Pregnancy safety of friedreich ataxia drug under scrutiny

NCT ID NCT06628687

Recruiting now Knowledge-focused Sponsor: Biogen Source: ClinicalTrials.gov ↗

First seen Jul 10, 2026 · Last updated Jul 10, 2026

Summary

This study tracks women with Friedreich ataxia who took the drug omaveloxolone (SKYCLARYS) during pregnancy or while breastfeeding. Researchers will watch for birth defects, pregnancy complications, and health problems in the baby during the first year of life. The goal is to better understand the risks of using this medication around the time of childbirth.

What this could mean

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

Active substance: omaveloxolone (SKYCLARYS)
What this could lead to: If safe, this could confirm that omaveloxolone can be used during pregnancy or breastfeeding without major harm to the baby.
What could go wrong: This is a small observational study with only 10 participants, so results may not apply to everyone. It cannot prove cause and effect.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

Friedreich ataxia

As listed by the trial registrant

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

FRIEDREICH ATAXIA

Contacts and locations

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Study contacts

Contact

Email: •••••@•••••
Contact

Phone: •••-•••-•••• Email: •••••@•••••

Locations

Evidera
RECRUITING

Morrisville, North Carolina, 27560, United States

Contact Phone: •••-•••-••••

Contact

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