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Building an SSPE registry, and the route through regulation

The one deliverable that needs no drug, no device and no new science — and what Pakistani law actually requires.

Updated 8 November 2026 Draft · awaiting Dr. Sana's medical review
A reading of the published literature, not a clinical guideline. Every claim below is sourced, and each source is marked with how it was actually obtained — a claim resting on an abstract alone says so. Treatment decisions belong to the clinician in front of the patient.

Why a registry comes first

Pakistan has what this field lacks: patients. One Peshawar clinic reported 90 confirmed cases in the year to September 2026 11Gavi VaccinesWork, 15 Oct 2026 (Dr Khalili, private facility, Peshawar)secondary, against an international registry that captured nine patients across four countries in three years 22Öncel I, Kravljanac R, Jaxybayeva A, Bakhtadze S, Wilmshurst J, Wirrell E, Anlar B, ICNC e-poster 624full text, and a Japanese national cohort of 37 survivors with no new case identified since 2017 33Okabe et al. 2024, Pediatr Infect Dis J, 2022 Japan nationwide SSPE survey, PMID 38134374abstract only.

A registry needs no investigational product, no device and no new science. It is the one piece of this work that can begin immediately, and a published call for exactly such a global registry appeared in 2026 44Gilboa 2026, published call for a global SSPE registry, PMID 42791058abstract only.

What to record

Use an established electronic data-capture platform with a three-tier common data set.

  • Tier 1 — identity and setting. Demographics including district, province, migration status and family clustering.
  • Tier 2 — the measles history. Age at infection, vaccination doses verified against immunisation records rather than parent report, latency to onset, stage at presentation, spinal-fluid measles antibody with antibody index, EEG and MRI pattern.
  • Tier 3 — every three months. Stage plus a functional score, standardised myoclonus frequency, every treatment with dose, route, device and dates, adverse events, feeding tube, tracheostomy, ventilation, cost borne by the family, and death with cause.

Bank spinal fluid and serum for genotyping where possible.

Fix the measurement problem at the outset

No SSPE study anywhere reports jerk frequency in a standardised way, and no validated continuous outcome scale for this disease exists: four instruments are in use and none has published reliability, responsiveness or a minimal important difference 55Campbell C, Levin S, Humphreys P, Walop W, Brannan R. BMC Pediatr 2005;5:47, Table 3full text.

Two corrections matter here. The Neurological Disability Index is not unobtainable, as earlier drafts of this work stated — all twenty items are reproduced in a 2005 review, which itself calls the index poorly described and complicated to apply 5, though the 1982 paper usually cited as its primary description is a treatment comparison that does not describe the instrument at all 66DuRant RH, Dyken PR, Swift AV 1982, J Pediatr 101:288-293 (NDI primary description)abstract only. And Hacettepe has two distinct instruments that are routinely conflated; the one worth requesting is the unnamed SSPE Scoring System, because it is the secondary endpoint of the field's only modern placebo-controlled trial 77Oncel I et al. 2020, aprepitant double-blind placebo-controlled SSPE trial, PMID 32718528full text yet appears in none of that trial's references, so it may have no traceable primary description.

Work on rating scales in comparable rare neurological disease shows what a properly developed instrument requires 88Leidy L, et al. 2025, J Patient Rep Outcomes 9:49, PMID 40327161 (MRC Prion Disease Rating Scale, TAPCJD)full text. Choosing one before enrolment starts is cheaper than discovering afterwards that nothing can be compared.

Partners, chosen for feasibility rather than prestige

Fukushima delivered intraventricular ribavirin as research treatment under its own ethics-board approval and patient consent, titrating against measured spinal-fluid levels and moving to an implanted pump 99Hashimoto K & Hosoya M 2021, SSPE treatment review (Fukushima Medical University), PMC7830519full text — the natural advisers on drug-level monitoring and pump delivery. Their published work records no standing consultation service, so the approach must be direct correspondence, not entry into an existing pathway.

Hacettepe offers registry design, outcome instruments and the only randomised-trial experience 7. A neutral international host already runs comparable rare-disease registry infrastructure 1010NIH NCATS Rare Diseases Registry Program (RaDaR), resource entry p=171record, and routing through one resolves the obstacle that Pakistan does not recognise the country the 2026 registry call came from.

Domestically the nodes exist: the national child-neurology group, the provincial paediatric association, the major Peshawar, Karachi and Lahore hospitals, and a parent-founded foundation with more than 100 patients 1111Gavi VaccinesWork, 28 October 2026secondary — a ready recruitment channel, though formal written consent must replace informal data sharing first.

The regulatory route, stated plainly

An observational registry with no investigational product should require only institutional ethics approval at each site, with National Bioethics Committee review advisable for a national study.

A diet, interferon or ribavirin intervention protocol counts as a clinical trial under the Bio-Study Rules 2017 1212Bio-Study Rules 2017, Drug Regulatory Authority of Pakistanrecord and DRAP's guidelines on clinical research 1313DRAP, Guidelines to Conduct of Clinical Research on Therapeutic Goods in Pakistan, 3rd Edition, July 2025record, requiring NBC approval plus DRAP Clinical Studies Committee approval and site licensing.

Access to unregistered medicines has its own route: personal import on a registered practitioner's prescription with DRAP permission, or hospital import under SRO 134(I)/2021 and the lifesaving-drug exemption notified on 1 August 2025 as SRO 1400(I)/2025, which runs five years with effect from 22 January 2025 1414Profit / Pakistan Today, 8 August 2025full text.

Register it, and report it

Seven SSPE studies are registered worldwide. None of the three landmark studies in the disease is registered anywhere, and no registered SSPE study has ever reported results. Pre-registration with a deposited analysis plan is therefore the cheapest single thing that would distinguish this from everything that came before it.

Publication bias in this literature is not a theoretical concern. A documented correspondence exchange shows how contested even the imaging findings have been 1515AJNR Am J Neuroradiol 2009;30(7):e99, correspondence exchange on NDI scoringfull text.

Sources

  1. 1.Gavi VaccinesWork, 15 Oct 2026 (Dr Khalili, private facility, Peshawar)secondary
    www.gavi.org/vaccineswork/doctors-say-rare-fatal-measles-linked-condition-rising-pakistan
  2. 2.Öncel I, Kravljanac R, Jaxybayeva A, Bakhtadze S, Wilmshurst J, Wirrell E, Anlar B, ICNC e-poster 624full text
    icnapedia.org/eposters/624
  3. 3.Okabe et al. 2024, Pediatr Infect Dis J, 2022 Japan nationwide SSPE survey, PMID 38134374abstract only
    pubmed.ncbi.nlm.nih.gov/38134374
  4. 4.Gilboa 2026, published call for a global SSPE registry, PMID 42791058abstract only
    pubmed.ncbi.nlm.nih.gov/42791058
  5. 5.Campbell C, Levin S, Humphreys P, Walop W, Brannan R. BMC Pediatr 2005;5:47, Table 3full text
    pmc.ncbi.nlm.nih.gov/articles/PMC1343569
  6. 6.DuRant RH, Dyken PR, Swift AV 1982, J Pediatr 101:288-293 (NDI primary description)abstract only
    doi.org/10.1016/s0022-3476(82)80143-1
  7. 7.Oncel I et al. 2020, aprepitant double-blind placebo-controlled SSPE trial, PMID 32718528full text
    openaccess.marmara.edu.tr/entities/publication/b0fd569e-9852-408d-bfe5-daeee2fa6c90/full
  8. 8.Leidy L, et al. 2025, J Patient Rep Outcomes 9:49, PMID 40327161 (MRC Prion Disease Rating Scale, TAPCJD)full text
    www.ncbi.nlm.nih.gov/pmc/articles/PMC12055732
  9. 9.Hashimoto K & Hosoya M 2021, SSPE treatment review (Fukushima Medical University), PMC7830519full text
    pmc.ncbi.nlm.nih.gov/articles/PMC7830519
  10. 10.NIH NCATS Rare Diseases Registry Program (RaDaR), resource entry p=171record
    registries.ncats.nih.gov/?p=171
  11. 11.Gavi VaccinesWork, 28 October 2026secondary
    www.gavi.org/vaccineswork/pakistani-parents-children-deadly-measles-linked-brain-disease-find-mutual-support
  12. 12.Bio-Study Rules 2017, Drug Regulatory Authority of Pakistanrecord
    www.dra.gov.pk/wp-content/uploads/2022/02/BiostudyRules2017-4.pdf
  13. 13.DRAP, Guidelines to Conduct of Clinical Research on Therapeutic Goods in Pakistan, 3rd Edition, July 2025record
    www.dra.gov.pk/wp-content/uploads/2025/07/Guidelines-to-Conduct-of-Clinical-Research-on-Therapeutic-Goods-in-Pakistan-3rd-Edition.pdf
  14. 14.Profit / Pakistan Today, 8 August 2025full text
    profit.pakistantoday.com.pk/2025/08/08/government-approves-exemption-for-import-of-unregistered-lifesaving-drugs-for-hospitals
  15. 15.AJNR Am J Neuroradiol 2009;30(7):e99, correspondence exchange on NDI scoringfull text
    www.ajnr.org/content/ajnr/30/7/e99.full-text.pdf