Clinical Trials in the UK / NCT07410143
Active, not recruiting
Phase 1/2
Investigation of Individualised Antisense Oligonucleotides (ASOs) in People With Unique Genetic Variants Causing Severely Debilitating, Life Threatening (SDLT) Central Nervous System (CNS) Conditions
NCT07410143 · tracked via the Priya Life Science UK tracker
Condition(s) studied
Pediatric SDLT CNS Disorders
Investigational drug(s) / intervention(s)
Individualized ASO
Individualized ASO: Individualized ASO
Study summary
This study is being conducted to evaluate individualised antisense oligonucleotides (ASOs) in participants with severely debilitating, life threatening (SDLT) central nervous system (CNS) conditions caused by unique genetic variants amenable to correction by an ASO.
Eligibility
Inclusion Criteria:
1. The first participant receiving the individualised ASO, must be between 1 and 17 years of age (inclusive) at the time they receive their first ASO dose.
2. The CNS condition is severely debilitating and/or life threatening.
3. The identified genetic variant is unique.
4. The identified genetic variant is considered the underlying cause of disease.
5. The identified genetic variant is amenable to correction by an ASO.
6. In the opinion of the investigator, the disease is at a stage that, if halted or slowed by treatment with the individualised ASO, has a reasonable chance to improve the participant's overall disease burden/impact on quality of life.
7. In the opinion of the investigator, participant, and/or the participant's legally authorised representative, existing therapies have not resulted in meaningful benefit.
Exclusion Criteria:
1. Known history or presence of any clinically significant hepatic, renal/genitourinary, gastrointestinal, cardiovascular, cerebrovascular, pulmonary, endocrine, immunological, musculoskeletal, neurological, psychiatric, dermatological, or haematological disease or condition other than the primary disease for which the individualised ASO is being developed that in the opinion of the Investigator could affect patient safety or interfere with study outcomes.
2. Any contraindication to brain MRI scans.
3. Any contraindication to sedation or anaesthesia.
4. Any contraindication to lumbar punctures or IT infusions.
5. Treatment with another ASO within 24 weeks of Screening.
6. Treatment with any gene replacement therapy at any time.
Primary outcome measure(s)
- Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) — 48 Weeks
Treatment-related incidence and severity of adverse events (AEs), including any unfavorable and unintended signs such as abnormal laboratory or test findings
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Great Ormond Street Hospital | London | United Kingdom |
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 NCT07410143 on ClinicalTrials.gov ↗ ← All trials in the UK