Evidence map›Paper›PMID 32944843›Full record

Trial reportQuality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation2021

Functional impairment and disability among patients with migraine: evaluation of galcanezumab in a long-term, open-label study.

Janet H Ford, Virginia L Stauffer, Peter McAllister, Sreelatha Akkala, Matthew Sexson, David W Ayer, Shufang Wang

Erratum issuedOpen access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
0.8field-weighted citation impact, top 29% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 3 institutions in 2 countries.

Janet H FordEli Lilly and Company, 893 S. Delaware Street, Indianapolis, IN, 46225, USA. ford_janet@lilly.com.
Virginia L StaufferEli Lilly and Company, 893 S. Delaware Street, Indianapolis, IN, 46225, USA.
Peter McAllisterNew England Institute for Neurology and Headache, Stamford, USA.
Sreelatha AkkalaEli Lilly Services India Pvt Ltd, Bengaluru, India.
Matthew SexsonEli Lilly and Company, 893 S. Delaware Street, Indianapolis, IN, 46225, USA.
David W AyerEli Lilly and Company, 893 S. Delaware Street, Indianapolis, IN, 46225, USA.
Shufang WangEli Lilly and Company, 893 S. Delaware Street, Indianapolis, IN, 46225, USA.
Eli Lilly (United States) · USEli Lilly (India) · INNew England Institute for Neurology and Headache · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeMigraine can negatively impact patient functioning and quality of life. Here, we report the effects of galcanezumab (GMB), a humanized monoclonal antibody that binds to calcitonin gene-related peptide, on patient-reported outcome (PRO) measures in migraine.

methodsCGAJ was a Phase III, randomized, open-label study (12-month open-label and 4-month post-treatment follow-up) in patients with episodic or chronic migraine. Patients aged 18-65 years with diagnosis of migraine (≥ 4 migraine headache days per month) as defined by International Classification of Headache Disorders (ICHD)-3 beta guidelines were included in the study. Patients were randomized 1:1 with subcutaneous GMB 120 mg (with a loading dose of 240 mg) or GMB 240 mg given once monthly for 12 months. Changes from baseline in PRO measures such as Migraine-Specific Quality of Life Questionnaire v2.1 (MSQ) and Migraine Disability Assessment (MIDAS) were assessed.

resultsA total of 135 patients were randomized to each galcanezumab dose group. Mean (SD) baseline MSQ total scores were 53.85 (20.34) [GMB 120 mg] and 53.69 (18.79) [GMB 240 mg]. For MIDAS, mean (SD) total scores were 45.77 (42.06) [GMB 120 mg] and 53.96 (61.24) [GMB 240 mg]. Within-group mean improvement from baseline on MSQ and MIDAS total scores and all individual item/domain scores were statistically significant for both GMB dose groups, at all-time points during the treatment phase (p < 0.001). For MSQ domain scores, greatest improvement was observed in the Role function-restrictive (RF-R) domain (overall least squares (LS) mean change ± SE: 31.55 ± 1.20 [GMB 120 mg] and 33.40 ± 1.16 [GMB 240 mg]). For MIDAS, the overall LS mean change ± SE from baseline across the entire 12-month treatment phase in total scores were: -33.58 ± 2.11 (GMB 120 mg) and -32.67 ± 2.04 (GMB 240 mg).

conclusionGalcanezumab was associated with statistically significant changes from baseline in the PRO measures across the entire 12-month treatment period. These results indicate improved health-related quality of life and decreased disability among patients treated with galcanezumab.

Indexed as

AdolescentAdultAgedAntibodies, Monoclonal, HumanizedFemaleHumansMaleMiddle AgedMigraine DisordersQuality of LifeTreatment OutcomeYoung AdultAntibodies, Monoclonal, HumanizedgalcanezumabGalcanezumabMigraineMigraine disability assessmentMigraine-specific quality of lifeOpen-label studyPatient reported outcomes

Identifiers

PMID32944843
PMCPMC7886775
OpenAlexW3086531653

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.