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Condition (MeSH)

Headache Disorders, Primary

ClinicalTrials.gov lists 1,741 trials for Headache Disorders, Primary or a narrower condition beneath it. Pfizer has the most among industry and government lead sponsors, with 42.

MeSH D051270 Nervous System Diseases C10 Listed by Orphanet as a rare disease
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Phase 1 Phase 1 101 Phase 1/2 Phase 1/2 16 Phase 2 Phase 2 156 Phase 2/3 Phase 2/3 27 Phase 3 Phase 3 245 Phase 4 Phase 4 172 Not applicable Not applicable 662 Observational Observational 359 Phase 1 Phase 1 101 Phase 1/2 Phase 1/2 16 Phase 2 Phase 2 156 Phase 2/3 Phase 2/3 27 Phase 3 Phase 3 245 Phase 4 Phase 4 172 Not applicable Not applicable 662 Observational Observational 359

Trials per phase (log scale)

1 more section with rows

42 of the 1,741 trials are tagged with Headache Disorders, Primary itself; the rest are tagged with a narrower condition beneath it.

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The PDF carries up to 50 rows of each section, where the page shows the first few, with the sources listed. Enter a work email and confirm it from the message we send, and the report follows by email.

When did Headache Disorders, Primary trials start? (31)

Shown in this order: most recent first, 1990 onwards. 2026 is partial: trials registered with a 2026 start date so far, not a full year. 6 trials are registered to start in 2027 or later, and not listed here.

Trials over time, by phase

  • Phase 1
  • Phase 1/2
  • Phase 2
  • Phase 2/3
  • Phase 3
  • Phase 4
  • Not applicable
  • Observational

Top of scale: 119

1994: 1 trials (Phase 1 1) 1995: 5 trials (Phase 3 5) 1998: 2 trials (Phase 3 2) 1999: 3 trials (Not applicable 2, Phase 2 1) 2000: 4 trials (Observational 2, Phase 3 2) 2001: 8 trials (Observational 2, Phase 4 1, Phase 3 4, Phase 2/3 1) 2002: 8 trials (Not applicable 3, Phase 4 1, Phase 3 2, Phase 2 2) 2003: 21 trials (Not applicable 4, Phase 4 2, Phase 3 10, Phase 2 4, Phase 1 1) 2004: 34 trials (Observational 3, Not applicable 5, Phase 4 8, Phase 3 12, Phase 2/3 1, Phase 2 3, Phase 1/2 1, Phase 1 1) 2005: 28 trials (Observational 3, Not applicable 2, Phase 4 5, Phase 3 10, Phase 2 7, Phase 1 1) 2006: 58 trials (Observational 7, Not applicable 16, Phase 4 7, Phase 3 15, Phase 2/3 1, Phase 2 10, Phase 1/2 1, Phase 1 1) 2007: 43 trials (Observational 4, Not applicable 12, Phase 4 3, Phase 3 10, Phase 2 9, Phase 1 5) 2008: 49 trials (Observational 7, Not applicable 7, Phase 4 5, Phase 3 6, Phase 2/3 2, Phase 2 11, Phase 1 11) 2009: 54 trials (Observational 12, Not applicable 9, Phase 4 9, Phase 3 9, Phase 2/3 2, Phase 2 10, Phase 1/2 1, Phase 1 2) 2010: 40 trials (Observational 6, Not applicable 12, Phase 4 9, Phase 3 5, Phase 2/3 2, Phase 2 3, Phase 1/2 1, Phase 1 2) 2011: 41 trials (Observational 9, Not applicable 18, Phase 4 4, Phase 3 3, Phase 2 2, Phase 1/2 1, Phase 1 4) 2012: 62 trials (Observational 11, Not applicable 23, Phase 4 4, Phase 3 9, Phase 2/3 2, Phase 2 8, Phase 1 5) 2013: 36 trials (Observational 3, Not applicable 18, Phase 4 5, Phase 3 2, Phase 2 3, Phase 1/2 1, Phase 1 4) 2014: 53 trials (Observational 8, Not applicable 20, Phase 4 10, Phase 3 1, Phase 2/3 1, Phase 2 6, Phase 1/2 1, Phase 1 6) 2015: 76 trials (Observational 15, Not applicable 33, Phase 4 6, Phase 3 12, Phase 2/3 1, Phase 2 3, Phase 1/2 1, Phase 1 5) 2016: 85 trials (Observational 11, Not applicable 31, Phase 4 10, Phase 3 15, Phase 2/3 2, Phase 2 7, Phase 1/2 2, Phase 1 7) 2017: 92 trials (Observational 9, Not applicable 40, Phase 4 4, Phase 3 12, Phase 2/3 5, Phase 2 12, Phase 1/2 2, Phase 1 8) 2018: 71 trials (Observational 17, Not applicable 30, Phase 4 4, Phase 3 7, Phase 2/3 1, Phase 2 6, Phase 1 6) 2019: 93 trials (Observational 17, Not applicable 31, Phase 4 13, Phase 3 17, Phase 2/3 2, Phase 2 6, Phase 1/2 1, Phase 1 6) 2020: 90 trials (Observational 18, Not applicable 35, Phase 4 13, Phase 3 14, Phase 2/3 1, Phase 2 5, Phase 1/2 1, Phase 1 3) 2021: 109 trials (Observational 24, Not applicable 49, Phase 4 7, Phase 3 14, Phase 2/3 1, Phase 2 9, Phase 1 5) 2022: 105 trials (Observational 26, Not applicable 41, Phase 4 14, Phase 3 18, Phase 2 4, Phase 1 2) 2023: 119 trials (Observational 39, Not applicable 55, Phase 4 6, Phase 3 9, Phase 2 3, Phase 1 7) 2024: 117 trials (Observational 48, Not applicable 45, Phase 4 8, Phase 3 6, Phase 2 7, Phase 1/2 1, Phase 1 2) 2025: 113 trials (Observational 26, Not applicable 61, Phase 4 7, Phase 3 8, Phase 2/3 1, Phase 2 6, Phase 1 4)

Trials registered with a start date in each year, 1990 onward, stacked by phase (complete years only; the current partial year is in the table's notes). The table below lists the same counts, most recent years first.

Trials started per year
Year Trials started
2026 (partial year) 109
2025 113
2024 117
2023 119
2022 105
2021 109
2020 90
2019 93
2018 71
2017 92

Showing 10 of 31 earlier years.

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Forecast of the full-year count, planned starts included, not rows of this table: about 120 trials starting in 2026 and about 120 in 2027, the average of the 24 months through September, counted as registered and carried forward. The rows of this table count trials registered so far with a start date in the year, planned starts included; the forecast looks ahead to the count for the whole year, so it is not the same measure. In backtests on conditions of this size, forecasts made part-way through the year were typically off by about 13 percent and ran about 12 percent low against the count later registered; forecasts made before the year began were off by about 19 percent and ran about 17 percent low against the count later registered, and had about the same error as repeating last year's count. These figures rest on a few years of history (target years from 2018 to 2025, varying by figure), place each condition as it is mapped today rather than as it was then, and score against a count for the newest year that was still being revised. Only condition series were scored.

Prediction, not a registry value: median of 36 months from start to primary completion across 135 trials still running at the 2026-10-09 snapshot; registered median of 16 months across 1,114 trials with a primary completion typed Actual. Source: ClinicalTrials.gov / AACT (CTTI), public domain.

What phase are Headache Disorders, Primary trials in? (9)

Shown in this order: phase order.

Show the trials by phase as a table
Trials by phase
Phase Trials
Phase 1 101
Phase 1/2 16
Phase 2 156
Phase 2/3 27
Phase 3 245
Phase 4 172
Not applicable 662
Observational 359
Expanded access 3

How many Headache Disorders, Primary trials are recruiting? (11)

Shown in this order: the order a trial moves through, from not yet recruiting to unknown.

Trials by recruitment status
Status Trials
Not yet recruiting 87
Recruiting 160
Enrolling by invitation 22
Active, not recruiting 39
Available 2

Showing 5 of 11 statuses.

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Status as registered on ClinicalTrials.gov. Each trial is counted once.

Which lead sponsors run the most Headache Disorders, Primary trials? (10)

Shown in this order: most trials first. Lead sponsors the registry classes as industry, NIH, US federal, other government or network. A hospital or university the registry files as government can appear here. Sponsors it classes as academic or other are shown on the full page, because that class cannot separate an institution from a named investigator.

Lead sponsors
Sponsor Trials
Pfizer 42
Eli Lilly and Company 33
GlaxoSmithKline 30
Allergan 25
Amgen 22

Showing 5 of 10 sponsors.

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Which drugs are being tested for Headache Disorders, Primary? (7)

Shown in this order: most trials first. One row per drug, matched to a single molecule under all its names, ranked by number of trials.

Drugs tested
Drug Trials
Eptinezumab 25
Galcanezumab 23
Fremanezumab 22
Atogepant 19
Amitriptyline 14

Showing 5 of 7 drugs.

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Interventions as named in the registry (8)

Shown in this order: most trials first.

Interventions as named in the registry
Drug Trials
Topiramate IR 47
Sumatriptan 5% 42
Erenumab PFS 40
Rimegepant/BHV3000 37
type A botulinum toxin 29

Showing 5 of 8 interventions.

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These are the names sponsors entered on ClinicalTrials.gov that we have not matched to a single molecule. Some are drugs under a brand or code name; others are procedures, doses or arm labels.

Which serious adverse events do Headache Disorders, Primary trials report? (10)

Shown in this order: most subjects affected first. Subjects affected summed across trials, a cross-trial signal, not a rate.

Serious adverse events in this condition's trials
Adverse event Subjects affected Trials
Migraine 110 47
Appendicitis 56 38
Pneumonia 46 34
Abortion spontaneous 35 23
Depression 32 21

Showing 5 of 10 adverse events.

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Which publications cover Headache Disorders, Primary? (45)

Shown in this order: major-topic papers first, then newest, then most linked to trials.

Publications
Publication Journal Year Major topic
Single-centre, randomised and double-blind clinical trial on the efficacy of transcutaneous auricular vagus nerve stimulation in preventing and treating primary headache in children and adolescents: a study protocol. BMJ open 2025 Yes
Earmuff and eye mask in the treatment of acute primary headache in emergency department: a randomized controlled open label study. BMC emergency medicine 2025 Yes
Primary headache disorders in adolescents in North- and South-Tyrol: Findings of the EVA-Tyrol-Study. Cephalalgia : an international journal of headache 2022 Yes
Comorbidities of primary headache disorders: a literature review with meta-analysis. The journal of headache and pain 2021 Yes
Neurostimulation methods in the treatment of chronic pain. Journal of neural transmission (Vienna, Austria : 1996) 2020 Yes

Showing 5 of 45 publications.

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Prevalence (1)

Shown in this order: jurisdiction, then disease name. Orphanet observation for the mapped ORPHA concept; the mapping relation column says whether that concept is exactly this condition or broader or narrower.

Prevalence
Orphanet disease Type Class Geography Jurisdiction Mapping relation
Hypnic headache Point prevalence Unknown Worldwide Not stated Unspecified

Sub-conditions in MeSH (3)

MeSH descendants one level down with at least one trial, most trials first.

Not on this page

Not measured: delivery record.

Checked, with nothing recorded for this condition: rare-disease identity.

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