Trial Outcomes & Findings for The Effects of Cannabidiol (CBD) on Electrical and Autonomic Cardiac Function in Children With Severe Epilepsy (NCT NCT02815540)

NCT ID: NCT02815540

Last Updated: 2022-08-30

Results Overview

Change from baseline Holter SDNN parameter to follow up visit Holter SDNN parameter.

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 2 participants
• Primary outcome timeframe: Baseline to 4 to 8 week follow up visit
• Results posted on: 2022-08-30

Participant Flow

Participant milestones

Measure	Heart Function and Dysautonomia This study looks at participants already receiving CBD from the state of MN. We are not providing the CBD. We are looking at heart function with ECGs and Holter monitoring before and after CBD is taken by the participant. We are also looking at dysautonomia signs and symptoms and seizure frequency before and after CBD is taken by the participant. 12-Lead ECG: Subjects will be monitored while on cannabidiol with a 12-Lead ECG and/or Holter monitoring Cannabidiol: Subjects who are planning to take state dispensed medical cannabidiol, or are already taking state dispensed medical cannabidiol.
Overall Study STARTED	2
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure

Heart Function and Dysautonomia This study looks at participants already receiving CBD from the state of MN. We are not providing the CBD. We are looking at heart function with ECGs and Holter monitoring before and after CBD is taken by the participant. We are also looking at dysautonomia signs and symptoms and seizure frequency before and after CBD is taken by the participant. 12-Lead ECG: Subjects will be monitored while on cannabidiol with a 12-Lead ECG and/or Holter monitoring Cannabidiol: Subjects who are planning to take state dispensed medical cannabidiol, or are already taking state dispensed medical cannabidiol.

Overall Study Physician left institution and study was discontinued. No other PI was available.

2

Baseline Characteristics

The Effects of Cannabidiol (CBD) on Electrical and Autonomic Cardiac Function in Children With Severe Epilepsy

Baseline characteristics by cohort

Measure	Observational n=2 Participants This study looks at participants already receiving CBD from the state of MN. We are not providing the CBD. We are looking at heart function with ECGs and Holter monitoring before and after CBD is taken by the participant. We are also looking at dysautonomia signs and symptoms and seizure frequency before and after CBD is taken by the participant. 12-Lead ECG: Subjects will be monitored while on cannabidiol with a 12-Lead ECG and/or Holter monitoring Cannabidiol: Subjects who are planning to take state dispensed medical cannabidiol, or are already taking state dispensed medical cannabidiol.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants
Age, Categorical <=18 years	2 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 4 to 8 week follow up visit

Population: Physician left institution and study was discontinued due to no other investigators available.

Change from baseline Holter SDNN parameter to follow up visit Holter SDNN parameter.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and 4 to 8 week follow up visit

Population: Physician left institution and study was discontinued due to no other investigators available.

Change from baseline seizure frequency to follow up visit seizure frequency.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and 4 to 8 week follow up visit

Population: Physician left institution and study was discontinued due to no other investigators available.

signs and symptoms assessed by questionnaire developed for this study that documents observable signs and symptoms of dysautonomia

Outcome measures

Outcome data not reported

Adverse Events

Observational

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Director of Research

Gillette Children's Specialty Healthcare

Phone: 651-229-1745

Email: Research@gillettechildrens.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place