RecruitingPHASE2INTERVENTIONAL

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

This study is called CAN-CHA and focuses on teenagers aged 14 to 17 who suffer from chronic migraine headaches. These are very frequent headaches that haven't improved with other treatments. Researchers are testing a cannabis-based medicine (MPL-001) to see if it's safe for this age group and what side effects it might cause. Previous research suggests cannabis products might help adults with headaches, so this study is exploring if it could also help younger people. The study will take place in Canada, starting with a month to understand the participant's usual headaches, followed by four months of gradually increasing the medicine's dose, and then a period to slowly stop the treatment.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

University of Manitoba

Enrolment target

Start

11 Oct 2024

Estimated completion

31 Dec 2025

Chronic Migraine

What is this study about?

Many young people struggle with chronic migraines, which are severe headaches that happen very often and can make daily life difficult. Sometimes, existing treatments don't work well enough or cause uncomfortable side effects. This study is exploring a new approach using a medicine that comes from the cannabis plant, specifically one that's rich in a compound called Cannabidiol (CBD).

While cannabis-based products have been used by adults to help with headaches, we don't know much about how they affect teenagers. This research, called the CAN-CHA trial, aims to find out if this specific cannabis-based medicine (MPL-001) is safe for young people aged 14 to 17 and what side effects they might experience. This is the main goal of the study.

The researchers hope that if this medicine proves to be safe and manageable, it could eventually offer a new option for teenagers whose chronic migraines haven't responded to other treatments. It's a key step in understanding if and how cannabis-based medicines could play a role in helping young people with long-term pain.

Key takeaways

The study is for teenagers (14-17) with chronic migraines that haven't responded to other treatments.
It's testing a cannabis-based medicine (MPL-001) to see if it's safe and well-tolerated.
The study involves monitoring your headaches, taking the medicine for four months, and then slowly stopping.
You'll also work with psychologists and physiotherapists if needed.
Your safety and any side effects will be carefully watched by the study team.

Who may be eligible?

To join this study, you need to be a teenager between 14 and 17 years old who experiences chronic migraines. This means you get headaches on 15 or more days a month for at least three months, and on at least 8 of those days, they feel like migraines.

It's important that you've already tried at least two other types of treatment for your headaches, such as certain antidepressants, magnesium, gabapentinoids, or topiramate, and these treatments either didn't work well enough or caused too many side effects. For girls who have started their periods, a pregnancy test will be done at the beginning.

You wouldn't be able to join if you have a history of headaches from a concussion or a new daily persistent headache. Also, if you have certain medical conditions like heart, kidney, or liver problems, complex regional pain syndrome, or if you're taking specific medications like opioids or antipsychotics, you wouldn't be eligible. Individuals with developmental delays, a history of schizophrenia, or those who are pregnant or breastfeeding also cannot participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 14 and 17 years old?
Do you get headaches on 15 or more days a month, with at least 8 of those being migraines?
Have you already tried and found at least two other headache treatments unhelpful or caused too many side effects?
Are you able to commit to regular appointments at a study centre in Canada?
Are you not currently pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the study will last several months. It starts with a one-month 'baseline' period where doctors will monitor your usual headaches to understand them better. After that, for four months, you'll take the cannabis-based medicine. The doctors will gradually increase the dose over this time. Towards the end, there will be a 'weaning period' where you slowly stop taking the medicine.

Throughout the study, you'll have regular visits with doctors and nurses who will check your health, ask about your headaches, and look for any side effects. You'll also be expected to work with psychologists and physiotherapists as needed to help manage your pain and overall well-being. The main focus is to see how well you tolerate the medicine and if you experience any side effects.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is that the cannabis-based medicine might help reduce your chronic migraines, or at least help us understand if it could be a future treatment option. However, as this is a new type of medicine for teenagers, there's always a possibility of side effects, which the researchers will monitor very closely. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (3)

University of British Columbia
Verified postcode
Vancouver, Canada· Not yet recruiting
Dalhousie University-
Verified postcode
Halifax, Canada· Not yet recruiting
North Toronto Neurology
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is MPL-001?

MPL-001 is a cannabis-based medicine being tested in this study. It's made from a cannabis plant extract that's high in Cannabidiol (CBD).

Will this medicine make me feel 'high'?

The study focuses on a cannabis extract rich in Cannabidiol (CBD). CBD is not known to create the 'high' feeling typically associated with cannabis.

How long will I have to take the medicine?

You'll take the study medicine for four months, with the dose gradually increasing, followed by a period where you slowly stop taking it.

Will I have to travel for the study?

This study is happening in Canada across three different centres, so you would need to be able to get to one of those locations regularly.

What if my headaches get worse during the study?

Your doctors will monitor you closely throughout the study. If your headaches worsen or if you experience any concerning side effects, you should tell the study team immediately.

How to find out more

Lauren E Kelly, PhD

lauren.kelly@umanitoba.ca 2042723149 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.