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

About this study

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

Drug

  • GTX-102

Study locations

Argentina
Buenos Aires
Pilar (1)
  • Hospital Universitario Austral — Site status not reported
Brazil
Paraná
Curitiba (1)
  • Hospital de Crianças César Pernetta e Hospital Pequeno Príncipe — Site status not reported
Porto Alegre
Santa Cecília (1)
  • Casa dos Raros — Site status not reported
France
State / region not reported
Marseille (1)
  • Hopital de la Timone — Site status not reported
Paris (1)
  • Necker-Enfants Malades Hospital — Site status not reported
Israel
State / region not reported
Ramat Gan (1)
  • Sheba Medical Center — Site status not reported
Italy
State / region not reported
Florence (1)
  • Azienda Ospedaliera Universitaria Meyer IRCCS — Site status not reported
Milan (1)
  • Fondazione IRCCS Istituto Neurologico C. Besta — Site status not reported
Rome (1)
  • Clinical Trial Site — Site status not reported
Portugal
State / region not reported
Lisbon (1)
  • Hospital de Santa Maria — Site status not reported
Porto (1)
  • Hospital Santa Joao — Site status not reported
United Kingdom
State / region not reported
London (1)
  • Clinical Trial Site — Site status not reported
Oxford (1)
  • University of Oxford — Site status not reported
United States
California
Los Angeles (1)
  • Cedars Sinai Medical Center — Site status not reported
Illinois
Chicago (1)
  • Rush University Medical Center — Site status not reported
Maryland
Baltimore (1)
  • Kennedy Kreiger Institute — Site status not reported
Missouri
Kansas City (1)
  • Clinical Trial Site — Site status not reported
North Carolina
Hillsborough (1)
  • Rare Disease Research — Site status not reported
Ohio
Akron (1)
  • Akron Children's Hospital — Site status not reported
Texas
Austin (1)
  • UT Health Austin — Site status not reported
Dallas (1)
  • Carum Research Inc. — Site status not reported
Full registry eligibility 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

Important information

Registry information may change. FAST context and classifications are editorial additions. Inclusion does not confirm eligibility or availability at a specific site. Review the official record and contact the study team for participation requirements.

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