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immunoglobulins

Phase 3

Post-polio Syndrome | Monoclonal antibody | Other |Verona Pharma plc Sponsored ADR|Last Updated: Feb 27, 2012

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_CONTROLLED
Total Trials1
Total Enrollment50
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01537575Intravenous Immunoglobulins for Post-Polio SyndromePHASE3 COMPLETED 50Jan 1, 2008 -Feb 27, 2012 -
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Study Endpoints
Primary Endpoints
SF-36 physical component
Baseline; 2 and 4 months after treatment
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
saline solutionPLACEBO_COMPARATOR -
intravenous immunoglobulinsEXPERIMENTAL -
Interventions
NameTypeDescription
intravenous immunoglobulinsBIOLOGICALOne course of Intravenous Immunoglobulins 0.4 g/kg/die for 5 consecutive days
Saline solutionBIOLOGICALPlacebo
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * a history of acute poliomyelitis * increased muscle weakness, muscle fatigue and pain in muscle groups previously affected by poliomyelitis * a diagnosis of postpolio syndrome according to the criteria of Halstead and Rossi Exclusion Criteria: * clinically relevant systemic ...

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