Using oxygen to treat acute attacks in children with alternating hemiplegia
Official title: Oxygen Therapy As an Acute Treatment for Dystonic And/or Plegic Attacks in Alternating Hemiplegia of Childhood
Run by Assistance Publique - Hôpitaux de Paris · NCT06248645 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study is testing whether high-flow oxygen can help stop sudden attacks in children with Alternating Hemiplegia of Childhood.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 1 Year and up |
| Sex | All |
| Enrollment | 24 (estimated) |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 2 sites (Lyon and 1 other locations) |
| Trial ID | NCT06248645 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children over 1 year old diagnosed with AHC due to ATP1A3 mutations who experience at least one dystonic or plegic attack per week.
✕Probably not a fit
Patients with severe respiratory diseases or those unable to follow the study protocol may not benefit from this treatment.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the use of high-flow oxygen as an acute treatment for dystonic and plegic attacks in children with Alternating Hemiplegia of Childhood (AHC), a rare neurodevelopmental disorder. The study is designed as a multicenter, randomized, placebo-controlled, double-blind crossover trial, where participants will receive either oxygen or a placebo (medical air) in two successive treatment periods. The primary outcome is the proportion of motor attacks that stop within 30 minutes of symptom onset over a 5-week period. Secondary outcomes include the duration of attacks, quality of life assessments, frequency of attacks, and treatment tolerance.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the management of acute attacks in children with AHC, enhancing their quality of life.
How similar studies have gone: While this approach is novel for AHC, previous studies have shown promising results with oxygen therapy in other conditions, suggesting potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age \> 1 year old 2. Patients able to administrate high-flow oxygen through a non rebreathing facial mask, either alone or with assistance 3. Patients with a diagnosis of AHC caused by ATP1A3 mutations presenting at least one dystonic or plegic attack per week lasting more than 30 minutes 4. Absence of long-term treatment or long-term treatment stable over the last month and during the duration of the trial 5. Patients able to give written informed consent 6. Affiliation to social insurance Exclusion Criteria: 1. Inability for the patients and/or caregivers to follow the protocol (inability to read or understand the instructions, no access to smartphone or computer to fill the informatics patient's form) 2. Patients with severe or uncontrolled obstructive or restrictive chronic respiratory disease (asthma, COPD, obesity, neuromuscular disease), acute systemic aggression (acute coronary syndrome, stroke, sepsis, head trauma) or congenital cardiopathy with a risk of hypercapnia following oxygen administration 3. Women that are pregnant (a negative pregnancy test is required for inclusion) or breath feeding 4. Patients involved in an other clinical trial
Where it's running
-
Hôpital Pitié Salpêtrière
Paris, France Recruiting -
Hcl Lyon
Lyon, France Not yet recruiting
Study contacts
- Study coordinator: Emmanuel Flamand-Roze, MD, PhD
- Email: flamand.roze.75012@gmail.com
- Phone: 0142162748
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.