Rare disease drug safety tracked in new observational study

NCT ID NCT04476862

First seen Jun 24, 2026 · Last updated Jul 01, 2026 · Updated 3 times

Summary

This study follows 35 children with CLN2 disease (a rare, severe brain disorder) who are taking cerliponase alfa (Brineura). Researchers will monitor for side effects and serious reactions over time. The goal is to better understand the long-term safety of this enzyme replacement therapy.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance

cerliponase alfa (Brineura)

What this could lead to

If successful, this study will provide important safety data on long-term use of cerliponase alfa for CLN2 disease, helping guide future treatment.

What could go wrong

This is an observational study, not a controlled trial, so it cannot prove the drug works. It only monitors safety in a small group of 35 patients.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Conditions

The condition(s) this trial relates to.

late infantile neuronal ceroid lipofuscinosis 2 neuronal ceroid lipofuscinosis 2 Neuronal Ceroid-Lipofuscinoses

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Advent Health

    Orlando, Florida, 32803, United States

  • Arkansas Children's Hospital

    Little Rock, Arkansas, 72205, United States

  • Boston Children's Hospital,

    Boston, Massachusetts, 02115, United States

  • Children's Healthcare of Atlanta

    Atlanta, Georgia, 30329, United States

  • Children's Hospital Minnesota

    Minneapolis, Minnesota, 55404, United States

  • Children's Hospital of Colorado

    Aurora, Colorado, 80045, United States

  • Children's Hospital of Orange County

    Orange, California, 92868, United States

  • Children's National Hospital

    Washington D.C., District of Columbia, 20010, United States

  • Mt. Sinai School of Medicine

    New York, New York, 10029, United States

  • NYU Langone Medical Center

    New York, New York, 10017, United States

  • Nationwide Children's Hospital

    Columbus, Ohio, 43130, United States

  • Rush University Medical Center

    Chicago, Illinois, 60612, United States

  • Seattle Children's Hospital

    Seattle, Washington, 98145-5005, United States

  • Texas Children's Hospital

    Houston, Texas, 77030, United States

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104, United States

  • University of Rochester Medical Center

    Rochester, New York, 14642, United States