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

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.

• Clinical evaluation (Drug), also known as Patients that under the criteria of the responsible physician receive oral or injectable treatment that are listed in the local Standard of Care: Patients will receive treatments under the criteria of the responsible physician and the response to these treatments will be prospectively collected.

Primary outcomes

• 50% response 8-12 [Weeks 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.

Secondary outcomes

• 50% response 20-24 [Weeks 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.
• 30% response 8-12 [Weeks 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.
• 30% response 20-24 [Weeks 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.
• 75% response 8-12 [Weeks 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.
• 75% response 20-24 [Weeks 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.
• Adverse events [Weeks 0-24]: To evaluate the frequency and type of treatment-related adverse effects
• Adverse events discontinuation [Weeks 0-24]: To evaluate the proportion of patients who discontinue each treatment due to adverse effects.
• Response predictors weeks 8-12 [Weeks 0-12]: 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.
• 50% response 8-12 in women [Weeks 0-12]: 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.
• Adverse events in women [Weeks 0-24]: To evaluate the frequency and type of treatment-related adverse effects in women
• 50% response 8-12 in patients older than 65 [Weeks 0-12]: 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.
• Adverse events in patients older than 65 [Weeks 0-24]: To evaluate the frequency and type of treatment-related adverse effects in patients older than 65
• 50% response 8-12 in patients older than 80 [Weeks 0-12]: 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.
• Adverse events in patients older than 80 [Weeks 0-24]: To evaluate the frequency and type of treatment-related adverse effects in patients older than 80

Sex: All, ages: 18 Years to any

Inclusion Criteria:

1. Nummular headache according to the criteria of the International Classification of Headache Disorders, third version (ICHD-3).
2. Nummular headache duration of more than three months.
3. Treatment with a medication with possible preventive drug according to the Clinical Practice Guidelines of the Spanish Society of Neurology21.
4. Age over 18 years.
5. Informed consent signature.

Exclusion Criteria:

1. Diagnosis is better accounted for by any other entity included in the International Classification of Headache Disorders, 3rd version.
2. Serious systemic or psychiatric pathology that makes it difficult to assess the patient.
3. Secondary nummular headache
4. Use of preventive treatment with another indication (e.g., epilepsy, other painful conditions, aesthetic).

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• Statistical Analysis Plan (PDF, 2021-07-11)

• David García-Azorín, MD, PhD, Principal investigator, Hospital Clínico Universitario de Valladolid