NCT05475769

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
98

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 15, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 27, 2022

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

2.8 years

First QC Date

July 15, 2022

Last Update Submit

February 26, 2024

Conditions

Headache Disorders, SecondaryHeadache DisordersCentral Nervous System DiseasesBrain DiseasesNeurologic ManifestationsNervous System DiseasesPain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (14)

  • 50% response 20-24

    Weeks 20-24

  • 30% response 8-12

    Weeks 8-12

  • 30% response 20-24

    Weeks 20-24

  • 75% response 8-12

    Weeks 8-12

  • 75% response 20-24

    Weeks 20-24

  • +9 more secondary outcomes

Study Arms (1)

Nummular headache patients

Patients that fulfill the International Classification of Headache Disorders, 3rd edition, for Nummular Headache.

Drug: Clinical evaluation

Interventions

Clinical evaluationDRUG

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
Nummular headache patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clínico Universitario de Valladolid

Valladolid, 47003, Spain

RECRUITING

Related Publications (24)

  • 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.

    PMID: 12058099BACKGROUND

  • 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.

    PMID: 29368949BACKGROUND

  • 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.

    PMID: 15186307BACKGROUND

  • 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.

    PMID: 18726731BACKGROUND

  • 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.

    PMID: 19220316BACKGROUND

  • 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.

    PMID: 21198563BACKGROUND

  • 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.

    PMID: 21271546BACKGROUND

  • 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.

    PMID: 22127666BACKGROUND

  • 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.

    PMID: 21675970BACKGROUND

  • 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.

    PMID: 22711962BACKGROUND

  • 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.

    PMID: 23865918BACKGROUND

  • 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.

    PMID: 23469985BACKGROUND

  • 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.

    PMID: 23279627BACKGROUND

  • 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.

    PMID: 25929432BACKGROUND

  • 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.

    PMID: 25647287BACKGROUND

  • 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.

    PMID: 29103335BACKGROUND

  • 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.

    PMID: 30961529BACKGROUND

  • 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.

    PMID: 31272194BACKGROUND

  • 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.

    PMID: 32100277BACKGROUND

  • 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.

    PMID: 33681785BACKGROUND

  • 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.

    PMID: 29504482BACKGROUND

  • 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.

    PMID: 30879893BACKGROUND

  • 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.

    PMID: 33723599BACKGROUND

  • 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.

    PMID: 34022054BACKGROUND

MeSH Terms

Conditions

Headache Disorders, SecondaryHeadache DisordersCentral Nervous System DiseasesBrain DiseasesNeurologic ManifestationsNervous System DiseasesPain

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • David García-Azorín, MD, PhD

    Hospital Clínico Universitario de Valladolid

    PRINCIPAL INVESTIGATOR

Central Study Contacts

David Garcia Azorín, MD, PhD

CONTACT

+34 665872228davilink@hotmail.com

Yesica González Osorio, MD

CONTACT

+34 634330426ygoinvestigacion@outlook.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Headache Unit, Department of Neurology

Study Record Dates

First Submitted

July 15, 2022

First Posted

July 27, 2022

Study Start

March 1, 2022

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

February 28, 2024

Record last verified: 2024-02

Locations

ES(1)