Chronic cluster headache
Conditions
Brief summary
Difference in change from the last 28 day period of the baseline in mean number of cluster headache attacks per week at weeks 5 – 8 post-intervention in the treatment group versus the placebo group.
Detailed description
Difference in occurrence of AEs and SAEs in the active group versus the placebo group, Difference in change from baseline week 5-8 in mean number of cluster headache attacks per week during weeks 9-12 post-intervention in the active group versus the placebo group, Difference in change from baseline week 5-8 in mean number of cluster headache attacks per week at weeks 5-8 post-intervention in the active group versus the placebo group, in the prespecified subgroups (cf 8.4.1.2) 3.1. In the high and the low frequency subgroups 3.2. In the high and the low frequency variation subgroups, Difference in change from baseline week 5-8 in mean number of cluster headache attacks per week during weeks 9-12 post-intervention in the active group versus the placebo group, in the prespecified subgroups (cf 8.4.1.2) 4.1. In the high and the low frequency subgroups 4.2. In the high and the low frequency variation subgroups, Difference in the number of therapeutic responders (≥ 30% reduction in attack frequency, intensity or both during weeks 5 – 8 post-intervention compared to baseline) in the active group versus the placebo group. 5.1. In the entire randomized population 5.2. In the high and the low frequency subgroups 5.3. In the high and the low frequency variation subgroups, Difference in the number of attack frequency responders (≥ 30% reduction in attack frequency during weeks 5 – 8 post-intervention compared to baseline). 6.1. In the entire randomized population 6.2. In the high and the low frequency subgroups 6.3. In the high and the low frequency variation subgroups, Difference in change from baseline week 5-8 in mean attack intensity week 5 – 8 post-intervention in the active group versus the placebo group. 7.1. In the entire randomized population 7.2. In the high and the low frequency subgroups 7.3. In the high and the low frequency variation subgroups
Interventions
DRUGoppløsning
DRUGBOTOX 50 Allergan-enheter Pulver til injeksjonsvæske
Sponsors
Norwegian University Of Science And Technolology
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in change from the last 28 day period of the baseline in mean number of cluster headache attacks per week at weeks 5 – 8 post-intervention in the treatment group versus the placebo group. | — |
Secondary
| Measure | Time frame |
|---|---|
| Difference in occurrence of AEs and SAEs in the active group versus the placebo group, Difference in change from baseline week 5-8 in mean number of cluster headache attacks per week during weeks 9-12 post-intervention in the active group versus the placebo group, Difference in change from baseline week 5-8 in mean number of cluster headache attacks per week at weeks 5-8 post-intervention in the active group versus the placebo group, in the prespecified subgroups (cf 8.4.1.2) 3.1. In the high and the low frequency subgroups 3.2. In the high and the low frequency variation subgroups, Difference in change from baseline week 5-8 in mean number of cluster headache attacks per week during weeks 9-12 post-intervention in the active group versus the placebo group, in the prespecified subgroups (cf 8.4.1.2) 4.1. In the high and the low frequency subgroups 4.2. In the high and the low frequency variation subgroups, Difference in the number of therapeutic responders (≥ 30% reduction in attack fr | — |
Countries
Germany, Norway
Outcome results
None listed