Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial (NCT01516892) involved 716 people who all received BOTOX® (botulinum toxin type A). The trial was looking at people with chronic migraine and tracked them over a long period — up to about two years (108 weeks). It measured things like how many days per month participants experienced headaches, and how much headaches were affecting their day-to-day life. Of the 716 people who started, 373 completed the trial and 343 did not finish. The reported data shows that, on average, participants started with around 22 headache days in a 28-day period at the beginning of the trial (the "baseline"). By around the two-year mark (Week 108), the reported average change was a reduction of approximately 10.7 headache days per 28-day period compared to that starting point. An earlier measurement at around Week 60 (roughly 14 months in) showed a reported average reduction of about 9.2 headache days per 28-day period from baseline. The reported data also shows results from a questionnaire called the HIT-6, which scores how much headaches affect a person's life — with 36 meaning no impact and 78 meaning the worst possible impact. Participants started with an average score of 64.7. The reported data shows average score reductions of 6.8 points at one time point and 7.1 points at another, with a lower score meaning less reported impact on daily life. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 41393002) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 4 Migraine Trial, Completed
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You have been diagnosed with chronic migraine, meaning you get headaches on 15 or more days per month, with each headache lasting at least 4 hours
Who may not be able to join:
- You have been diagnosed with myasthenia gravis, Eaton-Lambert Syndrome, or amyotrophic lateral sclerosis (ALS) — these are certain nerve and muscle conditions
- Your headaches are caused by another medical condition rather than migraine
- You have an infection or skin problem in the areas where injections would be given
- You have previously received any botulinum toxin treatment (such as Botox) for any reason
- You are expected to need any botulinum toxin treatment for any reason during the study period
- You have previously taken part in any clinical trial involving botulinum toxin
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Medical Director, Allergan
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
5 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Change From Baseline in the Frequency of Headache Days
Can't join this trial?
Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.