World Health Organization site
Skip Navigation Links

Main
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 11 January 2021
Main ID:  NCT04020848
Date of registration: 12/07/2019
Prospective Registration: Yes
Primary sponsor: Hospices Civils de Lyon
Public title: Observe Alternating Hemiplegia of Childhood (OBSERV-AHC) Study OBSERV-AHC
Scientific title: Observe Alternating Hemiplegia of Childhood (OBSERV-AHC) Prospective Observational Natural History and Therapy Study
Date of first enrolment: October 28, 2019
Target sample size: 20
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT04020848
Study type:  Observational
Study design:   
Phase: 
Countries of recruitment
France
Contacts
Name:     Eleni PANAGIOTAKAKI, MD
Address: 
Telephone: 4 27 85 60 60
Email: eleni.panagiotakaki@chu-lyon.fr
Affiliation: 
Name:     Eleni PANAGIOTAKAKI, Dr
Address: 
Telephone: 4 27 85 60 60
Email: eleni.panagiotakaki@chu-lyon.fr
Affiliation: 
Name:     Eleni PANAGIOTAKAKI, Dr
Address: 
Telephone:
Email:
Affiliation:  Hospices Civils de Lyon
Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients who fit the Aicardi Alternating Hemiplegia of Childhood clinical criteria of any
age. The Aicardi Criteria are six :

- Paroxysmal hemiplegia episodes.

- Bilateral hemiplegia or quadriplegia episodes.

- Other paroxysmal manifestations, such as abnormal eye movements, nystagmus,
strabismus, ataxia, dystonia, choreoathetosis, tonic spells, or autonomic
disturbances.

- Evidence of permanent neurological dysfunction, which can manifest as cognitive
impairment, developmental delay, and/or persistent motor deficits such as spastic
diplegia/quadriplegia, hypotonia, ataxia, choreoathetosis, or dystonia.

- Sleep relieves symptoms, although attacks may resume soon after awakening.

- First signs of dysfunction occur prior to the age of 18 months.

Exclusion Criteria:

- Patients who do not have a mutation of the ATP1A3 gene and having only some of the
above criteria

- Patients and / or their parents / legal guardian having provided their opposition to
the study.

- Incapacity of patient / parent or other referent adult to participate in the
prospective phase of observation of different paroxysmal events of the disease and in
the scoring of the Vineland II adaptive behavior scales.

- Diagnosis of another disease, which could explain the presence of symptoms mentioned
in the criteria of Aicardi.



Age minimum: N/A
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Alternating Hemiplegia
Intervention(s)
Other: Review of past medical history, clinical exam, and electroencephalogram, polysomnography and urine samples of melatonin and pupillometry.
Other: The patients' parents have to complete the VINELAND II adaptive behavior scales scoring, The Sleep Disturbance Scale for Children (SDSC) and Horne & Ostberg Circadian Typology Questionnaire
Primary Outcome(s)
final index compared to the initial index of non-paroxysmal disability [Time Frame: 1 year: Inclusion Visit up to 1 year visit]
Secondary Outcome(s)
Secondary ID(s)
2019-A00860-57
69HCL19_0199
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history