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



Status:Recruiting
Conditions:Other Indications
Therapuetic Areas:Other
Healthy:No
Age Range:Any
Updated:4/5/2019
Start Date:September 5, 2018
End Date:December 2019
Contact:Clinical Operations
Email:InsysCBD@insysrx.com
Phone:(602) 910-2617

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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

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.


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.
We found this trial at
5
sites
1 Perkins Square
Akron, Ohio 44308
(330) 543-1000
Phone: 330-543-0690
Akron Children's Hospital From humble beginnings as a day nursery in 1890, Akron Children
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Phone: 503-418-8297
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Miami, Florida 33155
Phone: 786-624-3611
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Miami, FL
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Royal Oak, Michigan 48073
Phone: 248-551-3302
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Royal Oak, MI
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Tacoma, Washington 98405
Phone: 253-403-9348
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Tacoma, WA
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