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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02318537
• Date of registration: 12/12/2014
• Prospective Registration: Yes
• Primary sponsor: INSYS Therapeutics Inc
• Public title: Cannabidiol Oral Solution as an Adjunctive Therapy for Treatment of Participants With Inadequately Controlled Lennox-Gastaut Syndrome
• Scientific 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
• Date of first enrolment: December 30, 2017
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT02318537
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 3

Contacts

• Name: Neha Parikh
• Affiliation: INSYS Therapeutics Inc

Key inclusion & exclusion 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



Age minimum: 2 Years
Age maximum: 30 Years
Gender: All

Health Condition(s) or Problem(s) studied

Lennox-Gastaut Syndrome

Intervention(s)

Drug: Cannabidiol Oral Solution

Drug: Placebo Solution

Primary Outcome(s)

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(s)

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 Severity (CGI-S) [Time Frame: Data point for observation period to data point for treatment period Weeks 9 through 12]

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]

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]

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]

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]

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]

Secondary ID(s)

INS011-14-024

Source(s) of Monetary Support

Please refer to primary and secondary sponsors