UnknownNot Applicable

Angelman Natural History Study - FAST Spain

Spain40 participantsStarted 2023-12-01

Plain-language summary

The goal of this study is to conduct a prospective, longitudinal study to observe the natural clinical progression and disease outcome of AS patients receiving no disease-modified intervention, with the purpose of obtaining data that will be useful for future clinical trials.

Who can participate

Age range3 Months – 99 Years

SexALL

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Inclusion criteria

✓. Male or female between 3 months and 99 years of age.
✓. Clinical diagnosis of Angelman Syndrome and molecular confirmation of the diagnosis.
✓. The participant has an acceptable guardian capable of giving consent on behalf of the participant,
✓. Willingness and ability of their guardians to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion criteria

✕. Patients with any comorbidity that, in the clinical judgment of the principal investigator, may affect the results of the study. Any confirmed chronic or acute condition or illness affecting any system(s) that could interfere with study results and/or compliance with study procedures is included.
✕. Patients who are participating in parallel studies with investigational drugs.
✕. Unwillingness or inability of their guardians to follow the procedures outlined in the protocol.

What they're measuring

Clinical Global Impression Scale for AS (CGI-AS)

Timeframe: 2 years

Hammersmith Neonatal Neurological Examination (HINE) (for 0-2 years)

Timeframe: 2 years

Trial details

NCT IDNCT06115109

SponsorPuerta de Hierro University Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-12-31

Contact for this trial

BELEN RUIZ ANTORAN, MD, Ph

+34911917479 bruizantoran@gmail.com

View on ClinicalTrials.gov More Angelman Syndrome trials