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

This study is not yet open for participant recruitment.
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Verified July 2017 by INSYS Therapeutics Inc
Sponsor:
Information provided by (Responsible Party):
INSYS Therapeutics Inc
ClinicalTrials.gov Identifier:
NCT02318537
First received: December 12, 2014
Last updated: July 31, 2017
Last verified: July 2017
  Purpose

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).


Condition Intervention Phase
Lennox-Gastaut Syndrome Drug: Cannabidiol Oral Solution Drug: Placebo Solution Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 of Subjects With Inadequately Controlled Lennox-Gastaut Syndrome

Resource links provided by NLM:


Further study details as provided by INSYS Therapeutics Inc:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 86
Anticipated Study Start Date: September 30, 2017
Estimated Study Completion Date: June 30, 2018
Estimated Primary Completion Date: June 30, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cannabidiol Oral Solution
Participants will receive cannabidiol oral solution at an appropriate dose (no higher than 40 mg/kg/day) determined by data from a previous trial. The total daily dose will be administered in twice daily doses, approximately 12 hours apart.
Drug: Cannabidiol Oral Solution
An oral solution containing pharmaceutical grade cannabidiol (nonplant-based).
Placebo Comparator: Placebo Solution
Participants will receive matching placebo solution administered twice daily, approximately 12 hours apart.
Drug: Placebo Solution
A matching oral solution containing no cannabidiol.

  Eligibility

Ages Eligible for Study:   2 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Meets protocol-specified criteria for qualification and contraception, including clinical diagnosis of refractory LGS and onset of seizures according to protocol-specified criteria
  • Is able to speak and understand the language in which the study is being conducted, is able to understand the procedures and study requirements and has voluntarily signed and dated an informed consent form approved by the Institutional Review Board before the conduct of any study procedure
  • In the opinion of the Investigator, the participants and parent(s)/caregiver(s) are willing and able to comply with the study procedures and visit schedules, including venipuncture, twice daily dosing, accurate diaries, and the Follow-up Visits (if applicable).

Exclusion Criteria:

  • Medical history is outside protocol-specified parameters
  • Clinically significant history of allergic reactions or significant sensitivities to cannabinoids or to any of the other ingredients in the study drug
  • Inadequate supervision by parents or guardians
  • 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: 1) the safety or well-being of the participant or study staff; 2) the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding); 3) the analysis of results
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02318537

Contacts
Contact: Clinical Operations (602) 910-2617 insyscbd@insysrx.com

Sponsors and Collaborators
INSYS Therapeutics Inc
Investigators
Study Director: Neha Parikh INSYS Therapeutics Inc
  More Information

Responsible Party: INSYS Therapeutics Inc
ClinicalTrials.gov Identifier: NCT02318537     History of Changes
Other Study ID Numbers: INS011-14-024
Study First Received: December 12, 2014
Last Updated: July 31, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by INSYS Therapeutics Inc:
Treatment-resistant seizures

Additional relevant MeSH terms:
Syndrome
Lennox Gastaut Syndrome
Disease
Pathologic Processes
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Pharmaceutical Solutions

ClinicalTrials.gov processed this record on August 22, 2017