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

Completed

• Conditions: Chronic Migraine

• Registration Number: NCT03175263
• Lead Sponsor: University Hospital, Limoges

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09-01
• Primary Completion: 2015-12-30
• Study Completion: 2015-12-30
• Status Verified: 2017-06
• Study First Submitted: 2017-06-01
• Study First Submitted QC: 2017-06-01
• Last Update Submitted: 2017-06-01
• Study First Posted: 2017-06-05
• Last Update Posted: 2017-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

• Patients refractory to conventional treatments

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
the proportion of patients with a ≥ 70% decrease in headache day frequency	Week 8	the proportion of patients with a ≥ 70% decrease in headache day frequency
the decrease in triptan consumption	Week 8	the decrease in triptan consumption
the assessment of patient satisfaction	Week 8	the assessment of patient satisfaction on a 0 to10 numerical scale (0=no improvement, and 10=maximum possible improvement).