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for people ages 1–30 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:



This is a multicenter, open-label trial to assess the long-term safety and efficacy of Cannabidiol Oral Solution as adjunctive therapy for pediatric and adult participants with treatment-resistant seizure disorders, including Lennox-Gastaut syndrome (LGS) or Dravet syndrome (DS). All participants have rolled over from previous trials: INS011-14-029 (NCT02324673), INS011-14-024 (NCT02318537), or INS011- 14-025 (NCT02318563).

Official Title

A Multicenter, Open-label, Flexible Dose Study to Assess the Long-term Safety of Pharmaceutical Cannabidiol Oral Solution as an Adjunctive Treatment for Pediatric and Adult Subjects With a Treatment-resistant Seizure Disorder Who Complete INS011-14-029 or Part A of INS011-15-054


Seizures Lennox-Gastaut syndrome Dravet syndrome Treatment-resistant seizures Epilepsy Pharmaceutical Solutions


You can join if…

Open to people ages 1–30

  • Completed all scheduled visits in the treatment phase of their core study
  • Informed consent/assent (as applicable) was voluntarily provided by the participant and/or parent(s)/caregiver(s) in accordance with applicable laws, regulations, and local requirements
  • Is medically stable with no anticipated changes in chronic medications
  • Continues to meet protocol-specified criteria for qualification and contraception,including treatment-resistant seizure disorder
  • In the opinion of the Investigator, the subject and/or parent(s)/caregiver(s) are able to continue keeping accurate seizure diaries

You CAN'T join if...

  • Inadequate supervision by parent(s)/caregiver(s)
  • History or current use of dietary supplements, drugs or over-the counter medications outside protocol-specified parameters
  • Signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:
  • the safety or well-being of the participant or study staff
  • the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding)
  • the analysis of results


  • University of California San Francisco Medical Center
    San Francisco, California, 94143, United States
  • Clinical Research Center of Nevada LLC
    Las Vegas, Nevada, 89104, United States


in progress, not accepting new patients
Start Date
Completion Date
INSYS Therapeutics Inc
Phase 3
Lead Scientist
Maria Roberta Cilio
Study Type
Last Updated
November 2, 2017