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A Study Testing Cabergoline to Prevent and Treat Episodic Migraine in Patients with Recurring Migraine Headaches

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is looking at migraine, a condition that causes recurring headaches often accompanied by other symptoms such as sensitivity to light or sound. The treatment being tested is cabergoline, which is given as tablets under the brand name Dostinex. Some participants will receive cabergoline while others will receive placebo. The purpose of the study is to compare how well cabergoline at two different doses works compared to placebo in reducing the number of migraine days in people who experience migraine attacks several times per month but not every day.

The study has two main phases. During the first phase, which lasts 12 weeks, participants will be randomly assigned to receive either cabergoline at a dose of 0.5 mg once weekly, cabergoline at a dose of 1.0 mg once weekly, or placebo once weekly. Neither the participants nor the doctors will know which treatment each person is receiving during this phase. Throughout the study, participants will keep a daily electronic diary to record their headaches and any medications they take for migraine attacks. The study will measure changes in the number of migraine days, how severe the headaches are, how often acute medications are needed, and how migraine affects daily activities and quality of life.

After the first 12-week phase, there will be an additional open-label phase where all participants will know what treatment they are receiving. The study will also collect blood samples to measure various substances in the body and look at genetic factors that might affect how people respond to the treatment. Safety will be monitored throughout the study by tracking any unwanted effects that occur. The total treatment period for each participant can last up to 24 weeks.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Baseline assessment and start of diary recording
At the beginning of the study, your current condition will be assessed. This includes recording how many days per month you experience migraine headaches.
You will be asked to complete several questionnaires that measure how migraine affects your daily life, work productivity, and overall well-being. These questionnaires are called MIDAS (Migraine Disability Assessment), HIT-6 (Headache Impact Test), and WPAI (Work Productivity and Activity Impairment).
You will begin keeping a daily electronic diary where you record each day whether you have a headache, how severe it is (mild, moderate, or severe), and what medication you take for it.
Blood samples will be taken to measure various levels in your body, including cholesterol, blood sugar markers, hormones, and a substance called prolactin.
A sample will also be collected for genetic testing to study how certain genes might affect migraine and response to treatment.
Step 2
12-week treatment phase with assigned medication
You will be randomly assigned to receive one of three treatment options: cabergoline 0.5 mg, cabergoline 1.0 mg, or placebo (an inactive tablet that looks like the real medication). Neither you nor your doctor will know which treatment you are receiving during this phase.
You will take your assigned medication once per week by mouth for 12 weeks.
Throughout these 12 weeks, you must continue recording information in your daily electronic diary every day. This includes noting any headache days, the severity of headaches, and any medication you use to treat acute migraine attacks.
The main goal of this phase is to see if the medication reduces the number of days per month you experience migraine headaches compared to your baseline.
Step 3
Assessment at the end of the 12-week treatment phase
At the end of the 12-week period, your condition will be assessed again.
You will complete the same questionnaires as at the beginning (MIDAS, HIT-6, and WPAI) to measure any changes in how migraine affects your life.
You will also complete a PGIC (Patient Global Impression of Change) questionnaire, where you rate how much your condition has improved, stayed the same, or worsened.
Blood samples will be taken again to measure the same markers as at baseline, including cholesterol, blood sugar, hormones, and prolactin levels.
The information from your daily diary will be reviewed to calculate changes in the number of migraine days, headache severity, and use of acute medications.
Step 4
Open-label treatment phase
After completing the 12-week phase, you will enter an additional treatment period where both you and your doctor will know which medication you are receiving. This is called the open-label phase.
During this phase, you will receive cabergoline at a specific dose, taken once per week by mouth. The duration of this phase will be determined by the study protocol.
You must continue keeping your daily electronic diary throughout this entire phase, recording headache days, severity, and medication use.
This phase allows for further assessment of how the medication works over a longer period and provides additional safety information.
Step 5
Assessment at the end of the open-label phase
At the end of the open-label treatment phase, another complete assessment will be performed.
You will complete the questionnaires (MIDAS, HIT-6, WPAI, and PGIC) again to evaluate changes in your condition.
Blood samples will be collected once more to measure cholesterol, blood sugar, hormones, and prolactin levels.
The information from your daily diary will be analyzed to determine changes in migraine frequency, headache severity, and medication use compared to both the baseline and the end of the 12-week phase.
Throughout the entire study, any side effects or adverse events you experience will be monitored and recorded.

Who can join the trial?

5 criteria

You must have episodic migraine, which means you experience migraine attacks that come and go, with or without aura. Aura refers to warning signs like seeing flashing lights or feeling tingling sensations before the headache starts. This condition must have been present for at least 12 months.
You must have had between 4 and 14 monthly migraine days in the last 3 months before joining the study. Monthly migraine days means the number of days each month when you experienced a migraine headache.
You must be 18 years of age or older.
You can be male or female.
You must provide written informed consent, which means you must read, understand, and sign a document agreeing to participate in the study after learning about what it involves.

Who cannot join the trial?

3 criteria

The source data does not provide specific exclusion criteria (reasons why patients cannot participate) for this clinical trial
Without detailed exclusion criteria listed in the trial information, it is not possible to identify which medical conditions, medications, or other factors would prevent participation
Typically, clinical trials have exclusion criteria to ensure patient safety and study accuracy, but these details are not available in the provided information

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Region Midtjylland
Aarhus, Denmark

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Investigated drugs

Cabergoline is a medication that will be tested in this trial to see if it can help reduce how often migraine headaches occur. Some participants will receive cabergoline once a week, while others will receive a placebo (an inactive substance) for comparison. Cabergoline works by affecting certain chemical messengers in the brain.

Cabergoline

What is already known about the treatment

Cabergoline – Cabergoline is a medication that comes in tablet form and is taken by mouth, typically once or twice weekly depending on the condition being treated. It is an approved medication that belongs to a class of drugs called dopamine agonists, which means it works by mimicking the action of dopamine, a natural chemical messenger in the brain. At the molecular level, cabergoline binds to and activates dopamine receptors, particularly the D2 type, which helps regulate various body functions including hormone levels and potentially blood vessel behavior in the brain. While it is primarily used to treat conditions related to high levels of the hormone prolactin and Parkinson's disease, this clinical trial is investigating whether it might also be effective in preventing migraine headaches by influencing brain chemistry and blood vessel function.

Investigated diseases

Migraine – Migraine is a neurological condition characterized by recurring headaches that are typically moderate to severe in intensity. The headache usually affects one side of the head and is often accompanied by nausea, vomiting, and increased sensitivity to light and sound. Migraine attacks can last from a few hours to several days, significantly interfering with daily activities. Some people experience warning symptoms called aura before the headache begins, which may include visual disturbances, tingling sensations, or difficulty speaking. The condition occurs in episodes, with periods of normal health between attacks. Migraine tends to run in families and can be triggered by various factors such as stress, certain foods, hormonal changes, or environmental stimuli.