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IBVM and SPECT imaging

Phase 1

Parkinson Disease | Small molecule | Neurology |United Therapeutics Corporation|Last Updated: Feb 9, 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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment75
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00556764Development of Cognitive Assessment Tools in Parkinson DiseaseEARLY_PHASE1 COMPLETED 75Jul 1, 2007Mar 1, 2011Feb 9, 20121 United States
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Study Endpoints
Primary Endpoints
The overall goal of this proposal is to validate ANAM-PD as an assessment tool for cognitive status in PD
6 mos
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeSCREENING
Treatment Arms
ArmTypeDescription
2 cohortsEXPERIMENTALIn this observational study 2 cohorts will participate. Cohort 1 will include people with Parkinson disease and Cohort 2 will include healthy volunteers. A subset of twelve subjects (8 PD and 4 HC) will be enrolled in the \[123I\] IBVM and SPECT imaging portion of this study
Interventions
NameTypeDescription
[123I] IBVM and SPECT imagingDRUGSubjects will be injected with up to 4 mCi of 123-I IBVM followed by SPECT imaging.
Subjects will undergo the 123-I IBVM imaging visitDRUGSubjects will be injected with a bolus of up to 4 mCi of 123-I IBVM followed by serial SPECT imaging.
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Eligibility Criteria
Age Range30 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion and Exclusion Criteria PD subjects Inclusion criteria: * The participant is 30 years or older. * Written informed consent is obtained. * Participants have a clinical diagnosis of Parkinson's disease based on Brain Bank Criteria. * Mini-mental status examination (MMSE) score ≥24 or signi...

Countries:United States
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