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The purpose of this study is to assess the efficacy of pimavanserin for the treatment of depression in adults with Parkinson's disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug - pimavanserin | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pimavanserin | Drug | Pimavanserin 34 mg total daily dose, tablets, once daily by mouth (provided as two 17 mg NUPLAZID® tablets) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 8 in HAMD-17 (Hamilton Depression Scale -17 Items) Total Score | The HAMD-17 is a multiple-item questionnaire to assess the severity of depression, including items of mood, feelings of guilt, suicide ideation, insomnia, agitation or retardation, anxiety, weight loss, and somatic symptoms. Each of the 17 items is scored on a 3- or 5-point scale (depending on the item). The minimum total score is 0; the maximum total score is 52. A higher total score signifies more severe depression. | From baseline to Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline (CFB) in HAMD-17 Total Score at Weeks 2, 4, and 6 | The HAMD-17 is a multiple-item questionnaire to assess the severity of depression, including items of mood, feelings of guilt, suicide ideation, insomnia, agitation or retardation, anxiety, weight loss, and somatic symptoms. Each of the 17 items is scored on a 3- or 5-point scale (depending on the item). The minimum total score is 0; the maximum total score is 52. A higher total score signifies more severe depression. |
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Inclusion Criteria:
Can understand and provide signed informed consent, request for medical records and/or subject privacy form if applicable according to local regulations
Has a clinical diagnosis of idiopathic Parkinson's disease with a minimum duration of 1 year, defined as the presence of at least three of the following cardinal features, in the absence of alternative explanations or atypical features:
Meets clinical criteria for depression with Parkinson's disease as listed in the NINDS/NIMH Guidelines
If currently taking an anti-depressant, is being treated with only one SSRI or SNRI antidepressant at a dose within the US FDA-approved dose range. Subjects who are currently taking a second antidepressant or antidepressant augmentation agent at a sub-therapeutic dose or for an inadequate duration at Screening, and can be discontinued from this agent before the Baseline visit (in the opinion of the Investigator), may be eligible for the study.
Is on a stable dose of anti-Parkinson's medication for 1 month prior to Screening
If the subject is female, she must be of non-childbearing potential or agree to use two methods of clinically acceptable contraception
Exclusion Criteria:
Additional inclusion/exclusion criteria apply. Subjects will be evaluated at screening to ensure that all criteria for study participation are met.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ATP Clinical Research, Inc. | Costa Mesa | California | 92626 | United States | ||
| The Parkinson's and Movement Disorder Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32804101 | Derived | DeKarske D, Alva G, Aldred JL, Coate B, Cantillon M, Jacobi L, Nunez R, Norton JC, Abler V. An Open-Label, 8-Week Study of Safety and Efficacy of Pimavanserin Treatment in Adults with Parkinson's Disease and Depression. J Parkinsons Dis. 2020;10(4):1751-1761. doi: 10.3233/JPD-202058. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pimavanserin | Pimavanserin 34 mg, taken as 2 tablets of pimavanserin 17 mg as a single dose once daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 8, 2019 | Jul 6, 2020 |
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| 2, 4, and 6 weeks from baseline |
| Clinical Global Impression-Improvement (CGI-I) | The CGI-I is a clinician-rated 7-point scale to rate the improvement in the patient's depression at the time of assessment relative baseline. The CGI-I ranges from 1 (very much improved) to 7 (very much worse) | At Week 8 |
| Change From Baseline (CFB) in Clinical Global Impression-Severity (CGI-S) | The CGI-S is a clinician-rated 7-point scale to rate the severity of the patient's depression at the time of assessment. The CGI-S ranges from 1 (normal) to 7 (patient is among the most severely ill). | From baseline to Week 8 |
| Change From Baseline (CFB) in Scale of Outcomes in PD-Sleep Scale (SCOPA) Nighttime Sleep (NS)Score | The SCOPA-NS subscale addresses problems in nighttime sleep and consists of 5 items (sleep initiation, sleep fragmentation, sleep efficiency, sleep duration, early wakening). Each item has 4 response options (ranging from 0=not at all to 3=a lot). The SCOPA-NS score ranges from 0 to 15, with a higher score indicating more severe nighttime sleep problems. | From baseline to Week 8 |
| Change From Baseline (CFB) in SCOPA Daytime Sleepiness (DS) Score | The SCOPA-DS subscale addresses problems in daytime sleepiness and consists of 6 items (falling asleep unexpectedly, falling asleep peacefully, falling asleep watching TV/reading, falling asleep while talking to someone, having difficulty staying awake, whether falling asleep in the daytime is considered a Problem). Each item has 4 response options (from 0=never to 3=often). The SCOPA-DS subscale score ranges from 0 to 18, with a higher score indicating more severe DS problems. | From baseline to Week 8 |
| The Number (or Percentage) of Responders | The HAMD-17 is a multiple-item questionnaire to assess the severity of depression, including items of mood, feelings of guilt, suicide ideation, insomnia, agitation or retardation, anxiety, weight loss, and somatic symptoms. Each of the 17 items is scored on a 3- or 5-point scale (depending on the item). The minimum total score is 0; the maximum total score is 52. A higher total score signifies more severe Depression. Response was defined as ≥50% reduction from baseline in HAMD-17 total score. Patients without Week-8 score were counted as nonresponders. | From baseline to Week 8 |
| Change From Baseline in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) | The EQ-5D-5L is a standardized measure of health status. The questionnaire consists of 2 components: the EQ-5D-5L descriptive system and the EQ-5D-5L Visual Analogue scale (EQ-5D-5L VAS). The descriptive system consists of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels (from 1=no problem to 5=extreme Problems). The digits for the 5 dimensions are combined into a 5-digit code that describes the patient's health state, which is then converted into a single summary index value. Health state index scores generally range from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility. The EQ-5D-5L VAS records the patient's health on a vertical visual analogue scale, ranging from 100 (=the best health you can imagine) to 0 (=the worst health you can imagine). | From baseline to Week 8 |
| Fountain Valley |
| California |
| 92708 |
| United States |
| SC3 Research-Reseda | Pasadena | California | 91105 | United States |
| The Neurology Group | Pomona | California | 91767 | United States |
| SC3 Research-Reseda | Reseda | California | 91335 | United States |
| CNS Network | Torrance | California | 90502 | United States |
| Associated Neurologists, P.C. | Danbury | Connecticut | 06810 | United States |
| Parkinson's Disease and Movement Disorder Center of Boca Raton | Boca Raton | Florida | 33486 | United States |
| University of Florida | Gainesville | Florida | 32607 | United States |
| Parkinson's Disease Treatment Center of SW Florida | Port Charlotte | Florida | 33980 | United States |
| Infinity Clinical Research, LLC | Sunrise | Florida | 33351 | United States |
| Tallahassee Neurological Clinic, P.A. | Tallahassee | Florida | 32308 | United States |
| SRI Biosciences, Clinical Trials and Strategic Development Services | Plymouth | Michigan | 48170 | United States |
| Washington University School of medicine | St Louis | Missouri | 63110 | United States |
| Bio Behavioral Health | Toms River | New Jersey | 08755 | United States |
| Albany Medical College | Albany | New York | 12208 | United States |
| David L. Kreitzman, MD, PC | Commack | New York | 11725 | United States |
| Asheville Neurology Specialists, PA | Asheville | North Carolina | 28806 | United States |
| Neurology/Neurophysiology | Johnstown | Pennsylvania | 15904 | United States |
| Booth Gardner Parkinson's Care Center | Kirkland | Washington | 98034 | United States |
| Inland Northwest Research | Spokane | Washington | 99202 | United States |
| COMPLETED |
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| NOT COMPLETED |
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Patients treated with study drug
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| ID | Title | Description |
|---|---|---|
| BG000 | Pimavanserin Safety Analysis Set | The Safety Analysis Set (SAS) includes all subjects (47 participants) who received at least one dose of study drug (34mg pimavanserin taken as two 17mg tablets, once daily by mouth) |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Duration of Parkinson's Disease (PD) | Mean | Standard Deviation | years |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline to Week 8 in HAMD-17 (Hamilton Depression Scale -17 Items) Total Score | The HAMD-17 is a multiple-item questionnaire to assess the severity of depression, including items of mood, feelings of guilt, suicide ideation, insomnia, agitation or retardation, anxiety, weight loss, and somatic symptoms. Each of the 17 items is scored on a 3- or 5-point scale (depending on the item). The minimum total score is 0; the maximum total score is 52. A higher total score signifies more severe depression. | Patients treated with study drug and with at least one post-baseline assessment of the HAMD-17. The Full Analysis Set had 45 participants at baseline. The Full Analysis Set at Week 8 had 39 participants. | Posted | Mean | Standard Error | score on a scale | From baseline to Week 8 |
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| Secondary | Change From Baseline (CFB) in HAMD-17 Total Score at Weeks 2, 4, and 6 | The HAMD-17 is a multiple-item questionnaire to assess the severity of depression, including items of mood, feelings of guilt, suicide ideation, insomnia, agitation or retardation, anxiety, weight loss, and somatic symptoms. Each of the 17 items is scored on a 3- or 5-point scale (depending on the item). The minimum total score is 0; the maximum total score is 52. A higher total score signifies more severe depression. | Patients treated with study drug and with at least one post-baseline assessment of the HAMD-17 | Posted | Mean | Standard Error | score on a scale | 2, 4, and 6 weeks from baseline |
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| Secondary | Clinical Global Impression-Improvement (CGI-I) | The CGI-I is a clinician-rated 7-point scale to rate the improvement in the patient's depression at the time of assessment relative baseline. The CGI-I ranges from 1 (very much improved) to 7 (very much worse) | Patients treated with study drug and with at least one post-baseline assessment of the HAMD-17 | Posted | Mean | Standard Error | score on a scale | At Week 8 |
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| Secondary | Change From Baseline (CFB) in Clinical Global Impression-Severity (CGI-S) | The CGI-S is a clinician-rated 7-point scale to rate the severity of the patient's depression at the time of assessment. The CGI-S ranges from 1 (normal) to 7 (patient is among the most severely ill). | Patients treated with study drug and with at least one post-baseline assessment of the HAMD-17 | Posted | Mean | Standard Error | score on a scale | From baseline to Week 8 |
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| Secondary | Change From Baseline (CFB) in Scale of Outcomes in PD-Sleep Scale (SCOPA) Nighttime Sleep (NS)Score | The SCOPA-NS subscale addresses problems in nighttime sleep and consists of 5 items (sleep initiation, sleep fragmentation, sleep efficiency, sleep duration, early wakening). Each item has 4 response options (ranging from 0=not at all to 3=a lot). The SCOPA-NS score ranges from 0 to 15, with a higher score indicating more severe nighttime sleep problems. | Patients treated with study drug and with at least one post-baseline assessment of the HAMD-17 | Posted | Mean | Standard Error | score on a scale | From baseline to Week 8 |
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| Secondary | Change From Baseline (CFB) in SCOPA Daytime Sleepiness (DS) Score | The SCOPA-DS subscale addresses problems in daytime sleepiness and consists of 6 items (falling asleep unexpectedly, falling asleep peacefully, falling asleep watching TV/reading, falling asleep while talking to someone, having difficulty staying awake, whether falling asleep in the daytime is considered a Problem). Each item has 4 response options (from 0=never to 3=often). The SCOPA-DS subscale score ranges from 0 to 18, with a higher score indicating more severe DS problems. | Patients treated with study drug and with at least one post-baseline assessment of the HAMD-17 | Posted | Mean | Standard Error | score on a scale | From baseline to Week 8 |
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| Secondary | The Number (or Percentage) of Responders | The HAMD-17 is a multiple-item questionnaire to assess the severity of depression, including items of mood, feelings of guilt, suicide ideation, insomnia, agitation or retardation, anxiety, weight loss, and somatic symptoms. Each of the 17 items is scored on a 3- or 5-point scale (depending on the item). The minimum total score is 0; the maximum total score is 52. A higher total score signifies more severe Depression. Response was defined as ≥50% reduction from baseline in HAMD-17 total score. Patients without Week-8 score were counted as nonresponders. | Patients treated with study drug and with at least one post-baseline assessment of the HAMD-17 | Posted | Count of Participants | Participants | From baseline to Week 8 |
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| Secondary | Change From Baseline in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) | The EQ-5D-5L is a standardized measure of health status. The questionnaire consists of 2 components: the EQ-5D-5L descriptive system and the EQ-5D-5L Visual Analogue scale (EQ-5D-5L VAS). The descriptive system consists of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels (from 1=no problem to 5=extreme Problems). The digits for the 5 dimensions are combined into a 5-digit code that describes the patient's health state, which is then converted into a single summary index value. Health state index scores generally range from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility. The EQ-5D-5L VAS records the patient's health on a vertical visual analogue scale, ranging from 100 (=the best health you can imagine) to 0 (=the worst health you can imagine). | Patients treated with study drug and with at least one post-baseline assessment of the HAMD-17 | Posted | Mean | Standard Error | score on a scale | From baseline to Week 8 |
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From the time of informed consent through a safety follow-up visit at Week 10
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pimavanserin | Pimavanserin 34 mg, taken as 2 tablets of pimavanserin 17 mg as a single dose once daily | 0 | 47 | 1 | 47 | 21 | 47 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colitis | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Oedema | General disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
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| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Non-cardiac chest pain | General disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Peripheral swelling | General disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Supraventricular extrasystoles | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Hypothyroidism | Endocrine disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
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| Laceration | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
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| Muscle strain | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
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| Blood glucose increased | Investigations | MedDRA 20.0 | Non-systematic Assessment |
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| Blood pressure increased | Investigations | MedDRA 20.0 | Non-systematic Assessment |
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| Gout | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Hypertonia | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Mental impairment | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Presyncope | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Abnormal dreams | Psychiatric disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Hallucination, auditory | Psychiatric disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Hallucination, visual | Psychiatric disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Illusion | Psychiatric disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Rapid eye movement sleep behaviour disorder | Psychiatric disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Suicidal ideation | Psychiatric disorders | MedDRA 20.0 | Non-systematic Assessment |
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Investigator may publish the study results, relative to his/her own patients, only after review, comment and approval by the sponsor. No publication of confidential information shall be made without the sponsor's prior written consent. At least 60 days prior to submitting a manuscript or prior to any public presentation, a copy of the manuscript or presentation will be provided to the sponsor for review and comment. The sponsor has 60 days to review and comment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. Dir. Medical Information and Medical Communications | ACADIA Pharmaceuticals Inc. | 858-261-2897 | medicalinformation@acadia-pharm.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 31, 2019 | Jul 6, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C510793 | pimavanserin |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Units | Counts |
|---|---|
| Participants |
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