HEmiplegia Arrhythmia Retrospective Trial

Completed

• Conditions: Alternating Hemiplegia of Childhood
• Interventions: Other: Recording of clinical parameters and electrocardiogram parameters

• Registration Number: NCT04944927
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

Alternating Hemiplegia of Childhood (AHC) is a rare and severe disease that is in need of effective, and hopefully even curative, therapies. Afflicted patients suffer from severe paralyzing crises, often excruciatingly painful muscle spasms, severe often life threatening epileptic seizures, frequently severe developmental and psychiatric/psychological disabilities and other comorbidities, such as cardiac disturbances. Recent data indicate that AHC genotype is in relation to cardiac repolarization troubles and to cardiac arrhythmias. The primary hypothesis to explore is that there is an association between genotype and cardiac phenotype in AHC.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-04-29
• Study First Submitted: 2021-06-02
• Study First Submitted QC: 2021-06-21
• Study First Posted: 2021-06-30
• Primary Completion: 2021-12-29
• Study Completion: 2022-06-29
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-20
• Last Update Posted: 2023-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patients that meet the clinical diagnostic criteria (Aicardi et al, 1995) for typical alternating hemiplegia with or without identified mutations in ATP1A3.
• At least one ECG study is required.
• Patients ages yearand more

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Exclusion Criteria

• Informed consent or assent not obtainable
• ATP1A3 testing not performed
• No ECG studies are available

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with Alternating Hemiplegia of Childhood	Recording of clinical parameters and electrocardiogram parameters	Patients that meet the clinical diagnostic criteria (Aicardi et al, 1995) for typical alternating hemiplegia with or without identified mutations in ATP1A3. At least one prolonged ECG study available is required.

Primary Outcome Measures

Name	Time	Method
Measurement of QTc interval and all relevant cardiac repolarization measurements	Day 1	Outcome measure: QTc interval and cardiac repolarization measurement in milliseconds.

Trial Locations

Locations (1)

Department of Clinical Epileptology, Sleep Disorders and Functional Neurology in Children, Hôpital Femme Mère Enfant, University Hospitals of Lyon (Hospices Civils de Lyon); 🇫🇷 Bron, France