[No standalone website (unbranded, no questionnaire)] A Study of Subjects With Psoriatic Arthritis to Investigate the Effectiveness of Adalimumab Introduction Compared With Methotrexate Dose Escalation (CONTROL)

How to apply

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Study’s contact

Call center

609-250-6932

Email address

CKnipe@ACADIA-pharm.com

Condition

Parkinson Disease Psychosis

Treatment type

Interventional

Investigational product

Pimavanserin

Phase

Phase 4

Sponsor

ACADIA Pharmaceuticals Inc.

ClinicalTrials.gov identifier

NCT04292223

Study number

ACP-103-063

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About the study

To assess the effect of pimavanserin on the activities of daily living in subjects with Parkinson's Disease Psychosis

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria
  1. MMSE) score ≥21 at Screening 3. Does not meet the criteria for all-cause dementia 4. Has a diagnosis of idiopathic Parkinson's disease (
  2. PD) 5. Has psychotic symptoms severe enough to warrant treatment with an antipsychotic agent 6. Psychotic symptoms developed after the diagnosis of PD was established 7. If the subject is female, she must not be pregnant or breastfeeding. She must also be of non-childbearing potential (defined as either surgically sterilized or at least 1 year
  3. postmenopausal) OR must agree to use TWO clinically acceptable methods of contraception.
Exclusion criteria
  1. NYHA) Class 2 congestive heart failure 2. Grade 2 or greater angina pectoris (by Canadian Cardiovascular Society Angina Grading
  2. Scale) 3. sustained ventricular tachycardia 4. ventricular fibrillation 5. torsades de pointes 6. syncope due to an arrhythmia 7. an implantable cardiac defibrillator 5. Has a known personal or family history of long QT syndrome or family history of sudden cardiac death 6. Requires treatment with a medication or other substance that is prohibited by the protocol 7. Has a body mass index (
  3. BMI) <18.5 kg/m2 or >35 kg/m2 at Screening or Baseline or known unintentional clinically significant weight loss (i.e., ≥7%) over past 6 months 8. Is suicidal at Screening or Baseline 9. Has a history of a significant psychotic disorder prior to or concomitantly with the onset of PD including, but not limited to, schizophrenia or bipolar disorder 10. Had dementia prior to or concomitantly with the onset of motor symptoms of PD 11. Is judged by the Investigator or the Medical Monitor to be inappropriate for the study for any reason Additional inclusion/exclusion criteria apply. Subjects will be evaluated at screening to ensure that all criteria for study participation are met.

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.

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