Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 1:27 AM
NCT ID:
NCT05109793
Eligibility Criteria:
Inclusion Criteria:
* Genetically confirmed GM1 Gangliosidosis or genetically confirmed Tay-Sachs or Sandhoff disease
* Onset of neurological symptoms on or after the patient's first birthday
* Achieved 12-month developmental milestones at normal developmental time points as per Principal Investigator's judgement
* Abnormal gait and/or speech disturbance
Exclusion Criteria:
* Patients who have received (within 6 months before screening), are currently receiving or are planned to receive (within the following 6 months) gene therapy, stem cell transplantation, experimental drugs, or any drug, which, in the Investigator´s opinion, may (have) interfere(d) with disease progression
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
20 Years
Study:
NCT05109793
Study Brief:
Protocol Section:
NCT05109793