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

• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04464707
• Collaborator: (none)
• Enrollment: 418
• Locations: 87
• Arms: 2
• Anticipated Duration (Months): 62.7
• Patients Per Site: 4.8
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The primary objective of the study is to evaluate the effectiveness of fremanezumab as compared to placebo for the preventive treatment of chronic migraine (CM).

Secondary objectives are to further demonstrate the efficacy of Fremanezumab as compared to placebo for the preventive treatment of CM, to evaluate the safety and tolerability of Fremanezumab in the preventive treatment of CM 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 48 months.

Condition or Disease	Intervention/Treatment	Phase
Migraine	Drug: Fremanezumab; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 418 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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 Chronic Migraine in Pediatric Patients 6 to 17 Years of Age
• Actual Study Start Date: Jul 30, 2020
• Anticipated Primary Completion Date: Oct 20, 2025
• Anticipated Study Completion Date: Oct 20, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fremanezumab Participants weighing ≥ threshold will receive Dose A subcutaneously monthly Participants weighing < threshold will receive Dose B subcutaneously monthly subcutaneously monthly, for 3 months.	Drug: Fremanezumab; Dose A or Dose B subcutaneous
Placebo Comparator: Placebo Matching placebo	Drug: Placebo; Matching placebo

Outcome Measures

Primary Outcome Measures

1. Mean change in the monthly average number of headache days of at least moderate severity after the first dose of study drug [Baseline - Month 3]

Secondary Outcome Measures

1. Mean change in monthly average number of migraine days after the first dose of study drug [Baseline - Month 3]

2. Number of participants reaching at least 50% reduction in the monthly average number of headache days of at least moderate severity after the first dose of study drug [Baseline - Month 3]

3. 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]

4. Mean change in the PedMIDAS questionnaire after administration of the first dose of study drug [Baseline and Month 3]

   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.

5. Mean change PedsQL after administration of the first dose of study drug [Baseline - Month 3]

   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.

6. Number of adverse events [Baseline - Month 3]

   including local injection site reaction/pain

7. Incidence of abnormal standard 12-lead electrocardiogram (ECG) findings [Baseline - Month 3]

8. Incidence of abnormal vital signs [Baseline - Month 3]

   (systolic and diastolic blood pressure, pulse, temperature, and respiratory rate), height, and weight measurements

9. Number of participants with clinically significant changes in laboratory values [Baseline, Month 1, and Month 3]

10. Incidence of abnormal physical examination findings [Baseline - Month 3]

11. Yes/No suicidality ideation [Screening - Month 3]

    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.

12. Number of participants developing antidrug antibodies (ADAs) throughout the study [Baseline - Month 3]

    The impact of ADAs on safety and efficacy will be analyzed if the number of ADA-positive participants allows.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 ≥15 headache days per month, of which ≥8 headache days were assessed as migraine 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 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, any prior history of a suicide attempt, or a history of suicidal ideation with a specific plan within the past 2 years, at the discretion of the investigator.

• 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, 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 patient has a current or past medical history of hemiplegic migraine.

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Teva Investigational Site 14358	Phoenix	Arizona	United States	85016
2	Teva Investigational Site 14281	Little Rock	Arkansas	United States	72202
3	Teva Investigational Site 14253	Banning	California	United States	92220
4	Teva Investigational Site 14370	Loma Linda	California	United States	92354
5	Teva Investigational Site 14322	Los Angeles	California	United States	90027
6	Teva Investigational Site 14361	Sacramento	California	United States	95815
7	Teva Investigational Site 14319	Aurora	Colorado	United States	80045
8	Teva Investigational Site 14368	Colorado Springs	Colorado	United States	80907
9	Teva Investigational Site 14244	Jacksonville	Florida	United States	32256
10	Teva Investigational Site 14325	Miami	Florida	United States	33155
11	Teva Investigational Site 14316	Miami	Florida	United States	33186
12	Teva Investigational Site 14250	West Palm Beach	Florida	United States	33407
13	Teva Investigational Site 14255	West Palm Beach	Florida	United States	33409
14	Teva Investigational Site 14243	Atlanta	Georgia	United States	30328
15	Teva Investigational Site 14258	Savannah	Georgia	United States	31406
16	Teva Investigational Site 14263	Hoffman Estates	Illinois	United States	60169
17	Teva Investigational Site 14283	Park Ridge	Illinois	United States	60068
18	Teva Investigational Site 14245	Wichita	Kansas	United States	67206
19	Teva Investigational Site 14360	Covington	Louisiana	United States	70433
20	Teva Investigational Site 14365	Baltimore	Maryland	United States	21201
21	Teva Investigational Site 14317	Silver Spring	Maryland	United States	20910
22	Teva Investigational Site 14246	Waltham	Massachusetts	United States	02451
23	Teva Investigational Site 14251	Ann Arbor	Michigan	United States	48104
24	Teva Investigational Site 14270	Minneapolis	Minnesota	United States	55402
25	Teva Investigational Site 14376	Ridgeland	Mississippi	United States	39157
26	Teva Investigational Site 14256	Bridgeton	Missouri	United States	63044-2513
27	Teva Investigational Site 14371	New Brunswick	New Jersey	United States	08901
28	Teva Investigational Site 14276	Amherst	New York	United States	14226
29	Teva Investigational Site 14377	Durham	North Carolina	United States	27705-4699
30	Teva Investigational Site 14248	Raleigh	North Carolina	United States	27607
31	Teva Investigational Site 14264	Cincinnati	Ohio	United States	45229-3039
32	Teva Investigational Site 14257	Oklahoma City	Oklahoma	United States	73112
33	Teva Investigational Site 14275	Oklahoma City	Oklahoma	United States	73116
34	Teva Investigational Site 14363	Tulsa	Oklahoma	United States	74136
35	Teva Investigational Site 14364	Philadelphia	Pennsylvania	United States	19104-4318
36	Teva Investigational Site 14374	Bristol	Tennessee	United States	37620
37	Teva Investigational Site 14252	Austin	Texas	United States	78731
38	Teva Investigational Site 14273	Austin	Texas	United States	78759
39	Teva Investigational Site 14367	Dallas	Texas	United States	75235-7701
40	Teva Investigational Site 14274	Houston	Texas	United States	77024
41	Teva Investigational Site 14312	Houston	Texas	United States	77087
42	Teva Investigational Site 14241	San Antonio	Texas	United States	78240
43	Teva Investigational Site 14375	Salt Lake City	Utah	United States	84109
44	Teva Investigational Site 14323	Norfolk	Virginia	United States	23510
45	Teva Investigational Site 14277	Tacoma	Washington	United States	98402
46	Teva Investigational Site 11180	Ajax	Ontario	Canada	L1Z0M1
47	Teva Investigational Site 11179	Ottawa	Ontario	Canada	K2G 1W2
48	Teva Investigational Site 40053	Helsinki		Finland	00380
49	Teva Investigational Site 40049	Kuopio		Finland	70210
50	Teva Investigational Site 40054	Oulu		Finland	90100
51	Teva Investigational Site 40052	Tampere		Finland	33521
52	Teva Investigational Site 32728	Bad Homburg		Germany	61348
53	Teva Investigational Site 32729	Berlin		Germany	13353
54	Teva Investigational Site 32725	Dresden		Germany	01307
55	Teva Investigational Site 32724	Essen		Germany	45257
56	Teva Investigational Site 32726	Leipzig		Germany	4103
57	Teva Investigational Site 80170	Be'er Ya'akov		Israel	70300
58	Teva Investigational Site 80166	Haifa		Israel	31048
59	Teva Investigational Site 80168	Holon		Israel	58100
60	Teva Investigational Site 80169	Jerusalem		Israel	9124001
61	Teva Investigational Site 80167	Ramat Gan		Israel	5265601
62	Teva Investigational Site 80164	Safed		Israel	13100
63	Teva Investigational Site 80165	Tel-Aviv		Israel	64239
64	Teva Investigational Site 30230	Firenze		Italy	50139
65	Teva Investigational Site 30239	Milano		Italy	20132
66	Teva Investigational Site 30226	Milano		Italy	20148
67	Teva Investigational Site 30228	Milan		Italy	20133
68	Teva Investigational Site 30238	Padua		Italy	35128
69	Teva Investigational Site 30227	Pavia		Italy	27100
70	Teva Investigational Site 30225	Rome		Italy	163
71	Teva Investigational Site 38138	Doetinchem		Netherlands	7009 BL
72	Teva Investigational Site 38135	Nijmegen		Netherlands	6532 SZ
73	Teva Investigational Site 38136	Rotterdam		Netherlands	3015 GD
74	Teva Investigational Site 53441	Gdansk		Poland	80-389
75	Teva Investigational Site 53437	Kielce		Poland	25-316
76	Teva Investigational Site 53443	Krakow		Poland	30-363
77	Teva Investigational Site 53452	Krakow		Poland	30-539
78	Teva Investigational Site 53440	Lublin		Poland	20-582
79	Teva Investigational Site 53439	Poznan		Poland	60-355
80	Teva Investigational Site 53451	Poznan		Poland	60-848
81	Teva Investigational Site 53442	Szczecin		Poland	70-111
82	Teva Investigational Site 31271	Barcelona		Spain	8035
83	Teva Investigational Site 31266	Elda		Spain	03600
84	Teva Investigational Site 31268	Madrid		Spain	28009
85	Teva Investigational Site 31267	Madrid		Spain	28046
86	Teva Investigational Site 31270	Valencia		Spain	46026
87	Teva Investigational Site 31265	Valladolid		Spain	47010

Sponsors and Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.

Investigators

• Study Director: Teva Medical Expert, MD, Teva Branded Pharmaceutical Products R&D, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Teva Branded Pharmaceutical Products R&D, Inc.
• ClinicalTrials.gov Identifier: NCT04464707
• Other Study ID Numbers: TV48125-CNS-30082; 2019-002053-33
• First Posted: Jul 9, 2020
• Last Update Posted: Aug 24, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Migraine Disorders

Study Results

No Results Posted as of Aug 24, 2022