Clinical trial NCT03107052: A Study to Explore the Long-Term Safety and Efficacy of Fremanezumab (TEV-48125) for the Prevention of Cluster Headache
Official 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Cluster Headache
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2017-04-11
Enrollment: 275
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a 68-week study to evaluate the long-term safety and efficacy of fremanezumab in participants with cluster headache (CH). Participants who complete the pivotal studies TV48125-CNS-30056 (NCT02945046) and TV48125-CNS-30057 (NCT02964338) and enroll into the current study will visit the investigational center for investigational medicinal product (IMP) administration, safety and efficacy assessments, and blood and urine collections for pharmacokinetics, immunogenicity (anti-drug antibodies \[ADAs\]), and biomarker analyses. Participants 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.


Eligibility criteria: 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

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

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Baseline up to follow-up (Week 68)
measure: Number of Participants With Potentially Clinically Significant Abnormal Laboratory Results: Serum Chemistry
timeFrame: Baseline up to end of treatment (Week 40)
measure: Number of Participants With Potentially Clinically Significant Abnormal Laboratory Results: Hematology
timeFrame: Baseline up to end of treatment (Week 40)
measure: Number of Participants With Potentially Clinically Significant Abnormal Laboratory Results: Urinalysis
timeFrame: Baseline up to end of treatment (Week 40)
measure: Number of Participants With Shift From Baseline to Endpoint (Last Assessment) in Coagulation Laboratory Test Results
timeFrame: Baseline up to end of treatment (Week 40)
measure: Number of Participants With Potentially Clinically Significant Abnormal Vital Signs Values
timeFrame: Baseline up to follow-up (Week 68)
measure: Number of Participants With Shift From Baseline to Endpoint (Last Assessment) in Electrocardiogram (ECG) Parameters
timeFrame: Baseline up to follow-up (Week 68)
measure: Number of Participants With Abnormal Physical Examination Findings
timeFrame: Baseline up to follow-up (Week 68)
measure: Number of Participants With Injection Site Reactions
timeFrame: Baseline up to Week 36
measure: Number of Participants With Hypersensitivity/Anaphylaxis Reactions
timeFrame: Baseline up to Week 36
measure: Number of Participants Who Received Concomitant Medications
timeFrame: Baseline up to follow-up (Week 68)
measure: Number of Participants With Suicidal Ideation and Suicidal Behavior as Assessed by the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS)
timeFrame: Baseline up to follow-up (Week 68)
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Teva Investigational Site 13834
state: Arizona
city: Canoga Park
country: United States
facility: Teva Investigational Site 13819
state: California
city: Santa Monica
country: United States
facility: Teva Investigational Site 13811
state: California
city: Stanford
country: United States
facility: Teva Investigational Site 13823
state: California
city: Aurora
country: United States
facility: Teva Investigational Site 13837
state: Colorado
city: Colorado Springs
country: United States
facility: Teva Investigational Site 13814
state: Colorado
city: Denver
country: United States
facility: Teva Investigational Site 13836
state: Colorado
city: Englewood
country: United States
facility: Teva Investigational Site 13813
state: Colorado
city: New Haven
country: United States
facility: Teva Investigational Site 13821
state: Connecticut
city: Stamford
country: United States
facility: Teva Investigational Site 13812
state: Connecticut
city: Gainesville
country: United States
facility: Teva Investigational Site 13810
state: Florida
city: Orlando
country: United States
facility: Teva Investigational Site 13815
state: Florida
city: Ormond Beach
country: United States
facility: Teva Investigational Site 13829
state: Florida
city: Saint Petersburg
country: United States
facility: Teva Investigational Site 13830
state: Florida
city: Tampa
country: United States
facility: Teva Investigational Site 13842
state: Florida
city: Tampa
country: United States
facility: Teva Investigational Site 13840
state: Florida
city: Columbus
country: United States
facility: Teva Investigational Site 13833
state: Georgia
city: Chicago
country: United States
facility: Teva Investigational Site 13826
state: Illinois
city: Ann Arbor
country: United States
facility: Teva Investigational Site 13818
state: Michigan
city: Las Vegas
country: United States
facility: Teva Investigational Site 13835
state: Nevada
city: Las Vegas
country: United States
facility: Teva Investigational Site 13832
state: Nevada
city: Lebanon
country: United States
facility: Teva Investigational Site 13831
state: New Hampshire
city: Princeton
country: United States
facility: Teva Investigational Site 13820
state: New Jersey
city: Albuquerque
country: United States
facility: Teva Investigational Site 13827
state: New Mexico
city: Amherst
country: United States
facility: Teva Investigational Site 13816
state: New York
city: New York
country: United States
facility: Teva Investigational Site 13817
state: New York
city: Raleigh
country: United States
facility: Teva Investigational Site 13809
state: North Carolina
city: Salisbury
country: United States
facility: Teva Investigational Site 13839
state: North Carolina
city: Cleveland
country: United States
facility: Teva Investigational Site 13825
state: Ohio
city: Philadelphia
country: United States
facility: Teva Investigational Site 13824
state: Pennsylvania
city: Richmond
country: United States
facility: Teva Investigational Site 13841
state: Texas
city: Virginia Beach
country: United States
facility: Teva Investigational Site 13822
state: Virginia
city: Auchenflower
country: Australia
facility: Teva Investigational Site 78120
city: Clayton
country: Australia
facility: Teva Investigational Site 78118
city: Melbourne
country: Australia
facility: Teva Investigational Site 78123
city: Parkville
country: Australia
facility: Teva Investigational Site 78122
city: Randwick
country: Australia
facility: Teva Investigational Site 78121
city: Newmarket
country: Canada
facility: Teva Investigational Site 11132
state: Ontario
city: Calgary
country: Canada
facility: Teva Investigational Site 11130
city: Helsinki
country: Finland
facility: Teva Investigational Site 40030
city: Oulu
country: Finland
facility: Teva Investigational Site 40031
city: Turku
country: Finland
facility: Teva Investigational Site 40029
city: Berlin
country: Germany
facility: Teva Investigational Site 32666
city: Bochum
country: Germany
facility: Teva Investigational Site 32667
city: Essen
country: Germany
facility: Teva Investigational Site 32660
city: Hamburg
country: Germany
facility: Teva Investigational Site 32665
city: Kiel
country: Germany
facility: Teva Investigational Site 32662
city: Konigstein im Taunus
country: Germany
facility: Teva Investigational Site 32661
city: Rostock
country: Germany
facility: Teva Investigational Site 32663
city: Ashkelon
country: Israel
facility: Teva Investigational Site 80124
city: Hadera
country: Israel
facility: Teva Investigational Site 80122
city: Holon
country: Israel
facility: Teva Investigational Site 80125
city: Jerusalem
country: Israel
facility: Teva Investigational Site 80121
city: Netanya
country: Israel
facility: Teva Investigational Site 80123
city: Ramat Gan
country: Israel
facility: Teva Investigational Site 80120
city: Tel Aviv
country: Israel
facility: Teva Investigational Site 80127
city: Tel-Aviv
country: Israel
facility: Teva Investigational Site 80126
city: Milan
country: Italy
facility: Teva Investigational Site 30190
city: Modena
country: Italy
facility: Teva Investigational Site 30192
city: Napoli
country: Italy
facility: Teva Investigational Site 30194
city: Pavia
country: Italy
facility: Teva Investigational Site 30193
city: Rome
country: Italy
facility: Teva Investigational Site 30191
city: Rome
country: Italy
facility: Teva Investigational Site 30189
city: Leiden
country: Netherlands
facility: Teva Investigational Site 38118
city: Nijmegen
country: Netherlands
facility: Teva Investigational Site 38119
city: Zwolle
country: Netherlands
facility: Teva Investigational Site 38117
city: Bialystok
country: Poland
facility: Teva Investigational Site 53380
city: Krakow
country: Poland
facility: Teva Investigational Site 53383
city: Krakow
country: Poland
facility: Teva Investigational Site 53379
city: Lodz
country: Poland
facility: Teva Investigational Site 53382
city: Szczecin
country: Poland
facility: Teva Investigational Site 53381
city: Galdakao.
country: Spain
facility: Teva Investigational Site 31211
city: Madrid
country: Spain
facility: Teva Investigational Site 31214
city: Sevilla
country: Spain
facility: Teva Investigational Site 31213
city: Valladolid
country: Spain
facility: Teva Investigational Site 31212
city: Zaragoza
country: Spain
facility: Teva Investigational Site 31215
city: Huddinge
country: Sweden
facility: Teva Investigational Site 42047
city: Vallingby
country: Sweden
facility: Teva Investigational Site 42045
city: Glasgow
country: United Kingdom
facility: Teva Investigational Site 34224
city: Liverpool
country: United Kingdom
facility: Teva Investigational Site 34222
city: London
country: United Kingdom
facility: Teva Investigational Site 34223
city: London
country: United Kingdom
facility: Teva Investigational Site 34220
city: Oxford
country: United Kingdom
facility: Teva Investigational Site 34221
Study officials:
affiliation: Teva Branded Pharmaceutical Products R&D, Inc.
name: Teva Medical Expert, MD
role: STUDY_DIRECTOR
References: