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

February 26, 2024 updated by: David García Azorín, Hospital Clínico Universitario de Valladolid

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

98

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Valladolid, Spain, 47003
        • Recruiting
        • Hospital Clinico Universitario de Valladolid
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
50% response 8-12
Time Frame: 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.
Weeks 8-12

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Clínico Universitario de Valladolid

Investigators

  • Principal Investigator: David García-Azorín, MD, PhD, Hospital Clinico Universitario de Valladolid

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

July 15, 2022

First Submitted That Met QC Criteria

July 23, 2022

First Posted (Actual)

July 27, 2022

Study Record Updates

Last Update Posted (Estimated)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 26, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI-GR-21-2394

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Anonymized data may be shared upon reasonable request to the principal investigator.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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