Study to Evaluate Safety and Daytime Sedation in Subjects With Parkinson's Disease With Neuropsychiatric Symptoms Treated With Pimavanserin or Low-Dose Quetiapine

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

Patrocinadores

Patrocinador principal: ACADIA Pharmaceuticals Inc.

Fuente ACADIA Pharmaceuticals Inc.
Resumen breve

This is a pilot, hypothesis-generating study to explore the effects of pimavanserin and low-dose quetiapine in subjects with Parkinson's disease with neuropsychiatric symptoms.

Estado general Recruiting
Fecha de inicio October 23, 2019
Fecha de Terminación December 2020
Fecha de finalización primaria November 2020
Fase Phase 2
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Treatment-emergent adverse events (TEAEs) 4 Weeks Treatment Duration
Inscripción 60
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: Pimavanserin

Descripción: Pimavanserin 34 mg (provided as 2×17 mg encapsulated tablets) administered orally as a single dose once daily

Etiqueta de grupo de brazo: Drug - pimavanserin

Tipo de intervención: Other

Nombre de intervención: Placebo

Descripción: Placebo (provided as 2 × placebo encapsulated tablets) administered orally as a single dose once daily

Etiqueta de grupo de brazo: Placebo

Tipo de intervención: Drug

Nombre de intervención: Quetiapine

Descripción: 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

Etiqueta de grupo de brazo: Quetiapine

Elegibilidad

Criterios:

Inclusion Criteria:

1. Male or female subjects 50 to 85 years of age, inclusive

2. Able to understand the protocol requirements and provide written informed consent

3. Able to complete questions on a handheld device / tablet, is willing to wear an actigraph and can be reliably rated on assessment scales

4. 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

5. Is able to swallow the test capsule without difficulty during the Screening visit

6. Has a Mini-Mental State Examination (MMSE) score ≥19

7. 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.

8. Has non-motor neuropsychiatric symptoms severe enough to warrant treatment with an antipsychotic agent based on investigator judgement and CGI-S score

9. 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)

10. 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:

1. Has atypical parkinsonism or secondary parkinsonism variants such as tardive or medication induced parkinsonism

2. Is in hospice, is receiving end-of-life palliative care, or is bedridden or confined to a wheelchair

3. Has neuropsychiatric symptoms that are primarily attributable to current delirium or substance abuse

4. 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

5. Has a known personal or family history of long QT syndrome or family history of sudden cardiac death

6. Has orthostatic hypotension as judged by the investigator and medical monitor

7. 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).

Género: All

Edad mínima: 50 Years

Edad máxima: 85 Years

Voluntarios Saludables: No

Contacto general

Apellido: Regina Griffin

Teléfono: 858-261-2761

Email: [email protected]

Ubicación
Instalaciones: Estado:
Movement Disorders Center of Arizona | Scottsdale, Arizona, 85258, United States Recruiting
Tucson Neuroscience Research | Tucson, Arizona, 85710, United States Recruiting
SC3 Research | Pasadena, California, 91105, United States Withdrawn
SC3 Research | Reseda, California, 91335, United States Withdrawn
Sutter Institute for Medical Research | Sacramento, California, 95816, United States Recruiting
Galiz Research | Hialeah, Florida, 30016, United States Recruiting
Charter Research, LLC | Lady Lake, Florida, 32159, United States Recruiting
Premier Clinical Research Institute, Inc. | Miami, Florida, 33122, United States Recruiting
Collier Neurologic Specialists | Naples, Florida, 34105, United States Withdrawn
Infinity Clinical Research, LLC | Sunrise, Florida, 33351, United States Recruiting
Vero Beach Neurology and Research Institute | Vero Beach, Florida, 32962, United States Withdrawn
Charter Research, LLC | Winter Park, Florida, 32792, United States Recruiting
Meridian Clinical Research | Savannah, Georgia, 31406, United States Recruiting
Hawaii Pacific Neuroscience, LLC. | Honolulu, Hawaii, 96817, United States Recruiting
University of lowa Hospital and Clinics | Iowa City, Iowa, 52242, United States Recruiting
SRI International | Plymouth, Michigan, 48170, United States Recruiting
The NeuroCognitive Institute | Mount Arlington, New Jersey, 07856, United States Withdrawn
Bio Behavioral Health | Toms River, New Jersey, 08755, United States Recruiting
M3 Wake Research, Inc. | Raleigh, North Carolina, 27612, United States Recruiting
Dayton Center for Neurological Disorders | Centerville, Ohio, 45459, United States Recruiting
Prisma Health-Upstate | Greenville, South Carolina, 29615, United States Not yet recruiting
Inland Northwest Research | Spokane, Washington, 99202, United States Withdrawn
Ubicacion Paises

United States

Fecha de verificación

July 2020

Fiesta responsable

Tipo: Sponsor

Tiene acceso ampliado No
Condición Examinar
Número de brazos 3
Grupo de brazo

Etiqueta: Drug - pimavanserin

Tipo: Experimental

Descripción: Pimavanserin 34 mg provided as 2 x 17 mg encapsulated tablets

Etiqueta: Placebo

Tipo: Placebo Comparator

Descripción: Placebo encapsulated tablet

Etiqueta: Quetiapine

Tipo: Active Comparator

Descripción: Immediate release Quetiapine encapsulated tablets

Datos del paciente No
Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Treatment

Enmascaramiento: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Fuente: ClinicalTrials.gov