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PROT-CL-NP101-015.01

Phase 1

Acute Migraine | Small molecule | Neurology |Teva Pharmaceutical Industries Limited|Last Updated: Feb 18, 2016

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
UNCONTROLLEDDMC
Total Trials1
Total Enrollment37
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02684409Safety, Pharmacokinetic, and Tolerability Study of Zecuity® in Adolescent Subjects With a History of Acute MigrainePHASE1 COMPLETED 37 — — Aug 1, 2013Nov 1, 2014Feb 18, 2016 - —
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Study Endpoints
Primary Endpoints
Safety- Percentage of Participants with Adverse Events
30 days
Patch Adherence Evaluation
4 hours

Adhesive Scoring Code- 0 (≥ 90% adhered (essentially no lift off of the skin)) through 4 (patch detached (patch completely off the skin))

Skin Irritation Examination
10 days

Skin Irritation Examination Scale- 0 (no erythema) through 4 (Intense erythema with edema and blistering/erosion)

Area under the concentration versus time curve from time 0 to the last time point with measurable concentration (Ct) (AUC0-last)
1 day
Area under the concentration versus time curve from time 0 to infinity (AUC0-∞); calculated as AUC0-last + Ct/λz2.
1 day
Maximum observed drug concentration (Cmax)
1 day
Time of maximum drug concentration (Tmax)
1 day
The terminal elimination rate constant (λz); calculated using non-linear regression Analysis
1 day
Terminal elimination half-life (t1/2); calculated as 0.693/λz2
1 day
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PROT-CL-NP101-015.01EXPERIMENTAL -
Interventions
NameTypeDescription
PROT-CL-NP101-015.01DRUG -
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Eligibility Criteria
Age Range12 Years — 17 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Subject has a diagnosis of migraine headache, with or without aura * Subject and subject's parent or legal guardian are able to read and write English * Subject must have a negative drug screen. * Female subjects are eligible for participation provided they are of non-child be...

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