refractory chronic cluster headache
Conditions
Brief summary
Change in weekly frequency of crisis over the period D7-D13 compared to the pre-treatment period
Detailed description
Change in weekly frequency of crisis over the period D14-D20, D21-D27, D28-D34 compared to the pre-treatment period, The proportion of responders at 30%, 50% and 75% each week post-infusion, Response to treatment according to initial serum magnesium, The weekly frequency and intensity of crisis between the 7 days preceding the infusion and each week post infusion, Crisis treatments intake, Anxiety and depression scoring (HAD), The PGIC scoring for the overall clinical evaluation on D15 and D90, The proportion of patients requiring additional treatment on D15, Direct medical costs, Evaluation of adverse effects, Evaluation of blinding quality
Interventions
DRUGCHLORURE DE SODIUM 0
DRUG9 % BAXTER
DRUGSULFATE DE MAGNESIUM LAVOISIER 15 POUR CENT (0
DRUG15 g/ml)
DRUGsolution injectable (I.V.) en ampoule
DRUGsolution injectable
Sponsors
University Hospital Of Clermont-Ferrand
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in weekly frequency of crisis over the period D7-D13 compared to the pre-treatment period | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in weekly frequency of crisis over the period D14-D20, D21-D27, D28-D34 compared to the pre-treatment period, The proportion of responders at 30%, 50% and 75% each week post-infusion, Response to treatment according to initial serum magnesium, The weekly frequency and intensity of crisis between the 7 days preceding the infusion and each week post infusion, Crisis treatments intake, Anxiety and depression scoring (HAD), The PGIC scoring for the overall clinical evaluation on D15 and D90, The proportion of patients requiring additional treatment on D15, Direct medical costs, Evaluation of adverse effects, Evaluation of blinding quality | — |
Countries
France
Outcome results
None listed