Investigation of Efficacy and Safety of Botulinum Toxin A (Botox-Allergan Inc) in Migraine Headaches

Yale University25 enrolled

Overview

The hypothesis of this study is that injection of botulinum toxin A into the muscles around the head (frontal, temporal, posterior neck, occipital) can reduce the intensity and frequency of migraine headaches by 50%.

Contact PI for study details

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Refractory Migraine

Interventions

BotoxDRUG

subjects randomized to receive Botox with have a series of injections of onobotulinumtoxinA totalling 200 to 300 units. Botox is prepared b adding 1cc of preservative free saline in 100 unit vial. Final dose is determined by bod and neck size.

PlaceboOTHER

subjects randomized to receive Placebo will have a series of injections of saline solution totalling 2cc's to 3cc's injected into the scalp in a halo pattern; and into affected neck muscles.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adults 18 and older * Migraine for more than three months, that fail to respond to two or more major anti-migraine drug, meeting criteria of chronic migraine Exclusion Criteria: * Age below 18 * Pregnant or may become pregnant * Disease of neuromuscular junction or drugs that affect N-M junction * Allergy to Botox * Previous use of Botox for migraine by similar methodology

Locations (1)

Yale Physician's Building, 800 Howard Ave, lower level,

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

Mean Number of Days of Decrease in Pain Level Using VAS

Number of days of decreased pain (2 grades or more) on Visual Analog scale. VAS ranges from 0-10, with 0 being no pain, and 10 being worst pain.

Time frame: 4 weeks

Secondary Outcomes

Number of Participants Satisfied With Treatment

Number of Patients whose Patient global impression of change (PGIC) moderately or much improved- The PGIC is a 7 point scale that requires the clinician to assess how much the patient's pain has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: No change (or condition has gotten worse) (1) Almost the same, hardly any change at all (2) A little better, but no noticeable change (3) Somewhat better, but the change has not made any real difference (4) Moderately better, and a slight but noticeable change (5) Better and a definite improvement that has made a real and worthwhile difference (6) A great deal better and a considerable improvement that has made all the difference (7)improved This outcome is number of patients who chose a 6 or above on the PGIC 6 weeks after treatment.

Time frame: 4 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.