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Clinical Trials in the USA / NCT06617429
Active, not recruiting Phase 3

Phase 3 Efficacy and Safety Study of GTX-102 in Pediatric Subjects With Angelman Syndrome (AS)

NCT06617429 · tracked via the Priya Life Science USA tracker
Sponsor
Ultragenyx Pharmaceutical Inc
Phase
Phase 3
Started
2024-12-03
Last updated
2026-08-06

Condition(s) studied

Angelman Syndrome

Investigational drug(s) / intervention(s)

GTX-102Sham-LP

GTX-102: antisense oligonucleotide

Sham-LP: Small needle prick on the lower back at the location where the LP injection is normally made

Study summary

The primary objective of this study is to evaluate the effect of GTX-102 in cognitive function in participants with deletion-type Angelman Syndrome (AS).

Eligibility

Sex
ALL
Min age
4 Years
Max age
17 Years
Healthy volunteers
No
Key Inclusion Criteria: * Signed informed consent from parent(s) or legal guardian(s) * Confirmed diagnosis of AS with genetic confirmation of full maternal ubiquitin-protein ligase E3A (UBE3A) gene deletion causing AS in the region of 15q11.2 q13 * Able to ambulate independently, or with assistance at the Screening Visit (note, a child whose primary means of mobility is by wheelchair is excluded from the study) * Platelet count, prothrombin time / international normalized ratio, and partial thromboplastin time within 1.5x the normal limits at the Screening Visit * Willing and able to comply with scheduled visits, drug administration plan, laboratory tests, and all study procedures, including LP procedure, MRI, and tolerating anesthesia without intubation * From the time of informed consent through to at least 6 months after the final dose of GTX-102, females of childbearing potential who are sexually active must use highly effective contraception or abstinence. Males are able to participate if they agree to remain abstinent (refrain from heterosexual intercourse) or use acceptable contraceptive methods during the study and for at least 3 months after the final dose of GTX-102 Key Exclusion Criteria: * Any change in medications or diet/supplements intended to treat symptoms of AS (eg, sleeping aids, antiseizure medications, supplements, dietary change including ketogenic or low-glycemic index diet, other) within the month prior to the Screening Visit (excluding weight-based adjustments) * Any condition that creates an increased risk of unsuccessful LP * Current or expected concomitant use of drugs that increase the risk of bleeding (eg, heparin, low molecular weight heparin, platelet inhibitors) * Known hypersensitivity to GTX-102 or its excipients that, in the judgment of the Investigator, places the subject at increased risk for adverse effects * Presence or history of any condition, lab abnormality, or infection, that, in the judgement of the Investigator, would interfere with participation, pose undue safety risk, or would confound interpretation of results * Pregnant or breastfeeding or planning to become pregnant (self or partner) at any time during the study * Use of any investigational product or investigational medical device within 6 months or 5 half-lives prior to the Screening Visit or any prior use of gene therapy or ASO regardless of duration since last administration * Concurrent participation in any interventional study

Primary outcome measure(s)

Trial sites (28)

FacilityCityRegionStatus
Cedars Sinai Los Angeles California
UCSD, Rady Children's Hospital San Diego California
UCSF San Francisco California
Children's Hospital Colorado Aurora Colorado
Nicklaus Children's Hospital Miami Florida
Rare Disease Research Atlanta Georgia
Rush University Chicago Illinois
Boston Children's Hospital Boston Massachusetts
Children's Mercy Kansas City Missouri
Columbia University Medical Center New York New York
UNC Chapel Hill Pediatrics Chapel Hill North Carolina
Rare Disease Research Hillsborough North Carolina
The University of Texas Austin Texas
Carum Research Inc Dallas Texas
McGill University Health Centre Montreal Quebec
British Columbia Children's Hospital Vancouver Canada
Universitaetsklinikum Hamburg-Eppendorf Hamburg Germany
University of Leipzig Leipzig Germany
Haunersche Kinderklinik Munich Germany
Nagoya City University Graduate School of Medical Sciences Nagoya Aichi-ken
Osaka City General Hospital Osaka Japan
Hokkaido University Hospital Sapporo Japan
Medical University of Gdańsk Gdansk Poland
Polish Mothers Memorial Institute Lodz Poland
Hospital Universitario Parc Tauli Barcelona Spain
Hospital Sant Joan de Deu Barcelona Spain
Hospital Universitario Puerta de Hierro Madrid Spain
Hospital Universitario Virgen del Rocio Seville Spain

More Ultragenyx Pharmaceutical Inc trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06617429 on ClinicalTrials.gov ↗ ← All trials in the USA