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Clinical Trials/2023-508413-16-00
2023-508413-16-00
Recruiting
Phase 2

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

Assistance Publique Hopitaux De Paris2 sites in 1 country24 target enrollmentStarted: March 27, 2024Last updated:
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Overview

Phase
Phase 2
Status
Recruiting
Enrollment
24
Locations
2
Primary Endpoint
The primary outcome will be the proportion of motor attacks stopped 30 minutes after the beginning of motor symptoms over 5 weeks.
OverviewEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

The aim of the study is to assess the effect of high-flow oxygen administration (against placebo) as an acute treatment of dystonic and plegic attacks

Eligibility Criteria

Ages
0 years to 65+ years (0-17 Years, 65+ Years, 18-64 Years)
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Age > 1 year old
  • •Patients able to administrate high-flow oxygen through a non rebreathing facial mask, either alone or with assistance
  • •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
  • •Absence of long-term treatment or long-term treatment stable over the last month and during the duration of the trial
  • •Patients able to give written informed consent
  • •Affiliation to social insurance

Exclusion Criteria

  • •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)
  • •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
  • •Women that are pregnant (a negative pregnancy test is required for inclusion) or breath feeding
  • •Patients involved in an other clinical trial

Outcomes

Primary Outcomes

The primary outcome will be the proportion of motor attacks stopped 30 minutes after the beginning of motor symptoms over 5 weeks.

The primary outcome will be the proportion of motor attacks stopped 30 minutes after the beginning of motor symptoms over 5 weeks.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Hospital/Clinic/Other health care facility
Responsible Party
Principal Investigator
Principal Investigator

Pr Flamand-Roze

Scientific

Assistance Publique Hopitaux De Paris

Study Sites (2)

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