Actively Recruiting

Age: 6Months - 17Years
MALE
NCT05659901

Rocket Study: A Study to Characterize Biomarkers and Disease Progression in Participants With Pelizaeus-Merzbacher Disease

Led by Ionis Pharmaceuticals, Inc. · Updated on 2026-04-17

32

Participants Needed

9

Research Sites

334 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The purpose of the study is to prospectively assess longitudinal changes in proteolipid protein 1 (PLP1) protein, disease-related biomarkers in cerebral spinal fluid (CSF) and blood, neuroimaging parameters relevant to Pelizaeus-Merzbacher disease (PMD) and longitudinal changes in performance on clinical, participant, and caregiver-reported outcome assessments to inform the development of therapies for PMD.

CONDITIONS

Official Title

Rocket Study: A Study to Characterize Biomarkers and Disease Progression in Participants With Pelizaeus-Merzbacher Disease

Who Can Participate

Age: 6Months - 17Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Participant has a parent or caregiver capable of providing informed consent and attending all study visits
  • Diagnosis of Pelizaeus-Merzbacher Disease with genetic confirmation of PLP1 duplication
  • Male aged 6 months to 17 years inclusive at time of consent with phenotype consistent with classic PMD
  • No contraindications for lumbar punctures, blood draws, neuroimaging, sedation, or other study procedures
Not Eligible

You will not qualify if you...

  • Clinically significant abnormalities in medical history or physical exam
  • More than 2 copies of the PLP1 gene
  • Any other conditions that would make the participant unsuitable or interfere with study participation according to the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 9 locations

1

Ionis Investigative Site

Atlanta, Georgia, United States, 30342

Actively Recruiting

2

Ionis Investigative Site

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

3

Ionis Investigative Site

Clermont-Ferrand, France

Active, Not Recruiting

4

Ionis Investigative Site

Le Kremlin-Bicêtre, France, 94270

Active, Not Recruiting

5

Ionis Investigative Site

Göttingen, Germany

Active, Not Recruiting

6

Ionis Investigative Site

Tel Aviv, Israel, 6423906

Actively Recruiting

7

Ionis Investigative Site

Milan, Italy, 20154

Actively Recruiting

8

Ionis Investigative Site

Amsterdam, Netherlands, 1081 HV

Actively Recruiting

9

Ionis Investigative Site

Leeds, United Kingdom, LS1 3EX

Actively Recruiting

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Research Team

I

Ionis Pharmaceuticals

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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