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MigraineQ-MIGALNCT04580641

Validation of a Questionnaire for Allodynia in Migraine.

An observational study of Migraine, run by University Hospital, Clermont-Ferrand at 14 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Migraine is very frequent (15% of the general population). During attacks, many subjects with migraine have allodynia (pain induced by normally non-painful stimuli), photophobia (hypersensitivity to light), phonophobia (hypersensitivity to sound) or osmophobia (hypersensitivity to odours). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Migraine
What is being tested?
Questionnaire
How many people
180 participants
Where
14 sitesFrance
Study dates
1 Oct 2020to Sep 2021
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: Subjects fulfilling 2018 international headache society criteria for migraine

Who may be able to join

  • Subjects fulfilling 2018 international headache society criteria for migraine.
  • Age > 17 years.
  • Written consent.

Who cannot join

  • Presence of neurological comorbidities that could lead to sensorial or sensitive abnormalities
  • Presence of dermatological comorbidities that could lead to sensorial or sensitive abnormalities
  • Presence of ENT comorbidities that could lead to sensorial or sensitive abnormalities
  • Significant cognitive dysfunction precluding proper completion of the self-administered questionnaire

Trial locations and contacts

14 sites in 1 country.

Lise Laclautre, PharmD contact

04 73 754 963 ext. 33

promo_interne_drci@chu-clermontferrand.fr

14 sites in 1 country

France14 sites

  • CH d'Annecy, Centre d'Etude et de Traitement de la Douleur

    Annecy, 74000

    Lise Laclautre, PharmD, 0473754963 ext. 33, promo_interne_drci@chu-clermontferrand.fr

    Pierric GIRAUD, MD

  • Cabinet de Neurologie

    Clermont-Ferrand, 63000

    Lise Laclautre, PharmD, 0473754963 ext. 33, promo_interne_drci@chu-clermontferrand.fr

    Michel LAUXEROIS, MD

  • CHU de Clermont-Ferrand, Centre d'Etude et de Traitement de la Douleur

    Clermont-Ferrand, 63000

  • CHU de Clermont-Ferrand, Service de Neurologie

    Clermont-Ferrand, 63000

    Lise Laclautre, PharmD, 0473754963 ext. 33, promo_interne_drci@chu-clermontferrand.fr

    Xavier MOISSET, MD, PhD

  • CH Emile Roux Le Puy en Velay, Service de Neurologie

    Le Puy-en-Velay, 43000

    Lise Laclautre, PharmD, 0473754963 ext. 33, promo_interne_drci@chu-clermontferrand.fr

    Jérémy DASSA, MD

  • CHU de Lille, Service de Neurologie

    Lille

  • CHU de Lyon, Hôpital Pierre Wertheimer, Service de neurologie fonctionelle et épileptologie

    Lyon, 69000

    Lise Laclautre, PharmD, 0473754963 ext. 33, promo_interne_drci@chu-clermontferrand.fr

    Geneviève DEMARQUAY, MD

  • Assistance Publique - Hôpitaux de Marseille, CHU La Timone, Centre d'Evaluation et Traitement de la Douleur

    Marseille, 13000

    Lise Laclautre, PharmD, 0473754963 ext. 33, promo_interne_drci@chu-clermontferrand.fr

    Anne DONNET, MD, PhD

  • CHU de Montpellier, Service de Neurologie

    Montpellier, 34000

    Lise Laclautre, PharmD, 0473754963 ext. 33, promo_interne_drci@chu-clermontferrand.fr

    Anne DUCROS, MD, PhD

  • CHU de Nantes, Service de Neurologie

    Nantes, 44000

    Lise Laclautre, PharmD, 0473754963 ext. 33, promo_interne_drci@chu-clermontferrand.fr

    Solène DE GAALON, MD

  • CHU de Nice, Département Evaluation et Traitement de la Douleur

    Nice, 06000

    Lise Laclautre, PharmD, 0473754963 ext. 33, promo_interne_drci@chu-clermontferrand.fr

    Michel LANTERI-MINET, MD, PhD

  • Assistance Publique - Hôpitaux de Paris, CHU Lariboisière, Service de Neurologie

    Paris, 75000

    Lise Laclautre, PharmD, 0473754963 ext. 33, promo_interne_drci@chu-clermontferrand.fr

    Caroline ROOS, MD

  • CHU de Rouen, Service de Neurologie

    Rouen, 76000

    Lise Laclautre, PharmD, 0473754963, promo_interne_drci@chu-clermontferrand.fr

    Evelyne MASSARDIER, MD

  • CH de Vichy, Service de Neurologie

    Vichy, 03200

    Lise Laclautre, PharmD, 0473754963 ext. 33, promo_interne_drci@chu-clermontferrand.fr

    Mitra NAJJAR-RAVAN, MD

Other trials in France

About this study

Official title: Allodynia and Sensorial Hypersensitivity in Patients With Migraine: Validation of a Specific Questionnaire

Migraine is very frequent (15% of the general population). During attacks, many subjects with migraine have allodynia (pain induced by normally non-painful stimuli), photophobia (hypersensitivity to light), phonophobia (hypersensitivity to sound) or osmophobia (hypersensitivity to odours). The goal of the present study is to validate a new questionnaire made of 4 parts evaluating the presence of these 4 types of hypersensitivity, both during or between migraine attacks. It will allow to look for associations of these 4 symptoms and association of hypersensitivity with patients' or migraine's characteristics.

Read the detailed description

The prevalence of migraine is around 15% worldwide (GBD 2016, Lancet Neurol 2018). During attacks, and even between attacks, especially when migraine frequency is high, many subjects with migraine present with photophobia, phonophobia, osmophobia or allodynia. These symptoms are though to correspond to central sensitization and can be found in animal models of migraine (Boyer et al., Pain 2017; Dallel et al., Cephalalgia 2018).

These 4 symptoms have been studied separately in previous studies but to date, there is no overall questionnaire evaluating these 4 sub-types of hypersensitivity. The investigators have constituted a questionnaire based on previous validated questionnaires that have been translated into French (Lipton et al., 2008 for cutaneous allodynia; Choi et al., 2009 for photophobia), a previous questionnaire validated in French (Khalfa et al, 2002 for phonophobia) and created a few questions for each of the 4 symptoms, including osmophobia.

Conditions
Migraine
Being tested
Questionnaire
Keywords
migraine, allodynia, photophobia, phonophobia, osmophobia, central sensitization
Medical subject headings
Migraine Disorders, Hyperalgesia, Photophobia, Hyperacusis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QuestionnaireOther

    A self-administered questionnaire will be completed by each study subject

Study groups in NCT04580641
Study groupRoleWhat they receive
Subjects with migraineNo medical intervention. All included subjects will filled in the questionnaire concerning migraine characteristics and associated symptoms.
Receives: Other: Questionnaire

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Predictive factors of allodynia/hypersensitivity in subjects with migraine

    Correlations between scores on specific questionnaires evaluating allodynia/hypersensitivity (cutaneous allodynia with the questionnaire by Lipton et al., 2008, osmophobia with a home-made questionnaire rated from 0 to 4, photophobia with the questionnaire by Choi et al., 2009, phonophobia with the questionnaire by Khalfa et al., 2002), patients characteristics (age, sex, Body mass index, habits, score on the Hospital Anxiety and Depression scale) and migraine characteristics (presence of aura or not, migraine duration in years, migraine frequency in attacks per month, pain intensity during migraine attacks rated from 0 to 4).

    Measured: baseline

Secondary outcomes (4)

  1. Predictive factors of cutaneous allodynia in subjects with migraine

    Correlations between score on the 12-item Allodynia Symptom Checklist (Lipton et al., 2008) (score from 0 to 24 with higher values indicating higher level of allodynia), patients characteristics (age in years, sex, body mass index in kg/m², consumption of alcohol and tobacco, score on the Hospital Anxiety and Depression scale) and migraine characteristics (presence of aura or not, migraine duration in years, migraine frequency in attacks per month, pain intensity during migraine attacks rated from 0 to 4) .

    Measured: baseline

  2. Predictive factors of photophobia in subjects with migraine

    Correlations between scores on two specific questionnaires evaluating photophobia (Choi et al., 2009; binary score for presence or absence of photophobia and home-made questionnaire with score from 0 to 4 with higher values indicating higher level of phonophobia), patients characteristics (age in years, sex, body mass index in kg/m², consumption of alcohol and tobacco, score on the Hospital Anxiety and Depression scale) and migraine characteristics (presence of aura or not, migraine duration in years, migraine frequency in attacks per month, pain intensity during migraine attacks rated from 0 to 4).

    Measured: baseline

  3. Predictive factors of phonophobia in subjects with migraine

    Correlations between scores on a questionnaire evaluating phonophobia (Khalfa et al. 2002, score from 0 to 42 with higher values indicating higher level of phonophobia), patients characteristics (age in years, sex, body mass index in kg/m², consumption of alcohol and tobacco, score on the Hospital Anxiety and Depression scale) and migraine characteristics, (presence of aura or not, migraine duration in years, migraine frequency in attacks per month, pain intensity during migraine attacks rated from 0 to 4).

    Measured: baseline

  4. Predictive factors of osmophobia in subjects with migraine

    Correlations between scores on a specific home-made questionnaire evaluating osmophobia (score from 0 to 4 with higher values indicating higher level of osmophobia), patients characteristics (age in years, sex, body mass index in kg/m², consumption of alcohol and tobacco, score on the Hospital Anxiety and Depression scale) and migraine characteristics (presence of aura or not, migraine duration in years, migraine frequency in attacks per month, pain intensity during migraine attacks rated from 0 to 4).

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2020
  2. Study start1 Oct 2020 (estimated)
  3. Primary completionJun 2021 (estimated)
  4. Study completionSep 2021 (estimated)

Resources

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
Case only
Time perspective
Cross-sectional
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04580641
Sponsor's protocol ID
RNI 2018 MOISSET (Q-MIGAL)
Acronym
Q-MIGAL
Status last verified
Sep 2020
First submitted
16 Sep 2020
Last updated
8 Oct 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Choi JY, Oh K, Kim BJ, Chung CS, Koh SB, Park KW. Usefulness of a photophobia questionnaire in patients with migraine. Cephalalgia. 2009 Sep;29(9):953-9. doi: 10.1111/j.1468-2982.2008.01822.x. Epub 2009 Feb 27.

    PubMed 19298545

  • Lipton RB, Bigal ME, Ashina S, Burstein R, Silberstein S, Reed ML, Serrano D, Stewart WF; American Migraine Prevalence Prevention Advisory Group. Cutaneous allodynia in the migraine population. Ann Neurol. 2008 Feb;63(2):148-58. doi: 10.1002/ana.21211.

    PubMed 18059010

  • Khalfa S, Dubal S, Veuillet E, Perez-Diaz F, Jouvent R, Collet L. Psychometric normalization of a hyperacusis questionnaire. ORL J Otorhinolaryngol Relat Spec. 2002 Nov-Dec;64(6):436-42. doi: 10.1159/000067570.

    PubMed 12499770

Questions about this trial

What is this clinical trial studying?

An observational study of Migraine, run by University Hospital, Clermont-Ferrand at 14 sites in France.

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 3 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 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in France. 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 Lise Laclautre, PharmD (04 73 754 963 ext. 33, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Predictive factors of allodynia/hypersensitivity in subjects with migraine (time frame: baseline). 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 NCT04580641, which also lists 3 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 8 Oct 2020; AzTrials last refreshed its copy on 7 Nov 2026.

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