Pimavanserin for Autism Spectrum Disorder (ASD)

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Autism Spectrum Disorder (ASD)Pimavanserin - Drug
Eligibility
5 - 18
All Sexes
What conditions do you have?
Select

Study Summary

This trial is an open-label extension of the double-blind study, which means that all participants will receive pimavanserin for an additional 52 weeks. The purpose of this trial is to determine the long-term safety and tolerability of pimavanserin in this population.

Eligible Conditions
  • Autism Spectrum Disorder (ASD)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: 52 weeks

52 weeks
Irritable Mood
Therapeutic procedure

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Open-label Treatment
33%sleepiness
17%skin irritation
17%weight gain
17%dry mouth
17%headache
17%arthralgia
17%diarrhea
This histogram enumerates side effects from a completed 2021 Phase 4 trial (NCT04188392) in the Open-label Treatment ARM group. Side effects include: sleepiness with 33%, skin irritation with 17%, weight gain with 17%, dry mouth with 17%, headache with 17%.

Trial Design

1 Treatment Group

Pimavanserin
1 of 1

Experimental Treatment

228 Total Participants · 1 Treatment Group

Primary Treatment: Pimavanserin · No Placebo Group · Phase 2 & 3

Pimavanserin
Drug
Experimental Group · 1 Intervention: Pimavanserin · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pimavanserin
2018
Completed Phase 4
~2410

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 52 weeks

Who is running the clinical trial?

ACADIA Pharmaceuticals Inc.Lead Sponsor
40 Previous Clinical Trials
8,710 Total Patients Enrolled

Eligibility Criteria

Age 5 - 18 · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have completed the treatment period of study ACP-103-069.
You are female and not pregnant or able to become pregnant.