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MiBlock - Botulinum toxin type A blockade of the sphenopalatine ganglion in treatment-refractory chronic migraine

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515165-34-00
Enrollment
170
Registered
2024-07-12
Start date
2019-10-01
Completion date
2025-06-13
Last updated
2024-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic migraine

Brief summary

Difference in change from baseline in the mean monthly headache days at weeks 5 – 8 post intervention in the treatment versus the placebo group

Detailed description

Difference in occurrence of adverse events and serious adverse events in the treatment versus the placebo group, Difference in change from baseline in the mean monthly migraine days* in the treatment versus the placebo group, Difference in number of treatment responders (≥ 30% reduction in mean monthly headache days at weeks 5 – 8 post-intervention compared to baseline) in the treatment versus the placebo group., Difference in change from baseline in the mean monthly headache intensity in the treatment versus the placebo group., Difference in change from baseline in the mean monthly occurrence of cumulative hours per 28 days of moderate/severe pain in the treatment versus the placebo group., Difference in change from baseline in the mean monthly number of days with rescue medication in the treatment versus the placebo group., Migraine specific quality of life questionnaire

Interventions

Sponsors

St. Olavs Hospital HF
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Difference in change from baseline in the mean monthly headache days at weeks 5 – 8 post intervention in the treatment versus the placebo group

Secondary

MeasureTime frame
Difference in occurrence of adverse events and serious adverse events in the treatment versus the placebo group, Difference in change from baseline in the mean monthly migraine days* in the treatment versus the placebo group, Difference in number of treatment responders (≥ 30% reduction in mean monthly headache days at weeks 5 – 8 post-intervention compared to baseline) in the treatment versus the placebo group., Difference in change from baseline in the mean monthly headache intensity in the treatment versus the placebo group., Difference in change from baseline in the mean monthly occurrence of cumulative hours per 28 days of moderate/severe pain in the treatment versus the placebo group., Difference in change from baseline in the mean monthly number of days with rescue medication in the treatment versus the placebo group., Migraine specific quality of life questionnaire

Countries

Norway

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026