← Back to Search

Other

trofinetide for Rett Syndrome

Phase 3

Waitlist Available

Research Sponsored by ACADIA Pharmaceuticals Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 32 months

Awards & highlights

Study Summary

This trial will study the safety and tolerability of the drug trofinetide in girls and women with Rett syndrome.

Eligible Conditions

Rett Syndrome

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 32 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~32 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 32 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of subjects with post-Baseline potentially clinically important changes in ECG

Number of subjects with post-Baseline potentially clinically important changes in body weight

Number of subjects with post-Baseline potentially clinically important changes in laboratory parameters

+6 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Drug - trofinetideExperimental Treatment1 Intervention

trofinetide oral solution

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

trofinetide

2020

Completed Phase 3

~80

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

ACADIA Pharmaceuticals Inc.Lead Sponsor

46 Previous Clinical Trials

10,862 Total Patients Enrolled

3 Trials studying Rett Syndrome

356 Patients Enrolled for Rett Syndrome

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Would this experiment involving human subjects be open to individuals who are over 55 years old?

"The required age parameters for participants of this study are 5 to 22 years old."

Answered by AI

Can we sign up for this research project now?

"No, at this time the study is not recruiting patients. The clinical trial was first posted on November 8th 2020 and last updated on August 10th 2022. There are 1448 other studies that are currently looking for candidates though."

Answered by AI

At how many different medical facilities is this trial being conducted?

"This clinical trial is available at 21 locations, some of which include the Texas Children's Hospital in Houston, Cleveland Clinic in Cleveland, and UC Davis MIND Institute in Sacramento."

Answered by AI

What type of patient would be a good candidate to participate in this clinical trial?

"As stated in the eligibility requirements, individuals with Rett syndrome that are aged betweeen 5 to 22 years old can participate in this 153-person clinical trial."

Answered by AI

Are there any dangers associated with trofinetide that people should be aware of?

"There is already some evidence of trofinetide's efficacy and it has undergone multiple rounds of testing, so its safety was rated a 3."

Answered by AI

Are there any existing precedents for trofinetide's efficacy?

"Emory Genetics Clinical Trial Center first studied trofinetide in 2020. 9 clinical trials have completed since then, with 2 more presently underway. The majority of these studies are based in Houston, Texas."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Open-Label Extension Study of Trofinetide for Rett Syndrome

2020. "Open-Label Extension Study of Trofinetide for Rett Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04776746.