Meranti Chronic Migraine Study

In the 2022 Migraine in Aotearoa New Zealand Survey, 22% of respondents had chronic migraine (15 or more headache days a month).

A Migraine is a disabling, neurological condition with a genetic basis. It usually presents as a moderate to severe headache affecting one side of the head, but can affect both sides. Migraines are often associated with sensitivity to light/sound, smell/touch, and nausea/vomiting. Some people can experience a migraine attack that doesn’t include a headache. Other migraine symptoms can include fatigue, dizziness or vertigo, numbness or tingling and visual disturbances.

While the disease cannot be cured, management focuses on reducing the frequency, duration, and severity of attacks through both preventive and acute treatments.

About the Study Medication 
The investigational medication is a potential new type of botulinum neurotoxin (similar to Botox) specifically designed to potentially prevent migraines. It is being developed to specifically treat both episodic (less frequent) and chronic (more frequent) migraines.

The investigational medication aims to reduce the number and severity of migraine days by blocking the release of certain pain-related chemical messengers in nerve terminals.

It is designed to have potentially:

Taking part in the study involves firstly meeting with the research Doctor to find out more about your health and to see if the study is right for you.  If you wish to participate and are eligible, we would like to see you for 6 to 7 clinic visits over a period of approximately 10 months. All participants will receive just one treatment session (consisting of the 28 injections) at the Day 1 visit, and then will be monitored throughout the follow-up period.

During the visits, we conduct health checks that may include physical examinations and blood tests. We want to ask you questions about your migraines and headaches throughout the study.

Some other health checks and assessments may include:

• Neurological examinations
• Vital signs
• ECG’s
• Electronic diaries  

You would be administered the medication or a placebo (looks like the investigational medicine but contains no active medication, only on day 1 of the study). This comparison between active treatment and placebo is crucial for determining whether any improvements in migraine symptoms are genuinely due to the study medication rather than to other factors such as the expectation of benefit.

The study medication is administered through a series of small injections into specific muscles in your head or neck.

How the administration works:

• You'll receive a total of 28 injections in a single treatment session
• Each injection is a small volume (0.1 mL) delivered intramuscularly (into the muscle)
• The injections target 7 different muscle groups on both sides of the head and neck
• These specific muscles were chosen because they overlap with nerve terminals involved in migraine
• The locations include muscles in the forehead, around the eyes, temples, back of the head, and upper neck
• The study doctor performs the entire procedure during your Day 1 (baseline) visit
• To help with comfort, topical ice may be applied to the injection sites

Please Note: This is a one-time treatment - you receive these injections only once during the study, and then you're monitored for the whole 36-week follow-up period to see how the treatment affects your migraines.

The study aims to investigate the potential of a new medication and determine whether it is effective in preventing migraines, involving approximately 600 people worldwide.