5.4 Structural Future: Funding, Advocacy, and Realistic Timelines

5.4.1 The funding numbers, quantified

peer-reviewed The updated, CH-specific funding-gap audit that the earlier pass could not find does exist: Parra-Hinojosa, Percy & Gómez-Emilsson, “The heavy tail of extreme pain exacerbates health inequality: evidence from cluster headache underinvestment,” Humanities and Social Sciences Communications, November 2025 (Nature). Its central finding, independently re-verified in this research pass by querying the UKRI and NIHR APIs directly:

Funder (period searched)	Multiple sclerosis	Cluster headache
UKRI Gateway to Research (since 2006)	£137,445,421	£0
NIHR Funding & Awards (since 1996)	£62,635,273	£0
Wellcome Trust (since 2005)	£27,147,667	£0
Total	≈£227 million	£0
UK charity income, 2023	£29.95M (MS Society + MS Trust)	£29,444 (OUCH UK)

This is despite CH being more globally prevalent than MS (roughly 53/100,000 one-year prevalence for CH vs 37/100,000 for MS globally). The paper’s methodological contribution is a new metric, Days Lived with Extreme Suffering (DLES), proposed because conventional DALY accounting flattens CH’s “heavy tail” of extreme but short-duration pain — CH patients rate their pain a mean 9.7/10 (72% rate it a full 10/10), higher than labour pain, kidney stones, gunshot wounds, or migraine. Globally, CH accounts for an estimated 3.13 million person-days per year at ≥9/10 pain intensity.

peer-reviewed At the US federal level, there is still no official NIH accounting category for cluster headache specifically — NIH’s own categorisation system tracks “Headaches” and “Migraine” but not CH. Reconstructing from grant-level data via NIH RePORTER, this research pass found exactly two CH-specific NIH grants active in FY2022–2026, both to the same two investigators (Burish and Yoo) at the same institution (UTHealth Houston):

Grant	Focus	Awarded to date	Full period value
R01NS136677	Trigeminal ganglion clock and headache pain	$1,422,467 (FY24–26)	~$2.4M over 5 years
R61NS144491	Multi-modal mouse model of CH	$392,223 (FY26)	(exploratory grant)

Set against NIH’s “Headaches” funding pool ($50–59M/year FY2022–2025), this derivation puts CH at roughly 0% of NIH headache funding in FY2022–2023 and ~0.8–1.0% in FY2024–2025 — a smaller share than the ~1.8% found by a 2007-era audit, even though the absolute dollar figure has roughly doubled. (This percentage is this pass’s own derivation from two differently-constructed datasets, not an official NIH statistic, and should be read as an approximation.)

Other identified funders, for context: the EU’s only CH money is €2.5M in company innovation funding to a Dutch neuromodulation device firm (not investigator-led science); Australia’s MRFF funded the first CH trial there in over 20 years (amount undisclosed); Sweden’s dedicated CH research centre at Karolinska received roughly £23,000 in total stipend funding in its entire 2025 announcement, two-thirds of which was pharmaceutical-company-sponsored. The single largest CH-relevant funder identified anywhere is private philanthropy — the Will Erwin Headache Research Foundation’s $20 million, 10-year pledge to a Houston research centre (not CH-exclusive, but the source of the preliminary work behind the only major NIH CH grant in existence).

5.4.2 Patient advocacy: doing the work public funders are not

peer-reviewed The clearest documented case of patient advocacy directly producing a clinical trial is Australian. Haghdoost, Wold (Clusterbusters’ founder, as co-author), Schindler (Yale, as co-author) and colleagues ran an unfunded (“Study funding: None”) national patient-priorities survey, February 2024–October 2025, n=202 (Headache 2026). Top-ranked research priorities: understanding underlying causes (90% “very important”), developing more effective medications (88%), educating doctors and the public (82%). Psilocybin drew the strongest interest of any intervention (66% “very interested,” 82% combined interest; 64% of all respondents said they would join a psilocybin trial specifically). The survey’s recruitment target was explicitly set from power calculations for a future trial — and that future trial is the MRFF-funded PEACE psilocybin pilot described in §5.1.3/5.1.6. This is a clean, documented, citable chain from patient survey to funded science.

[COMMUNITY-REPORT / CITIZEN-SCIENCE] Clusterbusters (US, founded 2002 by Bob Wold) runs on roughly $180,000/year in revenue (its total assets fell 85% between 2022 and 2023, from $221,569 to $34,340, per its IRS filings — worth flagging as a possible capacity constraint on future citizen-science work). Despite this small scale, it built what it describes as the world’s largest CH patient registry, helped fill enrolment for the CGRP antibody trials that led to Emgality’s FDA approval (the first drug ever specifically approved for CH), co-authored the Australian patient-priorities paper above, and runs the DMT citizen-science survey (§5.1.3).

peer-reviewed OUCH UK — on an annual income of £29,444 — funded, designed and conducted its own comparative-effectiveness study of standard versus ultra-high-flow “demand valve” oxygen delivery, purchasing 30 demand valves independently because it could not afford more, and finding a mean time-to-abort of 36 minutes on standard oxygen versus 11 minutes on the demand valve (Cephalalgia Reports 2025). The data was collected in 2013–2014 by a charity trustee and not published until 2025 — an eleven-year lag that is itself a symptom of how under-resourced this corner of medicine is.

citizen science Germany’s patient organisation (CSG e.V.) runs no grant programme of its own but actively recruits for and disseminates German academic studies, and supports CLUE, a formally registered citizen-science project (“Clusterkopfschmerzen erforschen”) that has produced at least one peer-reviewed output on medication effectiveness in CH (J Headache Pain 2021 peer-reviewed).

The pattern across every patient organisation checked — Clusterbusters, OUCH UK, CSG e.V., Norway’s Hodepine Norge, and others — is identical: recruitment, registries, surveys, conferences and in-kind support, never grant-making. No CH patient organisation anywhere runs a competitive research-grant programme with published award amounts, and no James Lind Alliance priority-setting exercise has ever been run for CH (unlike several adjacent neurological conditions).

5.4.3 Realistic timelines — informed projection, explicitly labelled as such

What could plausibly reach patients or produce a definitive answer in 2–5 years (projection, not fact):

• BOL-148 Phase 1 top-line data (Q2 2027) and, if positive, initiation of Phase 2 in CH patients
• CandClus2 candesartan Phase 3 readouts (episodic and chronic arms)
• SUNCET oxybate and light-therapy trial readouts, giving the field its first real evidence on whether circadian/nocturnal-targeted interventions work at all
• LSD minidosing (CHIT) Phase 2 completion (targeted April 2027)
• Possible, but currently unannounced: a first PACAP-targeting drug trial specifically in CH, contingent on Lundbeck’s or another sponsor’s migraine programme succeeding and being extended

What more plausibly sits in the 10+ year horizon (projection, not fact):

• A completed, successful Phase 3 psychedelic programme for CH (BOL-148 or otherwise) reaching approval
• Any orexin-antagonist trial being initiated in CH at all — nothing currently points toward this happening on any specific timeline
• A purpose-built clock-gene-targeting compound for headache — none exists even preclinically for this indication
• Structural funding parity with comparably-prevalent conditions (a UKRI/NIHR/Wellcome-scale investment) — nothing in the current advocacy or policy landscape suggests this is imminent; the funding-gap literature itself (Parra-Hinojosa 2025) frames its own recommendations modestly, as “supporting the few advocacy groups working to raise awareness,” not as a call that any funder has signalled it will answer