Current partner codePEPTIDESDE
NCT05284019·Phase 4·INTERVENTIONAL

Real World Effectiveness of Eptinezumab in Participants With Migraine

Status

Terminated

Phase

Phase 4

Enrollment

32

Locations

10

Results

Posted

Publications

0

Study summary

What the protocol is testing.

The purpose of this study is to examine how eptinezumab compares to other advanced preventive medications in a real-world community setting in adult participants with episodic migraine (EM) or chronic migraine (CM). These objectives include exploring the comparative effectiveness on patient reported outcomes.

Interventions

Treatment arms and agents.

DRUG

Eptinezumab

Concentrate for solution for IV infusion

DRUG

Erenumab

Solution for SC Injection

DRUG

Onabotulinumtoxin-A

Solution for IM Injection

DRUG

Fremanezumab

Solution for SC Injection

DRUG

Galcanezumab

Solution for SC Injection

Timeline

From registration to results.

  1. First posted

    Mar 17, 2022

  2. Study start

    Mar 4, 2022

  3. Primary completion

    Feb 17, 2023

  4. Study completion

    Apr 14, 2023

  5. Results posted

    May 29, 2024

  6. Registry updated

    May 29, 2024

Outcomes

What the study measures.

Primary outcomes

Change From Baseline in Patient-informed Most Bothersome Symptom (PI-MBS) Score at Week 24

Time frame · Baseline, Week 24

Participants select the symptom that they find most impairs them at the time of reporting and rate the severity of that symptom on a 7-point scale (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse) where a high score indicated worsening. Score ranges from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status. The MBS areas included: nausea, vomiting, sensitivity to light, sensitivity to sound, mental cloudiness, fatigue, pain with activity, mood changes, and other symptoms.

Number of "Good Days" From Baseline

Time frame · Up to Week 24

The participants report the number of "good days" and "bad days" they had in the previous week on a weekly basis using the good day/bad day scale.

Change From Baseline in Quality of Life (QOL) as Measured by the 5 Level Euro Quality of Life 5 Dimensional Questionnaire (EQ-5D-5L) Score at Week 24

Time frame · Baseline, Week 24

The EQ-5D-5L is a participant-reported assessment designed to measure the participant's well-being. It consists of 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a visual analog scale (VAS) of the overall health state. Each descriptive item is rated on a 5-point index ranging from 1 (no problems) to 5 (extreme problems). The VAS ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).

Health Care Resources Utilization (HCRU): Number of Participants Who Used Health Services and Medications

Time frame · Up to Week 24

QOL as Measured by the 6 Item Headache Impact Test (HIT-6) Score

Time frame · Up to Week 24

The HIT-6 (version 1.0) is a Likert-type, self-reporting questionnaire designed to assess the impact of an occurring headache and its effect on the ability to function normally in daily life. The HIT-6 contains 6 questions, each item is rated from never to always with the following response scores: never = 6, rarely = 8, sometimes = 10, very often = 11, and always = 13. The total score for the HIT-6 is the sum of each response score ranging from 36 to 78. The life impact derived from the total score is described as follows: severe (≥60), substantial (56-59), some (50-55), little to none (≤49).

QOL as Measured by the Migraine Disability Assessment (MIDAS) Total Score

Time frame · Up to Week 24

The Midas score is a participant completed 5-item questionnaire about lost time and productivity (for work, school or family/social activities) in the past 3 months (number of days missed) where: 0-5=Little or No disability, 6-10=Mild disability, 11-20=Moderate disability or 21+ Severe disability.

Participant Satisfaction Score as Measured by the Treatment Satisfaction Questionnaire for Medication (TSQM)

Time frame · Week 24

The TSQM assesses four domains of participants' satisfaction with treatment, with scale ranges from 0 (extremely dissatisfied) to 100 (not at all dissatisfied) for each of the categories (Effectiveness, Side Effects, Convenience, and Overall Satisfaction).

Percentage of Participants That Switch From the Preventive Medication They Are Randomized to at Baseline to Another Preventive Medication

Time frame · Week 24

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: * Have a diagnosis of migraine per International Headache Society (IHS) International Classification of Headache Disorder (ICHD)-3 guidelines at least 12 months prior to screening. * Have a history of ≥ 8 migraine days/month in 2 of the previous 3 months as confirmed by the treating physician through medical records. * Be able to understand the clinical description of treatment options and have the capability to participate fully in making their treatment preferences known. * Be willing to accept randomization to any of the possible study medications if allocated to that treatment arm. * Be willing and capable of completing daily reports and other participant reported outcome measures using a smartphone-based application. Exclusion Criteria: * The participant has a history of severe drug allergy or hypersensitivity, or known hypersensitivity or intolerance to either eptinezumab, erenumab, fremanezumab, galcanezumab or their excipients. * The participant has previous history of use of any of the study drugs (for example, eptinezumab, Botox, erenumab, fremanezumab or galcanezumab). Note that only previous Botox use for treatment of migraine is exclusionary. Prior use of Botox for cosmetic purposes is allowed. * The participant has a diagnosis of CM and has hypersensitivity to botulinum toxin preparation or to any of the components in the formulation. * The participant has used opioids or butalbital-containing products greater than 4 days per month in the last month. Other inclusion and exclusion criteria may apply.

Study locations

10 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Gilbert Neurology Partners/ CCT Research

Gilbert, Arizona, United States

Ki Clinical Research LLC, dba New England Institute for Clinical Research

Stamford, Connecticut, United States

Innovation Medical Group

Palmetto Bay, Florida, United States

The Headache Center

Ridgeland, Mississippi, United States

StudyMetrix Research

City of Saint Peters, Missouri, United States

North Kansas City Hospital

North Kansas City, Missouri, United States

Dent Neurologic Institute - Amherst

Amherst, New York, United States

Carolina Women's Research and Wellness Center

Durham, North Carolina, United States

AIM Trials, LLC

Plano, Texas, United States

Olympus Family Medicine/CCT Research

Salt Lake City, Utah, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

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Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.