Cluster Headache MedDRA version: 12.1 Level: LLT Classification code 10019232 Term: Headaches cluster
Conditions
Interventions
Trade Name: CARBOLITHIUM
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Lithium
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Trade Name: IMIGRAN*S
Sponsors
AZIENDA OSPEDALIERO UNIVERSITARIA DI CAGLIARI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Patients aged ≥ 18 years and ≤ 65 years ? Outpatients consecutively enrolled in the Headache Center of Clinical Pharmacology dell`AOUCA ? Diagnosis of episodic cluster headache (acute) or chronic according to the IHS criteria 2004 ? Eligibility to treatment with lithium as assessed by clinical practice ? Acceptance aware of the study and subsequent signing of informed consent 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: ? Patients with cardiac disease and renal failure ? Patients with severe debilitation ? With increased sodium depletion ? diuretics ? known or suspected pregnancy and lactation ? Hypersensitivity to sumatriptan or any of the excipients ? Ischemic heart disease ? previous myocardial infarction, variant angina (or angina), coronary vasospasm, peripheral vascular disease ? Patients with signs or symptoms connected to ischemic heart disease ? Patients with a history of cerebrovascular accident (CVA) or transient ischemic attack (TIA) ? Patients with severe hepatic ? Uncontrolled hypertension ? Patients treated with MAOIs or who have discontinued treatment with these drugs in the two weeks preceding ? Hemiplegic Migraine ? Patients treated with selective inhibitors of 5HT reuptake (SSRIs) ? Patients being treated with medicines containing ergotamine or its derivatives (including methysergide)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of tolerability of preventive treatment with lithium in combination with acute treatment with sumatriptan in patients suffering from cluster headache, specially about the risk of occurrence of serotonin syndrome.;Secondary Objective: ;Primary end point(s): - To assess the incidence of serotonin syndrome, diagnosed according to the criteria and criteria of Sternbach HUNTER, in patients with cluster headache treated with Imigran Carbolithium and in combination. - To assess the tolerability of prior treatment with lithium in combination with sumatriptan as needed in patients with cluster headache. | — |
Countries
Italy
Outcome results
None listed