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An Open-label Safety Study of Pimavanserin in Parkinson's Disease Patients
Phase 2 trial testing pimavanserin tartrate (ACP-103) in Parkinson's Disease Psychosis in 39 participants. Completed in 2 May 2013.
| Lead sponsor | ACADIA Pharmaceuticals Inc. |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 39 |
| Start date | 17 November 2004 |
| Primary completion | 2 May 2013 |
| Estimated completion | 2 May 2013 |
| Sites | 1 location across United States |
ACADIA Pharmaceuticals Inc. — full company profile →
Eligibility, any sex, with Parkinson's Disease Psychosis. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number (%) of patients with drug-related treatment-emergent AEs
| Group | Value | 95% CI |
|---|---|---|
| Pimavanserin | 17 |
Time frame: Study treatment (median treatment duration: 475 days). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Pimavanserin |
|---|---|---|
| Myocardial infarction | Cardiac disorders | — |
| Hip fracture | Injury, poisoning and procedural complications | — |
| Subdural haematoma | Injury, poisoning and procedural complications | — |
| Parkinson's disease | Nervous system disorders | — |
| Cardiac failure | Cardiac disorders | — |
| Diarrhoea | Gastrointestinal disorders | — |
| Inguinal hernia | Gastrointestinal disorders | — |
| Pyrexia | General disorders | — |
| Bronchitis | Infections and infestations | — |
| Cellulitis | Infections and infestations | — |
| Joint dislocation | Injury, poisoning and procedural complications | — |
| Dehydration | Metabolism and nutrition disorders | — |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | — |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | — |
| Cerebrovascular accident | Nervous system disorders | — |
| Depressed level of consciousness | Nervous system disorders | — |
| Agitation | Psychiatric disorders | — |
| Delusion | Psychiatric disorders | — |
| Mental status change | Psychiatric disorders | — |
| Aspiration | Respiratory, thoracic and mediastinal disorders | — |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | — |
| Reaction | System | Pimavanserin |
|---|---|---|
| Constipation | Gastrointestinal disorders | — |
| Hallucination | Psychiatric disorders | — |
| Anaemia | Blood and lymphatic system disorders | — |
| Urinary tract infection | Infections and infestations | — |
| Fall | Injury, poisoning and procedural complications | — |
| Weight decreased | Investigations | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — |
| Confusional state | Nervous system disorders | — |
| Oedema peripheral | General disorders | — |
| Prothrombin time prolonged | Investigations | — |
| Somnolence | Nervous system disorders | — |
| Depression | Psychiatric disorders | — |
| Orthostatic hypertension | Vascular disorders | — |
| Diarrhoea | Gastrointestinal disorders | — |
| Dysphagia | Gastrointestinal disorders | — |
| Contusion | Injury, poisoning and procedural complications | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — |
| Muscle spasms | Musculoskeletal and connective tissue disorders | — |
| Dyskinesia | Nervous system disorders | — |
| Agitation | Psychiatric disorders | — |
| Hallucination, visual | Psychiatric disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Asthenia | General disorders | — |
| Pain | General disorders | — |
| Cellulitis | Infections and infestations | — |
| Skin laceration | Injury, poisoning and procedural complications | — |
| Dehydration | Metabolism and nutrition disorders | — |
| Groin pain | Musculoskeletal and connective tissue disorders | — |
| Shoulder pain | Musculoskeletal and connective tissue disorders | — |
| Insomnia | Psychiatric disorders | — |
| Urinary retention | Renal and urinary disorders | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — |
| Hypertension | Vascular disorders | — |
| Hyponatraemia | Metabolism and nutrition disorders | — |
| Faecaloma | Gastrointestinal disorders | — |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | — |
| Fatigue | General disorders | — |
| Excoriation | Injury, poisoning and procedural complications | — |
| Blood bilirubin increased | Investigations | — |
| Haematocrit decreased | Investigations | — |
Most-reported serious reactions: Myocardial infarction, Hip fracture, Subdural haematoma, Parkinson's disease, Cardiac failure, Diarrhoea, Inguinal hernia, Pyrexia.
Data from ClinicalTrials.gov NCT01518309 adverse events section.
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).
4 peer-reviewed publications reference this trial (live from Europe PMC):
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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01518309.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing