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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03107052




Registration number
NCT03107052
Ethics application status
Date submitted
23/03/2017
Date registered
11/04/2017

Titles & IDs
Public title
A Study to Explore the Long-Term Safety and Efficacy of Fremanezumab (TEV-48125) for the Prevention of Cluster Headache
Scientific title
A Multicenter, Double-Blind, Double-Dummy Study to Explore the Long-Term Safety and Efficacy of TEV-48125 for the Prevention of Cluster Headache
Secondary ID [1] 0 0
2016-003172-43
Secondary ID [2] 0 0
TV48125-CNS-30058
Universal Trial Number (UTN)
Trial acronym
ENFORCE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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

Experimental: Fremanezumab 225 mg Monthly - Participants with ECH or CCH who received fremanezumab at 900 mg intravenous (IV) infusion at Week 0 and fremanezumab at 225 mg subcutaneous (SC) injection at Weeks 4 and 8, respectively in the pivotal study TV48125-CNS-30056 or TV48125-CNS-30057, and participants with CCH who received fremanezumab at 675 mg SC injection at Week 0 and placebo SC injection at Weeks 4 and 8, respectively in the pivotal study TV48125-CNS-30057; will receive fremanezumab at 225 mg SC injection monthly (approximately every 4 weeks, administered as single SC injection of fremanezumab at 225 mg \[225 mg/1.5 milliliter {mL}\] at Week 0 and 36; and 2 placebo SC injections at Weeks 0, 12, 24, and 36 for blinding in participants rolled over from Study TV48125-CNS-30056; fremanezumab at 225 mg as a single SC injection (225 mg/1.5 mL) at Week 0, 12, 24, and 36; 2 SC injections of placebo at Week 0 for blinding in participants rolled over from Study TV48125-CNS-30057) through Week 36 in this study.

Experimental: Fremanezumab 675/225 mg Monthly - Participants with CCH who received placebo IV infusion and SC injection at Week 0 and placebo SC injection at Weeks 4 and 8, respectively in the pivotal study TV48125-CNS-30057; will receive fremanezumab 675 mg SC injection as loading dose (administered as 3 SC injections of fremanezumab at 225 mg \[225 mg/1.5 mL\] at Week 0) followed by monthly (approximately every 4 weeks) fremanezumab at 225 mg SC injection (administered as single SC injection of fremanezumab at 225 mg \[225 mg/1.5 mL\] at Weeks 12, 24, and 36) through Week 36.

Experimental: Fremanezumab 675 mg Quarterly - Participants with ECH who received fremanezumab at 675 mg SC injection at Week 0 and placebo SC injection at Weeks 4 and 8, respectively in the pivotal study; or placebo IV infusion and SC injection at Week 0 and placebo SC injection at Weeks 4 and 8, respectively in the pivotal study TV48125-CNS-30056; will receive fremanezumab at 675 mg SC injection quarterly (approximately every 12 weeks, administered as 3 SC injections of fremanezumab at 225 mg \[225 mg/1.5 mL\] at Weeks 0 an 36; and single placebo SC injections at Weeks 4, 8, 16, 20, 28, and 32 for blinding) through Week 36.


Treatment: Drugs: Fremanezumab
Fremanezumab
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Adverse Events (AEs)
Timepoint [1] 0 0
Baseline up to follow-up (Week 68)
Primary outcome [2] 0 0
Number of Participants With Potentially Clinically Significant Abnormal Laboratory Results: Serum Chemistry
Timepoint [2] 0 0
Baseline up to end of treatment (Week 40)
Primary outcome [3] 0 0
Number of Participants With Potentially Clinically Significant Abnormal Laboratory Results: Hematology
Timepoint [3] 0 0
Baseline up to end of treatment (Week 40)
Primary outcome [4] 0 0
Number of Participants With Potentially Clinically Significant Abnormal Laboratory Results: Urinalysis
Timepoint [4] 0 0
Baseline up to end of treatment (Week 40)
Primary outcome [5] 0 0
Number of Participants With Shift From Baseline to Endpoint (Last Assessment) in Coagulation Laboratory Test Results
Timepoint [5] 0 0
Baseline up to end of treatment (Week 40)
Primary outcome [6] 0 0
Number of Participants With Potentially Clinically Significant Abnormal Vital Signs Values
Timepoint [6] 0 0
Baseline up to follow-up (Week 68)
Primary outcome [7] 0 0
Number of Participants With Shift From Baseline to Endpoint (Last Assessment) in Electrocardiogram (ECG) Parameters
Timepoint [7] 0 0
Baseline up to follow-up (Week 68)
Primary outcome [8] 0 0
Number of Participants With Abnormal Physical Examination Findings
Timepoint [8] 0 0
Baseline up to follow-up (Week 68)
Primary outcome [9] 0 0
Number of Participants With Injection Site Reactions
Timepoint [9] 0 0
Baseline up to Week 36
Primary outcome [10] 0 0
Number of Participants With Hypersensitivity/Anaphylaxis Reactions
Timepoint [10] 0 0
Baseline up to Week 36
Primary outcome [11] 0 0
Number of Participants Who Received Concomitant Medications
Timepoint [11] 0 0
Baseline up to follow-up (Week 68)
Primary outcome [12] 0 0
Number of Participants With Suicidal Ideation and Suicidal Behavior as Assessed by the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS)
Timepoint [12] 0 0
Baseline up to follow-up (Week 68)

Eligibility
Key inclusion criteria
* The participant 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 participant safety and participant compliance.
* Prior to 15 June 2018, participants from the ECH study and the CCH study were enrolled. After 15 June 2018, only participants who participated in the ECH study (Study TV48125-CNS-30056) will be enrolled for active treatment.
* In addition, participants who do not complete the pivotal efficacy studies, and participants 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
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

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
27/04/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
11/06/2019
Sample size
Target
Accrual to date
Final
275
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
Ontario
Country [20] 0 0
Canada
State/province [20] 0 0
Calgary
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


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/NCT03107052