| ID | Type | Description | Link |
|---|---|---|---|
| 2018-003251-37 | EudraCT Number |
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To evaluate the efficacy and safety of adjunctive pimavanserin compared to placebo in subjects with major depressive disorder who have an inadequate response to antidepressant therapy
Two separate studies, idential in design, were planned and initiated under 2 protocol IDs and NCTs, i.e. study ACP-103-54 (NCT03999918) and ACP-103-059 (NCT03968159). In March 2020, recruitment of new patients was paused due to the emerging coronavirus disease 2019 (COVID-19) pandemic. At that point in time, about half of the planned patients had been randomized. The Sponsor decided to combine the 2 identically designed trials, with a prespecified combined statistical analysis plan. As a result, both trials were closed and proceeded with database lock and statistical analysis of the combined data. No further patients were enrolled.
This entry now includes the combined data of studies ACP-103-054 and ACP-103-059.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug - pimavanserin | Experimental | Pimavanserin 34 mg tablets |
|
| Placebo | Placebo Comparator | Placebo tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pimavanserin | Drug | Pimavanserin 34 mg (provided as 2×17 mg tablets) administered orally as a single dose once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 5 in Hamilton Depression Scale (17 Items) (HAMD-17) Total Score | The HAMD-17 consists of 8 items with a score on a 3 point scale and 9 items with a score on a 5 point scale. The total score ranging from 0 to 52 will be calculated as the sum of the scores for all 17 items. Higher total scores denote more severe depression. | Baseline, Week 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 5 in Clinical Global Impression-Severity (CGI-S) Score for Depressive Symptoms | The CGI-S rates the severity of a subject's depression over the past 7 days and the score ranges from 1 to 7. Higher CGI-S scores denote more severe depression. | Baseline, 5 weeks |
| Change From Baseline to Week 5 in Sheehan Disability Scale (SDS) Score |
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Inclusion Criteria:
Adult patients, aged 18 years and above
A clinical diagnosis of major depressive disorder (MDD)
Is being treated with one of the following SSRI or SNRI antidepressants:
Inadequate response to SSRI/SNRI antidepressant treatment is confirmed
If the subject is female, she must not be pregnant or breastfeeding. She must also be of non-childbearing potential OR must agree to use acceptable methods of contraception
Exclusion Criteria:
Additional inclusion/exclusion criteria apply. Patients will be evaluated at screening to ensure that all criteria for study participation are met. Patients may be excluded from the study based on these assessments (and specifically, if it is determined that their baseline health and psychiatric condition do not meet all pre-specified entry criteria).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham (UAB) | Birmingham | Alabama | 35233 | United States | ||
| CNS Network |
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During the screening period, patients were assessed for study eligibility, and prohibited medications were discontinued when medically appropriate.
The study was performed in patients with with major depressive disorder who had an inadequate response to antidepressant treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pimavanserin | Pimavanserin 34 mg administered orally as a single dose once daily |
| FG001 | Placebo | Placebo tablets administered orally 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: Study ACP-103-059 protocol (NCT03968159) | Jun 21, 2020 |
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| Placebo | Drug | Placebo (2×placebo tablets [size- and color-matched to pimavanserin]) administered orally as a single dose once daily |
|
The SDS is a 3-item subject-facing questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. Subjects rate each item using an 11-point scale ranging from 0 (not at all) to 10 (extremely). Higher scores denote greater disability. |
| Baseline, 5 weeks |
| Change From Baseline to Week 5 in the Changes in Sexual Functioning Questionnaire Short Form | The CSFQ-14 is a 14-item version of the CSFQ. This is a patient-facing questionnaire, with a male version and a female version. The total score ranging from 14 to 70 will be calculated as the sum of the scores for all 14 items. Higher total scores denote better sexual functioning. | Baseline, 5 weeks |
| Change From Baseline to Week 5 in Karolinska Sleepiness Scale (KSS) Score | The KSS is a scale that measures the subject's drowsiness and is frequently used in studies measuring subjective sleepiness. Scoring is based on a 9-point verbally anchored scale going from "1 = extremely alert" to "9 = very sleepy, great effort to keep awake, fighting sleep". Higher scores denote more drowsiness. | Baseline, 5 weeks |
| Change From Baseline to Week 1 in the HAMD-17 Total Score | The HAMD-17 consists of 8 items with a score on a 3 point scale and 9 items with a score on a 5 point scale. The total score ranging from 0 to 52 will be calculated as the sum of the scores for all 17 items. Higher total scores denote more severe depression. | Baseline, 1 week |
| Treatment Responder and Treatment Remission Rates at Week 5 | The HAMD-17 consists of 8 items with a score on a 3 point scale and 9 items with a score on a 5 point scale. The total score ranging from 0 to 52 will be calculated as the sum of the scores for all 17 items. Treatment response is defined as a reduction from Baseline in HAMD-17 total score of 50% or more. Treatment remission is defined as a HAMD-17 total score ≤7. | Baseline, 5 weeks |
| Change From Baseline to Week 5 in the Hamilton Depression (HAMD) Anxiety/Somatization Factor Score | The Anxiety/Somatization factor of the HAMD-17 includes 6 items: psychic anxiety, somatic anxiety, gastrointestinal somatic symptoms, general somatic symptoms, hypochondriasis, and insight. The HAMD-17 Anxiety/Somatization factor score ranging from 0 to 18 will be calculated as the sum of the scores for the 6 items. Higher scores denote more severe anxiety/somatization condition. | Baseline, 5 weeks |
| Change From Baseline to Week 5 in the Barratt Impulsiveness Scale (BIS-11) | The BIS-11 is a questionnaire designed to assess the personality/behavioral construct of impulsiveness. It is composed of 30 items describing common impulsive or non-impulsive (reverse scored items: 1, 7, 8, 9, 10, 12, 13, 15, 20, 29, and 30) behaviors and preferences. Items are scored on the following 4-point scale: Rarely/Never = 1; Occasionally = 2; Often = 3; Almost Always/Always = 4. For reverse scored items, a response of 1 is recoded to 4; 2 is recoded to 3; 3 is recoded to 2; and 4 is recoded to 1. The BIS-11 score ranging from 30 to 120 will be calculated as the sum of the scores for all 30 items. Higher scores denote more impulsiveness. | Baseline, 5 weeks |
| Clinical Global Impression-Improvement (CGI-I) Score for Depressive Symptoms at Week 5 | The CGI-I rates the change in a subject's depression over the past 7 days relative to the subject's symptoms at Baseline and the score ranges from 1 to 7. Higher CGI-I scores denote less improvement in Depression. | Baseline, 5 weeks |
| Garden Grove |
| California |
| 92845 |
| United States |
| Behavioral Research Specialists | Glendale | California | 91206 | United States |
| Sun Valley Research Center | Imperial | California | 92251 | United States |
| Irvine Clinical Research | Irvine | California | 92614 | United States |
| Synergy San Diego | Lemon Grove | California | 91945 | United States |
| Pacific Research Partners, LLC | Oakland | California | 94607 | United States |
| NRC Research Institute | Orange | California | 92868 | United States |
| MCB Clinical Research Centers, LLC | Colorado Springs | Colorado | 80910 | United States |
| Mountain View Clinical Research, Inc. | Denver | Colorado | 80209 | United States |
| CT Clinical Research | Cromwell | Connecticut | 06416 | United States |
| Clinical Neuroscience Solutions ( CNS Healthcare)-Jacksonville | Jacksonville | Florida | 32256 | United States |
| Meridien Research | Maitland | Florida | 32751 | United States |
| Florida Research Center, Inc. | Miami | Florida | 33174 | United States |
| CNS Health Care (Orlando) | Orlando | Florida | 32801 | United States |
| Emory University School of Medicine | Atlanta | Georgia | 30322 | United States |
| Synexus Clinical Research | Atlanta | Georgia | 30328 | United States |
| Great Lakes Clinical Trials | Chicago | Illinois | 60640 | United States |
| Capstone Clinical Research | Libertyville | Illinois | 60048 | United States |
| Collective Medical Research, LLC | Prairie Village | Kansas | 66208 | United States |
| Clinical Trials of America (Monroe, LA) | Monroe | Louisiana | 71201 | United States |
| Adams Clinical | Watertown | Massachusetts | 02472 | United States |
| St. Charles Psychiatric Associates-Midwest Research Group | Saint Charles | Missouri | 63304 | United States |
| Integrative Clinical Trials | Brooklyn | New York | 11229 | United States |
| Social Psychiatry Research Institute (SPRI) | Brooklyn | New York | 11235 | United States |
| Mount Sinai Hospital | New York | New York | 10029 | United States |
| The Medical Research Network, LLC | New York | New York | 10128 | United States |
| Finger Lake Clinical Research | Rochester | New York | 14618 | United States |
| Clinical Trial of America, LLC | Hickory | North Carolina | 28601 | United States |
| Charak Clinical Research Center | Garfield Heights | Ohio | 44125 | United States |
| Summit Research Network (Oregon) Inc. | Portland | Oregon | 97210 | United States |
| University Of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Coastal Carolina Research Center | Mt. Pleasant | South Carolina | 26464 | United States |
| Psychiatric Consultants, PC | Franklin | Tennessee | 37067 | United States |
| Clinical Neuroscience Solutions CNS Healthcare | Memphis | Tennessee | 38119 | United States |
| Research Strategies of Memphis, LLC | Memphis | Tennessee | 38119 | United States |
| Future Search Trials of Dallas | Dallas | Texas | 75231 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| Clinical Trials of Texas, Inc. | San Antonio | Texas | 78229 | United States |
| Grayline Research Center | Wichita Falls | Texas | 76309 | United States |
| IPC Research | Waukesha | Wisconsin | 53188 | United States |
| ARTES Psykiatrinen Palvelukeskus Oy (Mederon Ltd.) | Helsinki | 00100 | Finland |
| Savon Psykiatripalvelu Oy | Kuopio | 70110 | Finland |
| Oulu Mentalcare Oy | Oulu | 90100 | Finland |
| Satakunnan Psykiatripalvelu Oy at Mehiläinen Pori | Pori | 28130 | Finland |
| Psykiatri- ja psykologikeskus Mentoria | Tampere | 33200 | Finland |
| Gabinet Lekarski Psychiatryczny Ireneusz Kaczorowski | Bełchatów | 97-400 | Poland |
| Przychodnia Śródmieście Sp. z o.o. | Bydgoszcz | 85-080 | Poland |
| Indywidualna Specijalistyczna Praktyka Lekarska Wiesław Jerzy Cubała | Gdansk | 80-438 | Poland |
| Nzop Mentis | Leszno | 64-100 | Poland |
| Neurologiczny NZOZ im. dr n. med. Hanki | Plewiska | 62-064 | Poland |
| Zachodniopomorski Instytut Psychoterapii | Szczecin | 70-480 | Poland |
| Mental Health Research Center, Department #6 | Moscow | 115522 | Russia |
| St. Nicholas the Wonder Worker Psychiatric Hospital | Saint Petersburg | 190121 | Russia |
| Psychoneurological Dispensary # 5 | Saint Petersburg | 195176 | Russia |
| City Narcology Hospital | Saint Petersburg | 199004 | Russia |
| Samara Psychiatric Hospital | Samara | 443016 | Russia |
| Saratov City Clinical Hospital # 2 n.a. V.I. Razumovsky | Saratov | 410028 | Russia |
| Regional Clinical Psychiatric Hospital of St. Sofia | Saratov | 410060 | Russia |
| LION-MED | Voronezh | 394052 | Russia |
| Clinical Center of Serbia, Clinic for psychiatry | Belgrade | 11000 | Serbia |
| Clinical Hospital Center Dr Dragisa Misovic | Belgrade | 11000 | Serbia |
| Special hospital for psychiatric diseases "Kovin" | Kovin | 26220 | Serbia |
| Clinical Center Kragujevac , Clinic for Psychiatry | Kragujevac | 34000 | Serbia |
| Clinical Center Kragujevac | Kragujevac | 34000 | Serbia |
| Centre for Mental Health Protection, Clinical Center Nis | Niš | 18000 | Serbia |
| Clinical Centre Nis, Clinic for Psychiatry Gornja | Toponica | 18202 | Serbia |
| EPAMED s r.o. | Košice | 040 17 | Slovakia |
| Liptovska nemocnice s poliklinikou MUDr. Ivana Stodolu, Psychiatricke oddelenie | Liptovský Mikuláš | 031 23 | Slovakia |
| Centrum Zdravia R.B.K., s.r.o. | Svidník | 089 01 | Slovakia |
| Cape Trial Centre | Cape Town | 7530 | South Africa |
| Dr DG Dennis Incorporated Knighton Surgery | Cape Town | 7708 | South Africa |
| Flexivest Fourteen Research Centre, Unit 1, Durbanville Health Center | Durbanville | 7550 | South Africa |
| Dr GP Bosch Clinical Research | Pretoria | 0081 | South Africa |
| Regional Centre of Psychosomatic Disorders based on Psychoneurology Department, Communal Institution "Dnipropetrovsk Regional Clinical Hospital named after I.I. Mechnykov | Dnipro | 49005 | Ukraine |
| Institute of neurology, Psychiatry and Narcology of NAMS of Ukraine, MC "Neuron" | Kharkiv | 61091 | Ukraine |
| Kyiv Railway Clinical Hospital № 1 of Branch "Health Center" of the Public joint stock company "Ukrainian Railway" | Kyiv | 01030 | Ukraine |
| Odesa Regional Medical Centre of Mental Health | Odesa | 65006 | Ukraine |
| Kherson Regional Psychiatric Hospital Department # 3 and # 10 Kherson region | Stepanovka | 73488 | Ukraine |
| Ternopil Regional Communal Clinical Psychoneurological Hospital, psychiatric department # 2 (men), psychiatric department # 6 (women), Ternopil State Medical University n.a. I.Y. Gorbachevskyy, Chair of Psychiatry, Narcology and Medical Psychology | Ternopil | 46027 | Ukraine |
| Communal Institution "Vinnytsia Regional Psychoneurological Hospital n.a. Acad. O.I.Yushchenko", Department #7 (male), Department #10 (female),Vinnytsia National Medical University n.a. M.I.Pyrogov, Department of Psychiatry, Narcology and Psychotherapeuti | Vinnytsia | 21005 | Ukraine |
| Municipal Institution "Vinnytsya Regional Psychoneurological Hospital n.a. Acad. O.I.Yushchenko", Male Department #14, Female Department #15, Vinnytsya National Medical University n.a. M.I.Pyrogov, Department of Psychiatry, Narcology and Psychotherapeutic | Vinnytsia | 21005 | Ukraine |
| MAC Clinical Research - Blackpool | Blackpool | FY2 0JH | United Kingdom |
| MAC Clinical Research Ltd - Liverpool | Liverpool | L34 1BH | United Kingdom |
| MAC Clinical Research - Manchester | Manchester | M13 9NQ | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pimavanserin | Pimavanserin 34 mg administered orally as a single dose once daily |
| BG001 | Placebo | Placebo tablets administered orally as a single dose once daily |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 5 in Hamilton Depression Scale (17 Items) (HAMD-17) Total Score | The HAMD-17 consists of 8 items with a score on a 3 point scale and 9 items with a score on a 5 point scale. The total score ranging from 0 to 52 will be calculated as the sum of the scores for all 17 items. Higher total scores denote more severe depression. | Full Analysis Set: all subjects who were randomized, received at least one dose of study drug, and had a baseline value and at least one postbaseline value for HAMD-17 total score. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 5 |
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| Secondary | Change From Baseline to Week 5 in Clinical Global Impression-Severity (CGI-S) Score for Depressive Symptoms | The CGI-S rates the severity of a subject's depression over the past 7 days and the score ranges from 1 to 7. Higher CGI-S scores denote more severe depression. | Full Analysis Set: all subjects who were randomized, received at least one dose of study drug, and had a baseline value and at least one postbaseline value for HAMD-17 total score. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, 5 weeks |
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| Secondary | Change From Baseline to Week 5 in Sheehan Disability Scale (SDS) Score | The SDS is a 3-item subject-facing questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. Subjects rate each item using an 11-point scale ranging from 0 (not at all) to 10 (extremely). Higher scores denote greater disability. | Full Analysis Set: all subjects who were randomized, received at least one dose of study drug, and had a baseline value and at least one postbaseline value for HAMD-17 total score. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, 5 weeks |
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| Secondary | Change From Baseline to Week 5 in the Changes in Sexual Functioning Questionnaire Short Form | The CSFQ-14 is a 14-item version of the CSFQ. This is a patient-facing questionnaire, with a male version and a female version. The total score ranging from 14 to 70 will be calculated as the sum of the scores for all 14 items. Higher total scores denote better sexual functioning. | Full Analysis Set: all subjects who were randomized, received at least one dose of study drug, and had a baseline value and at least one postbaseline value for HAMD-17 total score. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, 5 weeks |
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| Secondary | Change From Baseline to Week 5 in Karolinska Sleepiness Scale (KSS) Score | The KSS is a scale that measures the subject's drowsiness and is frequently used in studies measuring subjective sleepiness. Scoring is based on a 9-point verbally anchored scale going from "1 = extremely alert" to "9 = very sleepy, great effort to keep awake, fighting sleep". Higher scores denote more drowsiness. | Full Analysis Set: all subjects who were randomized, received at least one dose of study drug, and had a baseline value and at least one postbaseline value for HAMD-17 total score. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, 5 weeks |
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| Secondary | Change From Baseline to Week 1 in the HAMD-17 Total Score | The HAMD-17 consists of 8 items with a score on a 3 point scale and 9 items with a score on a 5 point scale. The total score ranging from 0 to 52 will be calculated as the sum of the scores for all 17 items. Higher total scores denote more severe depression. | Full Analysis Set: all subjects who were randomized, received at least one dose of study drug, and had a baseline value and at least one postbaseline value for HAMD-17 total score. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, 1 week |
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| Secondary | Treatment Responder and Treatment Remission Rates at Week 5 | The HAMD-17 consists of 8 items with a score on a 3 point scale and 9 items with a score on a 5 point scale. The total score ranging from 0 to 52 will be calculated as the sum of the scores for all 17 items. Treatment response is defined as a reduction from Baseline in HAMD-17 total score of 50% or more. Treatment remission is defined as a HAMD-17 total score ≤7. | Full Analysis Set: all subjects who were randomized, received at least one dose of study drug, and had a baseline value and at least one postbaseline value for HAMD-17 total score. | Posted | Count of Participants | Participants | Baseline, 5 weeks |
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| Secondary | Change From Baseline to Week 5 in the Hamilton Depression (HAMD) Anxiety/Somatization Factor Score | The Anxiety/Somatization factor of the HAMD-17 includes 6 items: psychic anxiety, somatic anxiety, gastrointestinal somatic symptoms, general somatic symptoms, hypochondriasis, and insight. The HAMD-17 Anxiety/Somatization factor score ranging from 0 to 18 will be calculated as the sum of the scores for the 6 items. Higher scores denote more severe anxiety/somatization condition. | Full Analysis Set: all subjects who were randomized, received at least one dose of study drug, and had a baseline value and at least one postbaseline value for HAMD-17 total score. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, 5 weeks |
|
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| Secondary | Change From Baseline to Week 5 in the Barratt Impulsiveness Scale (BIS-11) | The BIS-11 is a questionnaire designed to assess the personality/behavioral construct of impulsiveness. It is composed of 30 items describing common impulsive or non-impulsive (reverse scored items: 1, 7, 8, 9, 10, 12, 13, 15, 20, 29, and 30) behaviors and preferences. Items are scored on the following 4-point scale: Rarely/Never = 1; Occasionally = 2; Often = 3; Almost Always/Always = 4. For reverse scored items, a response of 1 is recoded to 4; 2 is recoded to 3; 3 is recoded to 2; and 4 is recoded to 1. The BIS-11 score ranging from 30 to 120 will be calculated as the sum of the scores for all 30 items. Higher scores denote more impulsiveness. | Full Analysis Set: all subjects who were randomized, received at least one dose of study drug, and had a baseline value and at least one postbaseline value for HAMD-17 total score. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, 5 weeks |
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| Secondary | Clinical Global Impression-Improvement (CGI-I) Score for Depressive Symptoms at Week 5 | The CGI-I rates the change in a subject's depression over the past 7 days relative to the subject's symptoms at Baseline and the score ranges from 1 to 7. Higher CGI-I scores denote less improvement in Depression. | Full Analysis Set: all subjects who were randomized, received at least one dose of study drug, and had a baseline value and at least one postbaseline value for HAMD-17 total score. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, 5 weeks |
|
|
Adverse Events (AEs) were to be documented through 30 days after the last planned dose in the study which was to be administered at Week 6.
Not provided
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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 administered orally as a single dose once daily | 0 | 148 | 2 | 148 | 54 | 148 |
| EG001 | Placebo | Placebo tablets administered orally as a single dose once daily | 0 | 150 | 2 | 150 | 43 | 150 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Multiple sclerosis | Nervous system disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Gastritis haemorrhagic | Gastrointestinal disorders | MedDRA (23.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (23.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (23.0) | Non-systematic Assessment |
|
In March 2020, recruitment of new patients was paused due to the emerging coronavirus disease 2019 (COVID-19) pandemic. At that point in time, about half of the planned patients had been randomized. The Sponsor decided to combine this trial with the identically designed trial ACP-103-054, with a prespecified combined statistical analysis plan. As a result, both trials were closed and proceeded with database lock and statistical analysis of the combined data. No further patients were enrolled.
Investigator may publish the study results, relative to their 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 |
| May 11, 2021 |
| Prot_000.pdf |
| Prot | Yes | No | No | Study Protocol: Study ACP-103-054 protocol (NCT03999918) | Jun 21, 2020 | Sep 21, 2021 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 22, 2020 | May 6, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| C510793 | pimavanserin |
Not provided
Not provided
Not provided
| Male |
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| Asian |
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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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| Finland |
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| Poland |
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| Russia |
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| Serbia |
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| Slovakia |
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| South Africa |
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| Ukraine |
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| United Kingdom |
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| Counts |
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| Participants |
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