ArticleNeurology. Clinical practice2025
Characterizing Prodrome (Premonitory Phase) in Migraine: Results From the PRODROME Trial Screening Period.
Article in Neurology. Clinical practice, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04492020 (A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine When Administered During the Prodrome), which is not on this map. Cited by 14 papers, 1 of them a synthesis that pooled it.
What it found
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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.
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.
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine When Administered During the Prodrome
Who cites it
14 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Unravelling the gut-brain connection: a systematic review of migraine and the gut microbiome.The journal of headache and pain · 2025Pooled it
- Review
- Dopaminergic Dysregulation in Migraine: From Hypothalamic A11 Dysfunction to a Systemic Biobehavioral Phenotype.International journal of molecular sciences · 2026Review
- Spectral Composition of Ambient White Light Modulates Photophobia and Headache Intensity During Migraine Attacks.Neurology and therapy · 2026Article
- From bench to bedside: relevant animal models across the migraine attack phases.The journal of headache and pain · 2026Review
- Sleep and Headache Disorders: What a Clinician Needs to Know.Current neurology and neuroscience reports · 2026Review
- Triggers, prodrome, aura, and headache interactions in migraine with typical aura: a prospective deep-phenotyping study.The journal of headache and pain · 2026Observational
- Premonitory phase in primary headaches: shared and divergent mechanisms in migraine and cluster headache, the Junior Editorial Board Members' vision.The journal of headache and pain · 2026Review
- Situational Prevention of Migraine Attacks: Can Early Treatment Change the Conversation?Drugs · 2025Review
- Characterizing the patient experience during the prodrome phase of migraine: A qualitative study of symptoms and their timing.Headache · 2025Article
- Physical activity as a predictor of fremanezumab response in chronic migraine - the Phy-Fre-Mig study.The journal of headache and pain · 2025Observational
- Analysis of free-living daytime movement in patients with migraine with access to acute treatment.The journal of headache and pain · 2025Observational
- Machine Learning and Wearable Technology: Monitoring Changes in Biomedical Signal Patterns during Pre-Migraine Nights.Healthcare (Basel, Switzerland) · 2024Article
- Acute Treatment of Migraine: Expert Consensus Statements from the United Arab Emirates (UAE).Neurology and therapy · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background and Objective: Limited data are available describing the frequency, severity, and consistency of prodromal symptoms followed by headache. This analysis of the PRODROME trial screening period characterized prodromal symptoms in people with migraine, including the most common symptoms and their severity, and the frequency and consistency with which prodromal symptoms were followed by headache. Methods: PRODROME was a multicenter, randomized, double-blind, placebo-controlled, crossover trial conducted in the United States that enrolled adults with 2-8 migraine attacks per month who stated they could identify prodromal symptoms that were reliably followed by a headache. The trial included a 60-day screening period designed to test the predictive validity of "qualifying prodrome events" before the onset of headache. Participants used an eDiary to report qualifying prodrome events, defined as prodromal symptoms whereby the participant was confident a headache would follow within 1-6 hours. This analysis evaluated common prodromal symptoms and their severity, time from prodrome onset to headache onset, and the percentage of participants who identified prodromal symptoms that were followed by a headache ≥75% of the time over the 60-day screening period. Results: A total of 920 participants entered eDiary data, with a mean of 5.2 qualifying prodrome events during the 60-day screening period. A total of 4,802 qualifying prodrome events were recorded. The most common prodromal symptoms identified were sensitivity to light (57.2%; 2,748/4,802), fatigue (50.1%; 2,408/4,802), neck pain (41.9%; 2,013/4,802), sensitivity to sound (33.9%; 1,630/4,802), either difficulty thinking or concentrating (30.0%; 1,442/4,802), and dizziness (27.8%; 1,333/4,802). Of all qualifying prodrome events reported, 81.5% (3,913/4,802) were followed by headache of any intensity within 1-6 hours. For each participant, a mean of 84.4% of their qualifying prodrome events were followed by a headache within 1-6 hours, with 76.9% of participants identifying qualifying prodrome events that were followed by headache within 1-6 hours ≥75% of the time. Discussion: Participants were able to identify migraine attacks in which prodromal symptoms were reliably followed by a headache within 1-6 hours. These findings suggest the potential for initiating treatment during the prodrome to prevent headache. Trial Registration Information: ClinicalTrials.gov NCT04492020. Submitted: July 27, 2020; First patient enrolled: August 21, 2020. clinicaltrials.gov/study/NCT04492020.
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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.