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

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Yale University

Status and phase

Completed
Phase 3
Phase 2

Conditions

Refractory Migraine

Treatments

Drug: Botox
Other: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT00660192
0709003056

Details and patient eligibility

About

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%.

Full description

Contact PI for study details

Enrollment

25 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

25 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
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.
Treatment:
Other: Placebo
Botox
Active Comparator group
Description:
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.
Treatment:
Drug: Botox

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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