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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02945046




Registration number
NCT02945046
Ethics application status
Date submitted
25/10/2016
Date registered
26/10/2016
Date last updated
9/11/2021

Titles & IDs
Public title
A Study to Evaluate the Efficacy and Safety of TEV-48125 (Fremanezumab) for the Prevention of Episodic Cluster Headache (ECH)
Scientific title
A Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel-Group Study Comparing the Efficacy and Safety of 2 Dose Regimens (Intravenous/Subcutaneous and Subcutaneous) of TEV-48125 Versus Placebo for the Prevention of Epidosic Cluster Headache
Secondary ID [1] 0 0
2016-003278-42
Secondary ID [2] 0 0
TV48125-CNS-30056
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Episodic Cluster Headache 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Fremanezumab
Treatment: Drugs - Placebo

Placebo comparator: Placebo - Participants will receive placebo administered via an approximately 1-hour intravenous infusion and as 3 subcutaneous injections at Week 0 followed by placebo administered as single subcutaneous injection at Weeks 4 and 8, respectively.

Experimental: Fremanezumab 675 mg/Placebo/Placebo - Participants will receive placebo as an approximately 1-hour intravenous infusion followed by fremanezumab at 675 milligrams (mg) administered as 3 subcutaneous injections (225 mg/1.5 milliliters \[mL\]) at Week 0 and placebo administered as single subcutaneous injection (225 mg/1.5 mL) at Weeks 4 and 8, respectively.

Experimental: Fremanezumab 900/225/225 mg - Participants will receive fremanezumab at 900 mg administered via an approximately 1-hour intravenous infusion followed by 3 placebo subcutaneous injections at Week 0 and fremanezumab at 225 mg administered as single subcutaneous injection (225 mg/1.5 mL) at Weeks 4 and 8, respectively.


Treatment: Drugs: Fremanezumab
Fremanezumab will be administered per dose and schedule specified in the arm.

Treatment: Drugs: Placebo
Placebo matching to fremanezumab will be administered per schedule specified in the arm.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean Change From Baseline in the Weekly Average Number of Cluster Headache (CH) Attacks During the 4-Week Period After Administration of the First Dose of the IMP
Timepoint [1] 0 0
Baseline (Week 0), up to Week 4
Secondary outcome [1] 0 0
Percentage of Participants With a =50% Reduction From Baseline in the Weekly Average Number of CH Attacks During the 4-Week Period After the First Dose of the IMP
Timepoint [1] 0 0
Baseline (Week 0), up to Week 4
Secondary outcome [2] 0 0
Mean Change From Baseline in Weekly Average Number of CH Attacks During the 12-Week Period After Administration of the First Dose of the IMP
Timepoint [2] 0 0
Baseline (Week 0), up to Week 12
Secondary outcome [3] 0 0
Mean Change From Baseline in Weekly Average Number of CH Attacks During the 4-Week Period After Administration of the Third Dose of the IMP
Timepoint [3] 0 0
Baseline (Week 0), Week 8 up to Week 12
Secondary outcome [4] 0 0
Mean Change From Baseline 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 the First Dose of the IMP
Timepoint [4] 0 0
Baseline (Week 0), up to Week 12
Secondary outcome [5] 0 0
Mean Change From Baseline in the Weekly Average Number of Days Oxygen Was Used to Treat Episodic Cluster Headache (ECH) During the 12-Week Period After the First Dose of the IMP
Timepoint [5] 0 0
Baseline (Week 0), up to Week 12
Secondary outcome [6] 0 0
Number of Participants Who Perceived Improvement of CH-Associated Pain From Baseline as Measured by the Patient-Perceived Satisfactory Improvement (PPSI) Scale at Weeks 1, 4, 8, and 12
Timepoint [6] 0 0
Baseline, Weeks 1, 4, 8, and 12
Secondary outcome [7] 0 0
Number of Participants With Adverse Events (AEs)
Timepoint [7] 0 0
Baseline up to Week 12
Secondary outcome [8] 0 0
Number of Participants With Potentially Clinically Significant Laboratory (Serum Chemistry, Hematology, and Urinalysis) Abnormal Results
Timepoint [8] 0 0
Baseline up to Week 12
Secondary outcome [9] 0 0
Number of Participants With Shift From Baseline to Endpoint in Coagulation Laboratory Test Results
Timepoint [9] 0 0
Baseline up to Week 12
Secondary outcome [10] 0 0
Number of Participants With Potentially Clinically Significant Abnormal Vital Signs Values
Timepoint [10] 0 0
Baseline up to Week 12
Secondary outcome [11] 0 0
Number of Participants With Shift From Baseline to Endpoint (Last Assessment) in Electrocardiogram (ECG) Parameters
Timepoint [11] 0 0
Baseline up to Week 12
Secondary outcome [12] 0 0
Number of Participants Who Received Concomitant Medications
Timepoint [12] 0 0
Baseline up to Week 12
Secondary outcome [13] 0 0
Number of Participants With Injection Site Reactions
Timepoint [13] 0 0
Baseline up to Week 12
Secondary outcome [14] 0 0
Number of Participants With Hypersensitivity/Anaphylaxis Reactions
Timepoint [14] 0 0
Baseline up to Week 12
Secondary outcome [15] 0 0
Number of Participants With Suicidal Ideation and Suicidal Behavior as Assessed by the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS)
Timepoint [15] 0 0
Baseline up to Week 12

Eligibility
Key inclusion criteria
* The participant has a history of ECH according to the International Classification of Headache Disorders - 3 beta criteria (Headache Classification Committee of the International Headache Society [IHS] 2013) for =12 months prior to screening.
* The participant has a total body weight of =45 kg (99 lbs.)
* The participant is in good health in the opinion of the investigator
* Women of childbearing potential (WOCBP) whose male partners are potentially fertile (that is, no vasectomy) must use highly effective birth control methods for the duration of the study.
* Men must be sterile, or if they are potentially fertile/reproductively competent (not surgically [for example, vasectomy] or congenitally sterile) and their female partners are of childbearing potential, must agree to use, together with their female partners, acceptable birth control for the duration of the study.
* If a participant is receiving Botox, it should be in a stable dose regimen, considered as having =2 cycles of Botox prior to screening. The participant should not receive Botox during the run-in period up to the evaluation period (4 weeks) where the primary endpoint is evaluated.

* Additional criteria apply, please contact the investigator for more information
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* The participant has used systemic steroids for any medical reason (including treatment of the current CH cycle within =7 days prior to screening The participant has used an intervention/device (for example, scheduled nerve blocks) for headache during the 4 weeks prior to screening.
* The participant has clinically significant hematological, renal, endocrine, immunologic, pulmonary, gastrointestinal, genitourinary, cardiovascular, neurologic, hepatic, or ocular disease at the discretion of the investigator.
* The participant has evidence or medical history of clinically significant psychiatric issues determined at the discretion of the investigator.
* The participant has a past or current history of cancer or malignant tumor in the past 5 years, except for appropriately treated non-melanoma skin carcinoma.
* The participant is pregnant or lactating.
* The participant has a history of hypersensitivity reactions to injected proteins, including monoclonal antibodies.
* The participant 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 participant received placebo during the study.
* The participant has a history of prior exposure to a monoclonal antibody targeting the calcitonin gene-related peptide (CGRP) pathway (AMG 334, ALD304, LY2951742, or fremanezumab). If participant has participated in a clinical study with any of these monoclonal antibodies, it has to be confirmed that the participant received placebo in order to be eligible for this study.
* The participant is an employee of the sponsor/participating study center who is directly involved in the study or is the relative of such an employee.
* The participant has an active implant for neurostimulation used in the treatment of CH.
* The participant is a member of a vulnerable population (for example, people kept in detention).
* The participant has a history of alcohol abuse prior to screening and/or drug abuse that in the investigator's opinion could interfere with the study evaluations or the participant's safety .

* Additional criteria apply, please contact the investigator for more information

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/01/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
13/05/2019
Sample size
Target
Accrual to date
Final
169
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Teva Investigational Site 78120 - Auchenflower
Recruitment hospital [2] 0 0
Teva Investigational Site 78118 - Clayton
Recruitment hospital [3] 0 0
Teva Investigational Site 78123 - Melbourne
Recruitment hospital [4] 0 0
Teva Investigational Site 78122 - Parkville
Recruitment hospital [5] 0 0
Teva Investigational Site 78121 - Randwick
Recruitment postcode(s) [1] 0 0
4066 - Auchenflower
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment postcode(s) [4] 0 0
3050 - Parkville
Recruitment postcode(s) [5] 0 0
2031 - Randwick
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Nevada
Country [10] 0 0
United States of America
State/province [10] 0 0
New Hampshire
Country [11] 0 0
United States of America
State/province [11] 0 0
New Jersey
Country [12] 0 0
United States of America
State/province [12] 0 0
New Mexico
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
North Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Ohio
Country [16] 0 0
United States of America
State/province [16] 0 0
Pennsylvania
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
United States of America
State/province [18] 0 0
Virginia
Country [19] 0 0
Canada
State/province [19] 0 0
Calgary
Country [20] 0 0
Canada
State/province [20] 0 0
Toronto
Country [21] 0 0
Finland
State/province [21] 0 0
Helsinki
Country [22] 0 0
Finland
State/province [22] 0 0
Oulu
Country [23] 0 0
Finland
State/province [23] 0 0
Turku
Country [24] 0 0
Germany
State/province [24] 0 0
Berlin
Country [25] 0 0
Germany
State/province [25] 0 0
Bochum
Country [26] 0 0
Germany
State/province [26] 0 0
Essen
Country [27] 0 0
Germany
State/province [27] 0 0
Hamburg
Country [28] 0 0
Germany
State/province [28] 0 0
Kiel
Country [29] 0 0
Germany
State/province [29] 0 0
Konigstein im Taunus
Country [30] 0 0
Germany
State/province [30] 0 0
Rostock
Country [31] 0 0
Israel
State/province [31] 0 0
Ashkelon
Country [32] 0 0
Israel
State/province [32] 0 0
Hadera
Country [33] 0 0
Israel
State/province [33] 0 0
Holon
Country [34] 0 0
Israel
State/province [34] 0 0
Jerusalem
Country [35] 0 0
Israel
State/province [35] 0 0
Netanya
Country [36] 0 0
Israel
State/province [36] 0 0
Ramat Gan
Country [37] 0 0
Israel
State/province [37] 0 0
Tel Aviv
Country [38] 0 0
Israel
State/province [38] 0 0
Tel-Aviv
Country [39] 0 0
Italy
State/province [39] 0 0
Milan
Country [40] 0 0
Italy
State/province [40] 0 0
Modena
Country [41] 0 0
Italy
State/province [41] 0 0
Napoli
Country [42] 0 0
Italy
State/province [42] 0 0
Pavia
Country [43] 0 0
Italy
State/province [43] 0 0
Rome
Country [44] 0 0
Netherlands
State/province [44] 0 0
Leiden
Country [45] 0 0
Netherlands
State/province [45] 0 0
Nijmegen
Country [46] 0 0
Netherlands
State/province [46] 0 0
Zwolle
Country [47] 0 0
Poland
State/province [47] 0 0
Bialystok
Country [48] 0 0
Poland
State/province [48] 0 0
Krakow
Country [49] 0 0
Poland
State/province [49] 0 0
Lodz
Country [50] 0 0
Poland
State/province [50] 0 0
Szczecin
Country [51] 0 0
Spain
State/province [51] 0 0
Galdakao.
Country [52] 0 0
Spain
State/province [52] 0 0
Madrid
Country [53] 0 0
Spain
State/province [53] 0 0
Sevilla
Country [54] 0 0
Spain
State/province [54] 0 0
Valladolid
Country [55] 0 0
Spain
State/province [55] 0 0
Zaragoza
Country [56] 0 0
Sweden
State/province [56] 0 0
Huddinge
Country [57] 0 0
Sweden
State/province [57] 0 0
Vallingby
Country [58] 0 0
United Kingdom
State/province [58] 0 0
Glasgow
Country [59] 0 0
United Kingdom
State/province [59] 0 0
Liverpool
Country [60] 0 0
United Kingdom
State/province [60] 0 0
London
Country [61] 0 0
United Kingdom
State/province [61] 0 0
Oxford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Teva Branded Pharmaceutical Products R&D, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Teva Medical Expert, MD
Address 0 0
Teva Branded Pharmaceutical Products R&D, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02945046