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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05293184




Registration number
NCT05293184
Ethics application status
Date submitted
27/06/2017
Date registered
24/03/2022

Titles & IDs
Public title
The Global Angelman Syndrome Registry
Scientific title
The Global Angelman Syndrome Registry
Secondary ID [1] 0 0
RG-16-078-AM01
Universal Trial Number (UTN)
Trial acronym
GASR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Angelman Syndrome 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Neurological 0 0 0 0
Other neurological disorders
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Individuals with Angelman Syndrome - Individuals from birth to adulthood with Angelman Syndrome
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Gather longitudinal data on individuals living with Angelman Syndrome
Timepoint [1] 0 0
70 years (lifespan)

Eligibility
Key inclusion criteria
* Diagnosis of Angelman Syndrome
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/09/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2099
Actual
Sample size
Target
5000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Queensland University of Technology - Brisbane
Recruitment postcode(s) [1] 0 0
4000 - Brisbane

Funding & Sponsors
Primary sponsor type
Other
Name
Foundation for Angelman Syndrome Therapeutics, Australia
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Queensland University of Technology
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Helen (Honey) Heussler, MBBS, FRACP DM
Address 0 0
The University of Queensland
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Megan Tones, PhD
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
curator@angelmanregistry.info
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All external researchers wishing to recruit registry participants for clinical trials or access data are encouraged to review the information on our website (https://www.angelmanregistry.info/collaborate-with-us/) and contact the data curator (curator@angelmanregistry.info)

Supporting document/s available: Study protocol, Informed consent form (ICF)
When will data be available (start and end dates)?
Duration of project.
Available to whom?
External researchers wishing to access registry data or recruit participants must comply with the directions outlined above.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://angelmanregistry.info


What supporting documents are/will be available?

TypeOther DetailsAttachment
Informed consent form https://cdn.clinicaltrials.gov/large-docs/84/NCT05293184/ICF_000.pdf



Results publications and other study-related documents



Results not provided in https://clinicaltrials.gov/study/NCT05293184