A Study to Evaluate Treatment Satisfaction With Erenumab in Participants With Migraine

Sponsor

Amgen (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04825678

Collaborator

(none)

322

Enrollment

Locations

Arm

27.1

Anticipated Duration (Months)

9.2

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main purpose of this study is to evaluate the effect of erenumab on medication-specific treatment satisfaction.

Condition or Disease	Intervention/Treatment	Phase
Migraine	Drug: Erenumab	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

322 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

Phase 4, Open-label Study to Evaluate Treatment Satisfaction With Erenumab in Patients With Migraine

Actual Study Start Date :

Jun 11, 2021

Anticipated Primary Completion Date :

Sep 15, 2023

Anticipated Study Completion Date :

Sep 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Erenumab	Drug: Erenumab Administered as a subcutaneous injection via the SureClick® Autoinjector Pen (AI/Pen). Other Names: AMG 334

Arm

Intervention/Treatment

Experimental: Erenumab

Drug: Erenumab

Administered as a subcutaneous injection via the SureClick® Autoinjector Pen (AI/Pen).

Other Names:

AMG 334

Outcome Measures

Primary Outcome Measures

Mean Change from Baseline in the Treatment Satisfaction Questionnaire for Medication (TSQM) Overall Satisfaction Scale Score at Week 24 [Baseline and Week 24]
As measured by items 12 to 14 of the TSQM version 1.4. Items 12 and 13 measure confidence in benefits and balance between good and bad things on a 5 point rating scale where 1 indicates least satisfaction and 5 indicates most satisfaction. Item 14 measures global satisfaction on a 7 point rating scale where 1 indicates least satisfaction and 7 indicates most satisfaction.

Secondary Outcome Measures

Number of Participants Achieving Overall Satisfaction at Week 24 [Week 24]
Overall satisfaction is defined by participant reporting of satisfied, very satisfied, or extremely satisfied on item 14 of the TSQM version 1.4. Item 14 of the TSQM measures global satisfaction on a 7 point rating scale where 1 indicates least satisfaction and 7 indicates most satisfaction.
Number of Participants Reporting Improvement in Participant Global Impression at Week 24 [Week 24]
Improvement is defined by participant reporting of much improved or a little improved on the migraine Global Impression Item (mGI-I).
Number of Clinician's Reporting Improvement in Treating Clinician's Global Impression at Week 24 [Week 24]
Improvement is defined by treating clinician's reporting of much improved or a little improved on the mGI-I for each individual participant.
Number of Key Family Member's Reporting Improvement in Key Family Member's Impression at Week 24 [Week 24]
Improvement is defined by key family member's reporting of much improved or a little improved on the mGI-I for each individual participant.
Mean Change from Baseline in Physical Function Domain Score as Measured by the Migraine Functional Impact Questionnaire (MFIQ) at Week 24 [Baseline and Week 24]
Mean Change from Baseline in Usual Activities Domain Score as Measured by the MFIQ at Week 24 [Baseline and Week 24]
Mean Change from Baseline in Emotional Function Domain Score as Measured by the MFIQ at Week 24 [Baseline and Week 24]
Mean Change from Baseline in Social Function Domain Score as Measured by the MFIQ at Week 24 [Baseline and Week 24]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age ≥ 18 years
Participant has provided informed consent
History of migraine (with or without aura) for ≥ 12 months before screening
≥ 4 migraine days per month on average across the 3 months prior to screening
Treatment with 1 oral migraine preventive medication and/or concomitant use of OnabotulinumtoxinA injections for migraine prevention.
Participant reports to their provider intolerance or insufficient response with their current preventative treatment

Exclusion Criteria:

History of cluster headache or hemiplegic migraine headache
Unable to differentiate migraine from other headaches
Evidence of substance-related disorders
Active chronic pain syndromes (eg, fibromyalgia and chronic pelvic pain)
No therapeutic response with > 3 migraine preventive medication categories
Used a prohibited medication, device, or procedure
Other clinically significant disorder, condition, or disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rehabilitation and Neurological Services LLC	Huntsville	Alabama	United States	35805
2	The Neurology Group	Pomona	California	United States	91767
3	Mountain Neurological Research Center	Basalt	Colorado	United States	81621
4	Mindscapes Counseling, LLC	Norwich	Connecticut	United States	06360
5	Reliable Clinical Research, LLC	Hialeah	Florida	United States	33012
6	The Community Research of South Florida	Hialeah	Florida	United States	33016
7	Homestead Associates In Research Inc	Homestead	Florida	United States	33032
8	Research Institute of Orlando	Orlando	Florida	United States	32806
9	PAS Research	Tampa	Florida	United States	33613
10	Georgia Institute for Clinical Research, LLC	Marietta	Georgia	United States	30060
11	Chicago Headache Center and Research Institute	Chicago	Illinois	United States	60657
12	College Park Family Care Center	Overland Park	Kansas	United States	66212
13	Family HealthCare	Germantown	Maryland	United States	20876
14	Neurology Center of New England	Foxboro	Massachusetts	United States	02035
15	ActivMed Practices and Research, LLC	Lowell	Massachusetts	United States	01852
16	Memorial Healthcare Foundation	Owosso	Michigan	United States	48867
17	SRI International	Plymouth	Michigan	United States	48170
18	Citizens Memorial Healthcare	Bolivar	Missouri	United States	65613
19	Psych Care Consultants	Saint Louis	Missouri	United States	63128
20	Clinvest Research LLC	Springfield	Missouri	United States	65810
21	Albany Medical College	Albany	New York	United States	12208
22	Montefiore Medical Center	Bronx	New York	United States	10461
23	Northwell Health Physician Partners Neuroscience Institute at Great Neck	Great Neck	New York	United States	11021
24	Island Neurological Associates	Plainview	New York	United States	11803
25	Nuvance Health Medical Practice Primary Care Division of Neurology	Poughkeepsie	New York	United States	12601
26	Asheville Neurology Specialists PA	Asheville	North Carolina	United States	28806
27	Saint Lukes Neurology Associates	Bethlehem	Pennsylvania	United States	18018
28	Clinical Trials of South Carolina	Charleston	South Carolina	United States	29406
29	Premier Neurology	Greer	South Carolina	United States	29650
30	Tri-State Mountain Neurology Associates	Johnson City	Tennessee	United States	37604
31	Pearland Neurology Services PLLC	Houston	Texas	United States	77089
32	Protenium Clinical Research	Hurst	Texas	United States	76054
33	Houston Neurology Associates	Sugar Land	Texas	United States	77478
34	Sugar Lakes Family Practice	Sugar Land	Texas	United States	77479
35	Vaught Neurological Services	Crab Orchard	West Virginia	United States	25827