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

Pain Clinical Trial

— NUMITOR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05475769
• Other study ID #: PI-GR-21-2394
• Status: Recruiting
• Start date: March 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Hospital Clínico Universitario de Valladolid
• Contact: David Garcia Azorín, MD, PhD
• Phone: +34 665872228
• Email: davilink[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 98
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Brain Diseases
• Central Nervous System Diseases
• Headache
• Headache Disorders
• Headache Disorders, Secondary
• Nervous System Diseases
• Neurologic Manifestations
• Pain

Intervention

Drug:
• Clinical evaluation
Patients will receive treatments under the criteria of the responsible physician and the response to these treatments will be prospectively collected.

Locations

Country	Name	City	State
Spain	Hospital Clínico Universitario de Valladolid	Valladolid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clínico Universitario de Valladolid

Country where clinical trial is conducted

Spain, 

References & Publications (24)

Alvaro 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. — View Citation

Baron 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. — View Citation

Chavarria-Miranda A, Guerrero AL, Talavera B, Martinez-Pias E, Trigo-Lopez J, Sierra A, Garcia-Azorin D. Linear Headache: A Novel Entity or a Variant of Nummular Headache? Clinical Characteristics and Treatment Response in a Series of 16 Patients. Pain Med. 2021 May 21;22(5):1158-1166. doi: 10.1093/pm/pnaa436. — View Citation

Clar-de-Alba B, Barriga FJ, Rodriguez-Caravaca G. [Clinical and pathophysiological description of nummular headaches: a case series]. Rev Neurol. 2020 Mar 1;70(5):171-178. doi: 10.33588/rn.7005.2019152. Spanish. — View Citation

Cortijo 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. — View Citation

Cortijo 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. — View Citation

Cuadrado ML, Lopez-Ruiz P, Guerrero AL. Nummular headache: an update and future prospects. Expert Rev Neurother. 2018 Jan;18(1):9-19. doi: 10.1080/14737175.2018.1401925. Epub 2017 Nov 9. — View Citation

Garcia-Azorin D, Trigo-Lopez J, Sierra A, Blanco-Garcia L, Martinez-Pias E, Martinez B, Talavera B, Guerrero AL. Observational, open-label, non-randomized study on the efficacy of onabotulinumtoxinA in the treatment of nummular headache: The pre-numabot study. Cephalalgia. 2019 Dec;39(14):1818-1826. doi: 10.1177/0333102419863023. Epub 2019 Jul 4. — View Citation

Garcia-Iglesias C, Martinez-Badillo C, Garcia-Azorin D, Trigo-Lopez J, Martinez-Pias E, Guerrero-Peral AL. Secondary Nummular Headache: A New Case Series and Review of the Literature. Pain Med. 2021 Nov 26;22(11):2718-2727. doi: 10.1093/pm/pnab174. — View Citation

GBD 2016 Neurology Collaborators. Global, regional, and national burden of neurological disorders, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2019 May;18(5):459-480. doi: 10.1016/S1474-4422(18)30499-X. Epub 2019 Mar 14. — View Citation

Guerrero 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. — View Citation

Guerrero 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. — View Citation

Guerrero 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. — View Citation

Headache 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. — View Citation

Herrero-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. — View Citation

Irimia 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. — View Citation

Mulero 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. — View Citation

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. — View Citation

Pareja 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. — View Citation

Patel UK, Saleem S, Anwar A, Malik P, Chauhan B, Kapoor A, Arumaithurai K, Kavi T. Characteristics and treatment effectiveness of the nummular headache: a systematic review and analysis of 110 cases. BMJ Neurol Open. 2020 Mar 12;2(1):e000049. doi: 10.1136/bmjno-2020-000049. eCollection 2020. — View Citation

Porta-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. — View Citation

Rodriguez 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. — View Citation

Tassorelli C, Diener HC, Dodick DW, Silberstein SD, Lipton RB, Ashina M, Becker WJ, Ferrari MD, Goadsby PJ, Pozo-Rosich P, Wang SJ; International Headache Society Clinical Trials Standing Committee. Guidelines of the International Headache Society for controlled trials of preventive treatment of chronic migraine in adults. Cephalalgia. 2018 Apr;38(5):815-832. doi: 10.1177/0333102418758283. Epub 2018 Mar 4. — View Citation

Trigo J, Garcia-Azorin D, Martinez Pias E, Sierra A, Chavarria A, Guerrero AL. Clinical characteristics of nummular headache and differentiation between spontaneous and posttraumatic variant: an observational study. J Headache Pain. 2019 Apr 8;20(1):34. doi: 10.1186/s10194-019-0981-4. — View Citation

* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Weeks 8-12
Secondary	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.	Weeks 20-24
Secondary	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.	Weeks 8-12
Secondary	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.	Weeks 20-24
Secondary	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.	Weeks 8-12
Secondary	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.	Weeks 20-24
Secondary	Adverse events	To evaluate the frequency and type of treatment-related adverse effects	Weeks 0-24
Secondary	Adverse events discontinuation	To evaluate the proportion of patients who discontinue each treatment due to adverse effects.	Weeks 0-24
Secondary	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.	Weeks 0-12
Secondary	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.	Weeks 0-12
Secondary	Adverse events in women	To evaluate the frequency and type of treatment-related adverse effects in women	Weeks 0-24
Secondary	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.	Weeks 0-12
Secondary	Adverse events in patients older than 65	To evaluate the frequency and type of treatment-related adverse effects in patients older than 65	Weeks 0-24
Secondary	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.	Weeks 0-12
Secondary	Adverse events in patients older than 80	To evaluate the frequency and type of treatment-related adverse effects in patients older than 80	Weeks 0-24