A Study to Explore the Long-Term Safety of TEV-48125 (Fremanezumab) for the Prevention of Cluster Headache
Status: | Enrolling by invitation |
---|---|
Conditions: | Migraine Headaches |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 18 - 70 |
Updated: | 2/20/2019 |
Start Date: | April 27, 2017 |
End Date: | October 9, 2021 |
A Multicenter, Double-Blind, Double-Dummy Study to Explore the Long-Term Safety of TEV-48125 for the Prevention of Cluster Headache
This is a 68-week study to evaluate the long-term safety of fremanezumab in patients with CH.
Patients who complete the pivotal studies and enroll into the current study will visit the
investigational center for IMP administration, safety and efficacy assessments, and blood and
urine collections for pharmacokinetics, immunogenicity (ADAs), and biomarker analyses.
Patients will return to the investigational center for a follow-up visit to evaluate ADAs,
fremanezumab concentrations, biomarkers, and safety (adverse events and concomitant
medications) approximately 7.5 months after the last dose of IMP.
Patients who complete the pivotal studies and enroll into the current study will visit the
investigational center for IMP administration, safety and efficacy assessments, and blood and
urine collections for pharmacokinetics, immunogenicity (ADAs), and biomarker analyses.
Patients will return to the investigational center for a follow-up visit to evaluate ADAs,
fremanezumab concentrations, biomarkers, and safety (adverse events and concomitant
medications) approximately 7.5 months after the last dose of IMP.
Inclusion Criteria:
- 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.
- 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.
- Additional criteria apply, please contact the investigator for more information
Exclusion Criteria:
- 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)
- Additional criteria apply, please contact the investigator for more information
We found this trial at
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