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The study was terminated for business reasons and not due to safety concerns.
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52-week, open-label extension study of double-blind study ACP-103-069 to determine the long-term safety and tolerability of pimavanserin for the treatment of irritability associated with ASD in children and adolescents (aged 5 to 17 years).
ACP-103-069 is a 6-week, randomized, double-blind, fixed-dose, placebo controlled, parallel group study of pimavanserin in children and adolescents with irritability associated with autism spectrum disorder (ASD).
This study will be conducted as a 52-week, open-label extension study of the antecedent double-blind study to determine the long-term safety and tolerability of pimavanserin for the treatment of irritability associated with ASD in children and adolescents (5 through 17 years old at the time of enrolling into the antecedent double-blind study).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pimavanserin | Experimental | Pimavanserin once daily. All patients will receive the pimavanserin low dose (patients aged 5 to 12 years: 10 mg/day pimavanserin; patients aged 13 to 17 years: 20 mg/day) the first 2 weeks of the study. Thereafter, the dose may be increased to the high dose (5 to 12 years: 20 mg/day; 13 to 17 years: 34 mg/day) based on the Investigator's assessment of clinical response. After Week 2 and up to Week 20, dose adjustments are allowed at any clinic visit based on the Investigator's assessment of clinical response and tolerability. No further dose adjustments are allowed after Week 20. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pimavanserin | Drug | Pimavanserin given once daily, as capsule of 10, 20, or 34 mg dose strength, respectively, according to the patient's age |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-emergent Adverse Events | Number (%) of patients with treatment emergent adverse events | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Aberrant Behavior Checklist-Irritability (ABC-I) and Clinical Global Impression-Improvement (CGI-I) Response Rate | The response rate was defined as the proportion of patients with at least 25% reduction from baseline to Week 52 in ABC-I and a CGI-I of irritability score of 1 (very much improved) or 2 (much improved) at Week 52, compared to baseline. Baseline was the baseline of the antecedent double-blind study APC-103-069. The ABC is a parent/caregiver-rated scale comprised of 5 subscales encompassing 58 items. Subscales are irritability, lethargy, stereotypic behavior, hyperactivity, and inappropriate speech. Items are rated on a 4-point Likert scale ranging from 0 (not at all a problem) to 3 (the problem is severe), with higher scores indicating more severe problems. Subscale scores are calculated by summing the items within that subscale. The CGI-I is a clinician-rated, 7-point scale to assess how much the patient's illness (here: the patient's irritability) has changed relative to baseline. Scores range from 1 (very much improved) to 7 (very much worse). |
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INCLUSION CRITERIA:
EXCLUSION CRITERIA:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southwest Autism Research and Resource Center | Phoenix | Arizona | 85006 | United States | ||
| Cortica Inc. (Glendale) |
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This was an open-label extension study of the antecedent double-blind study ACP-103-069. Patients were eligible for this study if they had completed the treatment period of study ACP-103-069.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pimavanserin | Pimavanserin once daily administered using age-based dosing:
|
| 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 | Feb 29, 2024 | Oct 29, 2025 |
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| 52 weeks |
| Glendale |
| California |
| 91361 |
| United States |
| Cortica Inc. | San Rafael | California | 94903 | United States |
| 1st Allergy and Clinical Research Group, d/b/a IMUNOe Research Centers | Centennial | Colorado | 80112 | United States |
| Children's Research Institute | Washington D.C. | District of Columbia | 20010 | United States |
| The EHS Medical Practice, PA, D/B/A Sarkis Clinical Trials | Gainesville | Florida | 32607 | United States |
| APG Research, LLC | Orlando | Florida | 32803-3809 | United States |
| AMR Baber Research Incorporated | Naperville | Illinois | 60563 | United States |
| Clinical Research of Southern Nevada, LLC | Las Vegas | Nevada | 89128 | United States |
| ERG Clinical Research - New York, PLLC DBA Richmond Behavioral Associates | Staten Island | New York | 10314 | United States |
| Quest Therapeutics of Avon Lake dba Haidar Almhana Nieding LLC | Avon Lake | Ohio | 44012 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19146 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Relaro Medical Trials, LLC | Dallas | Texas | 75243 | United States |
| Red Oak Psychiatry Associates, PA | Houston | Texas | 77090 | United States |
| AIM Trials, LLC | Plano | Texas | 75093 | United States |
| Eastside Therapeutic Resource, Inc. dba Core Clinical Research | Everett | Washington | 98201 | United States |
| Children's Health Queensland Hospital and Health Service | South Brisbane | Queensland | 4101 | Australia |
| Monash Health | Clayton | Victoria | 3168 | Australia |
| Murdoch Children's Research Institute | Parkville | Victoria | 3052 | Australia |
| Centre Hospitalier Charles Perrens | Bordeaux | 33076 | France |
| Centre de Ressources Autisme Rhône-Alpes - Center Hospitalier le Vinatier | Bron | 69678 | France |
| CHU de Nantes | Nantes | 44093 | France |
| L'Assistance Publique - Hôpitaux de Paris, labélisé Institut Carnot | Paris | 75019 | France |
| Magyarországi Református Egyház Bethesda Gyermekkórháza | Budapest | H-1146 | Hungary |
| Békés Megyei Központi Kórház | Gyula | H-5700 | Hungary |
| Szegedi Tudományegyetem | Szeged | H-6725 | Hungary |
| La Nostra Famiglia - Scientifica IRCCS Eugenio Medea | Bosisio Parini | LC | 23842 | Italy |
| Policlinico Riuniti - Azienda Ospedaliero Universitaria | Foggia | 71122 | Italy |
| Azienda Ospedaliera Universitaria "Federico II" | Naples | 80131 | Italy |
| Fondazione Istituto Neurologico Nazionale Casimiro Mondino - IRCCS | Pavia | 27100 | Italy |
| Fondazione PTV - Policlinico Tor Vergata | Rome | 00133 | Italy |
| Azienda Ospedaliera Universitaria Integrata di Verona (AOUI) | Verona | 37126 | Italy |
| Gdańskie Centrum Zdrowia Sp. z o.o. | Gdansk | 80-542 | Poland |
| Centrum Badań Klinicznych PI-House Sp. z o.o. | Gdansk | 80-546 | Poland |
| NAVICULA - Centrum Diagnozy i Terapii Autyzmu | Lodz | 91-129 | Poland |
| Ginemedica Sp. Zoo, S. K. | Wroclaw | 50-414 | Poland |
| Centrum Neuropsychiatrii Neuromed SP ZOZ | Wroclaw | 54-238 | Poland |
| MedicMental Indywidualna Specjalistyczna Praktyka Lekarska Monika Szewczuk-Boguslawska | Wroclaw | 54-617 | Poland |
| Institute of Mental Health | Belgrade | 11000 | Serbia |
| University Clinical Center Kragujevac, Clinic for Psychiatry | Kragujevac | 34000 | Serbia |
| University Clinical Center Nis, Center for Mental Health | Niš | 18000 | Serbia |
| Clinical Center of Vojvodina, Clinic for Psychiatry | Novi Sad | 21000 | Serbia |
| Hospital General de Alicante | Alicante | 03010 | Spain |
| Institut Global d´Atenció Integral del Neurodesenvolupament (IGAIN) | Barcelona | 08007 | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital ClÃnic de Barcelona | Barcelona | 08036 | Spain |
| COMPLETED |
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| NOT COMPLETED |
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All patients enrolled and treated
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| ID | Title | Description |
|---|---|---|
| BG000 | Pimavanserin | Pimavanserin once daily administered using age-based dosing:
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| 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 |
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| Region of Enrollment | Number | participants |
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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 | Treatment-emergent Adverse Events | Number (%) of patients with treatment emergent adverse events | All patients enrolled and treated | Posted | Count of Participants | Participants | 52 weeks |
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| ||||||||||||||||||||||||||
| Secondary | Aberrant Behavior Checklist-Irritability (ABC-I) and Clinical Global Impression-Improvement (CGI-I) Response Rate | The response rate was defined as the proportion of patients with at least 25% reduction from baseline to Week 52 in ABC-I and a CGI-I of irritability score of 1 (very much improved) or 2 (much improved) at Week 52, compared to baseline. Baseline was the baseline of the antecedent double-blind study APC-103-069. The ABC is a parent/caregiver-rated scale comprised of 5 subscales encompassing 58 items. Subscales are irritability, lethargy, stereotypic behavior, hyperactivity, and inappropriate speech. Items are rated on a 4-point Likert scale ranging from 0 (not at all a problem) to 3 (the problem is severe), with higher scores indicating more severe problems. Subscale scores are calculated by summing the items within that subscale. The CGI-I is a clinician-rated, 7-point scale to assess how much the patient's illness (here: the patient's irritability) has changed relative to baseline. Scores range from 1 (very much improved) to 7 (very much worse). | All patients enrolled and treated | Posted | Count of Participants | Participants | 52 weeks |
|
52 weeks (study terminated early by the sponsor)
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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 once daily administered using age-based dosing:
| 0 | 209 | 5 | 209 | 66 | 209 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Drug hypersensitivity | Immune system disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Pneumonia respiratory syncytial viral | Infections and infestations | MedDRA 26.1 | Non-systematic Assessment |
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| Heart rate irregular | Investigations | MedDRA 26.1 | Non-systematic Assessment |
| |
| Febrile convulsion | Nervous system disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Aggression | Psychiatric disorders | MedDRA 26.1 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 26.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 26.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 26.1 | Non-systematic Assessment |
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The study was terminated early by the Sponsor due to lack of efficacy in the antecedent double-blind study (ACP-103-069).
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. | 844-422-2342 | medicalinformation@acadia-pharm.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 19, 2025 | Nov 4, 2025 | 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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| Poland |
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| Italy |
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| France |
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| Serbia |
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| Australia |
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| Spain |
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