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Extension Study of Pimavanserin in Irritability Associated With Autism Spectrum Disorder

Primary Purpose

Irritability Associated With Autism Spectrum Disorder

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Pimavanserin
Sponsored by
ACADIA Pharmaceuticals Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritability Associated With Autism Spectrum Disorder

Eligibility Criteria

5 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

INCLUSION CRITERIA:

  • Has completed the treatment period of study ACP-103-069
  • Informed consent prior to the conduct of any study procedures
  • Continues to be both clinically stable and not at imminent risk of suicide or injury to self, others, or property
  • Continues to be medically stable at enrollment
  • For female patients only: unable to become pregnant or agree to use a highly effective non-hormonal method of contraception. Females of childbearing potential must have a negative pregnancy test

EXCLUSION CRITERIA:

  • Patient or parent/legally accepted representative is judged by the Investigator to be inappropriate for the study
  • Requires treatment with a medication prohibited by the protocol, including concomitant psychotropic drugs targeting irritability, including those used off-label (clonidine, guanfacine, and propranolol; lithium, valproate; stimulant and non-stimulant medications), medications that prolong the QT interval; and strong cytochrome P450 (CYP) 3A4 enzyme (CYP3A4) inhibitors and inducers
  • At a significant risk of suicide, or is a danger to self or others
  • At risk of significant violent behavior to the extent that participation would pose an undue risk to other patients, caregivers, or others
  • Positive urine drug test
  • Serious and/or unstable psychiatric, neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorder, including cancer or malignancies
  • Any change in medical or treatment status that may increase the risk associated with taking pimavanserin, would interfere with safety assessments, or would confound the interpretation of study results
  • Clinically significant abnormal ECG of protocol-defined cardiac conduction abnormalities
  • Weight <15 kg
  • Additional inclusion/exclusion criteria apply. Subjects will be evaluated at screening to ensure that all criteria for study participation are met.

Sites / Locations

  • Southwest Autism Research and Resource CenterRecruiting
  • Cortica Inc.Recruiting
  • Cortica Inc.Recruiting
  • 1st Allergy and Clinical Research Group, d/b/a IMUNOe Research CentersRecruiting
  • Children's Research InstituteRecruiting
  • The EHS Medical Practice, PA, D/B/A Sarkis Clinical TrialsRecruiting
  • APG Research, LLCRecruiting
  • AMR Baber Research IncorporatedRecruiting
  • Clinical Research of Southern Nevada, LLCRecruiting
  • ERG Clinical Research - New York, PLLC DBA Richmond Behavioral Associates
  • Quest Therapeutics of Avon Lake dba Haidar Almhana Nieding LLC
  • Cincinnati Children's Hospital Medical CenterRecruiting
  • Relaro Medical Trials, LLCRecruiting
  • Red Oak Psychiatry Associates, PARecruiting
  • Eastside Therapeutic Resource, Inc. dba Core Clinical ResearchRecruiting
  • CHU de NantesRecruiting
  • L'Assistance Publique - Hôpitaux de Paris, labélisé Institut CarnotRecruiting
  • Magyarországi Református Egyház Bethesda GyermekkórházaRecruiting
  • La Nostra Famiglia - Scientifica IRCCS Eugenio MedeaRecruiting
  • Policlinico Riuniti - Azienda Ospedaliero UniversitariaRecruiting
  • Fondazione Istituto Neurologico Nazionale Casimiro Mondino - IRCCSRecruiting
  • Gdańskie Centrum Zdrowia Sp. z o.o.Recruiting
  • Centrum Badań Klinicznych PI-House Sp. z o.o.Recruiting
  • Ginemedica Sp. Zoo, S. K.Recruiting
  • Centrum Neuropsychiatrii Neuromed SP ZOZRecruiting
  • MedicMental Indywidualna Specjalistyczna Praktyka Lekarska Monika Szewczuk-BoguslawskaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pimavanserin

Arm Description

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.

Outcomes

Primary Outcome Measures

Treatment-emergent adverse events
Number of Subjects With Adverse Events (AEs), Discontinuations Due to AEs and Serious AEs (SAEs) over 52 weeks of treatment. The Safety population consists of all subjects who received at least one dose of study drug in this study.

Secondary Outcome Measures

Evaluate the continued response to long-term pimavanserin treatment in children and adolescents with irritability associated with ASD, defined by a composite endpoint of ABC-I and CGI-I response.
Evaluate the continued response to long-term pimavanserin treatment in children and adolescents with irritability associated with ASD as assessed by a composite of a reduction in the Aberrant Behavior Checklist-Irritability (ABC-I) subscale score from baseline combined with a reduction in Clinical Global Impression-Improvement (CGI-I) of irritability score from baseline.

Full Information

First Posted
August 30, 2022
Last Updated
October 5, 2023
Sponsor
ACADIA Pharmaceuticals Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05555615
Brief Title
Extension Study of Pimavanserin in Irritability Associated With Autism Spectrum Disorder
Official Title
A 52-Week Open-Label Extension Study of Pimavanserin in Children and Adolescents With Irritability Associated With Autism Spectrum Disorder (ASD)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 2, 2022 (Actual)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ACADIA Pharmaceuticals Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
Detailed Description
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritability Associated With Autism Spectrum Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
228 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pimavanserin
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Pimavanserin
Other Intervention Name(s)
Nuplazid
Intervention Description
Pimavanserin given once daily, as capsule of 10, 20, or 34 mg dose strength, respectively, according to the patient's age
Primary Outcome Measure Information:
Title
Treatment-emergent adverse events
Description
Number of Subjects With Adverse Events (AEs), Discontinuations Due to AEs and Serious AEs (SAEs) over 52 weeks of treatment. The Safety population consists of all subjects who received at least one dose of study drug in this study.
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Evaluate the continued response to long-term pimavanserin treatment in children and adolescents with irritability associated with ASD, defined by a composite endpoint of ABC-I and CGI-I response.
Description
Evaluate the continued response to long-term pimavanserin treatment in children and adolescents with irritability associated with ASD as assessed by a composite of a reduction in the Aberrant Behavior Checklist-Irritability (ABC-I) subscale score from baseline combined with a reduction in Clinical Global Impression-Improvement (CGI-I) of irritability score from baseline.
Time Frame
52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA: Has completed the treatment period of study ACP-103-069 Informed consent prior to the conduct of any study procedures Continues to be both clinically stable and not at imminent risk of suicide or injury to self, others, or property Continues to be medically stable at enrollment For female patients only: unable to become pregnant or agree to use a highly effective non-hormonal method of contraception. Females of childbearing potential must have a negative pregnancy test EXCLUSION CRITERIA: Patient or parent/legally accepted representative is judged by the Investigator to be inappropriate for the study Requires treatment with a medication prohibited by the protocol, including concomitant psychotropic drugs targeting irritability, including those used off-label (clonidine, guanfacine, and propranolol; lithium, valproate), medications that prolong the QT interval; and strong cytochrome P450 (CYP) 3A4 enzyme (CYP3A4) inhibitors and inducers At a significant risk of suicide, or is a danger to self or others At risk of significant violent behavior to the extent that participation would pose an undue risk to other patients, caregivers, or others Positive urine drug test Serious and/or unstable psychiatric, neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorder, including cancer or malignancies Any change in medical or treatment status that may increase the risk associated with taking pimavanserin, would interfere with safety assessments, or would confound the interpretation of study results Clinically significant abnormal ECG of protocol-defined cardiac conduction abnormalities Weight <15 kg Additional inclusion/exclusion criteria apply. Subjects will be evaluated at screening to ensure that all criteria for study participation are met.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sharon Ortiz
Phone
646-397-7336
Email
Sharon.Ortiz@acadia-pharm.com
First Name & Middle Initial & Last Name or Official Title & Degree
Robert Hofbauer
Phone
609-250-6221
Email
rhofbauer@acadia-pharm.com
Facility Information:
Facility Name
Southwest Autism Research and Resource Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Individual Site Status
Recruiting
Facility Name
Cortica Inc.
City
San Rafael
State/Province
California
ZIP/Postal Code
94903
Country
United States
Individual Site Status
Recruiting
Facility Name
Cortica Inc.
City
Westlake Village
State/Province
California
ZIP/Postal Code
91361
Country
United States
Individual Site Status
Recruiting
Facility Name
1st Allergy and Clinical Research Group, d/b/a IMUNOe Research Centers
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Individual Site Status
Recruiting
Facility Name
Children's Research Institute
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Name
The EHS Medical Practice, PA, D/B/A Sarkis Clinical Trials
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Individual Site Status
Recruiting
Facility Name
APG Research, LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803-3809
Country
United States
Individual Site Status
Recruiting
Facility Name
AMR Baber Research Incorporated
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60563
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research of Southern Nevada, LLC
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Individual Site Status
Recruiting
Facility Name
ERG Clinical Research - New York, PLLC DBA Richmond Behavioral Associates
City
Staten Island
State/Province
New York
ZIP/Postal Code
10314
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Quest Therapeutics of Avon Lake dba Haidar Almhana Nieding LLC
City
Avon Lake
State/Province
Ohio
ZIP/Postal Code
44012
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Name
Relaro Medical Trials, LLC
City
Dallas
State/Province
Texas
ZIP/Postal Code
75243
Country
United States
Individual Site Status
Recruiting
Facility Name
Red Oak Psychiatry Associates, PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Individual Site Status
Recruiting
Facility Name
Eastside Therapeutic Resource, Inc. dba Core Clinical Research
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Individual Site Status
Recruiting
Facility Name
CHU de Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Name
L'Assistance Publique - Hôpitaux de Paris, labélisé Institut Carnot
City
Paris
ZIP/Postal Code
75019
Country
France
Individual Site Status
Recruiting
Facility Name
Magyarországi Református Egyház Bethesda Gyermekkórháza
City
Budapest
ZIP/Postal Code
H-1146
Country
Hungary
Individual Site Status
Recruiting
Facility Name
La Nostra Famiglia - Scientifica IRCCS Eugenio Medea
City
Bosisio Parini
State/Province
LC
ZIP/Postal Code
23842
Country
Italy
Individual Site Status
Recruiting
Facility Name
Policlinico Riuniti - Azienda Ospedaliero Universitaria
City
Foggia
ZIP/Postal Code
71122
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fondazione Istituto Neurologico Nazionale Casimiro Mondino - IRCCS
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Gdańskie Centrum Zdrowia Sp. z o.o.
City
Gdańsk
ZIP/Postal Code
80-542
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Badań Klinicznych PI-House Sp. z o.o.
City
Gdańsk
ZIP/Postal Code
80-546
Country
Poland
Individual Site Status
Recruiting
Facility Name
Ginemedica Sp. Zoo, S. K.
City
Wrocław
ZIP/Postal Code
50-414
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Neuropsychiatrii Neuromed SP ZOZ
City
Wrocław
ZIP/Postal Code
54-238
Country
Poland
Individual Site Status
Recruiting
Facility Name
MedicMental Indywidualna Specjalistyczna Praktyka Lekarska Monika Szewczuk-Boguslawska
City
Wrocław
ZIP/Postal Code
54-617
Country
Poland
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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Extension Study of Pimavanserin in Irritability Associated With Autism Spectrum Disorder

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