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

NCT00660192 | Completed Phase 2 Results DMC

• 1 other identifier: 0709003056
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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%.

Conditions

Refractory Migraine

Keywords

Migraine, refractory migraine, Pain, Botulinum Toxin , Botox

Outcome Measures

Primary Outcomes (1)

• 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.

  4 weeks

Secondary Outcomes (1)

• Number of Participants Satisfied With Treatment

  4 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Subjects are randomized to receive Placebo which is inactive saline (sterile salt water solution). The Subjects are injected with a comparable amount of placebo solution (2cc-3cc) as received by those randomized to receive active study drug. The randomization will be done in a double blinded manner where the investigator nor the subject knows which substance (Placebo vs. Botox) is being injected.

Other: Placebo

Botox

ACTIVE COMPARATOR

Subjects are randomized to receive Active study drug Botox (onobotulinumtoxinA). The Botox is prepare by diluting 100units of toxin /1cc Saline. The Subjects are injected with 200-300units of units of Botox which is 2cc-3cc of solution. The randomization will be done in a double blinded manner where the investigator nor the subject knows which substance (Placebo vs. Botox) is being injected.

Drug: Botox

Interventions

Botox DRUG

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.

Also known as: onobotulinumtoxinA

Botox

Placebo OTHER

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.

Also known as: Saline

Placebo

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

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

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Migraine Disorders; Pain

Interventions

Botulinum Toxins, Type A; Sodium Chloride

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

Small study- results could have been different if numbers were larger Technique of injection different from PREEMPT study. Larger doses were injected into temporal and posterior neck muscles. No trapezius injection.

Results Point of Contact

• Title: Baman,Jabbari M.D. Porfessor of Neurology
• Organization: Yale School of Medicine

bahman.jabbari@yale.edu

203-737-2464

Study Officials

• Bahman Jabbari, M.D.

  Yale- 203-737-2464

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2008
• First Posted: April 17, 2008
• Study Start: January 1, 2008
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2015
• Last Updated: March 14, 2016
• Results First Posted: March 14, 2016

Record last verified: 2016-02

Locations

US (1)