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Pramipexole, Amisulpride

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment52

FDA Designations

No designations recorded

Clinical trial landscape

Pramipexole, Amisulpride · 1 trial · 1 indication

Phase 1 1
NCT00471588Characterize The Modulatory Effects Of Dopamine D2/D3 Receptor Agonist And Antagonist Drugs On Compulsive BehaviorsObsessive-Compulsive Disorder
COMPLETED52 Analytics
PHASE1COMPLETED
Characterize The Modulatory Effects Of Dopamine D2/D3 Receptor Agonist And Antagonist Drugs On Compulsive Behaviors
Obsessive-Compulsive Disorder
NCT0047158852
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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 to 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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Frequently asked questions about Pramipexole, Amisulpride

What is Pramipexole, Amisulpride used for?

Pramipexole and Amisulpride are being studied for use in Obsessive-Compulsive Disorder (OCD). They are small molecule drugs in Phase 1 clinical development. A completed trial, NCT00471588, investigated the modulatory effects of these dopamine D2/D3 receptor agonist and antagonist drugs on compulsive behaviors.

What does Pramipexole, Amisulpride target?

Pramipexole and Amisulpride target dopamine D2/D3 receptors. Pramipexole acts as a dopamine D2/D3 receptor agonist, while Amisulpride acts as a dopamine D2/D3 receptor antagonist. The combination is being studied for its effects on compulsive behaviors in Obsessive-Compulsive Disorder.

Who makes Pramipexole, Amisulpride?

GSK plc (ticker: GSK) is developing Pramipexole and Amisulpride for Obsessive-Compulsive Disorder. The drugs are in Phase 1 clinical development, with one completed trial involving 52 participants in the United Kingdom.

What phase is Pramipexole, Amisulpride in?

Pramipexole and Amisulpride are in Phase 1 clinical development for Obsessive-Compulsive Disorder. They are investigational drugs and not yet approved. One Phase 1 trial, NCT00471588, has been completed with 52 participants.

What clinical trials is Pramipexole, Amisulpride in?

Pramipexole and Amisulpride have one completed clinical trial, NCT00471588, titled 'Characterize The Modulatory Effects Of Dopamine D2/D3 Receptor Agonist And Antagonist Drugs On Compulsive Behaviors.' This Phase 1 study enrolled 52 participants in the United Kingdom and included healthy volunteers.

Is Pramipexole, Amisulpride the same as Pramipexole or Amisulpride alone?

Pramipexole and Amisulpride are two separate drugs being studied together in a combination for Obsessive-Compulsive Disorder. Pramipexole is a dopamine D2/D3 receptor agonist, and Amisulpride is a dopamine D2/D3 receptor antagonist. They are not the same drug.