Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 10:55 PM
Study NCT ID:
NCT05796167
Status:
WITHDRAWN
Last Update Posted:
2024-12-20
First Post:
2023-01-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pimavanserin for Sleep in Parkinson Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D006212', 'term': 'Hallucinations'}, {'id': 'D003702', 'term': 'Delusions'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C510793', 'term': 'pimavanserin'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-01-17', 'size': 708628, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-04-03T11:18', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'self-control, pilot study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'The PI did not have eligible candidates. Therefore, Acadia Pharmaceuticals (the sponsor) closed the study.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2023-01-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-06-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-17', 'studyFirstSubmitDate': '2023-01-31', 'studyFirstSubmitQcDate': '2023-03-21', 'lastUpdatePostDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of pimavanserin on sleep fragmentation', 'timeFrame': '6 weeks', 'description': 'Number of arousals and the arousal index (arousals per hour of sleep) measured on polysomnography'}], 'secondaryOutcomes': [{'measure': 'Effect of pimavanserin on REM (Rapid Eye Movements) sleep behavior disorder', 'timeFrame': '6 weeks', 'description': 'Presence fo REM sleep without atonia (RWA) on polysomnograophy'}, {'measure': 'Effect of pimavanserin on sleep latency', 'timeFrame': '6 weeks', 'description': 'Time to first epoch on polysomnography'}, {'measure': 'Effect of pimavanserin on total sleep time', 'timeFrame': '6 weeks', 'description': 'Total sleep time measured on polysomnography'}, {'measure': 'Effect of pimavanserin on sleep efficiency', 'timeFrame': '6 weeks', 'description': 'Sleep Efficiency Index in percent is the ratio of total sleep time (based on polysomnography recordings) to time in bed'}, {'measure': 'Effect of pimavanserin on time in each sleep stage', 'timeFrame': '6 weeks', 'description': 'Time in each sleep stage as measured on polysomnography'}, {'measure': 'Effect of pimavanserin on subjective measure of REM Sleep behavior disorder', 'timeFrame': '6 weeks', 'description': "RBDSQ (REM (Rapid Eye Movements) Sleep Behavior Disorder Screening Questionnaire to assess the most prominent clinical features of RBD. It is a 10-item, patient self-rating instrument with short questions to be answered by either 'yes' or 'no'."}, {'measure': 'Effect of pimavanserin on subjective measures of sleep', 'timeFrame': '6 weeks', 'description': "PDSS-2 (Parkinson's Disease Sleep Scale Version 2) total score ranges from 0 (no disturbance) to 60 (maximum nocturnal disturbance). Scores \\> 18 are considered as relevant sleep disturbances"}, {'measure': 'Effect of pimavanserin on subjective measures of fatigue', 'timeFrame': '6 weeks', 'description': "PFS-16 (Parkinson's disease Fatigue Scale): 16-item scale with the following scoring for each item: strong disagree -1, disagree - 2, neither agree or disagree - 3, agree - 4, strongly agree - 5; with overall score of ≥8 indicates the presence of significant fatigue."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sleep', 'visual hallucinations', 'delusions'], 'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': "This pilot, self-control study is for patients with Parkinson's Disease (PD) psychosis (e.g., visual hallucinations, delusions) and sleep problems.", 'detailedDescription': 'This is a feasibility study to determine whether pimavanserin improves sleep quality in patients with PD and visual hallucinations/delusions.\n\nPatients will complete a Screening Visit to assess eligibility to participate in the study.\n\nFor more information, please contact Sofya Glazman, a study coordinator, at sofya.glazman@downstate.edu'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n1. Has a diagnosis of idiopathic PD according to UK (United Kingdom) PD Society Brain Bank diagnostic criteria\n2. Has a history of hallucinations or delusions associated with PD\n3. Has a history of sleep disturbance\n4. Is between the ages of 40 and 85\n5. Has been on a stable dose of all PD medications for at least 30 days prior to enrolment\n\nExclusion criteria\n\n1. Has evidence of an atypical or secondary parkinsonian disorder\n2. Has a contraindication to taking pimavanserin\n3. Has contraindication to PSG\n4. There has been a change to patient's neuropsychiatric medications including dopaminergic medications (Sinemet, dopamine agonists, MAO(monoamine oxidaze)-B inhibitors), SSRIs (Selective Serotonin Reuptake Inhibitors), SNRIs (Serotonin and Norepinephrine Reuptake Inhibitors), dopamine-blocking agents, anti-epileptics, anticholinergics, or benzodiazepines for at least 30 days prior to enrollment\n5. Has traveled through 3 or more time zones within 60 days prior to study screening\n6. Patient is a night-shift worker"}, 'identificationModule': {'nctId': 'NCT05796167', 'briefTitle': 'Pimavanserin for Sleep in Parkinson Disease', 'organization': {'class': 'OTHER', 'fullName': 'State University of New York - Downstate Medical Center'}, 'officialTitle': 'Does Pimavanserin (Nuplazid) Improve Sleep in Patients With Parkinson Disease Psychosis? A Pilot Study', 'orgStudyIdInfo': {'id': '22-02-723-205'}, 'secondaryIdInfos': [{'id': '1396075255', 'type': 'OTHER', 'domain': 'Acadia Pharmaceuticals Inc'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pimavanserin (Nuplazid)', 'description': 'Pimavanserin (Nuplazid) 34 mg oral capsules once a day for 6 weeks for patients with Parkinson disease psychosis (e.g., visual hallucinations, delusions) and sleep problems', 'interventionNames': ['Drug: Pimavanserin']}], 'interventions': [{'name': 'Pimavanserin', 'type': 'DRUG', 'otherNames': ['Nuplazid'], 'description': 'Pimavanserin (Nuplazid) 34 mg oral capsules once a day for 6 weeks', 'armGroupLabels': ['Pimavanserin (Nuplazid)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11203', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'SUNY Downstate Health Sciences University', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}], 'overallOfficials': [{'name': 'Christian J Amlang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'State University of New York - Downstate Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'State University of New York - Downstate Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'ACADIA Pharmaceuticals Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}