CTRI/2022/04/041968尚未招募3 期
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
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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
- •11The patient is willing and able to provide written informed consent
- •12Patient has an adult caregiver who is willing and able to accompany the subject to all visits
- •13Women of childbearing potential must have a negative urine pregnancy test before study entry and agree to use highly effective methods of contraception to prevent pregnancy from study entry till at least two weeks after the last dose of the study medication such contraception may include hormonal birth control e.g. combined estrogen and progestogen containing oral intravaginal or transdermal or progesterone only oral injectable or implantable hormonal contraception associated with inhibition of ovulation intrauterine devices intrauterine hormone releasing system or bilateral tubal occlusion vasectomized partner or total sexual abstinence
- •Note Women with childbearing potential are defined as those who are not 1 surgically sterile bilateral oophorectomy hysterectomy or bilateral tubal ligation or 2 Post menopausal Post menopausal woman will be defined as Woman not using hormonal replacement therapy and have had at least 12 continuous months of natural spontaneous amenorrhea and be greater than 45 years of age
- •14Male patie
排除标准
- •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
- •10Patient with hypokalemia or hypomagnesemia
- •11Patient with surgical or medical condition that in the judgment of the Investigator or Sponsor could interfere with absorption distribution metabolism or excretion of the study drug
- •12Patient with any surgery planned during the study period from screening to end of the study
- •13Patient with history of Human immunodeficiency virus and or Hepatitis B and or Hepatitis C
- •14Patient with history of alcohol and or any other drug abuse as per The Diagnostic and Statistical Manual of Mental Disorders 5 criteria
- •15Pregnant or lactating woman
- •16Patient with history of participation in another clinical trial in the past 30 days of screening or planning to participate during the study
- •17Any contraindication to quetiapine therapy
- •18Failure to tolerate quetiapine or pimavanserin previously
- •19Patient having hypersensitivity to the study drug or to drugs of similar chemical classes or to any of its excipients
- •20Investigator study personnel Sponsor representatives and their first degree relatives
研究者
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