Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this observational study is to evaluate clinical differences in patients who received preventive treatment with medication targeting calcitonin gene-related peptide (CGRP) or its receptor: monoclonal antibodies (erenumab, galcanezumab, fremanezumab, eptinezumab) or gepants (rimegepant, atogepant) during a 2-year period observation phase.
It is a 2-year, multicenter observational study. Patients who meet reimbursement criteria according to local regulations and willing to participate in the study will be included. Monoclonal antibodies (erenumab, galcanezumab, fremanezumab, eptinezumab) or gepants (rimegepant, atogepant) will be started and baseline assessment will be conducted. There will be visits every 6 months to assess effectiveness, side-effects, PROMs, and elegibility to continue with the study drug. The observation of patients will last 2 years.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Migraine Patients | Migraine patients who initiate a CGRP-targeted treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CGRP antibody or gepant | Drug | Patients will start anti-CGRP or its receptor antibody or gepants |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Monthly Headache Days and Monthly Migraine Days | Through study completion, an average of 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| HIT-6 | Change in HIT-6 (Headache Impact Test) scale, to assess migraine impact. | Through study completion, an average of 2 years |
| MIDAS | Change in MIDAS (Migraine Disability Assessment Scale) scale, to assess disability attributed to migraine. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Episodic and chronic migraine patients.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patricia Pozo-Rosich, MD, PhD | Contact | (+34) 93 489 30 00 | 2479 | cefalea@vhir.org |
| Edoardo Caronna, MD, PhD | Contact | (+34) 93 489 30 00 | 2479 | cefalea@vhir.org |
| Name | Affiliation | Role |
|---|---|---|
| Patricia Pozo-Rosich, MD, PhD | Vall d'Hebron University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami, Miller School of Medicine | Recruiting | Miami | Florida | 33136 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Through study completion, an average of 2 years |
| PGIC | PGIC (Patien Global Impression of Change) scale will be used to assess impression of change in migraine patients. | Through study completion, an average of 2 years. |
| BAI | Change in BAI (Beck Anxiety Inventory) scale, to assess anxiety in migraine patients. | Through study completion, an average of 2 years. |
| BDI-II | Change in BDI-II (Beck's Depression Inventory, 2nd version) scale, to assess depression in migraine patients. | Through study completion, an average of 2 years. |
| MSQ Version 2.1 | Changes in MSQ (Migraine-Specific Quality-of-Life) Version 2.1 scale, to assess patient's quality of life. | Through study completion, an average of 2 years. |
| WPAI | Changes in WPAI (Work Productivity and Activity Impairment) questionnaire, to assess how migraine impacts in work and productivity in migraine patients. | Through study completion, an average of 2 years. |
| ISI | Changes in ISI (Insomnia Severity Index) scale to assess insomnia in migraine patients. | Through study completion, an average of 2 years. |
| ASC-12 | Changes in ASC-12 (Allodynia Symptom Checklist) scale, to assess allodynia in migraine patients. | Through study completion, an average of 2 years. |
| m-TOQ | m-TOQ (Migraine Treatment Optimization Questionnaire) scale will be used to assess the effectiveness of migraine treatment. | Through study completion, an average of 2 years. |
| FLENI | Recruiting | Buenos Aires | Argentina |
|
| Pontificia Universidad Católica de Chile | Recruiting | Santiago | Chile |
|
| Neuromedica | Recruiting | Medellín | Colombia |
|
| Special Hospital for Orthopedics and Rehabilitation "Martin Horvat" Rovinj-Rovigno | Recruiting | Rovinj | Croatia |
|
| Charité Universitätsmedizin Berlin | Recruiting | Berlin | Germany |
|
| LMU University Hospital | Recruiting | München | Germany |
|
| University of L'Aquila | Recruiting | L’Aquila | Italy |
|
| University of Modena and Reggio Emilia | Recruiting | Modena | Italy |
|
| National Neurological Institute C. Mondino Foundation | Recruiting | Pavia | Italy |
|
| IRCCS San Raffaele | Recruiting | Roma | Italy |
|
| Universiti Putra Malaysia | Recruiting | Serdang | Selangor | Malaysia |
|
| Neuroclinic Norway | Recruiting | Lillestrøm | Norway |
|
| Wrocław Medical University | Recruiting | Wroclaw | Poland |
|
| Hospital Santa Maria Lisbon | Recruiting | Lisbon | Portugal |
|
| Germans Trias i Pujol Hospital | Recruiting | Badalona | Barcelona | Spain |
|
| Vall d'Hebron University Hospital | Recruiting | Barcelona | Barcelona | 08035 | Spain |
|
| Hospital Universitari de Bellvitge | Recruiting | L'Hospitalet de Llobregat | Barcelona | Spain |
|
| Fundació Sanitària Mollet | Not yet recruiting | Mollet del Vallès | Barcelona | Spain |
|
| Hospital de Viladecans | Recruiting | Viladecans | Barcelona | Spain |
|
| Hospital General Universitario de Albacete | Recruiting | Albacete | Spain |
|
| Fundación Jiménez Díaz | Recruiting | Madrid | Spain |
|
| Hospital Universitario Gregorio Marañón | Recruiting | Madrid | Spain |
|
| La Paz University Hospital | Recruiting | Madrid | Spain |
|
| Hospital Clínico Universitario Lozano Blesa | Recruiting | Zaragoza | Spain |
|
| Mersin University | Recruiting | Mersin | Turkey (Türkiye) |
|
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D006261 | Headache |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077221 | Calcitonin Gene-Related Peptide Receptor Antagonists |
| ID | Term |
|---|---|
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D045505 | Physiological Effects of Drugs |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
Not provided
Not provided