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Angelman Syndrome Italian Registry (RISA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03650569
Recruitment Status : Recruiting
First Posted : August 28, 2018
Last Update Posted : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
Fondazione per la Ricerca Ospedale Maggiore

Tracking Information
First Submitted Date June 26, 2018
First Posted Date August 28, 2018
Last Update Posted Date August 28, 2018
Actual Study Start Date February 16, 2018
Estimated Primary Completion Date February 16, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 27, 2018)
Medical and behavioral problems [ Time Frame: 3 years ]
Medical and behavioral problems associated with Angelman syndrome and their prevalence.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Angelman Syndrome Italian Registry
Official Title Italian Angelman Syndrome Registry Protocol
Brief Summary The Italian Angelman Registry is a national registry for patients with Angelman Syndrome. No experimental intervention is involved in participation. The data provided are stored in the registry according the EU General Data Protection Regulation (GDPR, enforced on 25 May 2018), unless participants wish to withdraw their child/ adult's information from the registry.
Detailed Description Parents/caregivers of a child or an adult with Angelman Syndrome living in Italy are eligible to insert data in this registry. The individuals must have a diagnosis of Angelman Syndrome confirmed by genetic testing results. The registry has been launched in February 2018 in coincidence with the International Angelman Day and the recruitment will be open until February 2021.
Study Type Observational [Patient Registry]
Study Design Observational Model: Family-Based
Time Perspective: Other
Target Follow-Up Duration 36 Months
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with Angelman syndrome (molecular and clinical diagnosis) from the ages of 1 day onwards
Condition Angelman Syndrome
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 27, 2018)
300
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 16, 2021
Estimated Primary Completion Date February 16, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Molecular diagnosis of Angelman syndrome

Exclusion Criteria:

  • Does not meet diagnostic criteria for Angelman Syndrome Other medical or genetic disorders (except autism)
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Pier Luigi Carriero, MD + 390352675134 registroangelman@asst-pg23.it
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT03650569
Other Study ID Numbers Version 1 08.02.2018
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Fondazione per la Ricerca Ospedale Maggiore
Study Sponsor Fondazione per la Ricerca Ospedale Maggiore
Collaborators Not Provided
Investigators
Study Director: Pier Luigi Carriero FROM
PRS Account Fondazione per la Ricerca Ospedale Maggiore
Verification Date August 2018