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NPS 1776

Phase 2

Migraine Headache | Small molecule | Neurology |Takeda Pharmaceutical Company Limited|Last Updated: Jun 3, 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-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment189
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00172094Safety and Efficacy of NPS 1776 in the Acute Treatment of Migraine HeadachesPHASE2 COMPLETED 189Dec 31, 2003Jul 31, 2004Jun 3, 202122 United States
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Study Endpoints
Primary Endpoints
The response rate at 2 hours post-dose such that the percentage of subjects whose migraine pain-intensity score is none [0] or mild [1] at 2 hours post-dose, after a baseline pain intensity of moderate [2] or severe [3]
2 hours post-dose
Secondary Endpoints
Pain-free rate at 2 hours post-dose
2 hours post-dose
Response rate up to 48 (±24) hours post-dose
48 hours post-dose
Recurrence rate of migraine headache within 24 hours post dose
24 hours post-dose
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1PLACEBO_COMPARATORPLACEBO
2EXPERIMENTAL400 mg 1776 powder
3EXPERIMENTAL1776 (800 mg)
Interventions
NameTypeDescription
NPS 1776 (800 mg)DRUGNPS 1776 (800 mg) powder
PLACEBODRUGPlacebo in non-carbonated fruit flavored drink (150 ml)
NPS 1776 (400 mg)DRUGNPS1776 in powdered form to be mixed with a non-carbonated fruit flavored drink
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersNo
Study Sites22

Inclusion Criteria: 1. Diagnosis of migraine for at least a year prior to screening. 2. Experiences 2-10 migraine headaches per month (with at least 24 hours between episodes) and no more than 15 headache days per month in the 3 months prior to screening. 3. Ability and willingness to arrive at the...

Countries:United States
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