post-baseline visit. The CGI-C uses the following categories and scoring assignments: 1=Very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; and 7=Very much worse. Severity of illness was assessed at baseline by the CGI-S, which consists of the following categories: 1=Normal (shows no signs of illness); 2=Borderline ill; 3=Mildly (Slightly) ill; 4=Moderately ill; 5=Markedly ill; 6=Severely ill; and 7=Among the most extremely ill patients.

Maximum observed plasma drug concentration (Cmax) by inspection
Day 1 + up to 72 hours after administration
Time to maximum observed plasma drug concentration (tmax) by inspection
Day 1 + up to 72 hours after administration
Area under the plasma drug concentration by time curve from time 0 to infinity
Day 1 + up to 72 hours after administration
Area under the plasma drug concentration by time curve from time 0 to the time of the last measurable drug concentration
Day 1 + up to 72 hours after administration
Terminal half-life
Day 1 + up to 72 hours after administration
Terminal elimination rate constant
Day 1 + up to 72 hours after administration
Apparent total plasma clearance
Day 1 + up to 72 hours after administration
Apparent volume of distribution
Day 1 + up to 72 hours after administration
Predicted accumulation ratio
Day 1 + up to 72 hours after administration
Maximum observed plasma drug concentration (Cmax)
Day 42 + up to 72 hours after administration
Time to maximum observed plasma drug concentration
Day 42 + up to 72 hours after administration
AUC over 1 dosing interval
Day 42 + up to 72 hours after administration
AUC 0-t
Day 42 + up to 72 hours after administration
Observed accumulation ratio
Day 42 + up to 72 hours after administration
Steady-state accumulation ratio
Day 42 + up to 72 hours after administration
Secondary Endpoints
Mean sleep latency
2 Days (Baseline + Day 1)
Clinical Global Impression of Change (CGI-C)
Day 1
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALArmodafinil 250 mg
2EXPERIMENTALArmodafinil 150 mg
3PLACEBO_COMPARATORPlacebo
Armodafinil 50 mgEXPERIMENTALIn period 1, patients will receive a single 50-mg dose of armodafinil on day 1. In period 2, patients will receive a single 50-mg dose daily on days 1 through 42.
Armodafinil 100 mgEXPERIMENTALIn period 1, patients will receive a single 100 mg dose of armodafinil on day 1. In period 2, patients will receive a single 50-mg dose on day 1 then daily 100-mg doses on days 2 through 42.
Armodafinil 150 mgEXPERIMENTALIn period 1, patients will receive a single 150-mg dose of armodafinil on day 1. In period 2, patients will receive a single 50-mg dose on day 1, 100-mg doses on days 2 and 3, then daily 150-mg doses on days 4 through 42.
Interventions
NameTypeDescription
ArmodafinilDRUGArmodafinil 250 mg once daily in the morning
PlaceboDRUGMatching placebo tablets once daily
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo

Diagnosis and Criteria for Inclusion: Patients are included in the study if all of the following criteria are met: * Written informed consent is obtained * The patient is an outpatient, man or woman of any ethnic origin, 18 to 65 years of age (inclusive) * The patient has a complaint of excessive ...

Countries:United StatesFinland
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