Study to Evaluate Safety and Daytime Sedation in Subjects With Parkinson's Disease With Neuropsychiatric Symptoms Treated With Pimavanserin or Low-Dose Quetiapine
21. september 2021 oppdatert av: ACADIA Pharmaceuticals Inc.
A Pilot Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety and Daytime Sedation in Subjects With Parkinson's Disease With Neuropsychiatric Symptoms Treated With Pimavanserin or Low-Dose Quetiapine
This is a pilot study to explore the effects of pimavanserin and low-dose quetiapine in subjects with Parkinson's disease with neuropsychiatric symptoms.
Studieoversikt
Status
Avsluttet
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
11
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Arizona
-
Scottsdale, Arizona, Forente stater, 85258
- Movement Disorders Center of Arizona
-
Tucson, Arizona, Forente stater, 85710
- Tucson Neuroscience Research
-
-
California
-
Sacramento, California, Forente stater, 95816
- Sutter Institute for Medical Research
-
-
Florida
-
Hialeah, Florida, Forente stater, 30016
- Galiz Research
-
Lady Lake, Florida, Forente stater, 32159
- Charter Research, LLC
-
Miami, Florida, Forente stater, 33122
- Premier Clinical Research Institute, Inc.
-
Sunrise, Florida, Forente stater, 33351
- Infinity Clinical Research, LLC
-
Winter Park, Florida, Forente stater, 32792
- Charter Research, LLC
-
-
Georgia
-
Savannah, Georgia, Forente stater, 31406
- Meridian Clinical Research
-
-
Hawaii
-
Honolulu, Hawaii, Forente stater, 96817
- Hawaii Pacific Neuroscience, LLC.
-
-
Iowa
-
Iowa City, Iowa, Forente stater, 52242
- University of lowa Hospital and Clinics
-
-
Michigan
-
Plymouth, Michigan, Forente stater, 48170
- SRI International
-
-
New Jersey
-
Toms River, New Jersey, Forente stater, 08755
- Bio Behavioral Health
-
-
North Carolina
-
Raleigh, North Carolina, Forente stater, 27612
- M3 Wake Research, Inc.
-
-
Ohio
-
Centerville, Ohio, Forente stater, 45459
- Dayton Center for Neurological Disorders
-
-
South Carolina
-
Greenville, South Carolina, Forente stater, 29615
- Prisma Health-Upstate
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
50 år til 85 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Male or female subjects 50 to 85 years of age, inclusive
- Able to understand the protocol requirements and provide written informed consent
- Able to complete questions on a handheld device / tablet, is willing to wear an actigraph and can be reliably rated on assessment scales
- Able to designate an 'informant' (relative, housemate, friend) who can provide information about the subject's well being and attend clinic visits with the subject
- Is able to swallow the test capsule without difficulty during the Screening visit
- Has a Mini-Mental State Examination (MMSE) score ≥19
- Has a diagnosis of idiopathic Parkinson's disease, without any other known or suspected cause of parkinsonism. Initial diagnosis of PD must have been made more than 1 year prior to Screening.
- Has non-motor neuropsychiatric symptoms severe enough to warrant treatment with an antipsychotic agent based on investigator judgement and CGI-S score
- If the subject is on anti-Parkinsonian medication, they must be on a stable regimen for 1 month prior to Baseline and not planning (at the time of the Baseline visit) to make a major change in dose(s)
- If the subject is female, she must not be pregnant or breastfeeding. She must also be of non-childbearing potential or must agree to use a clinically acceptable method of contraception or be abstinent for at least 1 month prior to the Baseline visit, during the study, and 41 days following completion of double-blind treatment.
Exclusion Criteria:
- Has atypical parkinsonism or secondary parkinsonism variants such as tardive or medication induced parkinsonism
- Is in hospice, is receiving end-of-life palliative care, or is bedridden or confined to a wheelchair
- Has neuropsychiatric symptoms that are primarily attributable to current delirium or substance abuse
- Has current evidence of an unstable neurological, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical or psychiatric disorder, including cancer or malignancies that, in the judgment of the Investigator, would jeopardize the safe participation of the subject in the study or significantly interfere with the conduct or interpretation of the study
- Has a known personal or family history of long QT syndrome or family history of sudden cardiac death
- Has orthostatic hypotension as judged by the investigator and medical monitor
- Is judged by the Investigator or the Medical Monitor to be inappropriate for the study for any reason, including if the subject is judged to be a danger to self or others
Additional inclusion/exclusion criteria apply. Patients will be evaluated at screening to ensure that all criteria for study participation are met. Patients may be excluded from the study based on these assessments (and specifically, if it is determined that their baseline health and condition do not meet all pre-specified entry criteria).
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Drug - pimavanserin
Pimavanserin 34 mg provided as 2 x 17 mg encapsulated tablets
|
Pimavanserin 34 mg (provided as 2×17 mg encapsulated tablets) administered orally as a single dose once daily
|
|
Placebo komparator: Placebo
Placebo encapsulated tablet
|
Placebo (provided as 2 × placebo encapsulated tablets) administered orally as a single dose once daily
|
|
Aktiv komparator: Quetiapine
Immediate release Quetiapine encapsulated tablets
|
Quetiapine 25 mg (provided as 1×25 mg quetiapine encapsulated tablet and 1 × placebo encapsulated tablet), OR 50 mg (provided as 2×25 mg quetiapine encapsulated tablets), OR 100 mg (provided as 2×50 mg quetiapine encapsulated tablets) administered orally as a single dose once daily
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Treatment-emergent Adverse Events (TEAEs)
Tidsramme: 4-week treatment duration, plus 30 days treatment-free safety follow-up
|
Assess the safety and tolerability of pimavanserin in patients with PD in terms of treatment-emergent adverse events.
|
4-week treatment duration, plus 30 days treatment-free safety follow-up
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
23. oktober 2019
Primær fullføring (Faktiske)
25. september 2020
Studiet fullført (Faktiske)
25. september 2020
Datoer for studieregistrering
Først innsendt
13. november 2019
Først innsendt som oppfylte QC-kriteriene
13. november 2019
Først lagt ut (Faktiske)
15. november 2019
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
14. oktober 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
21. september 2021
Sist bekreftet
1. september 2021
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Hjernesykdommer
- Sykdommer i sentralnervesystemet
- Sykdommer i nervesystemet
- Parkinsonlidelser
- Basal ganglia sykdommer
- Bevegelsesforstyrrelser
- Synukleinopatier
- Nevrodegenerative sykdommer
- Parkinsons sykdom
- Fysiologiske effekter av legemidler
- Nevrotransmittere agenter
- Molekylære mekanismer for farmakologisk virkning
- Sentralnervesystemdepressiva
- Antipsykotiske midler
- Beroligende midler
- Psykotropiske stoffer
- Serotoninmidler
- Antidepressive midler
- Serotonin 5-HT2-reseptorantagonister
- Serotonin-antagonister
- Antiparkinsonmidler
- Midler mot dyskinesi
- Quetiapinfumarat
- Pimavanserin
Andre studie-ID-numre
- ACP-103-056
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .