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PEARL Study

Contents

Pan-European prospective observational study of fremanezumab effectiveness in patients with chronic or episodic migraine in the Real-World: PEARL study

Fremanezumab is a humanized monoclonal antibody that selectively targets calcitonin gene-related peptide and is approved in Europe for migraine prevention in adults with ≥4 migraine days/month. The Pan-European Real Life (PEARL) study is a 24-month, prospective, observational study of fremanezumab in chronic or episodic migraine. End points include proportion of patients with ≥50% reduction in monthly migraine days during 6 months of treatment (primary); changes in monthly migraine days, disability scores and acute headache medication use; adherence and persistence; and effectiveness in patients switching from another calcitonin gene-related peptide pathway-targeting monoclonal antibody. PEARL is being conducted in approximately 100 centers in 11 European countries (estimated n = 1100). PEARL will generate important real-world data on effectiveness of fremanezumab and treatment patterns in patients with chronic migraine or episodic migraine. 

Section 1. Purpose of the Study

You are asked to take part in this non-interventional study because you are suffering from chronic or episodic migraine and your doctor has decided to start prophylactic migraine therapy with Ajovy ® independently from this study. This study aims to provide evidence of routine treatment with Ajovy® (fremanezumab) in clinical practice. It intends to obtain information on treatment effectiveness and factors influencing effectiveness, severity of the migraine attacks, migraine and non-migraine medication use, injection intervals and the duration of Ajovy® treatment. Approximately 1100 patients will participate in this non-interventional study and about 10 patients are expected to take part at Newcastle upon Tyne Hospitals NHS Foundation Trust. This study will be performed in several European countries.

Section 2. Procedures

Your participation in this study will not change the way your physician is going to treat your migraine. All procedures and drugs prescribed or administered will be per yours and your physician’s joint decision and standard of care.

Section 3. Time Duration of the Procedures and Study

In this study routine data like medical history or current medical data will be collected at the time of study inclusion and at each study visit. This includes where (location of the Ajovy® injection) and how (autoinjector or prefilled syringe) Ajovy® was administered, medical results, concomitant medication, the course of migraine complaints based on migraine-specific patient questionnaires and your headache / migraine diary. Therefore your study participation requires that you maintain your daily headache diary as part of routine disease management and can recall the location of Ajovy® injection. Additionally, if Ajovy® treatment was started before your enrollment, your headache diary must have been maintained reliably (at least 21 days of headache diary data per month since Ajovy® treatment start).

Follow-up visits will be part of your routine visits, usually about every three months over a maximum individual study period of two years.

If this is part of your doctor’s routine treatment, you will receive two short questionnaires for assessment of your current health status at study start.These questionnaires may be completed prior to each visit again. It will take you approximately 15 minutes to complete the questionnaires. Besides these two questionnaires your study participation will not consume extra time. 

At each follow-up visit, you will also be asked as a standard of your doctor's normal clinical practice, if you have suffered any adverse events (unwanted effects) or side effects as a standard of your doctor's normal clinical practice.

Section 4. Risks

This is an observational study that is observing the treatment and outcomes of the treatment over time. This study exposes you to no additional risks beyond your usual medical treatment.

Section 5. Potential Benefits

The results of this study may guide the future treatment of patients with migraine. Due to the observational design of this study, it is not expected to experience direct benefits from your study participation.