Refractory chronic cluster headache
Conditions
Interventions
Trade Name: ketamine
Product Name: ketamine
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: KETAMINE
CAS Number: 6740-88-1
Trade Name: hydroxyzine
Product Name: hydroxyzine
Pharmaceut
Sponsors
CHU de Clermont-Ferrand
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age >= 18 - Chronic cluster headache diagnosis made according to ICHD-3 criteria - A mean of at least 2 attacks/day during the 14 days before infusion - Insufficient efficacy or intolerance or contra-indication to the use of the 3 main validated treatments (verapamil, lithium and sub-occipital steroids injections) - Stable preventive treatment for at least 7 days before infusion Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 90 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Pregnant or lactating woman - Contra-indication to ketamine use (uncontrolled high blood pressure, stoke history, severe cardiac failure) - Ketamine use during the previous year - Hypersensitivity to the product or their metabolites - Severe renal insufficiency (creatinine clearance < 30ml/min)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the efficacy of a single infusion of ketamine combined with magnesium sulfate compared to a control group receiving hydroxyzine (active placebo) in terms of the proportion of patients with at least 50% daily attacks decrease between the 7 days before infusion and days 7 and 8 after infusion.;Secondary Objective: - Evaluate patient's global impression of change (PGIC) at D8, D15, D29 and D90 - Evaluate the delay between infusion and daily attacks frequency reduction - Evaluate pain intensity during attacks - Evaluate psychological impact - Evaluate safety of use of this treatment (side effects during the infusion) - Evaluate the cost effectiveness of such treatment;Primary end point(s): Proportion of responders in each group, defined by a 50% decrease in the daily attack frequency between the 7 days before infusion (D0) and 7 and 8 days (D7-D8) after the infusion.;Timepoint(s) of evaluation of this end point: Days 7 and 8 after infusion (noted D0) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Proportion of 30%, 50% and 75% responders at D7-8, D9-15, D16-22, D23-29 and D83-90 according to the attack diary - Treatment response according to initial magnesemia - Daily attacks frequency and attacks intensity between the 7 days before infusion and D7-8 (attacks diary) - Area under the curve (AUC) for daily attacks evaluated each week between D0 and D90 (attacks diary) - Attacks treatment consumption (injectable sumatriptan and oxygene) - Anxiety and depression evolution (HAD scale) - patient global impression of change at D8, D15, D29 and D90 - Proportion of patients necessitating rescue therapy (infusion of ketamine combined with magnesium) at D15 - Direct medical cost (treatments, consultations, hospitalisations) in each group and cost effectiveness ratio taking 50% responder rate as efficacy criteria;Timepoint(s) of evaluation of this end point: Daily attacks diary completed every day from D0 to D90 For HAD and PGIC: D8, D15, D29 and D90 | — |
Countries
France
Contacts
Public ContactLACLAUTRE Lise
CHU de Clermont-Ferrand
Outcome results
None listed