A Study to Test if Fremanezumab is Effective in Preventing Episodic Migraine in Patients 6 to 17 Years of Age

Migraine Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04458857
• Other study ID #: TV48125-CNS-30083
• Secondary ID: 2019-002055-42
• Status: Completed
• Phase: Phase 3
• Start date: July 15, 2020
• Est. completion date: March 13, 2024

Study information

• Verified date: April 2024
• Source: Teva Branded Pharmaceutical Products R&D, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 237
• Est. completion date: March 13, 2024
• Est. primary completion date: March 13, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• Fremanezumab
Dose A or Dose B subcutaneous
• Placebo
Matching placebo

Locations

Country	Name	City	State
Canada	Teva Investigational Site 11180	Ajax	Ontario
Canada	Teva Investigational Site 11181	Montreal	Quebec
Canada	Teva Investigational Site 11179	Nepean	Ontario
Canada	Teva Investigational Site 11182	Ottawa	Ontario
Finland	Teva Investigational Site 40053	Helsinki
Finland	Teva Investigational Site 40049	Kuopio
Finland	Teva Investigational Site 40054	Oulu
Finland	Teva Investigational Site 40052	Tampere
Germany	Teva Investigational Site 32728	Bad Homburg
Germany	Teva Investigational Site 32729	Berlin
Germany	Teva Investigational Site 32725	Dresden
Germany	Teva Investigational Site 32724	Essen
Germany	Teva Investigational Site 32726	Leipzig
Israel	Teva Investigational Site 80170	Be'er Ya'akov
Israel	Teva Investigational Site 80166	Haifa
Israel	Teva Investigational Site 80168	Holon
Israel	Teva Investigational Site 80169	Jerusalem
Israel	Teva Investigational Site 80167	Ramat Gan
Israel	Teva Investigational Site 80164	Safed
Israel	Teva Investigational Site 80165	Tel-Aviv
Italy	Teva Investigational Site 30230	Firenze
Italy	Teva Investigational Site 30226	Milano
Italy	Teva Investigational Site 30228	Milano
Italy	Teva Investigational Site 30239	Milano
Italy	Teva Investigational Site 30238	Padua
Italy	Teva Investigational Site 30227	Pavia
Italy	Teva Investigational Site 30225	Rome
Netherlands	Teva Investigational Site 38138	Doetinchem
Netherlands	Teva Investigational Site 38135	Nijmegen
Netherlands	Teva Investigational Site 38136	Rotterdam
Poland	Teva Investigational Site 53441	Gdansk
Poland	Teva Investigational Site 53437	Kielce
Poland	Teva Investigational Site 53443	Krakow
Poland	Teva Investigational Site 53452	Krakow
Poland	Teva Investigational Site 53440	Lublin
Poland	Teva Investigational Site 53439	Poznan
Poland	Teva Investigational Site 53451	Poznan
Poland	Teva Investigational Site 53442	Szczecin
Spain	Teva Investigational Site 31271	Barcelona
Spain	Teva Investigational Site 31266	Elda
Spain	Teva Investigational Site 31267	Madrid
Spain	Teva Investigational Site 31268	Madrid
Spain	Teva Investigational Site 31270	Valencia
Spain	Teva Investigational Site 31265	Valladolid
United States	Teva Investigational Site 14276	Amherst	New York
United States	Teva Investigational Site 14251	Ann Arbor	Michigan
United States	Teva Investigational Site 14243	Atlanta	Georgia
United States	Teva Investigational Site 14319	Aurora	Colorado
United States	Teva Investigational Site 14252	Austin	Texas
United States	Teva Investigational Site 14273	Austin	Texas
United States	Teva Investigational Site 14365	Baltimore	Maryland
United States	Teva Investigational Site 14253	Banning	California
United States	Teva Investigational Site 14274	Bellaire	Texas
United States	Teva Investigational Site 14256	Bridgeton	Missouri
United States	Teva Investigational Site 14374	Bristol	Tennessee
United States	Teva Investigational Site 14264	Cincinnati	Ohio
United States	Teva Investigational Site 14368	Colorado Springs	Colorado
United States	Teva Investigational Site 14360	Covington	Louisiana
United States	Teva Investigational Site 14367	Dallas	Texas
United States	Teva Investigational Site 14377	Durham	North Carolina
United States	Teva Investigational Site 14263	Hoffman Estates	Illinois
United States	Teva Investigational Site 14312	Houston	Texas
United States	Teva Investigational Site 14244	Jacksonville	Florida
United States	Teva Investigational Site 14281	Little Rock	Arkansas
United States	Teva Investigational Site 14370	Loma Linda	California
United States	Teva Investigational Site 14322	Los Angeles	California
United States	Teva Investigational Site 14327	Louisville	Kentucky
United States	Teva Investigational Site 14325	Miami	Florida
United States	Teva Investigational Site 14270	Minneapolis	Minnesota
United States	Teva Investigational Site 14371	New Brunswick	New Jersey
United States	Teva Investigational Site 14323	Norfolk	Virginia
United States	Teva Investigational Site 14257	Oklahoma City	Oklahoma
United States	Teva Investigational Site 14275	Oklahoma City	Oklahoma
United States	Teva Investigational Site 14283	Park Ridge	Illinois
United States	Teva Investigational Site 14364	Philadelphia	Pennsylvania
United States	Teva Investigational Site 14248	Raleigh	North Carolina
United States	Teva Investigational Site 14376	Ridgeland	Mississippi
United States	Teva Investigational Site 14361	Sacramento	California
United States	Teva Investigational Site 14375	Salt Lake City	Utah
United States	Teva Investigational Site 14241	San Antonio	Texas
United States	Teva Investigational Site 14366	San Antonio	Texas
United States	Teva Investigational Site 14258	Savannah	Georgia
United States	Teva Investigational Site 14317	Silver Spring	Maryland
United States	Teva Investigational Site 14277	Tacoma	Washington
United States	Teva Investigational Site 14363	Tulsa	Oklahoma
United States	Teva Investigational Site 14246	Waltham	Massachusetts
United States	Teva Investigational Site 14250	West Palm Beach	Florida
United States	Teva Investigational Site 14255	West Palm Beach	Florida
United States	Teva Investigational Site 14245	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Teva Branded Pharmaceutical Products R&D, Inc.

Countries where clinical trial is conducted

United States,  Canada,  Finland,  Germany,  Israel,  Italy,  Netherlands,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in the monthly average number of migraine days after the first dose of study drug		Baseline - Month 3
Secondary	Number of adverse events	including local injection site reaction/pain	Baseline - Month 3
Secondary	Incidence of abnormal standard 12-lead electrocardiogram (ECG) findings		Baseline - Month 3
Secondary	Incidence of abnormal vital signs	(systolic and diastolic blood pressure, pulse, temperature, and respiratory rate), height, and weight measurements	Baseline - Month 3
Secondary	Number of participants with clinically significant changes in laboratory values		Baseline, Month 1, and Month 3
Secondary	Incidence of abnormal physical examination findings		Baseline - Month 3
Secondary	Yes/No suicidality ideation	Columbia-Suicide Severity Rating Scale (C-SSRS) The C-SSRS is an assessment tool that evaluates suicidal ideation and behavior. Scale range: Yes or No response to 10 questions, with minimum to maximum range of 0 to 10. Lower score represents better outcomes.	Screening - Month 3
Secondary	Mean change in monthly average number of headache days of at least moderate severity after the first dose of study drug		Baseline - Month 3
Secondary	Proportion of participants reaching at least 50% reduction in the monthly average number of migraine days after the first dose of study drug		Baseline - Month 3
Secondary	Mean change in the monthly average number of days of use of any acute headache medications after the first dose of study drug		Baseline - Month 3
Secondary	Mean change in the PedMIDAS questionnaire after administration of the first dose of study drug	The Pediatric Migraine Disability Assessment (PedMIDAS) is used to assess migraine disability across multiple domains of functioning including school, home, social, and recreational. The measure consists of 6 items measuring the number of days in which activities were missed as a result of headache/migraine. The measure yields a total score by summing items. Total scores correspond to one of four "disability grades:" 0-10 = little to no disability, 11-30 = mild disability, 31-50 = moderate disability, and >50 = severe disability.	Baseline and Month 3
Secondary	Mean change PedsQL after administration of the first dose of study drug	Pediatric Quality of Life Inventory (PedsQL) A health-related quality-of-life instrument that consists of a well-validated generic core measure and some condition and disease-specific modules. The instructions ask how much of a problem each item has been during the past 1 month. A 5-point response scale is utilized across child self-report and parent proxy report as follows: 0=never a problem; almost never a problem; sometimes a problem; often a problem; almost always a problem.	Baseline - Month 3
Secondary	Proportion of participants developing antidrug antibodies (ADAs) throughout the study	The impact of ADAs on safety and efficacy will be analyzed if the number of ADA-positive participants allows.	Baseline - Month 3