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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05293184
Registration number
NCT05293184
Ethics application status
Date submitted
27/06/2017
Date registered
24/03/2022
Date last updated
23/02/2024
Titles & IDs
Public title
The Global Angelman Syndrome Registry
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Scientific title
The Global Angelman Syndrome Registry
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Secondary ID [1]
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RG-16-078-AM01
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Universal Trial Number (UTN)
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Trial acronym
GASR
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Angelman Syndrome
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Condition category
Condition code
Human Genetics and Inherited Disorders
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0
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Other human genetics and inherited disorders
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Neurological
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Other neurological disorders
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Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Observational [Patient Registry]
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Other interventions - Observational study only
Individuals with Angelman Syndrome - Individuals from birth to adulthood with Angelman Syndrome
Other interventions: Observational study only
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Gather longitudinal data on individuals living with Angelman Syndrome
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Assessment method [1]
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Parent/ caregiver reporting on diagnosis, clinical status, and patient-reported outcomes of individual living with Angelman Syndrome. This will be achieved by inviting parents/ caregivers with additional questionnaire like modules, and tracking changes in their responses over time.
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Timepoint [1]
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70 years (lifespan)
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Eligibility
Key inclusion criteria
- Diagnosis of Angelman Syndrome
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
-
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
28/09/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/12/2099
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Actual
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Sample size
Target
5000
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Queensland University of Technology - Brisbane
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Recruitment postcode(s) [1]
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4000 - Brisbane
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Funding & Sponsors
Primary sponsor type
Other
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Name
Foundation for Angelman Syndrome Therapeutics, Australia
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Queensland University of Technology
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
The Global Angelman Syndrome Registry is an online patient organisation driven registry to
collect information about the natural history of children and adults with Angelman Syndrome.
The registry will facilitate 1) recruitment for clinical trials into therapies and
interventions to benefit participants with Angelman Syndrome and their families, and 2)
advancement of research and best standards of care for Angelman Syndrome.
The registry is currently available in English, Spanish, Traditional Chinese, Italian,
Polish, Hindi, and Brazilian Portuguese.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05293184
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Trial related presentations / publications
Napier KR, Tones M, Simons C, Heussler H, Hunter AA, Cross M, Bellgard MI. A web-based, patient driven registry for Angelman syndrome: the global Angelman syndrome registry. Orphanet J Rare Dis. 2017 Aug 1;12(1):134. doi: 10.1186/s13023-017-0686-1.
Tones M, Cross M, Simons C, Napier KR, Hunter A, Bellgard MI, Heussler H. Research protocol: The initiation, design and establishment of the Global Angelman Syndrome Registry. J Intellect Disabil Res. 2018 May;62(5):431-443. doi: 10.1111/jir.12482.
Tones M, Zeps N, Wyborn Y, Smith A, Barrero RA, Heussler H, Cross M, McGree J, Bellgard M. Does the registry speak your language? A case study of the Global Angelman Syndrome Registry. Orphanet J Rare Dis. 2023 Oct 19;18(1):330. doi: 10.1186/s13023-023-02904-1.
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Public notes
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Contacts
Principal investigator
Name
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Helen (Honey) Heussler, MBBS, FRACP DM
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Address
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The University of Queensland
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Megan Tones, PhD
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Address
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Country
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Phone
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05293184
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