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RN624

Phase 2

Neuralgia, Postherpetic | Small molecule | Other |Pfizer, Inc.|Last Updated: May 28, 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_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment99
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00568321RN624 For Pain Of Post-Herpetic NeuralgiaPHASE2 COMPLETED 99 — — Dec 19, 2007Jan 7, 2009May 28, 202131 United States
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Study Endpoints
Primary Endpoints
Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Week 6
Baseline, Week 6

Participants assessed their average daily pain during the past 24 hours on an 11--point NRS ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicating less pain. Week 6 score was calculated as the mean of average daily pain NRS scores over the past 7 days. The change from baseline was calculated using difference between Week 6 mean score and Baseline mean score.

Secondary Endpoints
Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12 and 16
Baseline, Week 1, 2, 4, 8, 12, 16
Change From Baseline in Average Daily Pain Numeric Rating Scale (NRS) Score Over Weeks 1 to 4, 1 to 8, 1 to 12, 1 to 16, 5 to 8, 5 to 12 and 5 to 16
Baseline, Week 1 to 4, Week 1 to 8, Week 1 to 12, Week 1 to 16, Week 5 to 8, Week 5 to 12, Week 5 to 16
Change From Baseline in Modified Brief Pain Inventory-Short Form (mBPI-sf) Scale Score for Worst Pain, Average Pain and Pain Severity at Weeks 1, 2, 4, 6, 8 ,12 and 16
Baseline, Weeks 1, 2, 4, 6, 8 ,12, 16
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
2ACTIVE_COMPARATOR -
3PLACEBO_COMPARATOR -
Interventions
NameTypeDescription
RN624DRUG50 mcg/kg
PlaceboDRUGplacebo
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites31

Inclusion Criteria: * Male or female of any race, at least 18 years of age. * Patients must have pain present for more than 3 months after healing of the herpes zoster skin rash. * Has a pain score at screening that qualifies. * Completes at least 3 average daily pain diaries during the 3 days prio...

Countries:United States
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