OXYTAHANE - Oxygen therapy: Acute Treatment for paroxysmal dystonic or plegic attacks in alternating hemiplegia of childhood

Phase 1

• Conditions: Alternating Hemiplegia of Childhood; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: CTIS2023-508413-16-00
• Lead Sponsor: Assistance Publique Hopitaux De Paris

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-21
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified