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Pramipexole, Amisulpride

Phase 1

Obsessive-Compulsive Disorder | Small molecule | Psychiatry |GSK plc|Last Updated: Sep 15, 2014

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-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment52
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00471588Characterize The Modulatory Effects Of Dopamine D2/D3 Receptor Agonist And Antagonist Drugs On Compulsive BehaviorsPHASE1 COMPLETED 52 — — Aug 1, 2006Dec 1, 2007Sep 15, 20141 United Kingdom
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Study Endpoints
Primary Endpoints
Investigate that drug addicts or OCD patients will show similar abnormalities of compulsive behaviour and functional activation of ventral fronto-striatal systems. MRI scans will occur on Wk 1, 2 and 3. Neuropsychological testing Wk 1, 2 and 3.
on Wk 1, 2 and 3
Secondary Endpoints
Test the prediction that a dopamine D2/D3 agonist drug (pramipexole)by PK levels. PK sample taken on Week 1 only.
on Week 1 only.
Measure of brain functional activation at rest.
up to week 3
Measure of behavioural performance
up to week 3
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT
Interventions
NameTypeDescription
Pramipexole, AmisulprideDRUGStudy Drug
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male or female, between 18 - 55 years of age; the groups will be matched for either handedness. * Participants must have the ability to comprehend the key components of the consent form and provide informed consent. * Participants must lead and write (in English) at a level su...

Countries:United Kingdom
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