An observational study in Headache Disorders, Secondary, Headache Disorders and Central Nervous System Diseases, sponsored by Hospital Clínico Universitario de Valladolid. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-28.
Sponsored by Hospital Clínico Universitario de Valladolid · Observational
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.
52 studies on the registry are indexed under Headache Disorders, Secondary; 13 are open to participants now.
This study's planned enrollment of 98 is below the median of 122 across 17 observational studies indexed under Headache Disorders, Secondary.
Browse Headache Disorders, Secondary studies →Hospital Clínico Universitario de Valladolid is the lead sponsor of 21 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population will be made up of 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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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
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.
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
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided — Anonymized data may be shared upon reasonable request to the principal investigator.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Headache Disorders, Secondary →
Hospital Clínico Universitario de Valladolid