A Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled,<br>Parallel-Group Study Comparing the Efficacy and Safety of 2 Dose Regimens<br>(Intravenous/Subcutaneous and Subcutaneous) of TEV-48125 versus Placebo for the<br>Prevention of Episodic Cluster Headache
- Conditions
- Cluster Headache10019231
- Registration Number
- NL-OMON47278
- Lead Sponsor
- TEVA Pharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 20
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 a history of ECH 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 in periods lasting from 7 days to 1 year, separated by
pain-free periods lasting at least 1 month.
d. CH attacks of a new cluster cycle have started within 2 weeks (14 days, inclusive) prior to
screening and, based on the patient*s previous medical history, it is expected that
the patient*s CH attacks will continue for *6 weeks after the screening visit.
e. The patient has a total body weight of *45 kg
f. The patient is not using or using * 2 concomitant medications that are
commonly prescribed as preventive treatments for CH (Appendix H), regardless of
the indication for which the medication was prescribed. Patients must be on a stable
dose and regimen for at least 2 weeks prior to screening and throughout the study.
g. If a patient is receiving Botox, it should be in a stable dose regimen, considered as having *2 cycles of Botox prior to screening. The patient should not receive Botox during the run-in period up to the evaluation period (4 weeks) where the primary endpoint is evaluated.
h. The patient has 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.
i. The patient has at least 7 CH attacks during the run-in period.
j. 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.
k. Women may be included only if they have a negative serum beta-human chorionic
gonadotropin (*-HCG) test at screening, are sterile or postmenopausal, and are not lactating. Definitions of
sterile and postmenopausal are given in Appendix E.
l. 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.
m. 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
a. The patient has used systemic steroids for any reason (including treatment of the current CH cycle) within *7 days prior to screening.
b. The patient reports using butalbital on more than 7 days during the 4 weeks prior to
screening or using butalbital on more than 3 days during the screening/run-in period.
c. The patient reports using opioids on more than 15 days during the 4 weeks prior to
screening or using opioids on more than 4 days during the screening/run-in period.
d. The patient has used an intervention/device (eg, scheduled nerve blocks) for headache
during the 4 weeks prior to screening.
e. The patient has clinically significant hematological, renal, endocrine, immunologic, pulmonary,
gastrointestinal, genitourinary, cardiovascular, neurologic, hepatic, or ocular disease at the
discretion of the investigator.
f. The patient has evidence or medical history of clinically significant psychiatric issues
determined at the discretion of the investigator.
g. The patient has a history of any suicide attempt in the past or current active suicidal
ideation, as measured by the eC-SSRS.
h. The patient has a history of clinically significant cardiovascular disease or vascular
ischemia (such as myocardial, neurological [eg, cerebral ischemia], peripheral
extremity ischemia, or other ischemic event) or thromboembolic events (arterial or
venous thrombotic or embolic events), such as cerebrovascular accident (including
transient ischemic attacks), deep vein thrombosis, or pulmonary embolism.
i. The patient has a past or current history of cancer or malignant tumor in the past 5 years, except for appropriately treated non-melanoma skin carcinoma.
j. The patient is pregnant or lactating.
k. The patient has a history of hypersensitivity reactions to injected proteins, including
monoclonal antibodies.
l. The patient has participated in a clinical study of a new chemical entity or a
prescription medicine within 2 months or 5 half-lives before administration of the
first dose of the IMP, whichever is longer.
m. The patient has participated in a clinical study of a monoclonal antibody within 3 months or 5 half-lives before administration of the first dose of the IMP, whichever is longer, unless it is
known that the patient received placebo during the study.
n. The patient has a history of prior exposure to a monoclonal antibody targeting the
CGRP pathway (AMG 334, ALD304, LY2951742, or fremanezumab). If patient has participated in a clinical study with any of these monoclonal antibodies, it has to be confirmed that the patient received placebo in order to be eligible for this study).
o. The patient has any finding in the baseline 12-lead ECG considered clinically
significant in the judgment of the investigator.
p. The patient has 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).
q. The patient has hepatic enzymes (alanine aminotransferase [ALT] and aspartate
aminotransferase [AST]) >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 × the ULN or evi
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method