In short
There is currently 1 ongoing clinical trial investigating preventive treatment for infantile spasms in high-risk infants. This trial focuses on using vigabatrin to prevent the development of infantile spasm syndrome in children under one year of age who have tuberous sclerosis or significant brain injuries.
Clinical trial locations
Prevention of Infantile Spasms with Vigabatrin in High-Risk Children Under 1 Year Old: A Study for Patients with Tuberous Sclerosis or Large Vascular Brain Injury
This trial is investigating whether giving vigabatrin early to high-risk infants can prevent the development of infantile spasm syndrome before any signs appear. The study is being conducted in Finland and will continue until December 2033.
Who can participate:
- Children under 1 year of age who have tuberous sclerosis, a rare genetic disorder that causes non-cancerous tumors in various parts of the body
- Children with large vascular brain injuries, including severe brain bleeds, infections, trauma, or lack of oxygen
- Children with grade IV intraventricular hemorrhage, which is severe bleeding inside brain spaces with damage to brain tissue
- Children with grade III-IV periventricular leukomalacia, which is severe damage to the white matter in the brain
- Children who have had a brain MRI scan as part of regular medical care
- Parents who can communicate in Finnish, Swedish, or English
Who cannot participate:
- Children over 1 year of age
- Children who do not have tuberous sclerosis or the specific types of brain injuries listed above
- Patients who started treatment after November 2023 for tuberous sclerosis
What the trial involves:
The study uses vigabatrin, an anticonvulsant medication that works by increasing the levels of a natural calming substance in the brain called GABA. This helps reduce abnormal electrical activity in the brain that can lead to seizures. The medication comes in the form of granules that are mixed with liquid and taken by mouth. The maximum daily dose is 150 milligrams per kilogram of body weight, and the treatment can continue for up to 11 months.
Throughout the study, doctors will regularly monitor for signs of infantile spasm syndrome to determine if the preventive treatment is effective. Children will undergo brain development assessments using eye tracking analysis and EEG measurements to monitor brain activity. The study also evaluates how the children's development progresses over time with regular check-ups.
Main focus of the trial:
The primary goal is to determine whether giving vigabatrin as a preventive treatment to high-risk infants can stop infantile spasm syndrome from developing. The researchers are particularly interested in children with tuberous sclerosis or those who have experienced significant brain injuries, as these conditions put them at higher risk for developing this serious seizure disorder. The trial also aims to understand how early preventive treatment affects brain development and long-term outcomes in these vulnerable children.
Summary
Currently, there is one clinical trial available for infantile spasms, located in Finland. This trial takes a preventive approach, focusing on treating high-risk infants before symptoms develop rather than waiting for the condition to appear. The study concentrates specifically on vigabatrin as the investigational drug, which has shown particular effectiveness in treating infantile spasms, especially in children with tuberous sclerosis.
The trial is notable for its long-term follow-up period, continuing until 2033, which will provide valuable information about the long-term effects of early preventive treatment. The study includes comprehensive monitoring of brain development using multiple methods, including eye tracking and brain wave measurements, which may help researchers better understand how early intervention affects developmental outcomes in high-risk children.
