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

• Status: Terminated
• Trial end date: 2019-05-29
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Benuvia Therapeutics Inc.; INSYS Therapeutics Inc
• Treatments: Cannabidiol; Pharmaceutical Solutions; Vigabatrin

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.