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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03175263
First Posted: June 5, 2017
Last Update Posted: June 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Limoges
  Purpose
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.

Condition
Chronic Migraine

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: OnabotulinumtoxinA Injections in Chronic Migraine, Targeted to Sites of Pericranial Myofascial Pain : an Observational, Open Label, Real-life Cohort Study.

Resource links provided by NLM:


Further study details as provided by University Hospital, Limoges:

Primary Outcome Measures:
  • frequency of headache days [ Time Frame: 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:
  • the proportion of patients with a ≥ 70% decrease in headache day frequency [ Time Frame: Week 8 ]
    the proportion of patients with a ≥ 70% decrease in headache day frequency

  • the decrease in triptan consumption [ Time Frame: Week 8 ]
    the decrease in triptan consumption

  • the assessment of patient satisfaction [ Time Frame: Week 8 ]
    the assessment of patient satisfaction on a 0 to10 numerical scale (0=no improvement, and 10=maximum possible improvement).


Enrollment: 57
Actual Study Start Date: September 1, 2008
Study Completion Date: December 30, 2015
Primary Completion Date: December 30, 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with chronic migraine
Patients with chronic migraine refractory to conventional treatments

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with chronic migraine
Criteria

Inclusion Criteria:

  • Patients refractory to conventional treatments

Exclusion Criteria:

  • Contra-indication to botulinum toxin treatment Inability to sign informed consent
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03175263


Sponsors and Collaborators
University Hospital, Limoges
Investigators
Principal Investigator: Daniele RANOUX, PH University Hospital, Limoges
  More Information

Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT03175263     History of Changes
Other Study ID Numbers: I17022
First Submitted: June 1, 2017
First Posted: June 5, 2017
Last Update Posted: June 5, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Limoges:
onabotulinumtoxinA, chronic migraine, myofascial pain

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
onabotulinumtoxinA
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents