Clinical trials on Migraine

Migraine Overview

Migraine is a neurological condition often characterized by intense, debilitating headaches. Symptoms may include nausea, vomiting, difficulty speaking, numbness or tingling, and sensitivity to light and sound. Migraines can cause significant pain for hours to days and can be so severe that the pain is disabling. Warning symptoms known as aura may occur before or with the headache. These can include visual disturbances, such as flashes of light or blind spots, or other disturbances, such as tingling on one side of the face or in an arm or leg and difficulty speaking.

There are several types of migraines, including migraine with aura, migraine without aura, chronic migraine, and vestibular migraine. The causes of migraines are not fully understood but involve genetic and environmental factors. Triggers can vary from person to person and include stress, certain foods, alcohol, hormonal changes, and changes in sleep patterns. Treatment is aimed at preventing a full-blown attack, and alleviating symptoms if they come. This can include medication, lifestyle changes, and avoiding known triggers. For many people, migraines are a chronic disorder but can be managed with the right approach.

  • Preventive medications: Aimed at reducing the frequency, severity, and length of migraines and may increase the effectiveness of symptom-relieving medicines used during migraine attacks.
  • Lifestyle modifications: Including stress management, avoiding known triggers, regular physical exercise, and maintaining a regular sleep schedule can help manage migraine.
  • Acute or abortive treatment: These treatments are taken during migraine attacks and are designed to stop symptoms or prevent them from getting worse.

Prognosis for Migraine: Understanding Long-Term Outcomes

Migraine is a neurological condition characterized by intense, debilitating headaches often accompanied by nausea and sensitivity to light and sound. The long-term prognosis for migraine varies; it is a chronic condition, yet periods of remission are common where symptoms may improve or become less frequent over time. The frequency and intensity of migraine attacks can fluctuate, and a decrease in episodes with age is observed in some cases. However, a consistent or even increased pattern of migraine attacks may persist throughout life for others. It is not uncommon for the condition to demonstrate an ebb and flow, with changes in the pattern of attacks often influenced by factors such as stress, hormonal changes, and lifestyle. While migraines can significantly impact the quality of life, they are not typically life-threatening, and management strategies are often found to maintain an active lifestyle.

Complications in Migraine

Living with migraine can lead to several complications that affect daily life. A common issue is chronic migraine, where headaches occur on 15 or more days per month. This can lead to increased sensitivity to light and sound, causing disruptions in both personal and professional activities. There may be experiences of status migrainosus, a severe migraine that lasts longer than 72 hours, requiring medical attention. Migraines can also trigger vestibular symptoms, such as dizziness or balance problems, making routine tasks challenging. Additionally, persistent migraines can contribute to the development of anxiety or depression, impacting mental health. Another complication is medication-overuse headaches, which occur from frequent use of headache pain relief, ironically causing more headaches. These complications can significantly diminish quality of life, making it difficult to maintain a normal routine and enjoy everyday activities.

Treatment Methods for Migraine Relief

For effective migraine management, lifestyle adjustments are considered essential. The incorporation of a balanced diet and regular physical activity has been shown to significantly reduce the frequency and severity of migraines. The identification and avoidance of specific dietary triggers are recommended. Regular exercise, such as aerobic activities, can improve overall health and stress management, which may lead to a reduction in migraine occurrences.

Pharmacotherapy options, although not always included in clinical trials, are frequently suggested. These encompass over-the-counter pain relievers and prescription medications designed to prevent or halt migraines. Consulting with a healthcare provider is important for the development of a personalized medication plan.

Modern technology provides innovative solutions. Biofeedback and relaxation apps enable monitoring of physiological responses and the learning of control over them, which may reduce migraine triggers. Additionally, wearable devices that deliver neurostimulation have demonstrated potential in managing migraine pain by transmitting mild electrical pulses to nerves implicated in migraines.

These methods, while not always part of clinical trials, have proven beneficial for many in the management of migraine symptoms.

  • CT-EU-00084810

    Testing new medicine for children’s migraine relief

    This study is a test to see how safe and effective a medicine called Atogepant is when given to children and teenagers (6 to 17 years old) who get migraines. Migraines are bad headaches that can make feel sick or sensitive to light and sound. Atogepant is a tablet that is already approved for adults who get migraines, and now the researchers want to see how it works for younger people. The patients will be divided into six groups, which will be given either a placebo, a low-dose Atogepant, or a high-dose Atogepant. This will continue for 12 weeks. After this, there may be further follow-up visits or another study where the patients can continue to take the Atogepant. Testing during the study will include doctor’s visits, blood tests, questionnaires and checking for any side effects.

    • Atogepant
  • Studying rimegepant’s effectiveness on Migraine

    This study is testing a new treatment, rimegepant, for adults with migraines who cannot take traditional migraine medications, such as triptans, possibly due to reasons like having a heart condition. The research aims to evaluate the effectiveness and tolerability of rimegepant over a 12-week period. Participants will be asked to rate their headache pain on a scale ranging from 0 (no pain) to 3 (severe pain) as one of the methods to assess the treatment’s impact.

    • Rimegepant
  • Comparing atogepant and topiramate for migraine prevention

    In this study, a comparison is being made between two different medicines aimed at preventing migraines in adults. Migraines manifest as severe headaches on one side of the head, accompanied by symptoms such as nausea, throbbing pain, or sensitivity to light and sound. The two medicines under comparison are named atogepant and topiramate. Atogepant is currently employed for migraine prevention in individuals experiencing migraines from 0 to 14 days per month, and the study seeks to evaluate its potential broader application. Topiramate is already widely utilized for migraine prevention. Participants in this study will be divided into two groups: one group will be administered atogepant, while the other will receive topiramate for a duration of 24 weeks. Following this period, those eligible to continue will all receive atogepant for an additional 52 weeks. The study will assess their progress and monitor any potential side effects.

    • Topiramate
    • Atogepant
  • Discovering rimegepant’s effectiveness in preventing migraines

    In this study, rimegepant is being investigated to determine its potential in migraine prevention. Various dosages and frequency of administration are being tested. The medication is administered daily for some individuals, while others receive it every other day. A comparison is being made between these groups and a control group that does not receive the medication. The primary objective is to assess the monthly frequency of migraines among patients, both before and after treatment initiation.

    • Rimegepant
  • Testing eptinezumab for children’s migraine relief

    This study aims to test a new treatment called Eptinezumab in children aged 6 to 17 years diagnosed with Episodic Migraine, which is a type of headache that happens less than 15 days a month. The treatment involves a single intravenous infusion of Eptinezumab that may be either 100 mg or 300 mg. The study is randomized, double-blind, placebo-controlled, and estimated to enroll 315 participants. The primary goal is to determine the efficacy and safety of Eptinezumab in pediatric patients, and the study will look at the change in the number of monthly migraine days after receiving the treatment. Secondary outcome measures include percentage reduction in migraine days, the presence of migraine after dosing, the change in the number of monthly headache days, and plasma Eptinezumab concentrations.

    • Eptinezumab
  • Migraine study for kids and teens: testing galcanezumab

    This detailed study examines if a new medicine, galcanezumab, is good at preventing migraines in kids and teens. In this study, they will get shots of either the medicine or a saltwater solution that does nothing (placebo) for three months. Researchers will count the days they have migraines each month to see if the medicine helps. If they have fewer migraine days with the medicine than with the saltwater shots, it means the medicine might be working. After the first part, they can choose to keep getting the medicine for nine more months. The study will also look at how safe the medicine is and if there are any side effects.

    • Galcanezumab
  • Migraine in children and teenagers: erenumab treatment study for younger patients

    This clinical study seeks to investigate the effectiveness and safety of a migraine prevention treatment called erenumab in children (6-11 years) and adolescents (12–17 years) struggling with episodic migraines. Participants will receive erenumab at different dosage levels based on their body weight or a placebo, administered via subcutaneous injection once a month. The aim is to determine whether erenumab can significantly reduce monthly migraine days when compared with the placebo. The trial includes a 24-week double-blind treatment phase, where neither the participants nor the researchers know who is receiving which treatment.

    • Erenumab