NCT04466826

Brief Summary

Single-center, open-label, pre-post treatment pilot study to evaluate the safety and effectiveness of sphenopalatine ganglia blocks for the treatment of chronic migraine in the pediatric population. 50 children with a diagnosis of chronic migraines will undergo a series of three transnasal sphenopalatine ganglia blocks to measure their effect on headache frequency, headache intensity, headache duration, and use of headache medication.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2021

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 10, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

January 2, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2021

Completed
Last Updated

February 10, 2021

Status Verified

February 1, 2021

Enrollment Period

1 month

First QC Date

July 6, 2020

Last Update Submit

February 5, 2021

Conditions

Migraine in ChildrenPain, Neuropathic

Outcome Measures

Primary Outcomes (2)

  • Reduction in frequency of headache days: pre-treatment

    Weekly headache journal check in - 5 questions with y/n answers and free text entry

    Up to 4 weeks following consent

  • Reduction in frequency of headache days: post-treatment

    Weekly headache journal check in - 5 questions with y/n answers and free text entry

    Up to one year following consent

Secondary Outcomes (6)

  • Maximum headache severity: pre-treatment

    up to 4 weeks following consent

  • Maximum headache severity: post-treatment

    up to one year following consent

  • Headache duration: pre-treatment

    Up to 4 weeks following consent

  • Headache duration: post-treatment

    Up to one year following consent

  • Use of rescue medication: pre-treatment

    Up to 4 weeks following consent

  • +1 more secondary outcomes

Study Arms (1)

Minors with chronic migraines

EXPERIMENTAL
Other: Headache JournalDrug: Sphenopalatine BlockDevice: Tx360

Interventions

Headache JournalOTHER

Phase 1 of study to determine a baseline for headache frequency, headache intensity and medication usage patterns

Minors with chronic migraines
Sphenopalatine BlockDRUG

Phase 2 of study providing medication using 0.3ml of 0.5% Bupivacaine per nares delivered intranasal via the Tx360 device

Minors with chronic migraines
Tx360DEVICE

Phase 2 of study providing medication using 0.3ml of 0.5% Bupivacaine per nares delivered intranasal via the Tx360 device

Minors with chronic migraines

Eligibility Criteria

Age8 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children ages 8 to 17 years old Meet the criteria for chronic migraines Have remained stable on their current headache medication for a minimum of 4 weeks.
  • Able to provide informed consent from parent or legal guardian Able to provide assent if subject is a minor of appropriate age

You may not qualify if:

  • Allergy to local anesthetic Developmental delay (e.g. non-verbal) Inability to use numeric pain scale Inability to perform or tolerate transnasal procedure Substance abuse disorders Known pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Louis Children's Hospital

St Louis, Missouri, 63110, United States

Location

Related Publications (3)

  • Abu-Arafeh I, Razak S, Sivaraman B, Graham C. Prevalence of headache and migraine in children and adolescents: a systematic review of population-based studies. Dev Med Child Neurol. 2010 Dec;52(12):1088-97. doi: 10.1111/j.1469-8749.2010.03793.x. Epub 2010 Sep 28.

    PMID: 20875042BACKGROUND

  • Vos T, Flaxman AD, Naghavi M, Lozano R, Michaud C, Ezzati M, Shibuya K, Salomon JA, Abdalla S, Aboyans V, Abraham J, Ackerman I, Aggarwal R, Ahn SY, Ali MK, Alvarado M, Anderson HR, Anderson LM, Andrews KG, Atkinson C, Baddour LM, Bahalim AN, Barker-Collo S, Barrero LH, Bartels DH, Basanez MG, Baxter A, Bell ML, Benjamin EJ, Bennett D, Bernabe E, Bhalla K, Bhandari B, Bikbov B, Bin Abdulhak A, Birbeck G, Black JA, Blencowe H, Blore JD, Blyth F, Bolliger I, Bonaventure A, Boufous S, Bourne R, Boussinesq M, Braithwaite T, Brayne C, Bridgett L, Brooker S, Brooks P, Brugha TS, Bryan-Hancock C, Bucello C, Buchbinder R, Buckle G, Budke CM, Burch M, Burney P, Burstein R, Calabria B, Campbell B, Canter CE, Carabin H, Carapetis J, Carmona L, Cella C, Charlson F, Chen H, Cheng AT, Chou D, Chugh SS, Coffeng LE, Colan SD, Colquhoun S, Colson KE, Condon J, Connor MD, Cooper LT, Corriere M, Cortinovis M, de Vaccaro KC, Couser W, Cowie BC, Criqui MH, Cross M, Dabhadkar KC, Dahiya M, Dahodwala N, Damsere-Derry J, Danaei G, Davis A, De Leo D, Degenhardt L, Dellavalle R, Delossantos A, Denenberg J, Derrett S, Des Jarlais DC, Dharmaratne SD, Dherani M, Diaz-Torne C, Dolk H, Dorsey ER, Driscoll T, Duber H, Ebel B, Edmond K, Elbaz A, Ali SE, Erskine H, Erwin PJ, Espindola P, Ewoigbokhan SE, Farzadfar F, Feigin V, Felson DT, Ferrari A, Ferri CP, Fevre EM, Finucane MM, Flaxman S, Flood L, Foreman K, Forouzanfar MH, Fowkes FG, Franklin R, Fransen M, Freeman MK, Gabbe BJ, Gabriel SE, Gakidou E, Ganatra HA, Garcia B, Gaspari F, Gillum RF, Gmel G, Gosselin R, Grainger R, Groeger J, Guillemin F, Gunnell D, Gupta R, Haagsma J, Hagan H, Halasa YA, Hall W, Haring D, Haro JM, Harrison JE, Havmoeller R, Hay RJ, Higashi H, Hill C, Hoen B, Hoffman H, Hotez PJ, Hoy D, Huang JJ, Ibeanusi SE, Jacobsen KH, James SL, Jarvis D, Jasrasaria R, Jayaraman S, Johns N, Jonas JB, Karthikeyan G, Kassebaum N, Kawakami N, Keren A, Khoo JP, King CH, Knowlton LM, Kobusingye O, Koranteng A, Krishnamurthi R, Lalloo R, Laslett LL, Lathlean T, Leasher JL, Lee YY, Leigh J, Lim SS, Limb E, Lin JK, Lipnick M, Lipshultz SE, Liu W, Loane M, Ohno SL, Lyons R, Ma J, Mabweijano J, MacIntyre MF, Malekzadeh R, Mallinger L, Manivannan S, Marcenes W, March L, Margolis DJ, Marks GB, Marks R, Matsumori A, Matzopoulos R, Mayosi BM, McAnulty JH, McDermott MM, McGill N, McGrath J, Medina-Mora ME, Meltzer M, Mensah GA, Merriman TR, Meyer AC, Miglioli V, Miller M, Miller TR, Mitchell PB, Mocumbi AO, Moffitt TE, Mokdad AA, Monasta L, Montico M, Moradi-Lakeh M, Moran A, Morawska L, Mori R, Murdoch ME, Mwaniki MK, Naidoo K, Nair MN, Naldi L, Narayan KM, Nelson PK, Nelson RG, Nevitt MC, Newton CR, Nolte S, Norman P, Norman R, O'Donnell M, O'Hanlon S, Olives C, Omer SB, Ortblad K, Osborne R, Ozgediz D, Page A, Pahari B, Pandian JD, Rivero AP, Patten SB, Pearce N, Padilla RP, Perez-Ruiz F, Perico N, Pesudovs K, Phillips D, Phillips MR, Pierce K, Pion S, Polanczyk GV, Polinder S, Pope CA 3rd, Popova S, Porrini E, Pourmalek F, Prince M, Pullan RL, Ramaiah KD, Ranganathan D, Razavi H, Regan M, Rehm JT, Rein DB, Remuzzi G, Richardson K, Rivara FP, Roberts T, Robinson C, De Leon FR, Ronfani L, Room R, Rosenfeld LC, Rushton L, Sacco RL, Saha S, Sampson U, Sanchez-Riera L, Sanman E, Schwebel DC, Scott JG, Segui-Gomez M, Shahraz S, Shepard DS, Shin H, Shivakoti R, Singh D, Singh GM, Singh JA, Singleton J, Sleet DA, Sliwa K, Smith E, Smith JL, Stapelberg NJ, Steer A, Steiner T, Stolk WA, Stovner LJ, Sudfeld C, Syed S, Tamburlini G, Tavakkoli M, Taylor HR, Taylor JA, Taylor WJ, Thomas B, Thomson WM, Thurston GD, Tleyjeh IM, Tonelli M, Towbin JA, Truelsen T, Tsilimbaris MK, Ubeda C, Undurraga EA, van der Werf MJ, van Os J, Vavilala MS, Venketasubramanian N, Wang M, Wang W, Watt K, Weatherall DJ, Weinstock MA, Weintraub R, Weisskopf MG, Weissman MM, White RA, Whiteford H, Wiersma ST, Wilkinson JD, Williams HC, Williams SR, Witt E, Wolfe F, Woolf AD, Wulf S, Yeh PH, Zaidi AK, Zheng ZJ, Zonies D, Lopez AD, Murray CJ, AlMazroa MA, Memish ZA. Years lived with disability (YLDs) for 1160 sequelae of 289 diseases and injuries 1990-2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012 Dec 15;380(9859):2163-96. doi: 10.1016/S0140-6736(12)61729-2.

    PMID: 23245607BACKGROUND

  • Wober-Bingol C. Epidemiology of migraine and headache in children and adolescents. Curr Pain Headache Rep. 2013 Jun;17(6):341. doi: 10.1007/s11916-013-0341-z.

    PMID: 23700075BACKGROUND

MeSH Terms

Conditions

Neuralgia

Interventions

Sphenopalatine Ganglion Block

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Autonomic Nerve BlockNerve BlockAnesthesia, ConductionAnesthesiaAnesthesia and AnalgesiaDenervationNeurosurgical ProceduresSurgical Procedures, Operative

Study Officials

  • Jacob AuBuchon, MD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: Open label, pre/post-treatment pilot study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2020

First Posted

July 10, 2020

Study Start

January 2, 2021

Primary Completion

February 5, 2021

Study Completion

February 5, 2021

Last Updated

February 10, 2021

Record last verified: 2021-02

Locations

US(1)