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Serotonin inverse agonist/antagonist

pimavanserin tartrate (ACP-103) for Hallucinations

Phase 2
Waitlist Available
Research Sponsored by ACADIA Pharmaceuticals Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first to last study drug dose plus 30 days
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group

Summary

This is an open-label extension study to assess the long-term safety and tolerability of pimavanserin (ACP-103) in subjects with Parkinson's Disease Psychosis (PDP).

Eligible Conditions
  • Hallucinations

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first to last study drug dose plus 30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first to last study drug dose plus 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number (%) of Patients With Drug-related Treatment-emergent Adverse Events (AEs)

Side effects data

From 2013 Phase 2 trial • 39 Patients • NCT01518309
23%
Constipation
23%
Hallucination
21%
Urinary tract infection
21%
Anaemia
18%
Fall
18%
Weight decreased
15%
Pain in extremity
15%
Confusional state
13%
Oedema peripheral
13%
Prothrombin time prolonged
13%
Depression
13%
Somnolence
13%
Orthostatic hypertension
10%
Diarrhoea
10%
Contusion
10%
Arthralgia
10%
Muscle spasms
10%
Dyskinesia
10%
Agitation
10%
Hallucination, visual
10%
Dysphagia
8%
Myocardial infarction
8%
Hip fracture
8%
Asthenia
8%
Pain
8%
Skin laceration
8%
Dehydration
8%
Groin pain
8%
Shoulder pain
8%
Urinary retention
8%
Hypertension
8%
Nausea
8%
Cellulitis
8%
Insomnia
8%
Hyponatraemia
8%
Cough
5%
Subdural haematoma
5%
Parkinson's disease
5%
Gastrooesophageal reflux disease
5%
Fatigue
5%
Blood bilirubin increased
5%
Lymphocyte count decreased
5%
Anorexia
5%
Hypercholesterolaemia
5%
Hypokalaemia
5%
Back pain
5%
Buttock pain
5%
Amnesia
5%
Balance disorder
5%
Dementia
5%
Dystonia
5%
Gait disturbance
5%
Anxiety
5%
Delusion
5%
Paranoia
5%
Sleep disorder
5%
Haematuria
5%
Benign prostatic hypertrophy
5%
Decubitus ulcer
5%
Seborrhoeic dermatitis
5%
Faecaloma
5%
Excoriation
5%
Haematocrit decreased
5%
Haemoglobin decreased
5%
Low density lipoprotein increased
5%
Pyuria
5%
Retyculocyte count decreased
5%
Facial wasting
5%
Dizziness
3%
Cardiac failure
3%
Pyrexia
3%
Bronchitis
3%
Joint dislocation
3%
Mental status change
3%
Inguinal hernia
3%
Rhabdomyolysis
3%
Cerebrovascular accident
3%
Depressed level of consciousness
3%
Aspiration
3%
Pneumonia aspiration
3%
Intervertebral disc protrusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pimavanserin

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: pimavanserin tartrate (ACP-103)Experimental Treatment1 Intervention
Tablets taken once daily by mouth at 20, 40, or 60 mg doses
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pimavanserin
FDA approved

Find a Location

Who is running the clinical trial?

ACADIA Pharmaceuticals Inc.Lead Sponsor
47 Previous Clinical Trials
11,556 Total Patients Enrolled
2 Trials studying Hallucinations
98 Patients Enrolled for Hallucinations
~2 spots leftby Dec 2025
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