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Last Updated: April 7, 2020

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CLINICAL TRIALS PROFILE FOR NUPLAZID

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All Clinical Trials for NUPLAZID

Trial ID Title Status Sponsor Phase Start Date Summary
NCT03947216 Randomized Placebo Controlled Trial Evaluating the Efficacy of Pimavanserin, a Selective Serotonin 5-HydroxyTryptamine-2A (5HT2A) Inverse Agonist, to Treat Impulse Control Disorders in Parkinson's Disease. Not yet recruiting University Hospital, Strasbourg, France Phase 2 2019-09-01 There is no consensus on the treatment of Impulse Control Disorder (ICD) in Parkinson Disease (PD) though it is recommended to reduce the dosage of dopamine agonists (DA). Reduction of DA frequently leads to a worsening of motor signs (parkinsonism or dyskinesias due to the concomitant increase of levodopa doses) and non-motor signs with the appearance of a DA withdrawal syndrome (DAWS). Chronic stimulation of the sub-thalamic nuclei may reduce ICD but is restricted to a minority of patients and cases of new-onset ICD symptoms post stimulation have been reported. The benefit of amantadine in pathological gambling is controversial and the efficacy of clozapine has been reported in a few cases but with serious safety limitations. Very recently, naltrexone did not significantly improve ICD. Thus, an efficacious and safe treatment of ICD in PD remains an unmet need for clinical practice. Recently, it has been reported that pimavanserin, a selective serotonin 5-HT2A inverse agonist with a satisfactory safety profile without motor side effects, was efficient in improving psychosis, insomnia and day-time sleep in PD. Pimavanserin, marketed under the tradename NUPLAZID® was approved in 2016 by the U.S. Food and Drug Administration (FDA) for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis. The link between serotonin and ICD has been well established, since the enhancement of 5HT2A receptors stimulation is associated to ICD, since serotonin modulates mesolimbic dopaminergic reward system transmission and given that serotonin neurotransmission is increased during chronic intake of dopamine agonist such as pramipexole which is well-known to induce ICD in PD patients. Thus, there is a large body of evidence suggesting that the decrease of the 5HT2A activity could be efficient in reducing ICD in PD. This further supports the concept of testing the efficacy of pimavanserin (a selective 5HT2A inverse agonist) for treating ICD in PD. Our aim is to conduct a study evaluating the efficacy and safety of pimavanserin on ICD in PD. This clinical trial is conducted with the support of the French NS-Park/FCRIN (French Clinical Research Infrastructure Network) network.
NCT04188392 Pimavanserin for Insomnia In Veterans With Posttraumatic Stress Disorder Not yet recruiting Baylor College of Medicine Phase 4 2019-12-15 This preliminary, open-label study assesses the feasibility of 34mg at bedtime for 6 weeks in Veterans with Posttraumatic Stress Disorder and insomnia.
NCT04292223 Open-Label Study With Pimavanserin on Activities of Daily Living in Subjects With Parkinson's Disease Psychosis Recruiting ACADIA Pharmaceuticals Inc. Phase 4 2020-02-10 To assess the effect of pimavanserin on the activities of daily living in subjects with Parkinson's Disease Psychosis
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for NUPLAZID

Condition Name

Condition Name for NUPLAZID
Intervention Trials
Post-traumatic Stress Disorder 1
Parkinson Disease Psychosis 1
Parkinson Disease 1
Insomnia 1
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Condition MeSH

Condition MeSH for NUPLAZID
Intervention Trials
Parkinson Disease 2
Sleep Initiation and Maintenance Disorders 1
Disease 1
Psychotic Disorders 1
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Clinical Trial Locations for NUPLAZID

Trials by Country

Trials by Country for NUPLAZID
Location Trials
United States 6
France 1
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Trials by US State

Trials by US State for NUPLAZID
Location Trials
Virginia 1
Texas 1
New Jersey 1
Georgia 1
Florida 1
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Clinical Trial Progress for NUPLAZID

Clinical Trial Phase

Clinical Trial Phase for NUPLAZID
Clinical Trial Phase Trials
Phase 4 2
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for NUPLAZID
Clinical Trial Phase Trials
Not yet recruiting 2
Recruiting 1
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Clinical Trial Sponsors for NUPLAZID

Sponsor Name

Sponsor Name for NUPLAZID
Sponsor Trials
ACADIA Pharmaceuticals Inc. 1
Baylor College of Medicine 1
University Hospital, Strasbourg, France 1
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Sponsor Type

Sponsor Type for NUPLAZID
Sponsor Trials
Other 2
Industry 1
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