A Study to Assess the Efficacy, Safety, and Tolerability of Cannabidiol Oral Solution With Vigabatrin as Initial Therapy in Participants With Infantile Spasms

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Brief Title

A Study to Assess the Efficacy, Safety, and Tolerability of Cannabidiol Oral Solution With Vigabatrin as Initial Therapy in Participants With Infantile Spasms

Official Title

A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Safety, and Tolerability of Cannabidiol Oral Solution as Adjunctive Therapy With Vigabatrin as Initial Therapy in Patients With Infantile Spasms

Brief Summary

      The primary objective of this study is to evaluate the efficacy of Cannabidiol Oral Solution
      as adjunctive therapy with vigabatrin as initial therapy in treating participants with
      Infantile Spasms. The secondary objectives for this study are to evaluate the continued
      efficacy of Cannabidiol Oral Solution after the 14-day treatment with vigabatrin or
      vigabatrin plus Cannabidiol Oral Solution is complete and to evaluate the safety and
      tolerability of Cannabidiol Oral Solution as adjunctive therapy with vigabatrin as initial
      therapy in treating participants with infantile spasms.
    


Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Percentage of Participants Considered Complete Responders

Secondary Outcome

 Percentage of Participants with Resolution of Infantile Spasms

Condition

Infantile Spasm

Intervention

Cannabidiol Oral Solution

Study Arms / Comparison Groups

 Cannabidiol Oral Solution (CBD)
Description:  Cannabidiol Oral Solution, up to 40 milligrams per kilogram per day (mg/kg/day), participants will be dosed approximately every 12 hours with food.
Participants will also be taking vigabatrin, up to 150 mg/kg/day, divided twice daily with food.

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

2

Start Date

September 5, 2018

Completion Date

May 29, 2019

Primary Completion Date

May 29, 2019

Eligibility Criteria

        Inclusion Criteria:

          1. Parent(s)/caregiver(s) fully comprehends and signs the informed consent form,
             understands all study procedures, and can communicate satisfactorily with the
             Investigator and study coordinator, in accordance with applicable laws, regulations,
             and local requirements.

          2. Clinical diagnosis of Infantile Spasms and hypsarrythmia, confirmed by a 9-hour
             video-EEG obtained during screening Period and read by the central reader.

          3. General good health (defined as the absence of any clinically relevant abnormalities
             as determined by the Investigator) based on physical and neurological examinations,
             medical history, and clinical laboratory values completed during the Screening Visit
             (Visit 1).

          4. In the opinion of the investigator, the parent(s)/caregiver(s) is (are) willing and
             able to comply with the study procedures and visit schedules.

        Exclusion Criteria:

          1. Is considered by the investigator, for any reason (including, but not limited to, the
             risks described as precautions, warnings, and contraindications in the current version
             of the Investigator's Brochure for Cannabidiol Oral Solution) to be an unsuitable
             candidate to receive the study drug.

          2. Known or suspected allergy to cannabidiol.

          3. History of an allergic reaction or a known or suspected sensitivity to any substance
             that is contained in the investigational product formulation.

          4. Use of any cannabidiol/cannabis product within 30 days of study entry.

          5. Patient is diagnosed or suspected of having tuberous sclerosis.

          6. Patient has received treatment with either vigabatrin, ACTH, or high-dose steroids
             previously.

          7. Previous or concomitant therapy with felbamate, clobazam, valproic acid, or the
             ketogenic diet.

          8. Patient currently on any disallowed CYP3A4-related medication listed in Appendix 1
             (phenytoin, fluvoxamine, carbamazepine, and St. John's Wort).

          9. Previously received any investigational drug or device or investigational therapy
             within 30 days before Screening.

         10. Clinically significant abnormal laboratory values, including: liver function tests
             (LFTs) such as albumin, direct bilirubin, total bilirubin, aspartate aminotransferase
             (AST), and alanine aminotransferase (ALT) ≥3 times the upper limit of normal (ULN).
             The investigator may deem the patient eligible if he or she judges the laboratory
             values to be not clinically significant.
      

Gender

All

Ages

1 Month - 24 Months

Accepts Healthy Volunteers

No

Contacts

Ahmed Elkashef, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03421496

Organization ID

INS011-16-082


Responsible Party

Sponsor

Study Sponsor

Benuvia Therapeutics Inc.


Study Sponsor

Ahmed Elkashef, MD, Study Director, INSYS Therapeutics Inc


Verification Date

November 2020