Evidence map›Paper›PMID 34001002›Full record

Observational studyThe journal of headache and pain2021

Long term safety, tolerability, and efficacy of intracutaneous zolmitriptan (M207) in the acute treatment of migraine.

Stephanie J Nahas, Nada Hindiyeh, Deborah I Friedman, Nada Elbuluk, Donald J Kellerman, Pamela K Foreman, Peter Schmidt

Registry-linked trialOpen access · goldAbstract readMulticenter StudyObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in The journal of headache and pain, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03282227 (A Long-Term, Open-Label Study to Evaluate the Safety of M207), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.7field-weighted citation impact, top 17% 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.

NCT03282227 phase3completednot on this map

A Long-Term, Open-Label Study to Evaluate the Safety of M207 (Zolmitriptan Intracutaneous Microneedle System) in the Acute Treatment of Migraine

TypeinterventionalSponsorZosano Pharma CorporationRan2017 to 2019Enrolled342ConditionsMigraineArmsM207 Microneedle System
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 14 citations in OpenAlex.

  1. Review
  2. Article
  3. Review
  4. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 5 institutions in 1 country.

Stephanie J NahasDepartment of Neurology, Jefferson Headache Center, Thomas Jefferson University, Philadelphia, PA, USA.
Nada HindiyehDepartment of Neurology, Stanford University Medical Center, Stanford, CA, USA.
Deborah I FriedmanUniversity of Texas Southwestern Medical Center, Dallas, TX, USA.
Nada ElbulukUniversity of Southern California, Keck School of Medicine, Los Angeles, CA, USA.
Donald J KellermanZosano Pharmaceuticals, Fremont, CA, USA. Dkellerman@zosanopharma.com.ORCID http://orcid.org/0000-0002-0789-5877
Pamela K ForemanZosano Pharmaceuticals, Fremont, CA, USA.
Peter SchmidtZosano Pharmaceuticals, Fremont, CA, USA.
Stanford Medicine · USThe University of Texas Southwestern Medical Center · USThomas Jefferson University · USUniversity of Southern California · USZoo Atlanta · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo determine the long-term safety and tolerability profile of M207 in the acute treatment of migraine.

backgroundM207 is an investigational microneedle-based system for intracutaneous delivery of zolmitriptan for the treatment of migraine attacks. Following on the positive results of a Phase 2/3 placebo-controlled efficacy study (ZOTRIP), this study was designed to evaluate the safety of this novel product during repeated use for the treatment of migraine attacks.

methodsIn this 6-12 month open-label, multicenter observational study, participants used an eDiary to record headache symptoms and adverse events at specified intervals up to 48 h following treatment of a qualifying attack with M207 3.8 mg (intracutaneous zolmitriptan). Participants underwent clinical evaluations at specified intervals up to 12 months.

resultsAmong 335 participants who treated ≥1 migraine attack, 257 completed 6 months and 127 completed 1 year of treatment. The most common reason for withdrawal from the study was a low frequency of reported attacks post randomization. Overall, 5963 migraine attacks were treated. Most participants (96%) experienced at least 1 adverse event, the vast majority of which concerned the application site, and > 95% of which were mild. Fifteen participants (4%) withdrew due to adverse events; 4 withdrew due to 7 application site reactions, 6 of which were mild. Participants achieved pain freedom in 2477/5617 (44%) of attacks, most bothersome symptom freedom in 3315/5330 (62%) of attacks, and pain relief 2 h post-dose in 4552/5617 (81%) of attacks. Sustained pain freedom 2-24 h was seen in 1761/4698 (38%) of attacks, and 2-48 h in 1534/4429 (35%) of attacks.

conclusionsThe majority of participants experienced cutaneous adverse reactions such as application site erythema, swelling, and bleeding, and most reactions were scored as mild. These results are consistent with what was observed in the single migraine attack treatment ZOTRIP trial indicating that M207 is well tolerated in the setting of longer-term repeated use. Efficacy findings were also similar to those in the ZOTRIP trial.

trial registrationClinicaltrials.gov on September 13, 2017 ( NCT03282227 ).

Indexed as

Migraine DisordersOxazolidinonesDouble-Blind MethodHumansTreatment OutcomeTryptaminesOxazolidinonesTryptamineszolmitriptanIntracutaneousM207MicroneedleMigraine

Identifiers

PMID34001002
PMCPMC8127195
OpenAlexW3163250090

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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.