The NUMITOR study is an analytical observational study with an multicenter ambisective (retrospective and prospective) cohort design.
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 Type
OBSERVATIONAL
Enrollment
98
Patients will receive treatments under the criteria of the responsible physician and the response to these treatments will be prospectively collected.
Hospital Clínico Universitario de Valladolid
Valladolid, Spain
RECRUITING50% 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.
Time frame: Weeks 8-12
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Weeks 20-24
Adverse events
To evaluate the frequency and type of treatment-related adverse effects
Time frame: Weeks 0-24
Adverse events discontinuation
To evaluate the proportion of patients who discontinue each treatment due to adverse effects.
Time frame: 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.
Time frame: 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.
Time frame: Weeks 0-12
Adverse events in women
To evaluate the frequency and type of treatment-related adverse effects in women
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: Weeks 0-24
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