Chronic Migraine study: MPL-001
Official title Cannabis for Chronic Headaches in Adolescents: the CAN-CHA Trial
ClinicalTrials.gov ID: NCT05337033
What this study is testing
What is MPL-001?
MPL-001 is an investigational medicine, being studied as a potential treatment for chronic migraine.
Also referred to as medical cannabis oil.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study will see how well a cannabidiol‑rich cannabis extract is tolerated by teens with chronic migraines and how many side effects occur.
- Who it's for
- Teens aged 14 to 17 who have chronic migraines and can travel to one of three Canadian sites.
- What's involved
- Participants will have a one‑month baseline period, then take the extract at increasing doses for four months, followed by a tapering period. They will attend clinic visits and report any side effects.
- Time commitment
- The study lasts about six months, with regular clinic visits during the baseline, dosing, and weaning phases.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 14 to 17
You may be able to join if
- 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...
- Failed at least two treatment options on the grounds of safety (side effects) and/or how well it works, including but not limited to antidepressant...
- 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.
You likely can't join if
- 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...
- 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)
See the full eligibility 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...
- Failed at least two treatment options on the grounds of safety (side effects) and/or how well it works, including but not limited to antidepressant (tricyclic antidepressant or selective norepinephrine reuptake...
- 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.
- 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 treatment 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
The study team makes the final eligibility decision.
Where it is enrolling
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 14 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Toronto, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.