NUMITOR Study: Nummular Headache Iberian Study on the Treatments and Outcomes in Real-World Setting

Study Overview
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Brief Summary
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The NUMITOR study is an analytical observational study with an multicenter ambisective (retrospective and prospective) cohort design.

Detailed Description
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This study aims to create a multicenter registry that will increase the knowledge of nummular headache and assess which treatments are more effective and better tolerated. The study population will be patients with nummular headache who, under the opinion of their responsible neurologists, have required or require preventive treatment, in any of its modalities, oral or injectable.

Official Title
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Nummular Headache Iberian Study on the Treatments and Outcomes in Real-World Setting

Conditions
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Headache Disorders, Secondary, Headache Disorders, Central Nervous System Diseases, Brain Diseases, Neurologic Manifestations, Nervous System Diseases, Pain

Intervention / Treatment
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* Drug: Clinical evaluation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Nummular headache according to the criteria of the International Classification of Headache Disorders, third version (ICHD-3). Nummular headache duration of more than three months. Treatment with a medication with possible preventive drug according to the Clinical Practice Guidelines of the Spanish Society of Neurology21. Age over 18 years. Informed consent signature. Exclusion Criteria: Diagnosis is better accounted for by any other entity included in the International Classification of Headache Disorders, 3rd version. Serious systemic or psychiatric pathology that makes it difficult to assess the patient. Secondary nummular headache Use of preventive treatment with another indication (e.g., epilepsy, other painful conditions, aesthetic).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Nummular headache patients<br>Patients that fulfill the International Classification of Headache Disorders, 3rd edition, for Nummular Headache. | Drug: Clinical evaluation<br>* Patients will receive treatments under the criteria of the responsible physician and the response to these treatments will be prospectively collected.<br>* Other names: Patients that under the criteria of the responsible physician receive oral or injectable treatment that are listed in the local Standard of Care;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 50% response 8-12 | To evaluate the 50% responder rate in patients with NH treated with each preventive drug between weeks 8-12, compared to the baseline situation (month prior to the treatment onset) for each different drug. | Weeks 8-12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 50% response 20-24 | To evaluate the 50% responder rate in the period between weeks 20-24, compared to the baseline situation (month prior to the treatment onset) for each different drug. | Weeks 20-24 | 
| 30% response 8-12 | To evaluate the proportion of patients with partial response, determined by the 30% response rate, between weeks 8-12, compared to the baseline situation. | Weeks 8-12 | 
| 30% response 20-24 | To evaluate the proportion of patients with partial response, determined by the 30% response rate, between weeks 20-24, compared to the baseline situation. | Weeks 20-24 | 
| 75% response 8-12 | To evaluate the proportion of patients with an optimal response, determined by the 75% responder rate, between weeks 8-12, compared to the baseline situation. | Weeks 8-12 | 
| 75% response 20-24 | To evaluate the proportion of patients with an optimal response, determined by the 75% response rate, between weeks 20-24, compared to the baseline situation. | Weeks 20-24 | 
| Adverse events | To evaluate the frequency and type of treatment-related adverse effects | Weeks 0-24 | 
| Adverse events discontinuation | To evaluate the proportion of patients who discontinue each treatment due to adverse effects. | Weeks 0-24 | 
| Response predictors weeks 8-12 | To calculate which demographic or clinical variables present an odds ratio higher or lower than 1, including the 95% confidence interval, in a logistic regression analysis where the dependent variable is the presence of a 50% responder rate between weeks 8-12. | Weeks 0-12 | 
| 50% response 8-12 in women | To evaluate the 50% responder rate in women with NH treated with each preventive drug between weeks 8-12, compared to the baseline situation (month prior to the treatment onset) for each different drug. | Weeks 0-12 | 
| Adverse events in women | To evaluate the frequency and type of treatment-related adverse effects in women | Weeks 0-24 | 
| 50% response 8-12 in patients older than 65 | To evaluate the 50% responder rate in patients older than 65 with NH treated with each preventive drug between weeks 8-12, compared to the baseline situation (month prior to the treatment onset) for each different drug. | Weeks 0-12 | 
| Adverse events in patients older than 65 | To evaluate the frequency and type of treatment-related adverse effects in patients older than 65 | Weeks 0-24 | 
| 50% response 8-12 in patients older than 80 | To evaluate the 50% responder rate in patients older than 80 with NH treated with each preventive drug between weeks 8-12, compared to the baseline situation (month prior to the treatment onset) for each different drug. | Weeks 0-12 | 
| Adverse events in patients older than 80 | To evaluate the frequency and type of treatment-related adverse effects in patients older than 80 | Weeks 0-24 |