Sphenopalatine Ganglion Block for the Treatment of Post-Stroke Headache

NCT05365880 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: 138103
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Determine the effects of sphenopalatine ganglion (SPG) block in post-stroke headache.

Conditions

Headache; Stroke; Ischemic Stroke

Keywords

Post-Stroke Headache; Sphenopalatine Ganglion (SPG) block

Outcome Measures

Primary Outcomes (1)

• Change in Number of Migraine Headaches During Treatment Phase

  Evaluate the efficacy of Lidocaine delivered to SPG, based on the use of rescue medication and number of headache in headache diary

  90 days

Secondary Outcomes (2)

• Numeric Pain Rating Scale

  90 days

• Adverse effect

  90 days

Study Arms (2)

Liquid Lidocaine

EXPERIMENTAL

The investigational treatment is 1.5 mL of aqueous 2% lidocaine.

Drug: Liquid Lidocaine

Sham Placebo

PLACEBO COMPARATOR

The placebo arm is 1.5mL of aqueous of saline.

Drug: Placebo

Interventions

Liquid Lidocaine DRUG

The investigational treatment is 2 mL of aqueous 2% lidocaine.

Liquid Lidocaine

Placebo DRUG

The active placebo comparator will be provided to participant.

Sham Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older;
• hospitalization at the University of Utah Hospital with a diagnosis of acute ischemic or hemorrhagic stroke; confirmed acute post-stroke headache by treating physician;
• meets at least one of the following International Classification of Headache Disorder-3 (ICHD-3) criteria: 6.1.1.1 (Acute Headache Attributed to Ischemic Stroke), 6.2.1 (Headache attributed to non-traumatic intracerebral hemorrhage), 6.2.2 (Acute headache attributed to non-traumatic subarachnoid hemorrhage); received at least one medication for headache during hospitalization.

You may not qualify if:

• Previous treatment with SPG Block for post-stroke headache
• history of prophylactic medication use for headache or migraine;
• pregnant at time of stroke

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84108, United States

Location

Related Publications (10)

• Delpont B, Blanc C, Osseby GV, Hervieu-Begue M, Giroud M, Bejot Y. Pain after stroke: A review. Rev Neurol (Paris). 2018 Dec;174(10):671-674. doi: 10.1016/j.neurol.2017.11.011. Epub 2018 Jul 24.

  PMID: 30054011 RESULT

• Lai J, Harrison RA, Plecash A, Field TS. A Narrative Review of Persistent Post-Stroke Headache - A New Entry in the International Classification of Headache Disorders, 3rd Edition. Headache. 2018 Oct;58(9):1442-1453. doi: 10.1111/head.13382. Epub 2018 Aug 27.

  PMID: 30152015 RESULT

• Ho KWD, Przkora R, Kumar S. Sphenopalatine ganglion: block, radiofrequency ablation and neurostimulation - a systematic review. J Headache Pain. 2017 Dec 28;18(1):118. doi: 10.1186/s10194-017-0826-y.

  PMID: 29285576 RESULT

• Rosso C, Felisati G, Bulfamante A, Pipolo C. Cluster headache: crosspoint between otologists and neurologists-treatment of the sphenopalatine ganglion and systematic review. Neurol Sci. 2019 May;40(Suppl 1):137-146. doi: 10.1007/s10072-019-03796-5.

  PMID: 30877613 RESULT

• Androulakis XM, Krebs KA, Ashkenazi A. Hemicrania continua may respond to repetitive sphenopalatine ganglion block: A case report. Headache. 2016 Mar;56(3):573-9. doi: 10.1111/head.12783. Epub 2016 Mar 1.

  PMID: 26926875 RESULT

• Harriott AM, Karakaya F, Ayata C. Headache after ischemic stroke: A systematic review and meta-analysis. Neurology. 2020 Jan 7;94(1):e75-e86. doi: 10.1212/WNL.0000000000008591. Epub 2019 Nov 6.

  PMID: 31694924 RESULT

• Mulder IA, Li M, de Vries T, Qin T, Yanagisawa T, Sugimoto K, van den Bogaerdt A, Danser AHJ, Wermer MJH, van den Maagdenberg AMJM, MaassenVanDenBrink A, Ferrari MD, Ayata C. Anti-migraine Calcitonin Gene-Related Peptide Receptor Antagonists Worsen Cerebral Ischemic Outcome in Mice. Ann Neurol. 2020 Oct;88(4):771-784. doi: 10.1002/ana.25831. Epub 2020 Aug 7.

  PMID: 32583883 RESULT

• Levin M. Opioids in headache. Headache. 2014 Jan;54(1):12-21. doi: 10.1111/head.12266.

  PMID: 24127913 RESULT

• Cady R, Saper J, Dexter K, Manley HR. A double-blind, placebo-controlled study of repetitive transnasal sphenopalatine ganglion blockade with tx360((R)) as acute treatment for chronic migraine. Headache. 2015 Jan;55(1):101-16. doi: 10.1111/head.12458. Epub 2014 Oct 23.

  PMID: 25338927 RESULT

• Maizels M, Scott B, Cohen W, Chen W. Intranasal lidocaine for treatment of migraine: a randomized, double-blind, controlled trial. JAMA. 1996 Jul 24-31;276(4):319-21.

  PMID: 8656545 RESULT

MeSH Terms

Conditions

Headache; Stroke; Ischemic Stroke; Bites and Stings

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Officials

• Adam H de Havenon, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2022
• First Posted: May 9, 2022
• Study Start: March 23, 2022
• Primary Completion: March 22, 2025
• Study Completion: June 1, 2025
• Last Updated: November 13, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)