CTRI/2022/04/041968
Not yet recruiting
Phase 3
A Multicenter, Randomized, Assessor-blind, Parallel-group, Phase III, Active-controlled Comparative Study to Evaluate the Efficacy and Safety of Pimavanserin in Comparison to Quetiapine for the Treatment of Hallucinations and Delusions Associated with Parkinson’s Disease Psychosis
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: F22- Delusional disorders
- Sponsor
- Sun Pharma Laboratories Limited
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1Patients of either gender aged greater than or equal to 40 years with a documented clinical diagnosis of idiopathic Parkinsons Disease as per UK PD Society Brain Bank Clinical Diagnostic Criteria of duration greater than or equal to 5\.5 years and Hoehn and Yahr stage less than or equal to 3
- •2Presence of visual and or auditory hallucinations and or delusions for at least four weeks prior to study screening and the patient must have actively experienced psychotic symptoms each week during last 4 weeks prior to study screening
- •3Psychotic symptoms must have developed after Parkinsons disease diagnosis was established
- •4Patients must be on a stable dose of anti Parkinsons medication for the last 4 weeks before randomization Day 1 and during the trial
- •5Patients who have received stereotaxic surgery for the subthalamic nucleus deep brain stimulation must be at least 6 months post surgery and the stimulator settings must have been stable for at least 4 weeks before randomization Day 1 and must remain stable during the trial
- •6Patient with psychotic symptoms as mentioned in criteria 3 severe enough to warrant treatment with an antipsychotic agent patient to have a combined score of at least 6 or an individual a score of at least 4 on the neuropsychiatric inventory items A delusions and or B hallucinations at Screening
- •7Patient with Scale for the Assessment of Positive Symptoms Hallucinations or Delusions global item H7 or D13 score greater than or equal to 3 and a score greater than 3 on at least one other non global item using the modified 9 item SAPS PD Hallucinations and Delusions domains
- •8Patient with a clear sensorium at study entry oriented to time person and place and Mini Mental State Examination MMSE score greater than 21 at Screening
- •9Patients taking acetylcholinesterase inhibitors must have the dose of these medications unchanged for at least 21 days before randomization Day 1 and must remain unchanged until the subjects final visit
- •10Patients taking anti depressant and anxiolytic medications must have the dose of these medications unchanged for at least 21 days before randomization Day 1 and must remain unchanged until the subjects final visit
Exclusion Criteria
- •1Patient with history of significant psychotic disorders prior to or concomitantly with the diagnosis of Parkinsons disease including but not limited to schizophrenia or bipolar disorder
- •2Patient with psychotic symptoms hallucinations and delusions which could be better explained clinically as a part of a toxic metabolic or infection induced delirium encephalopathy psychosis due to substance abuse psychosis associated with schizophrenia bipolar disorder or psychotic depression
- •3Patients who have received previous ablative stereotaxic surgery i.e. pallidotomy and thalamotomy to treat Parkinsons disease
- •4Patient with atypical Parkinsonism or secondary Parkinsonism variants such as tardive or medication induced Parkinsonism
- •5Patients with dementia prior to or concomitantly with the diagnosis of Parkinsons disease that may be inconsistent with a PD diagnosis
- •6Patient with clinically significant conditions including but not limited to pulmonary central nervous system stroke dementia thyroid uncontrolled hypertension SeSBP greater than or equal to 160 and or SeDBP greater than or equal to 100 mm of Hg and diabetes HbA1c greater than 9 percent at screening renal disease eGFR less than 30 ml per min per 1\.73 meter square
- •7Patient with cardiac conditions in the last six months including but not limited to myocardial infarction moderate to severe congestive heart failure New York Heart Association NYHA class III or IV congenital prolongation of QT symptomatic bradycardia Bazetts corrected QT QTcB greater than 460 msec if male or 470 msec if female
- •8Patient already on antipsychotic medications for PDP
- •9Patient who are taking any prior medication as mentioned in the Section 8\.1 and are unable to follow a washout period of 21 days before randomization
- •Patients taking medications that can cause QT prolongation requiring washout period 5 times of half life of more than 21 days e.g. amiodarone are not eligible for the study as per Investigators discretion
Outcomes
Primary Outcomes
Not specified
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