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Clinical Trials/CTIS2023-508413-16-00
CTIS2023-508413-16-00
Active, not recruiting
Phase 1

OXYTAHANE - Oxygen therapy: Acute Treatment for paroxysmal dystonic or plegic attacks in alternating hemiplegia of childhood - APHP230673

Assistance Publique Hopitaux De Paris0 sites24 target enrollmentDecember 21, 2023

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Alternating Hemiplegia of Childhood
Sponsor
Assistance Publique Hopitaux De Paris
Enrollment
24
Status
Active, not recruiting
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 21, 2023
End Date
TBD
Last Updated
last year
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility 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

Outcomes

Primary Outcomes

Not specified

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