NCT05337033RecruitingPhase 2
A Multi-Centre, Tolerability Study of a Cannabidiol-enriched Cannabis Herbal Extract for Chronic Headaches in Adolescents: the CAN-CHA Trial
University of Manitoba3 sites in 1 country20 target enrollmentStarted: October 11, 2024Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- University of Manitoba
- Enrollment
- 20
- Locations
- 3
- Primary Endpoint
- Cannabis-related adverse events
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 14 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •To be eligible to participate in this study, an individual must meet all of the following criteria:
- •Adolescents aged between 14-17 years of age at the time of screening.
- •Diagnosed with Chronic Migraine according to ICHD-3: headache (migraine-like or tension-type like) occurring on 15 or more days per month for more than 3 months which on at least 8 days per month have features of migraine headache. [121]
- •Failed at least two treatment options on the grounds of safety (tolerability) and/or efficacy, including but not limited to antidepressant (tricyclic antidepressant or selective norepinephrine reuptake inhibitor), magnesium, gabapentinoids topiramate and/or non-pharmacological therapies.
- •Females who have reached menarche should have a negative pregnancy test during screening.
- •Must be willing to engage with psychology and physiotherapy throughout the trial as appropriate.
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
- •Participants with known allergy to cannabinoids and/or palm/coconut oil
Arms & Interventions
Cannabidiol-enriched Cannabis Herbal Extract
Experimental
CBD50 plus
Intervention: MPL-001 (Drug)
Outcomes
Primary Outcomes
Cannabis-related adverse events
Time Frame: Reported daily through study completion, an average of 6 months
The frequency of adverse events will be measured and characterized using standard CTCAE coding
Secondary Outcomes
- Pain intensity compared to baseline(Reported daily through study completion, an average of 6 months)
- Changes in anxiety compared to baseline(Reported monthly for 6 months)
- Pain impact on participants quality of life compared to baseline(Reported monthly for 6 months)
- Number of hours of sleep per night compared to baseline(Reported daily through study completion, an average of 6 months)
- Change in mood, positive affect from baseline(Reported monthly for 6 months)
- Change in self-directed goal attainment from baseline(Reported monthly for 6 months)
- The frequency and duration of headache compared to baseline(Reported daily through study completion, an average of 6 months)
- Change in sleep quality(Reported monthly for 6 months)
- Change in mood, depression from baseline(Reported monthly for 6 months)
Investigators
Lauren Kelly
Lauren E Kelly PhD, MSc, BMedSci, CCRP, Assistant Professor, Dept. of Pediatrics & Child Health, University of Manitoba Scientific Director, Canadian Childhood Cannabinoid Clinical Trials (www.C4Trials.org)
University of Manitoba
Study Sites (3)
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