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

Chronic Migraine Clinical Trial

Official title:

OnabotulinumtoxinA Injections in Chronic Migraine, Targeted to Sites of Pericranial Myofascial Pain : an Observational, Open Label, Real-life Cohort Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03175263
• Other study ID #: I17022
• Status: Completed
• Phase: N/A
• First received: June 1, 2017
• Last updated: June 1, 2017
• Start date: September 1, 2008
• Est. completion date: December 30, 2015

Study information

• Verified date: June 2017
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: December 30, 2015
• Est. primary completion date: December 30, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients refractory to conventional treatments

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Chronic Migraine
• Migraine Disorders

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Week 8
Secondary	the proportion of patients with a = 70% decrease in headache day frequency	the proportion of patients with a = 70% decrease in headache day frequency	Week 8
Secondary	the decrease in triptan consumption	the decrease in triptan consumption	Week 8
Secondary	the assessment of patient satisfaction	the assessment of patient satisfaction on a 0 to10 numerical scale (0=no improvement, and 10=maximum possible improvement).	Week 8