Cluster Headache
Conditions
Interventions
Female and male patients with CCH and ECH who complete the pivotal efficacy
studies (Studies TV48125-CNS-30056 and TV48125-CNS-30057) may enter this long
term safety study if they provide informed c
blinding will be retained from the pivotal
studies and throughout this long-term safety extension study. Patients will be
assigned to treatments as described in Table 1 based on their randomization
Cluster Headache
Long-Term Safety
Sponsors
TEVA Pharma
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: a. The patient is a male or female and 18 to 70 years of age, inclusive, at the start of the pivotal study. b. The patient signs and dates the informed consent document. c. The patient completes either the Phase 3 pivotal study for ECH (Study TV48125 CNS-30056) or the Phase 3 pivotal study for CCH (Study TV48125-CNS-30057) without important protocol deviations related to patient safety and patient compliance and at least 75% diary data completion during the pivotal study. Prior to 15 June 2018, patients from the ECH study and the CCH study were enrolled. After 15 June 2018, only patients who participated in the ECH study (Study TV48125 CNS 30056) will be enrolled for active treatment. * In addition, patients who do not complete the pivotal efficacy studies, and patients who complete the pivotal efficacy studies but will not continue treatment during this long-term safety study, will be offered to enroll in this study for the purpose of evaluating ADAs and safety (adverse events and concomitant medications) approximately 7.5 months after administration of the last dose of the IMP. d. Women may be included only if they have a negative beta-human chorionic gonadotropin test at visit 1; are sterile or postmenopausal; and are not lactating (not applicable for patients participating in safety follow-up only). Definitions of sterile and postmenopausal are given in Appendix E. e. Women of childbearing potential (WOCBP) whose male partners are potentially fertile (ie, no vasectomy) must use highly effective birth control methods (see Appendix E) for the duration of the study and for 7.5 months after discontinuation of IMP. 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 administration of IMP. Definitions of women of non-childbearing potential, sterile and postmenopausal women; male contraception; and highly effective and acceptable birth control methods, including examples, are given in Appendix E. f. The patient must be willing to stop concomitant medications used in clinical practice for the prevention of CH (ie, verapamil, topiramate, valproate, lithium, or methysergide) for the duration of this study. Patients must begin tapering these preventive medications as soon as they begin this study. The period of time needed to taper off these medications will be based on the investigator*s medical judgment but should not exceed 1 month from the beginning of participation in this study (Appendix H) (not applicable for patients participating in safety follow up only). g. 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 (not applicable for patients participating in safety follow-up only). h. The patient must be willing and able to comply with study restrictions to remain at the clinic for the required duration during the study period and to return to the clinic for the follow up evaluations, as specified in this protocol.
Exclusion criteria
Exclusion criteria: a. The patient has a history of any suicide attempt in the past or current active suicidal ideation, as measured by the eC-SSRS. b. Any finding in the 12-lead ECG performed as part of the EOT visit (visit 5) procedures for the pivotal studies considered clinically significant in the judgment of the investigator c. Any finding that, in the judgment of the investigator, is a clinically significant abnormality, including serum chemistry, hematology, coagulation, and urinalysis test values (abnormal tests may be repeated for confirmation) d. Hepatic enzymes (alanine aminotransferase and aspartate aminotransferase) >1.5 × the upper limit of the normal range (ULN) after confirmation in a repeat test or suspected hepatocellular damage that fulfills criteria for Hy*s law e. Serum creatinine >1.5 × the ULN or evidence of clinically significant renal disease in the judgment of the investigator Patients rolling over only for safety follow-up and ADA, who are not receiving study medication, are not required to fulfil all inclusion exclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| As of 15 June 2018, only patients from the ECH study (Study TV48125 CNS 30056) will enroll in this study for active treatment. As of 15 June 2018, all CCH patients included in this study have been asked to discontinue treatment, and are encouraged to continue in the ADA and safety follow-up portion of this study. Data from CCH patients enrolled prior to 15 June 2018 will be evaluated per all objectives of this study. Safety endpoints are as follows: * occurrence of adverse events throughout the study * changes from baseline (day 0 of the Phase 3 pivotal efficacy studies) in clinical laboratory (serum chemistry, hematology, coagulation, and urinalysis) test results * changes from baseline (day 0 of the Phase 3 pivotal efficacy studies) in vital signs (pulse, systolic and diastolic blood pressure, and oral temperature) measurements 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. * abnormal standard 12-lead electrocardiogram (ECG) findings * clinically significant changes in physical examination, including body weight * occurrence of injection site reactions (ie, erythema, induration, and ecchymosis) and injection site pain * occurrence of anaphylaxis and hypersensitivity reactions * use of concomitant medications during the study * suicidal ideation and behavior as measured by the electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) | — |
Countries
The Netherlands
Outcome results
None listed