Cluster Headache
Conditions
Interventions
Patients will complete a screening visit (visit 1) after providing written
informed consent, and eligible patients will enter a run-in period lasting at
least 4 weeks (+3 days) during which they wil
Placebo
Prevention
Chronic Cluster Headache
Sponsors
TEVA Pharma
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: a. Patients are capable of giving signed informed consent as described in Appendix D which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. b. The patient is a man or woman 18 to 70 years of age, inclusive c. The patient has history of CCH according to ICHD-3 beta criteria (Headache Classification Committee of the IHS 2013) for >=12 months prior to screening including the following: Attacks of severe, strictly unilateral pain, which is orbital, supraorbital, temporal or in any combination of these sites, lasting 15 to 180 minutes and occurring from once daily every other day to 8 times a day for more than half of the time when the disorder is active. The pain is associated with at least 1 of the following symptoms or signs: ipsilateral conjunctival injection, lacrimation, nasal congestion, rhinorrhea, forehead and facial sweating, miosis and/or ptosis and/or eyelid edema, and/or sense of restlessness or agitation. CH attacks occurring for more than 1 year without remission, or with remission periods lasting less than 1 month. d. The patient has a total body weight of >=45 kg. e. The patient is not using or using =2 cycles of Botox prior to screening. The patient should not receive Botox during the run-in period up to the evaluation period (12 weeks) where the primary endpoint is evaluated. g. The patient demonstrated compliance with the electronic headache diary during the run-in period by entry of headache data on 85% of days during the run-in period. h. The patient has at least 10 CH attacks during the run-in period. i. The patient is in good health in the opinion of the investigator as determined by a medical and psychiatric history; medical examination; 12-lead ECG; and serum chemistry, hematology, coagulation, and urinalysis. j. Women may be included only if they have a negative serum beta-human chorionic gonadotropin (β-HCG) test at screening, are sterile, or postmenopausal, and are not lactating. Definitions of sterile and postmenopausal are given in Appendix E. k. Women of childbearing potential (WOCBP) whose male partners are potentially fertile (ie, no vasectomy) must use highly effective birth control methods for the duration of the study (ie, starting at screening) and for 7.5 months after discontinuation of IMP. l. Men must be sterile, or if they are potentially fertile/reproductively competent (not surgically [eg, vasectomy] or congenitally sterile) and their female partners are of childbearing potential, must agree to use, together with their female partners, acceptable birth control methods for the duration of the study and for 7.5 months after discontinuation of the IMP. Definitions of women of non-childbearing potential, sterile women, and postmenopausal women; male contraception; and highly effective and acceptable birth control methods including examples are given in Appendix E. m. The patient mu
Exclusion criteria
Exclusion criteria: a. The patient has used systemic steroids for any medical reason (including treatment of the current CH cycle ) within 1.5 × the upper limit of normal (ULN) range after confirmation in a repeat test, or the patient has suspected hepatocellular damage that fulfills criteria for Hy*s law at screening. r. The patient has serum creatinine >1.5 × th
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • the proportion of patients with a >=50% reduction from baseline (run-in period) in the monthly average number of cluster headache (CH) attacks over the 12 week period after the administration of the first dose of the IMP, ie, based on week 0 to 12 data • the mean change from baseline (run-in period) in the number of CH attacks during the 4 week period after administration of the first dose of the IMP, ie, based on week 0 to 4 data • the mean change from baseline (run-in period) in the number of CH attacks during the 4 week period after administration of the third dose of the IMP, ie, based on week 8 to 12 data • the mean change from baseline (run-in period) in the weekly average number of days with use of cluster-specific acute headache medications (triptans and ergot compounds) during the 12 week period after administration of the first dose of the IMP, ie, based on week 0 to 12 data • the mean change from baseline (run-in period) in the weekly average number of days oxygen is used to treat CCH during the 12-week period after administration of the first dose of the IMP, ie, based on week 0 to 12 data • assessment of patient*s perceived improvement, as measured by the Patient-Perceived Satisfactory Improvement (PPSI) at 1, 4, 8, and 12 weeks after administration of the first dose of the IMP relative to baseline (day 0) | — |
Secondary
| Measure | Time frame |
|---|---|
| - occurrence of adverse events throughout the study - clinical laboratory (serum chemistry, hematology, coagulation, and urinalysis) test results at each visit - vital signs (systolic and diastolic blood pressure, oral temperature, and pulse rate) measurements at each visit. Note: Oxygen saturation will be measured in cases of suspected anaphylaxis and severe hypersensitivity. Respiratory rate will also be measured in these cases but not as a standard vital sign. - 12-lead electrocardiogram (ECG) findings at screening, baseline, and week 12 - use of concomitant medication during the study - clinically significant changes in physical examinations, including body weight - injection site reaction (ie, erythema, induration, and ecchymosis) and injection site pain assessments - occurrence of hypersensitivity/anaphylaxis reactions - suicidal ideation and behavior as measured by the electronic Columbia Suicide Severity Rating Scale (eC-SSRS) | — |
Countries
Australia, Canada, Finland, Germany, Israel, Italy, Netherlands, Poland, Spain, Sweden, United Kingdom, United States of America
Outcome results
None listed