- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02318537
Cannabidiol Oral Solution as an Adjunctive Therapy for Treatment of Participants With Inadequately Controlled Lennox-Gastaut Syndrome
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
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).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
|
A matching oral solution containing no cannabidiol.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Data point for observation period to data point for treatment period Weeks 9 through 12
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
Data point for observation period to data point for treatment period Weeks 9 through 12
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Neha Parikh, INSYS Therapeutics Inc
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- INS011-14-024
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Lennox-Gastaut Syndrome
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Eisai Inc.TerminatedLennox-Gastaut Syndrome (LGS)Korea, Republic of, United States, Australia, Belgium, Japan, Czechia, India
-
TakedaCompletedLennox Gastaut Syndrome (LGS)United States, China, Canada, France, Hungary, Australia, Poland, Spain, Japan, Belgium, Greece, Serbia, Germany, Italy, Latvia, Netherlands, Russian Federation, Ukraine
-
TakedaRecruitingLennox Gastaut Syndrome (LGS) | Dravet Syndrome (DS)United States, China, Spain, France, Belgium, Australia, Brazil, Canada, Germany, Greece, Hungary, Italy, Japan, Latvia, Netherlands, Poland, Serbia, Mexico, Russian Federation, Ukraine
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University College, LondonKing's College London; King's College Hospital NHS Trust; University of Oxford; Great Ormond Street Hospital for Children NHS Foundation TrustRecruitingEpilepsy | Lennox-Gastaut Syndrome, IntractableUnited Kingdom
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TakedaRecruitingDravet Syndrome (DS) | Lennox-Gastaut Syndrome (LGS)Spain
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NeuroPaceNational Institute of Neurological Disorders and Stroke (NINDS); University...RecruitingEpilepsy | Seizures | Lennox Gastaut Syndrome | Lennox-Gastaut Syndrome, Intractable | Seizures, GeneralizedUnited States
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TakedaActive, not recruitingEpilepsy | Dravet Syndrome (DS) | Lennox-Gastaut Syndrome (LGS)United States, Canada, Australia, China, Israel, Poland, Spain, Portugal
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GlaxoSmithKlineBausch Health Americas, Inc.Terminated
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EpygenixNot yet recruiting
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Eisai LimitedCompletedLennox-Gastaut SyndromeJapan
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