Headache Disorders, SecondaryNUMITORNCT05475769
NUMITOR Study: Nummular Headache Iberian Study on the Treatments and Outcomes in Real-World Setting
An observational study of Headache Disorders, Secondary and Headache Disorders, run by Hospital Clínico Universitario de Valladolid at 1 site in Spain.
Trial summary
The NUMITOR study is an analytical observational study with an multicenter ambisective (retrospective and prospective) cohort design. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Headache Disorders, Secondary, Headache Disorders, Central Nervous System Diseases
- What is being tested?
- Clinical evaluation
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 98 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2022to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clínico Universitario de Valladolid
Valladolid, 47003
David García Azorín, MD, PhD, +34665872228, davilink@hotmail.com
Yesica González Osorio, MD, +34 634330426, ygoinvestigacion@outlook.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Headache Disorders, Secondary, Headache Disorders, Central Nervous System Diseases, Brain Diseases, Neurologic Manifestations, Nervous System Diseases
- Being tested
- Clinical evaluation
- Medical subject headings
- Headache Disorders, Secondary, Headache Disorders, Central Nervous System Diseases, Brain Diseases, Neurologic Manifestations, Nervous System Diseases, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical evaluationDrug
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Nummular headache patients | Patients that fulfill the International Classification of Headache Disorders, 3rd edition, for Nummular Headache. Receives: Drug: Clinical evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Weeks 8-12
Secondary outcomes (14)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Weeks 20-24
Adverse events
To evaluate the frequency and type of treatment-related adverse effects
Measured: Weeks 0-24
Adverse events discontinuation
To evaluate the proportion of patients who discontinue each treatment due to adverse effects.
Measured: 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.
Measured: 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.
Measured: Weeks 0-12
Adverse events in women
To evaluate the frequency and type of treatment-related adverse effects in women
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: Weeks 0-24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2022
- Study start1 Mar 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Headache Disorders, SecondaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clínico Universitario de Valladolid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David García Azorín, Hospital Clínico Universitario de Valladolid
- Investigators
- David García-Azorín, MD, PhD, Principal investigator, Hospital Clínico Universitario de Valladolid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05475769
- Sponsor's protocol ID
- PI-GR-21-2394
- Acronym
- NUMITOR
- Status last verified
- Feb 2024
- First submitted
- 15 Jul 2022
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Anonymized data may be shared upon reasonable request to the principal investigator.
Publications
Pareja JA, Caminero AB, Serra J, Barriga FJ, Baron M, Dobato JL, Vela L, Sanchez del Rio M. Numular headache: a coin-shaped cephalgia. Neurology. 2002 Jun 11;58(11):1678-9. doi: 10.1212/wnl.58.11.1678.
PubMed 12058099Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018 Jan;38(1):1-211. doi: 10.1177/0333102417738202. No abstract available.
PubMed 29368949Pareja JA, Pareja J, Barriga FJ, Baron M, Dobato JL, Pardo J, Sanchez C, Vela L. Nummular headache: a prospective series of 14 new cases. Headache. 2004 Jun;44(6):611-4. doi: 10.1111/j.1526-4610.2004.446011.x.
PubMed 15186307Guerrero AL, Martin-Polo J, Gutierrez F, Iglesias F. [Representation of the nummular healdache in general consultation in neurology]. Neurologia. 2008 Sep;23(7):474. No abstract available. Spanish.
PubMed 18726731Alvaro LC, Garcia JM, Areitio E. Nummular headache: a series with symptomatic and primary cases. Cephalalgia. 2009 Mar;29(3):379-83. doi: 10.1111/j.1468-2982.2008.01722.x.
PubMed 19220316Porta-Etessam J, Lapena T, Cuadrado ML, Guerrero A, Parejo B. Multifocal nummular headache with trophic changes. Headache. 2010 Nov;50(10):1612-3. doi: 10.1111/j.1526-4610.2010.01773.x. Epub 2010 Oct 12. No abstract available.
PubMed 21198563Cortijo E, Guerrero-Peral AL, Herrero-Velazquez S, Penas-Martinez ML, Rojo-Martinez E, Mulero P, Fernandez R. [Nummular headache: clinical features and therapeutic experience in a series of 30 new cases]. Rev Neurol. 2011 Jan 16;52(2):72-80. Spanish.
PubMed 21271546Cortijo E, Guerrero-Peral AL, Herrero-Velazquez S, Penas-Martinez ML, Rojo-Martinez E, Mulero P, Fernandez R. [Nummular headache: shedding light on some concepts. Reply]. Rev Neurol. 2011 Dec 16;53(12):768. No abstract available. Spanish.
PubMed 22127666Guerrero AL, Cuadrado ML, Garcia-Garcia ME, Cortijo E, Herrero-Velazquez S, Rodriguez O, Mulero P, Porta-Etessam J. Bifocal nummular headache: a series of 6 new cases. Headache. 2011 Jul-Aug;51(7):1161-6. doi: 10.1111/j.1526-4610.2011.01940.x. Epub 2011 Jun 15.
PubMed 21675970Guerrero AL, Cortijo E, Herrero-Velazquez S, Mulero P, Miranda S, Penas ML, Pedraza MI, Fernandez R. Nummular headache with and without exacerbations: comparative characteristics in a series of 72 patients. Cephalalgia. 2012 Jun;32(8):649-53. doi: 10.1177/0333102412447537.
PubMed 22711962Mulero P, Matarazzo M, Pedraza MI, Llamas S, Herrero S, Domingo-Santos A, Martinez-Salio A, Guerrero AL. Nummular headache related to exercise or Valsalva maneuver. Clinical characteristics of 3 cases. Headache. 2013 Jul-Aug;53(7):1167-8. doi: 10.1111/head.12133. No abstract available.
PubMed 23865918Irimia P, Palma JA, Idoate MA, Espana A, Riverol M, Martinez-Vila E. Cephalalgia alopecia or nummular headache with trophic changes? A new case with prolonged follow-up. Headache. 2013 Jun;53(6):994-7. doi: 10.1111/head.12072. Epub 2013 Mar 7.
PubMed 23469985Herrero-Velazquez S, Guerrero AL, Pedraza MI, Mulero P, Ayllon B, Ruiz-Pinero M, Rojo E, Marco J, Fernandez-Buey N, Cuadrado ML. Nummular headache and epicrania fugax: possible association of epicranias in eight patients. Pain Med. 2013 Mar;14(3):358-61. doi: 10.1111/pme.12022. Epub 2012 Dec 28.
PubMed 23279627Rodriguez C, Herrero-Velazquez S, Ruiz M, Baron J, Carreres A, Rodriguez-Valencia E, Guerrero AL, Madeleine P, Cuadrado ML, Fernandez-de-Las-Penas C. Pressure pain sensitivity map of multifocal nummular headache: a case report. J Headache Pain. 2015;16:523. doi: 10.1186/s10194-015-0523-7. Epub 2015 Apr 30.
PubMed 25929432Baron J, Rodriguez C, Ruiz M, Pedraza MI, Guerrero AL, Madeleine P, Cuadrado ML, Fernandez-de-Las-Penas C. Atypical nummular headache or circumscribed migraine: the utility of pressure algometry. Pain Res Manag. 2015 Mar-Apr;20(2):60-2. doi: 10.1155/2015/567072. Epub 2015 Feb 3.
PubMed 25647287
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nummular Headache Iberian Study on the Treatments and Outcomes in Real-World Setting
- ClinicalTrials.gov ID
- NCT05475769
- Acronym / sponsor ID
- NUMITOR / PI-GR-21-2394
- Conditions
- Headache Disorders, Secondary, Headache Disorders, Central Nervous System Diseases, Brain Diseases, Neurologic Manifestations, Nervous System Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Hospital Clínico Universitario de ValladolidUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 27 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The NUMITOR study is an analytical observational study with an multicenter ambisective (retrospective and prospective) cohort design.
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
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nummular headache patients | – | Drug: Clinical evaluationPatients that fulfill the International Classification of Headache Disorders, 3rd edition, for Nummular Headache. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical evaluationAlso: Patients that under the criteria of the responsible physician receive oral or injectable treatment that are listed in the local Standard of CarePatients will receive treatments under the criteria of the responsible physician and the response to these treatments will be prospectively collected. | Drug | Nummular headache patients |
Primary outcome
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.
14 secondary outcomes
50% response 20-24
Time frame: Weeks 20-24
30% response 8-12
Time frame: Weeks 8-12
30% response 20-24
Time frame: Weeks 20-24
75% response 8-12
Time frame: Weeks 8-12
75% response 20-24
Time frame: Weeks 20-24
Adverse events
Time frame: Weeks 0-24
Adverse events discontinuation
Time frame: Weeks 0-24
Response predictors weeks 8-12
Time frame: Weeks 0-12
50% response 8-12 in women
Time frame: Weeks 0-12
Adverse events in women
Time frame: Weeks 0-24
50% response 8-12 in patients older than 65
Time frame: Weeks 0-12
Adverse events in patients older than 65
Time frame: Weeks 0-24
50% response 8-12 in patients older than 80
Time frame: Weeks 0-12
Adverse events in patients older than 80
Time frame: Weeks 0-24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Background: PubMed 12058099Pareja JA, Caminero AB, Serra J, Barriga FJ, Baron M, Dobato JL, Vela L, Sanchez del Rio M. Numular headache: a coin-shaped cephalgia. Neurology. 2002 Jun 11;58(11):1678-9. doi: 10.1212/wnl.58.11.1678.
- Background: PubMed 29368949Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018 Jan;38(1):1-211. doi: 10.1177/0333102417738202. No abstract available.
- Background: PubMed 15186307Pareja JA, Pareja J, Barriga FJ, Baron M, Dobato JL, Pardo J, Sanchez C, Vela L. Nummular headache: a prospective series of 14 new cases. Headache. 2004 Jun;44(6):611-4. doi: 10.1111/j.1526-4610.2004.446011.x.
- Background: PubMed 18726731Guerrero AL, Martin-Polo J, Gutierrez F, Iglesias F. [Representation of the nummular healdache in general consultation in neurology]. Neurologia. 2008 Sep;23(7):474. No abstract available. Spanish.
- Background: PubMed 19220316Alvaro LC, Garcia JM, Areitio E. Nummular headache: a series with symptomatic and primary cases. Cephalalgia. 2009 Mar;29(3):379-83. doi: 10.1111/j.1468-2982.2008.01722.x.
- Background: PubMed 21198563Porta-Etessam J, Lapena T, Cuadrado ML, Guerrero A, Parejo B. Multifocal nummular headache with trophic changes. Headache. 2010 Nov;50(10):1612-3. doi: 10.1111/j.1526-4610.2010.01773.x. Epub 2010 Oct 12. No abstract available.
- Background: PubMed 21271546Cortijo E, Guerrero-Peral AL, Herrero-Velazquez S, Penas-Martinez ML, Rojo-Martinez E, Mulero P, Fernandez R. [Nummular headache: clinical features and therapeutic experience in a series of 30 new cases]. Rev Neurol. 2011 Jan 16;52(2):72-80. Spanish.
- Background: PubMed 22127666Cortijo E, Guerrero-Peral AL, Herrero-Velazquez S, Penas-Martinez ML, Rojo-Martinez E, Mulero P, Fernandez R. [Nummular headache: shedding light on some concepts. Reply]. Rev Neurol. 2011 Dec 16;53(12):768. No abstract available. Spanish.
- Background: PubMed 21675970Guerrero AL, Cuadrado ML, Garcia-Garcia ME, Cortijo E, Herrero-Velazquez S, Rodriguez O, Mulero P, Porta-Etessam J. Bifocal nummular headache: a series of 6 new cases. Headache. 2011 Jul-Aug;51(7):1161-6. doi: 10.1111/j.1526-4610.2011.01940.x. Epub 2011 Jun 15.
- Background: PubMed 22711962Guerrero AL, Cortijo E, Herrero-Velazquez S, Mulero P, Miranda S, Penas ML, Pedraza MI, Fernandez R. Nummular headache with and without exacerbations: comparative characteristics in a series of 72 patients. Cephalalgia. 2012 Jun;32(8):649-53. doi: 10.1177/0333102412447537.
- Background: PubMed 23865918Mulero P, Matarazzo M, Pedraza MI, Llamas S, Herrero S, Domingo-Santos A, Martinez-Salio A, Guerrero AL. Nummular headache related to exercise or Valsalva maneuver. Clinical characteristics of 3 cases. Headache. 2013 Jul-Aug;53(7):1167-8. doi: 10.1111/head.12133. No abstract available.
- Background: PubMed 23469985Irimia P, Palma JA, Idoate MA, Espana A, Riverol M, Martinez-Vila E. Cephalalgia alopecia or nummular headache with trophic changes? A new case with prolonged follow-up. Headache. 2013 Jun;53(6):994-7. doi: 10.1111/head.12072. Epub 2013 Mar 7.
- Individual participant dataSharing planned: Undecided. Anonymized data may be shared upon reasonable request to the principal investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David García-Azorín, MD, PhD principal investigator
Hospital Clínico Universitario de Valladolid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Headache Disorders, Secondary and Headache Disorders, run by Hospital Clínico Universitario de Valladolid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Garcia Azorín, MD, PhD (+34 665872228, davilink@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
50% response 8-12 (time frame: Weeks 8-12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05475769, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.