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Cannabis for Chronic Headaches in Adolescents: the CAN-CHA Trial (CAN-CHA)

Primary Purpose

Chronic Migraine

Status

Not yet recruiting

Phase

Phase 1

Locations

Canada

Study Type

Interventional

Intervention

MPL-001

About this trial

This is an interventional treatment trial for Chronic Migraine focused on measuring Adolescents, Children, Cannabis, Migraine, Cannabidiol, Tetrahydrocannbinol

Eligibility Criteria

14 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

To be eligible to participate in this study, an individual must meet all of the following criteria:

Adolescents between 14-17 years of age at the time of screening
Diagnosed with chronic migraine for more than three months
Failed other treatment options on the grounds of safety (tolerability) or efficacy, including but not limited to antidepressants (tricyclic antidepressant or selective norepinephrine reuptake inhibitor), gabapentinoids or topiramate.
Females who have reached menarche should have a negative serum pregnancy test during screening.
Must be willing to engage with psychology and physiotherapy throughout the trial

Exclusion Criteria:

Adolescents meeting any of the following criteria will be excluded from the study:

As per investigator judgment, the participant is not an ideal candidate due to a personal issue or medical condition that is likely to impede successful completion of the study
Participants with a history of post-concussion headache
Participants with a diagnosis of medication overuse headache or tension-type headache
Participants with cardiac, renal, or hepatic disease (assessed by the site investigator)
Participants with other chronic pain conditions including complex regional pain syndrome-II
Participants with abnormal ECG findings at baseline
Participants who are on the following medications: opioids, antipsychotics, antimanic, barbiturates, benzodiazepines, muscle relaxants, sedatives, or tramadol.
Participants with developmental delay or impairments including autism, cerebral palsy, or intellectual disability.
Participants who are pregnant or breastfeeding or those who cannot commit to using two forms of contraception or those who plan to become pregnant within the study timeframe.
Participants with a family history of psychotic disorders or schizophrenia

Sites / Locations

University of British Columbia
Dalhousie University-
Neurology Centre of Toronto

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cannabidiol-enriched Cannabis Herbal Extract

Arm Description

CBD50 plus

Outcomes

Primary Outcome Measures

Cannabis-related adverse events

The frequency of adverse events will be measured and characterized using standard CTCAE coding

Secondary Outcome Measures

The frequency and duration of headache compared to baseline

Reported headache frequency and duration daily and reported as a monthly average documented at baseline.

Pain intensity compared to baseline

The average intensity measured using a Numeric Rating Scale (NRS) will be reported as a percentage change from the monthly average documented at baseline and an increasing score(highest score =10) indicates a greater severity of pain.

Pain impact on participants quality of life compared to baseline

The impact of pain on participants quality of life using the PROMIS Pediatric Pain Interference- Short Form 8a will be reported as a percentage change from the monthly average documented at baseline.

Number of hours of sleep per night compared to baseline

The number of hours of sleep per night will be measured using a actigraphy device

Change in sleep quality

PROMIS Pediatric Short Form v2.0 - Pediatric Sleep-Related Impairment 8a scale as a percentage change from the monthly average documented at baseline

Change in mood, depression from baseline

PROMIS Pediatric Short Form v2.0 - Depressive Symptoms 8a scale as a percentage change from the monthly average documented at baseline

Change in mood, positive affect from baseline

Change in mood, positive affect will be evaluated using PROMIS Pediatric Positive Affect - Short Form 8 and reported as a percentage change from the monthly average documented at baseline

Change in self-directed goal attainment from baseline

Participants will self-directed goal attainment (participant and parent reported) as a percentage of goal attained at each study visit

Changes in anxiety compared to baseline

Changes in anxiety will be measured using the PROMIS Pediatric Anxiety Short Form v2.0 and reported as percentage change from the monthly average documented at baseline

Full Information

NCT ID

NCT05337033

First Posted

March 29, 2022

Last Updated

June 8, 2023

Sponsor

University of Manitoba

Collaborators

SickKids Foundation, The Canadian Collaborative for Childhood Cannabinoid Therapeutics (C4T)

1. Study Identification

Unique Protocol Identification Number

NCT05337033

Brief Title

Cannabis for Chronic Headaches in Adolescents: the CAN-CHA Trial

Acronym

CAN-CHA

Official Title

A Multi-Centre, Tolerability Study of a Cannabidiol-enriched Cannabis Herbal Extract for Chronic Headaches in Adolescents: the CAN-CHA Trial

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

July 1, 2023 (Anticipated)

Primary Completion Date

December 31, 2025 (Anticipated)

Study Completion Date

December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Manitoba

Collaborators

SickKids Foundation, The Canadian Collaborative for Childhood Cannabinoid Therapeutics (C4T)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Chronic headaches are a major cause of disability among adolescents. Cannabis products have supported the management of headaches in adults and may play a role in pediatric chronic pain. We propose a multisite, open-label, tolerability study conducted across three centers in Canada of Cannabidiol-enriched Cannabis Herbal Extract in adolescents (ages 14 to 17 years old) with chronic headaches. The study includes a one month baseline assessment, four months of escalating treatment doses and a weaning period. Our primary outcome is tolerability defined as the number and severity of reported adverse events.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Migraine

Keywords

Adolescents, Children, Cannabis, Migraine, Cannabidiol, Tetrahydrocannbinol

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Model Description

Open label tolerability trial

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cannabidiol-enriched Cannabis Herbal Extract

Arm Type

Experimental

Arm Description

CBD50 plus

Intervention Type

Drug

Intervention Name(s)

MPL-001

Other Intervention Name(s)

medical cannabis oil

Intervention Description

CBD50 plus is a medical cannabis oil with flavouring agent produced under Good Manufacturing Practice by MediPharm Labs and purchased for this study. Each ml of oil contains 2 mg/ml of delta-9-THC and 50 mg/ml of CBD. Participants will receive escalating doses from 0.2-0.4 mg/kg/day of CBD to 0.8-1 mg/kg of CBD per day for four months, with dose increases monthly in 0.2mg/kg increments. Participants will following a weekly weaning protocol.

Primary Outcome Measure Information:

Title

Cannabis-related adverse events

Description

The frequency of adverse events will be measured and characterized using standard CTCAE coding

Time Frame

Reported daily through study completion, an average of 6 months

Secondary Outcome Measure Information:

Title

The frequency and duration of headache compared to baseline

Description

Reported headache frequency and duration daily and reported as a monthly average documented at baseline.

Time Frame

Reported daily through study completion, an average of 6 months

Title

Pain intensity compared to baseline

Description

Time Frame

Reported daily through study completion, an average of 6 months

Title

Pain impact on participants quality of life compared to baseline

Description

The impact of pain on participants quality of life using the PROMIS Pediatric Pain Interference- Short Form 8a will be reported as a percentage change from the monthly average documented at baseline.

Time Frame

Reported monthly for 6 months

Title

Number of hours of sleep per night compared to baseline

Description

The number of hours of sleep per night will be measured using a actigraphy device

Time Frame

Reported daily through study completion, an average of 6 months

Title

Change in sleep quality

Description

PROMIS Pediatric Short Form v2.0 - Pediatric Sleep-Related Impairment 8a scale as a percentage change from the monthly average documented at baseline

Time Frame

Reported monthly for 6 months

Title

Change in mood, depression from baseline

Description

PROMIS Pediatric Short Form v2.0 - Depressive Symptoms 8a scale as a percentage change from the monthly average documented at baseline

Time Frame

Reported monthly for 6 months

Title

Change in mood, positive affect from baseline

Description

Change in mood, positive affect will be evaluated using PROMIS Pediatric Positive Affect - Short Form 8 and reported as a percentage change from the monthly average documented at baseline

Time Frame

Reported monthly for 6 months

Title

Change in self-directed goal attainment from baseline

Description

Participants will self-directed goal attainment (participant and parent reported) as a percentage of goal attained at each study visit

Time Frame

Reported monthly for 6 months

Title

Changes in anxiety compared to baseline

Description

Changes in anxiety will be measured using the PROMIS Pediatric Anxiety Short Form v2.0 and reported as percentage change from the monthly average documented at baseline

Time Frame

Reported monthly for 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

14 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: To be eligible to participate in this study, an individual must meet all of the following criteria: Adolescents between 14-17 years of age at the time of screening Diagnosed with chronic migraine for more than three months Failed other treatment options on the grounds of safety (tolerability) or efficacy, including but not limited to antidepressants (tricyclic antidepressant or selective norepinephrine reuptake inhibitor), gabapentinoids or topiramate. Females who have reached menarche should have a negative serum pregnancy test during screening. Must be willing to engage with psychology and physiotherapy throughout the trial Exclusion Criteria: As per the investigator judgement, the participant is not an ideal candidate due to a personal issue or medical condition that is likely to impede in the successful completion of the study Participants with a history of post-concussion headache or new daily persistent headache Participants with a diagnosis of medication overuse headache Participants with cardiac, renal or hepatic disease (assessed by the site investigator) Participants with complex regional pain syndrome-II Participants with abnormal ECG findings at baseline (as determined by the investigator) Participants who are on the following medications: opioids, antipsychotics, antimanic, barbiturates, benzodiazepines, muscle relaxants, sedatives, or tramadol. Participants with developmental delay or impairments including autism, cerebral palsy or intellectual disability. Participants with a personal or family history of schizophrenia or psychotic disorders Participants who are pregnant or breast/chest-feeding or plans to become pregnant within the study period or within three months of interventional product discontinuation Participants who cannot commit to using contraception and refraining from recreational cannabis use and driving throughout the study period

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lauren E Kelly, PhD

Phone

2042723149

lauren.kelly@umanitoba.ca

First Name & Middle Initial & Last Name or Official Title & Degree

Lauren Kelly

Phone

2042723149

lauren.kelly@umanitoba.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lauren E Kelly, PhD

Organizational Affiliation

University of Manitoba

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of British Columbia

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V6T1Z4

Country

Canada

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dr. Tim Oberlander, MD, FRCPC

Facility Name

Dalhousie University-

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3K 6R8

Country

Canada

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dr. G Allen Finley, MD, FRCPC, FAAP

Facility Name

Neurology Centre of Toronto

City

Toronto

State/Province

Ontario

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Cannabis for Chronic Headaches in Adolescents: the CAN-CHA Trial

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