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ACTIVE NOT RECRUITINGPhase2

A Safety and Efficacy Study of GTX-102 in Subjects With Deletion- or Nondeletion-type Angelman Syndrome (AS)

Sponsor: Ultragenyx Pharmaceutical Inc

NCT ID: NCT07157254

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
No intervention (other), GTX-102 (drug)
How long the study runs
Study runs about 51 months (dates as stated)
About the drug or intervention
No intervention — other: During the no treatment period participants do not receive any study drug · GTX-102 — drug: antisense oligonucleotide
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
1 Year to 64 Years
Who
All
Number of participants
60
Started
2025-10-13
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for angelman syndrome
  • • Phase2 - 60 participants
  • • The main goal of the study is to evaluate the safety and efficacy of GTX-102 in participants with Angelman syndrome

Who can take part?

  • • Ages 1 Year to 64 Years
  • • Diagnosed with angelman syndrome

Where?

  • • London - Clinical Trial Site
  • • Oxford - University of Oxford

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

The main goal of the study is to evaluate the safety and efficacy of GTX-102 in participants with Angelman syndrome.

More detail

This basket study is designed to evaluate safety and efficacy of GTX-102 in participants with Angelman syndrome across genotypes and age groups. The study consists of subprotocols A, B, C and D. All subprotocols are open-label and follow the same design which includes a Screening, Loading and Maintenance period. Subprotocols A, B and C are single arm only. In subprotocol D, participants are randomized 2:1 to a GTX-102 group or a No Treatment group. The No Treatment group follows the same schedule of events as all other groups after completion of the No Treatment period. Participants from all the subprotocols have the option to continue treatment in a long-term extension study following their end of study visit.

Angelman Syndrome

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 1 Year - 64 Years
  • Who can join: All genders

What the study is looking for

  • ✓Signed agreement to take part from parent(s) or legal guardian(s)
  • ✓Males and females of the following ages and genotypes at time of agreement to take part:
  • ✓Subprotocol A: ≥ 1 to \< 4 years of age with a genetically confirmed diagnosis of deletion-type Angelman syndrome
  • ✓Subprotocol B: ≥ 4 to \< 18 years of age with a genetically confirmed diagnosis of UPD/ICD Angelman syndrome
  • ✓Subprotocol C: ≥ 18 to \< 65 years of age with a genetically confirmed diagnosis of Angelman syndrome, any genotype

Who cannot take part

  • ✗Any condition that creates an increased risk of unsuccessful lumbar puncture
  • ✗Current or expected concomitant use of drugs that increase the risk of bleeding (eg, heparin, low molecular weight...
  • ✗Known hypersensitivity to GTX-102 or its excipients or required premedication that, in the judgment of the...
  • ✗Pregnant or breastfeeding or planning to become pregnant (self or partner) at any time during the study
  • ✗Concurrent participation in any interventional study
See the full criteria
Inclusion Criteria: 1. Signed informed consent from parent(s) or legal guardian(s) 2. Males and females of the following ages and genotypes at time of informed consent: 1. Subprotocol A: ≥ 1 to \< 4 years of age with a genetically confirmed diagnosis of deletion-type Angelman syndrome 2. Subprotocol B: ≥ 4 to \< 18 years of age with a genetically confirmed diagnosis of UPD/ICD Angelman syndrome 3. Subprotocol C: ≥ 18 to \< 65 years of age with a genetically confirmed diagnosis of Angelman syndrome, any genotype 4. Subprotocol D: ≥ 4 to \< 18 years of age with a genetically confirmed diagnosis of mutation-type Angelman syndrome 3. Weight ≥ 8 kg at Screening Visit 4. Platelet count, prothrombin time / international normalized ratio, and partial thromboplastin time \< 1.5x the upper limit of normal and platelets \> 75,000 cells/mm3 at the Screening Visit 5. Willing and able to comply with scheduled visits, drug administration plan, laboratory tests, and all study procedures, including lumbar puncture (LP) procedure, magnetic resonance imaging (MRI) and tolerating anesthesia without intubation 6. 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 Exclusion Criteria: 1. Any change in medications or diet/supplements intended to treat symptoms of Angelman Syndrome (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) 2. Any condition that creates an increased risk of unsuccessful lumbar puncture 3. Current or expected concomitant use of drugs that increase the risk of bleeding (eg, heparin, low molecular weight heparin, platelet inhibitors) 4. Known hypersensitivity to GTX-102 or its excipients or required premedication that, in the judgment of the Investigator, places the subject at increased risk for adverse effects 5. Presence or history of any condition, lab abnormality, or infection that, in the judgment of the Investigator, would interfere with study participation, pose undue safety risk, or would confound interpretation of results 6. Pregnant or breastfeeding or planning to become pregnant (self or partner) at any time during the study 7. 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 an ASO regardless of length of time since last use 8. Concurrent participation in any interventional study

Where Is This Study? (2 UK sites)

Clinical Trial Site

London, United Kingdom

University of Oxford

Oxford, United Kingdom

Hospital R&D contact (matched)

Shahista Hussain

ouhtma@ouh.nhs.uk---
Data sourced from ClinicalTrials.gov · Last verified: 2026-09