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

Sponsor

Hospital Clínico Universitario de Valladolid (Other)

Overall Status

Recruiting

CT.gov ID

NCT05475769

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

9.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Headache Disorders, Secondary Headache Disorders Central Nervous System Diseases Brain Diseases Neurologic Manifestations Nervous System Diseases Pain	Drug: Clinical evaluation

Detailed Description

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

98 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

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

Actual Study Start Date :

Mar 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Nummular headache patients Patients that fulfill the International Classification of Headache Disorders, 3rd edition, for Nummular Headache.	Drug: Clinical evaluation Patients will receive treatments under the criteria of the responsible physician and the response to these treatments will be prospectively collected. 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

Arm

Intervention/Treatment

Nummular headache patients

Patients that fulfill the International Classification of Headache Disorders, 3rd edition, for Nummular Headache.

Drug: Clinical evaluation

Patients will receive treatments under the criteria of the responsible physician and the response to these treatments will be prospectively collected.

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).