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Study of Trofinetide for the Treatment of Girls and Women With Rett Syndrome (LAVENDER™)

NCT04181723 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 187

Last updated 2024-04-08

Study results available
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Summary

To investigate the efficacy of treatment with oral trofinetide versus placebo in females with Rett syndrome

Conditions

Interventions

DRUG

Trofinetide

Trofinetide solution administered based on the subject's weight at Baseline, twice daily for 12 weeks

OTHER

Placebo

Trofinetide placebo solution administered based on the subject's weight at Baseline, twice daily for 12 weeks

Sponsors & Collaborators

  • ACADIA Pharmaceuticals Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
20 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-06
Primary Completion
2021-10-28
Completion
2021-10-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04181723 on ClinicalTrials.gov