Clinical Trial: Cannabidiol Oral Solution as an Adjunctive Therapy for Treatment of Participants With Inadequately Controlled Dravet 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

Brief Summary:

This Phase 3 study will enroll participants diagnosed with Dravet Syndrome (DS) who are still experiencing at least one tonic-clonic, clonic, and/or focal seizures with motor components (FSMC) per week, despite ongoing treatment with up to three antiepileptic drugs (AEDs), and meet the other 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 in the frequency of tonic-clonic, clonic, and focal seizures with motor components [ 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 the severity of tonic-clonic, clonic, and focal seizures with motor components [ 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 tonic-clonic, clonic, and focal seizures with motor components [ Time Frame: Data point for observation period to data point for treatment period Weeks 9 through 12 ]
  • Percent change from baseline in the 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 ]
  • 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 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-I [ 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