Cluster headache
Conditions
Brief summary
Retention rate (= time between the first injection and end-of-treatment; survival curves verum vs. placebo)
Detailed description
Frequency of daily cluster headache attacks, The use of acute attack medication per day (subcutaneous sumatriptan and 100% oxygen), Mean duration and severity (1-10) of attacks, Injection interval, Total number of injections in study period, Proportion of participants still in study at 1 year, Participants idea: did they receive placebo or verum?, Physician's idea: did they administer placebo or verum?, Adverse events + ultrasound structural integrity measurements greater occipital nerve, Proportion of subjects with a >50% and 100% reduction in attack frequency, Daily quality of life (EQ 5D), Healthcare use & productivity losses
Interventions
DRUGNaCl 0
DRUG9 % B. Braun
DRUGsolution injectable
DRUGDepo-Medrone 40 mg/ml Suspension for Injection.
Sponsors
Leids Universitair Medisch Centrum (LUMC)
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Retention rate (= time between the first injection and end-of-treatment; survival curves verum vs. placebo) | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of daily cluster headache attacks, The use of acute attack medication per day (subcutaneous sumatriptan and 100% oxygen), Mean duration and severity (1-10) of attacks, Injection interval, Total number of injections in study period, Proportion of participants still in study at 1 year, Participants idea: did they receive placebo or verum?, Physician's idea: did they administer placebo or verum?, Adverse events + ultrasound structural integrity measurements greater occipital nerve, Proportion of subjects with a >50% and 100% reduction in attack frequency, Daily quality of life (EQ 5D), Healthcare use & productivity losses | — |
Countries
Netherlands
Outcome results
None listed