Clinical Trial: Cannabidiol Oral Solution as an Adjunctive Therapy for Treatment of Participants With Inadequately Controlled Lennox-Gastaut Syndrome

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Interventional Study to Assess the Safety and Efficacy of Pharmaceutical Cannabidiol Oral Solution as an Adjunctive Therapy for Treatment o

Brief Summary:

This Phase 3 trial will enroll participants diagnosed with Lennox-Gastaut Syndrome (LGS) who are still experiencing at least 4 motor seizures involving the trunk or extremities per week, despite ongoing treatment with up to 3 antiepileptic drugs (AEDs) and who meet inclusion/exclusion criteria.

Following a 28-day baseline period, participants will begin an 84-day treatment period. Participants will be assigned to receive twice daily doses of placebo or cannabidiol oral solution at the highest dose determined to be safe in a previous trial.

Following study completion, all participants will be invited to receive Cannabidiol Oral Solution in an open label extension study (under a separate protocol).


Detailed Summary:
Sponsor: INSYS Therapeutics Inc

Current Primary Outcome: Percent change from baseline in the frequency of motor seizures involving the trunk or extremities [tonic, atonic, generalized tonic-clonic (GTC), focal seizures with motor components (FSMC)] [ Time Frame: Data point for observation period to data point for treatment period Weeks 9 through 12 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Percent change from baseline in severity of motor seizures involving the trunk or extremities (tonic, clonic, GTC, FSMC) [ Time Frame: Data point for observation period to data point for treatment period Weeks 9 through 12 ]
  • Percent change from baseline in frequency of all seizure activity independent of seizure type [ Time Frame: Data point for observation period to data point for treatment period Weeks 9 through 12 ]
  • Percent change from baseline in the severity of all seizure activity independent of seizure type [ Time Frame: Data point for observation period to data point for treatment period Weeks 9 through 12 ]
  • Percent change from baseline in the duration of all seizure activity independent of seizure type [ Time Frame: Data point for observation period to data point for treatment period Weeks 9 through 12 ]
  • Change from baseline in parent(s)/caregiver(s) Clinical Global Impressions of Improvement (CGI-I) [ Time Frame: Data point for observation period to data point for treatment period Weeks 9 through 12 ]
  • Change from baseline in Investigator CGI-I [ Time Frame: Data point for observation period to data point for treatment period Weeks 9 through 12 ]
  • Change from baseline in parent(s)/caregiver(s) Clinical Global Impressions of Severity (CGI-S) [ Time Frame: Data point for observation period to data point for treatment period Weeks 9 through 12 ]
  • Change from baseline in Investigator CGI-S [ Time Frame: Data point for observation period to data point for treatment period Weeks 9 through 12 ]


Original Secondary Outcome: Same as current

Information By: INSYS Therapeutics Inc

Dates:
Date Received: December 12, 2014
Date Started: August 2017
Date Completion: June 2018
Last Updated: April 28, 2017
Last Verified: April 2017