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Summary

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

Description

Summary

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

Keywords

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

Eligibility

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

Locations

  • 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

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
INSYS Therapeutics Inc
ID
NCT02318602
Phase
Phase 3
Lead Scientist
Maria Roberta Cilio
Study Type
Interventional
Last Updated
December 1, 2017