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CompletedNCT03175263Updated Jun 5, 2017

OnabotulinumtoxinA Injections in Chronic Migraine, Targeted to Sites of Pericranial Myofascial Pain

An observational study in Chronic Migraine, sponsored by University Hospital, Limoges. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-06-05.

Sponsored by University Hospital, Limoges · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
57
Ages
18 Years and older
Sex
All
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Study summary

This study was an observational, open-label, cohort-study conducted in accordance with the principles of the Helsinki Declaration. We prospectively and systematically recorded data from the patients and analyzed them retrospectively. During a first phase, called adaptation period, the injector (DR) used a follow-the-pain approach in order to determine the optimal injection scheme for each individual. The possible injection sites were the corrugator, temporalis, and trapezius muscles. Patients were systematically asked about the usual topography and time course of migraine attacks, and the existence of pain or stiffness of the cervical muscles. If the pain was predominantly located in the frontotemporal area, the corrugator and temporalis muscles were injected bilaterally. When the patients had predominant pain in the back of the head, or when their headache pain frequently started and/or ended in the trapezius muscles, both trapezius muscles were injected. These muscle groups were injected together if pain was both frontotemporal and cervico-occipital. When this first set of injections was efficacious, patients were re-injected in the same manner at the time when the frequency of headache days definitely increased. In the absence of efficacy, the paradigm was modified using the same follow-the-pain approach. Once the best procedure was determined for each patient, it was reproduced at each subsequent injection session. This adaptation phase could necessitate up to three sessions. The observation period started 8 weeks before the first efficacious injection and ended 2 months after the second consecutive efficacious injection, or in case of inefficacy. Throughout the adaptation and the observation phases, patients kept a headache diary where they were asked to note the days with headache and the use of rescue medication.

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Conditions studied

  • Chronic Migraine

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Keywords

  • onabotulinumtoxinA, chronic migraine, myofascial pain
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In context

Migraine Disorders

1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.

This study's enrollment of 57 is below the median of 130 across 299 observational studies indexed under Migraine Disorders.

Browse Migraine Disorders studies →

Lead sponsor

University Hospital, Limoges is the lead sponsor of 255 studies on the registry; 36 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with chronic migraine

Inclusion criteria

  • Patients refractory to conventional treatments

Exclusion criteria

Exclusion Criteria:

  • Contra-indication to botulinum toxin treatment Inability to sign informed consent
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
57 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients with chronic migraine

    Patients with chronic migraine refractory to conventional treatments

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What researchers measure

Primary outcomes

  1. frequency of headache days

    change from baseline in frequency of headache days (as recorded in the patient diary) for the 2 months-period ending with week 8

    Time frame: Week 8

Secondary outcomes

  1. the proportion of patients with a ≥ 70% decrease in headache day frequency

    the proportion of patients with a ≥ 70% decrease in headache day frequency

    Time frame: Week 8

  2. the decrease in triptan consumption

    the decrease in triptan consumption

    Time frame: Week 8

  3. the assessment of patient satisfaction

    the assessment of patient satisfaction on a 0 to10 numerical scale (0=no improvement, and 10=maximum possible improvement).

    Time frame: Week 8

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Ranoux D, Martine G, Espagne-Dubreuilh G, Amilhaud-Bordier M, Caire F, Magy L. OnabotulinumtoxinA injections in chronic migraine, targeted to sites of pericranial myofascial pain: an observational, open label, real-life cohort study. J Headache Pain. 2017 Dec;18(1):75. doi: 10.1186/s10194-017-0781-7. Epub 2017 Jul 21. PubMed 28733943 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 5, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03175263
Lead sponsor
University Hospital, Limoges
Responsible party
Sponsor
First posted
Jun 5, 2017
Start date
Sep 1, 2008
Primary completion
Dec 30, 2015
Completion
Dec 30, 2015
Last update
Jun 5, 2017

Study contacts

Daniele RANOUX, PH
principal investigator · University Hospital, Limoges

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

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