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Liatermin

Phase 1

Parkinson's Disease | Monoclonal antibody | Neurology |Amgen Inc.|Last Updated: Feb 26, 2010

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment34
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00111982Trial of Extended Treatment With Liatermin (r-metHuGDNF) Administered by Continuous Intraputaminal (IPu)Infusion to Subjects With Idiopathic Parkinson's Disease Who Have Completed a Previous Trial of LiaterminPHASE1 COMPLETED 34Dec 1, 2003Feb 1, 2006Feb 26, 2010 -
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Study Endpoints
Primary Endpoints
Percent change in UPDRS
24 months
Secondary Endpoints
Incidence of treatment emergent and device related adverse events
24 months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
LiaterminEXPERIMENTALBilateral continuous infusion of liatermin for up to 24 months.
Interventions
NameTypeDescription
LiaterminBIOLOGICALLiatermin
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Eligibility Criteria
Age Range35 Years — 70 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: - Completion of the 20020168 protocol

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