Cannabidiol Oral Solution for Treatment of Refractory Infantile Spasms

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-27

Study Completion Date

2016-09-06

Brief Summary

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Infantile Spasms (IS) is a diagnosis described as a fairly rare and terrible form of epilepsy that usually strikes children in the first year of life. There is a great need for safe and effective therapies in the treatment of IS. This need is even more important for infants and toddlers still sick after being treated with medicine that is already available.

This is a multi-center study to evaluate the efficacy and safety of Cannabidiol Oral Solution (CBD) in the treatment of children aged 6 months through 36 months with a diagnosis of infantile spasms who have not responded to first line therapies.

The overall study duration is expected to be 64 weeks for those subjects who respond to CBD treatment. The maximum possible study duration for each patient is approximately 64 weeks, however a subject will be deemed to have completed the study after 58 weeks.

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Detailed Description

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A protocol amendment in May 2016 created two parts to this trial: Part A (the extended treatment period) and Part B (the safety treatment period), whose objectives are as follows:

Primary Part A: To evaluate the efficacy of Cannabidiol Oral Solution in treating refractory infantile spasms (IS).

Secondary:

Part A:

* To evaluate the safety of Cannabidiol Oral Solution in treating refractory infantile spasms.

Part B:

* To assess the long-term safety of Cannabidiol Oral Solution as an adjunctive treatment for subjects with Infantile Spasms (IS)
* To establish the continued efficacy of Cannabidiol Oral Solution in maintaining seizure control in subjects with IS
* To assess the global status of subjects taking Cannabidiol Oral Solution for an extended period of time determined by various qualitative assessments
* To monitor for changes in plasma levels of Cannabidiol Oral Solution during long-term treatment of subjects with IS

Conditions

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Spasms, Infantile

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cannabidiol Oral Solution: 20 or 40 mg/kg/day BID

The dose of Cannabidiol Oral Solution will begin at 20 mg/kg/day \[10 mg/kg twice per day (BID)\], will be adjusted at any time if the investigator feels the safety or well-being of the participant is at risk, and will be titrated up or down according to protocol-stipulated parameters and at the investigator's discretion after Day 14 to enhance efficacy. Dose will not exceed 40 mg/kg/day.

Group Type EXPERIMENTAL

Cannabidiol Oral Solution

Intervention Type DRUG

20 or 40 mg/kg/day BID

Interventions

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Cannabidiol Oral Solution

20 or 40 mg/kg/day BID

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Meets protocol-specified criteria for qualification, including infantile spasms
* Parent(s)/caregiver(s) fully comprehend and sign the informed consent form, understand all study procedures, and can communicate satisfactorily with the Investigator and study coordinator.

Exclusion Criteria

* History or current use of over-the-counter medications, dietary supplements, or drugs 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 analysis of results
* During the Safety Treatment and Follow-up Periods, subjects are not to receive the following:

1. any cannabinoids (CBD, Δ9-tetrahydrocannabinol (THC), hemp oil, Realm Oil or marijuana)
2. any other investigational drug or investigational device

Minimum Eligible Age

6 Months

Maximum Eligible Age

36 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No