Cannabidiol Oral Solution as an Adjunctive Therapy for Treatment of Participants With Inadequately Controlled Dravet Syndrome

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Brief Title

Cannabidiol Oral Solution as an Adjunctive Therapy for Treatment of Participants With Inadequately Controlled Dravet Syndrome

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 Dravet Syndrome

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).
    


Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Percent change in the frequency of tonic-clonic, clonic, and focal seizures with motor components

Secondary Outcome

 Percent change from baseline in the severity of tonic-clonic, clonic, and focal seizures with motor components

Condition

Dravet Syndrome

Intervention

Cannabidiol Oral Solution

Study Arms / Comparison Groups

 Cannabidiol Oral Solution
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

0

Start Date

December 30, 2017

Completion Date

June 17, 2018

Primary Completion Date

June 17, 2018

Eligibility Criteria

        Inclusion Criteria:

          -  Meets protocol-specified criteria for qualification and contraception, including
             clinical diagnosis of refractory DS 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 subject and/or parent(s)/caregiver(s) are able
             to keep accurate seizure diaries and the participant is able to take study drug and
             comply with the protocol, including dosing, medications and diet

        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
      

Gender

All

Ages

1 Year - 30 Years

Accepts Healthy Volunteers

No

Contacts

Neha Parikh, , 



Administrative Informations


NCT ID

NCT02318563

Organization ID

INS011-14-025


Responsible Party

Sponsor

Study Sponsor

INSYS Therapeutics Inc


Study Sponsor

Neha Parikh, Study Director, INSYS Therapeutics Inc


Verification Date

January 2018