RecruitingPhase 1Phase 2NCT06430385

ATTUNE: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intrathecally-Administered ION440 in Participants With Methyl CpG Binding Protein 2 (MECP2) Duplication Syndrome (MDS)

A Phase 1-2, Double-Blind, Sham-Controlled Multiple Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intrathecally-Administered ION440 in Patients With MECP2 Duplication Syndrome


Sponsor

Ionis Pharmaceuticals, Inc.

Enrollment

48 participants

Start Date

Oct 21, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The primary purpose of this study is to evaluate the safety and tolerability of ION440.


Eligibility

Sex: MALEMin Age: 2 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called ION440 and Sham procedure for people with methyl cpg binding protein 2 (mecp2) duplication syndrome. The study is currently recruiting participants at 11 locations. People eligible for this study include men aged 2 Years to 65 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGION440

ION440 will be administered by intrathecal bolus (ITB) injection.

PROCEDURESham procedure

An LP will be performed with CSF collection but will not be followed by the administration of study treatment by ITB injection.


Locations(11)

Rady Children's Hospital

San Diego, California, United States

University of Colorado Hopsital - Anschutz Medical Campus

Aurora, Colorado, United States

Kennedy Krieger

Baltimore, Maryland, United States

Boston Children's Hospital

Boston, Massachusetts, United States

Gillette Children's Specialty Healthcare

Saint Paul, Minnesota, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Baylor College of Medicine

Houston, Texas, United States

Kepler University Hospital

Linz, Austria

CHU Dijon Bourgogne

Dijon, France

Hospital Saint Joan de Deu

Barcelona, Spain

View Full Details on ClinicalTrials.gov

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NCT06430385