Clinical trial investigating the efficacy and safety of investigational drug TEV-48125 developed to prevent cluster headache
- Conditions
- Episodic Cluster headache (ECH)Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2016-003278-42-GB
- Lead Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 300
a. Patients are capable of giving signed informed consent which includes compliance with the requirements and
restrictions listed in the informed consent form (ICF) and in the
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 (ß- HCG) test at screening, are sterile or
postmenopausal, and are not lactating.
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 s
a. The patient has used systemic steroids for any medical 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 clinic
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method