18 and older, any sex, with Migraine Disorders. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Incidence Rate of DysphagiaPrimary· 64 weeks
Incidence rates are reported for subjects with events per 1,000 person-months and are based on the first reported occurrence of dysphagia from study enrollment up to 64 weeks. Dysphagia is difficulty or discomfort swallowing.
Group
Value
95% CI
Botulinum Toxin Type A
0.4
0.1 – 0.9
Incidence Rate of Intractable MigraineSecondary· 64 weeks
Incidence rates are reported for subjects with events per 1,000 person-months and are based on the first reported occurrence of intractable migraine from study enrollment up to 64 weeks. Intractable migraine is a migraine that does not seem to go away.
Group
Value
95% CI
Botulinum Toxin Type A
1.6
0.9 – 2.4
Adverse events — posted to ClinicalTrials.gov
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is a post authorization observational study to monitor the utilization practices and describe the safety profile of BOTOX® in clinical practice for the prophylactic treatment of headaches in adult patients with chronic migraine.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
NCT03193359 — Open Label Study of BOTOX® (Botulinum Toxin Type A) as Headache Prophylaxis in Chinese Patients With Chronic Migraine
· Phase 3
· withdrawn
NCT03193346 — BOTOX® (Botulinum Toxin Type A) as Headache Prophylaxis in Chinese Participants With Chronic Migraine
· Phase 3
· withdrawn
NCT02590250 — A Safety and Efficacy Study of BOTOX® (Botulinum Toxin Type A) in Patients With Urinary Incontinence Due to Neurogenic D
· completed
NCT02072928 — Study of Botulinum Toxin Type A (BOTOX®) to Treat Urinary Incontinence From Neurogenic Detrusor Overactivity in Belgium
· completed
NCT02010775 — Botulinum Toxin Type A (BOTOX®) Treatment of Masseter Muscle Hypertrophy
· Phase 2
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Allergan
Last refreshed: 8 January 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01432379.