Clinical trial NCT04458857: A Study to Test if Fremanezumab is Effective in Preventing Episodic Migraine in Patients 6 to 17 Years of Age
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing the Efficacy, Safety, and Tolerability of Subcutaneous Administration of Fremanezumab Versus Placebo for the Preventive Treatment of Episodic Migraine in Pediatric Patients 6 to 17 Years of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine
Keywords: episodic migraine
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2020-07-07
Enrollment: 235
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to evaluate the efficacy of fremanezumab as compared to placebo for the preventive treatment of episodic migraine (EM).

Secondary objectives are to further demonstrate the efficacy of fremanezumab as compared to placebo for the preventive treatment of EM, to evaluate the safety and tolerability of fremanezumab in the preventive treatment of EM and to evaluate the immunogenicity of fremanezumab and the impact of antidrug antibodies (ADAs) on clinical outcomes in participants exposed to fremanezumab.

The total duration of the study is planned to be up to 51 months.


Eligibility criteria: Inclusion Criteria:

* The participant has a clinical history of recurrent headache consistent with the diagnosis of migraine for at least 6 months before screening, consistent with ICHD-3 criteria (Headache Classification Committee of the IHS 2013), and a history of ≤=14 headache days per month in each of the 3 months prior to screening (visit 1).
* The participant or parent/caregiver maintain a prospectively collected headache diary
* The participant does not have chronic daily headache. For the purposes of this study, chronic daily headache is operationally defined as \<4 headache-free days during the 28-day baseline period.

NOTE: Additional criteria apply; please contact the investigator for more information.

Exclusion Criteria:

* The participant is using medications containing opioids (including codeine) or barbiturates (including Fiorinal®, Fioricet®, or any other combination containing butalbital) for the treatment of migraine during the 3 months prior to the day of the screening visit.
* The participant or parent/caregiver maintain a prospectively collected headache diary
* The participant has used an intervention/device (eg, scheduled nerve block or transcranial magnetic stimulation) for the treatment of migraine or in the head or neck area for any condition during the 2 months prior to the day of the screening visit.
* The participant has a current history of a clinically significant psychiatric condition, at the discretion of the investigator. Any prior history of a suicide attempt, or a history of suicidal ideation with a specific plan within the past 2 years, must be excluded.
* The participant has an ongoing infection or a known history of human immunodeficiency virus infection, tuberculosis, Lyme disease, or chronic hepatitis B or C, or a known active infection of coronavirus disease 2019 (COVID-19).
* The participant has a past or current history of cancer.
* The participant is pregnant or nursing.
* The participant has a history of hypersensitivity reactions to injected proteins, including mAbs, or a history of Stevens-Johnson Syndrome or toxic epidermal necrolysis syndrome, or the participant is concomitantly using lamotrigine.
* The participant received a live attenuated vaccine (eg, intranasal flu vaccine, and measles, mumps, and rubella vaccine) within the 12-week period prior to screening. Note: If a medical need arises during the study, the participant may receive a live attenuated vaccine.
* The participant has a current or past medical history of hemiplegic migraine.

NOTE: Additional criteria apply; please contact the investigator for more information.

Primary outcomes:
measure: Mean Change From Baseline in Monthly Average Number of Migraine Days During 12-Week Period After the First Dose of Study Drug
timeFrame: Baseline (Day -28 to Day -1), up to Week 12
Secondary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Baseline up to Month 3
measure: Number of Participants With Shift From Baseline to Last Assessment in Electrocardiogram (ECG) Findings (Assessed by Investigator)
timeFrame: Baseline to last assessment (up to Month 3)
measure: Number of Participants With Shift From Baseline to Last Assessment in ECG Findings (Assessed by Cardiologist)
timeFrame: Baseline to last assessment (up to Month 3)
measure: Number of Participants With Any One or More Potentially Clinically Significant Vital Signs Abnormalities
timeFrame: Baseline up to Month 3
measure: Number of Participants With Potentially Clinically Significant Abnormal Laboratory (Serum Chemistry, Hematology, Coagulation, and Urinalysis) Results
timeFrame: Baseline up to Month 3
measure: Number of Participants With Abnormal Physical Examination Findings as Identified by the Investigator
timeFrame: Baseline up to Month 3
measure: Number of Participants With Suicidal Ideation or Suicidal Behavior as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: Baseline and Month 3
measure: Mean Change From Baseline in Monthly Average Number of Headache Days of at Least Moderate Severity During 12-Week Period After the First Dose of Study Drug
timeFrame: Baseline (Day -28 to Day -1), up to Week 12
measure: Number of Participants Reaching at Least 50% Reduction in the Monthly Average Number of Migraine Days During the 12-week Period After the First Dose of Study Drug
timeFrame: Baseline (Day -28 to Day -1) up to Week 12
measure: Mean Change From Baseline in Monthly Average Number of Days of Use of Any Acute Headache Medications During 12-Week Period After the First Dose of Study Drug
timeFrame: Baseline (Day -28 to Day -1), up to Week 12
measure: Mean Change From Baseline in Migraine-related Disability Score at Week 12, as Measured by the Pediatric Migraine Disability Assessment (PedMIDAS) Questionnaire
timeFrame: Baseline, Week 12
measure: Mean Change From Baseline in Quality of Life at Week 12, as Measured by Pediatric Quality of Life Inventory (PedsQL) Questionnaire
timeFrame: Baseline, Week 12
measure: Number of Participants Developing Anti-drug Antibodies (ADAs) Throughout the Study
timeFrame: Baseline up to Month 3
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Teva Investigational Site 14281
state: Arkansas
city: Banning
country: United States
facility: Teva Investigational Site 14253
state: California
city: Loma Linda
country: United States
facility: Teva Investigational Site 14370
state: California
city: Los Angeles
country: United States
facility: Teva Investigational Site 14322
state: California
city: Sacramento
country: United States
facility: Teva Investigational Site 14361
state: California
city: Aurora
country: United States
facility: Teva Investigational Site 14319
state: Colorado
city: Colorado Springs
country: United States
facility: Teva Investigational Site 14368
state: Colorado
city: Jacksonville
country: United States
facility: Teva Investigational Site 14244
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 14325
state: Florida
city: West Palm Beach
country: United States
facility: Teva Investigational Site 14250
state: Florida
city: West Palm Beach
country: United States
facility: Teva Investigational Site 14255
state: Florida
city: Atlanta
country: United States
facility: Teva Investigational Site 14243
state: Georgia
city: Savannah
country: United States
facility: Teva Investigational Site 14258
state: Georgia
city: Hoffman Estates
country: United States
facility: Teva Investigational Site 14263
state: Illinois
city: Park Ridge
country: United States
facility: Teva Investigational Site 14283
state: Illinois
city: Wichita
country: United States
facility: Teva Investigational Site 14245
state: Kansas
city: Louisville
country: United States
facility: Teva Investigational Site 14327
state: Kentucky
city: Covington
country: United States
facility: Teva Investigational Site 14360
state: Louisiana
city: Baltimore
country: United States
facility: Teva Investigational Site 14365
state: Maryland
city: Silver Spring
country: United States
facility: Teva Investigational Site 14317
state: Maryland
city: Waltham
country: United States
facility: Teva Investigational Site 14246
state: Massachusetts
city: Ann Arbor
country: United States
facility: Teva Investigational Site 14251
state: Michigan
city: Minneapolis
country: United States
facility: Teva Investigational Site 14270
state: Minnesota
city: Ridgeland
country: United States
facility: Teva Investigational Site 14376
state: Mississippi
city: Bridgeton
country: United States
facility: Teva Investigational Site 14256
state: Missouri
city: New Brunswick
country: United States
facility: Teva Investigational Site 14371
state: New Jersey
city: Amherst
country: United States
facility: Teva Investigational Site 14276
state: New York
city: Durham
country: United States
facility: Teva Investigational Site 14377
state: North Carolina
city: Raleigh
country: United States
facility: Teva Investigational Site 14248
state: North Carolina
city: Cincinnati
country: United States
facility: Teva Investigational Site 14264
state: Ohio
city: Oklahoma City
country: United States
facility: Teva Investigational Site 14257
state: Oklahoma
city: Oklahoma City
country: United States
facility: Teva Investigational Site 14275
state: Oklahoma
city: Tulsa
country: United States
facility: Teva Investigational Site 14363
state: Oklahoma
city: Philadelphia
country: United States
facility: Teva Investigational Site 14364
state: Pennsylvania
city: Bristol
country: United States
facility: Teva Investigational Site 14374
state: Tennessee
city: Austin
country: United States
facility: Teva Investigational Site 14252
state: Texas
city: Austin
country: United States
facility: Teva Investigational Site 14273
state: Texas
city: Bellaire
country: United States
facility: Teva Investigational Site 14274
state: Texas
city: Dallas
country: United States
facility: Teva Investigational Site 14367
state: Texas
city: Houston
country: United States
facility: Teva Investigational Site 14312
state: Texas
city: San Antonio
country: United States
facility: Teva Investigational Site 14366
state: Texas
city: San Antonio
country: United States
facility: Teva Investigational Site 14241
state: Texas
city: Salt Lake City
country: United States
facility: Teva Investigational Site 14375
state: Utah
city: Norfolk
country: United States
facility: Teva Investigational Site 14323
state: Virginia
city: Tacoma
country: United States
facility: Teva Investigational Site 14277
state: Washington
city: Ajax
country: Canada
facility: Teva Investigational Site 11180
state: Ontario
city: Ottawa
country: Canada
facility: Teva Investigational Site 11182
state: Ontario
city: Ottawa
country: Canada
facility: Teva Investigational Site 11179
state: Ontario
city: Montreal
country: Canada
facility: Teva Investigational Site 11181
state: Quebec
city: Helsinki
country: Finland
facility: Teva Investigational Site 40053
city: Kuopio
country: Finland
facility: Teva Investigational Site 40049
city: Oulu
country: Finland
facility: Teva Investigational Site 40054
city: Tampere
country: Finland
facility: Teva Investigational Site 40052
city: Bad Homburg
country: Germany
facility: Teva Investigational Site 32728
city: Berlin
country: Germany
facility: Teva Investigational Site 32729
city: Dresden
country: Germany
facility: Teva Investigational Site 32725
city: Essen
country: Germany
facility: Teva Investigational Site 32724
city: Leipzig
country: Germany
facility: Teva Investigational Site 32726
city: Be'er Ya'akov
country: Israel
facility: Teva Investigational Site 80170
city: Haifa
country: Israel
facility: Teva Investigational Site 80166
city: Holon
country: Israel
facility: Teva Investigational Site 80168
city: Jerusalem
country: Israel
facility: Teva Investigational Site 80169
city: Ramat Gan
country: Israel
facility: Teva Investigational Site 80167
city: Safed
country: Israel
facility: Teva Investigational Site 80164
city: Tel-Aviv
country: Israel
facility: Teva Investigational Site 80165
city: Firenze
country: Italy
facility: Teva Investigational Site 30230
city: Milano
country: Italy
facility: Teva Investigational Site 30239
city: Milano
country: Italy
facility: Teva Investigational Site 30228
city: Milano
country: Italy
facility: Teva Investigational Site 30226
city: Padua
country: Italy
facility: Teva Investigational Site 30238
city: Pavia
country: Italy
facility: Teva Investigational Site 30227
city: Rome
country: Italy
facility: Teva Investigational Site 30225
city: Doetinchem
country: Netherlands
facility: Teva Investigational Site 38138
city: Nijmegen
country: Netherlands
facility: Teva Investigational Site 38135
city: Rotterdam
country: Netherlands
facility: Teva Investigational Site 38136
city: Gdansk
country: Poland
facility: Teva Investigational Site 53441
city: Kielce
country: Poland
facility: Teva Investigational Site 53437
city: Krakow
country: Poland
facility: Teva Investigational Site 53443
city: Krakow
country: Poland
facility: Teva Investigational Site 53452
city: Lublin
country: Poland
facility: Teva Investigational Site 53440
city: Poznan
country: Poland
facility: Teva Investigational Site 53439
city: Poznan
country: Poland
facility: Teva Investigational Site 53451
city: Szczecin
country: Poland
facility: Teva Investigational Site 53442
city: Barcelona
country: Spain
facility: Teva Investigational Site 31271
city: Elda
country: Spain
facility: Teva Investigational Site 31266
city: Madrid
country: Spain
facility: Teva Investigational Site 31268
city: Madrid
country: Spain
facility: Teva Investigational Site 31267
city: Valencia
country: Spain
facility: Teva Investigational Site 31270
city: Valladolid
country: Spain
facility: Teva Investigational Site 31265
Study officials:
affiliation: Teva Branded Pharmaceutical Products R&D, Inc.
name: Teva Medical Expert, MD
role: STUDY_DIRECTOR
References: