See below for the upcoming trial.
A New Two-Part Clinical Trial Will Investigate Cannabidiol Oral Solution as an Add-On Therapy in Infants with Seizures Caused by Tuberous Sclerosis Complex
The study will be comprised of two parts:
- Part A will evaluate the safety and pharmacokinetics of GWP42003-P compared with standard of care treatment for a period of 17 weeks in participants with TSC. This means half of the infants who take part in this study will be treated with GWP42003-P as well as their usual ongoing medicines, known as standard of care. The other half will be treated with their ongoing medicines only. Part A will last approximately 29 weeks total, which includes a 1- to 2-week screening period, a 4-week baseline period and a 17-week treatment period (including a 2- to 5- week titration period). Infants who complete Part A of the trial and continue to meet all eligibility criteria will be invited to continue in Part B. Parents/caregivers who do not wish their infants to continue in Part B will enter an up to 2-week taper period and a safety follow-up period (4 weeks after the end-of-taper visit).
- Part B will evaluate the long-term safety and tolerability of GWP42003-P for 52 weeks. All Part B participants will receive GWP42003-P. The duration of Part B will be approximately 59 weeks total, including a 2- to 5-week titration period for those participants randomized to standard of care treatment only in Part A of the trial, a 2-week taper period and a safety follow-up period (4 weeks and end-of-taper visit).
For More Information:
Several TSC clinics in the United States will conduct this study. To find the closest location to you and for more information about enrolling, go to www.clinicaltrials.gov and enter NCT04485104 in the “Other terms” field. Recruitment is expected to start in early 2021.