Chronic Migraine Treatment With Botulinum Toxin-A: an Investigation of Functional Magnetic Resonance Imaging Changes.

NCT02436499 | Completed Phase 4

• 1 other identifier: B2015:022
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Pilot study evaluating effect of Botox injection treatment for 12 individuals suffering from chronic migraine on function MRI imaging, before and after treatment.

Conditions

Chronic Migraine

Outcome Measures

Primary Outcomes (1)

• function MRI imaging changes

  3 fMRI scans will be done - one prior to treatment and two subsequent scans at Day 56 and Day 140

  140 days

Study Arms (1)

Treatment with Botox and fMRI screening

EXPERIMENTAL

Following baseline screening, participants will receive two subsequent treatments with botulinum-A toxin, each separated by 12 weeks. Participants will receive standardized botulinum-A toxin dosing for chronic migraine prophylaxis, comprised of 155 total units given at 31 specified sites across 7 head/neck muscles (protocol to be explicitly described in full protocol). Second dose of botulinum-A toxin will either be maintained at 155 total units as dosed initially, or be increased to 195 total units, depending on response to clinical questionnaires and examination to evaluate response and efficacy (to be described in full protocol, consistent with the "Follow-the-Pain Injection Paradigm").

Drug: Botulinum Toxin-A

Interventions

Botulinum Toxin-A DRUG

Also known as: Botox

Treatment with Botox and fMRI screening

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female and male patients, 18-65 years of age with confirmed chronic migraine (defined as migraine headache with or without aura, occurring on \> 15 days of each month for at least 3 months
• Headaches must have at least two of the following characteristics: unilateral location, pulsating quality, moderate-severe pain intensity and/or aggravation by or causing avoidance of routine physical activity (eg. Walking or climbing stairs)
• Headaches must also have at least one of: nausea and/or vomiting or photophobia and/or phonophobia.
• Patients must be cognitively able to understand questionnaires and be able to complete Headache Logs.
• Patients must be physically able to undergo treatment administration, including the required positional changes needed for administration.

You may not qualify if:

• Headaches that could be attributed to other causes, as determined by clinician, including medication overuse headaches and chronic tension type headache.
• Females of childbearing age with confirmed or suspected pregnancy, those planning on conceiving during the trial duration and women who are breastfeeding.
• Previous treatment with botulinum toxin-A for chronic migraine.
• Confirmed allergy to botulinum toxin-A or any of the product components.
• Contraindications to fMRI procedure.
• Patients unable to discontinue migraine prophylaxis medications, including tricyclic antidepressants, beta-blockers and various antiepileptic medications, either due to unwillingness or safety issues (eg. Antiepileptics being used to manage seizure disorder). This will be determined by clinician.
• Participants exhibiting severe depression (BDI score \>40) and/or suicidal ideation. These individuals will receive appropriate medical follow-up for psychological management.
• Active skin infection at planned injection site(s).

Sponsors & Collaborators

• University of Manitoba: lead
• Dr. Behzad Mansouri (Co-Primary Investigator): collaborator

Study Sites (1)

University of Manitoba

Winnipeg, Manitoba, R3E0T5, Canada

Location

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 1, 2015
• First Posted: May 6, 2015
• Study Start: July 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: September 15, 2017

Record last verified: 2017-09

Locations

CA (1)