Evidence map›Paper›PMID 32895855›Full record

Trial reportPharmaceutical research2020

An Innovative Pharmacometric Approach for the Simultaneous Analysis of Frequency, Duration and Severity of Migraine Events.

Alejandro Perez-Pitarch, Gopichand Gottipati, Ramana Uppoor, Mehul Mehta, Sreedharan Sabarinath

Abstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Pharmaceutical research, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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

1 citing paper in PubMed.

  1. A tutorial on pharmacometric Markov models.CPT: pharmacometrics & systems pharmacology · 2025
    Article
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

5 authors.

Alejandro Perez-PitarchDivision of Neuropsychiatric Pharmacology, Office of Clinical Pharmacology, US Food and Drug Administration, 10903 New Hampshire Avenue, White Oak Building 51, RM 2116, Silver Spring, MD, 20993, USA.
Gopichand GottipatiDivision of Neuropsychiatric Pharmacology, Office of Clinical Pharmacology, US Food and Drug Administration, 10903 New Hampshire Avenue, White Oak Building 51, RM 2116, Silver Spring, MD, 20993, USA.
Ramana UppoorDivision of Neuropsychiatric Pharmacology, Office of Clinical Pharmacology, US Food and Drug Administration, 10903 New Hampshire Avenue, White Oak Building 51, RM 2116, Silver Spring, MD, 20993, USA.
Mehul MehtaDivision of Neuropsychiatric Pharmacology, Office of Clinical Pharmacology, US Food and Drug Administration, 10903 New Hampshire Avenue, White Oak Building 51, RM 2116, Silver Spring, MD, 20993, USA.
Sreedharan SabarinathDivision of Neuropsychiatric Pharmacology, Office of Clinical Pharmacology, US Food and Drug Administration, 10903 New Hampshire Avenue, White Oak Building 51, RM 2116, Silver Spring, MD, 20993, USA. Sreedharan.Sabarinath@fda.hhs.gov.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo explore the use of a multistate repeated, time-to-categorical event model describing the frequency, severity and duration of migraines.

methodsSubject level data from patients in placebo arms from two efficacy trials for migraine-preventive treatments were used. Models were developed using NONMEM 7.3. A survival model was combined with an ordered categorical model to form the repeated-time-to-start of categorical migraine event model, which simultaneously described the time-to-start of migraines and the severity of the starting migraine event. This was linked to a repeated-time-to-end of migraine event model with different hazard functions depending on the severity of the ongoing migraine event. Model performance was internally and externally qualified.

resultsThe successfully qualified model showed that patients responding to placebo had a reduction in migraine incidence rate, and a decreased proportion of severe migraines. There was an increase in moderate migraine duration, an increased proportion of mild migraines and a reduction in proportion of severe migraines. Age was related to migraine duration.

conclusionsThe model represents an innovative framework for clinical trial modeling and simulation, and successfully describes placebo effect in migraine prevention. This approach can be adapted to investigate exposure-response relationship of drugs and can also be implemented in other therapeutic areas where the rate, duration and severity of disease episodes are relevant to trial outcomes.

Indexed as

AdolescentAdultAgedAge FactorsAlgorithmsClinical Trials as TopicDouble-Blind MethodFemaleHumansIncidenceMaleMiddle AgedMigraine DisordersModels, StatisticalResearch DesignSeverity of Illness IndexMarkov modelmigraine preventionNONMEMordered categoricalTime-to-event

Identifiers

PMID32895855

What OpenQuestion holds

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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.