Pilot Study of Injection of OnabotulinumtoxinA Toward the Sphenopalatine Ganglion for the Treatment of Classical Trigeminal Neuralgia

Joan Crespi, Daniel Bratbak, David William Dodick, Manjit Matharu, Kent Are Jamtøy, Erling Tronvik

Research output: Contribution to journalArticle

Abstract

BACKGROUND: The sphenopalatine ganglion (SPG) has previously been targeted in trigeminal neuralgia (TN), but its role in this condition has not been established. OBJECTIVE: To investigate the safety of injecting onabotulinumtoxinA (BTA) toward the SPG using the MultiGuide® in 10 patients with refractory classical TN, and collect preliminary efficacy data. METHODS: Twenty-five international units (IU) of BTA were injected toward the SPG in a prospective, open-label study in 10 patients with refractory classical TN. All patients were recruited and treated on an out-patient basis at St. Olav's University Hospital in Trondheim (Norway). PRIMARY OUTCOME: adverse events (AEs). Primary efficacy outcome: number of TN attacks at weeks 5-8 after injection compared to baseline. A treatment responder was predefined as at least 50% reduction in the median number of attacks per day between baseline and weeks 5-8. Other efficacy outcomes were intensity of attacks (numeric rating scale, 0 to 10) and functional level (1 to 4; 1 best and 4 worst) at weeks 5-8 after injection compared to baseline. Percentage of the day with concomitant persistent pain was registered at baseline and at weeks 1-4, 6, 8, and 12 after injection. Patient global impression of change (PGIC) was ascertained at month 3. RESULTS: For the primary endpoint, we analyzed data for all 10 patients. For efficacy outcomes we analyzed data for 9 patients (1 patient violated protocol). We registered 13 AEs, none of which were serious. The median number of TN attacks during the 4-week baseline and weeks 5-8 after injection was 5.5 (range: 1.0-51.5) and 5 (range: 0-225.0), respectively (P = .401). Four patients were treatment responders. The median intensity of attacks at baseline and weeks 5-8 after injection was 6 (range: 3.0-8.5) and 3 (range: 0.0-9.0) respectively (P = .024). The median functional level at baseline was 2 (range: 1.0-3.3) and at month 2, 1 (range 1.0-4.0; P = .750). Median percentage of the day with concomitant persistent pain was 75% (minimum 37.5%, maximum 100%) at baseline and 18.75% (minimum 0%, maximum 100%) at week 8 (P = .023). CONCLUSIONS: Injection of BTA toward the SPG using the MultiGuide® in patients with TN appears to be safe and well tolerated. This study was negative for the main efficacy endpoint (reduction in the number of attacks from baseline to weeks 5-8). Further studies examining the role of the SPG in TN are necessary.

Original languageEnglish (US)
Pages (from-to)1229-1239
Number of pages11
JournalHeadache
Volume59
Issue number8
DOIs
StatePublished - Sep 1 2019

Fingerprint

Trigeminal Neuralgia
Ganglia
Injections
Therapeutics
onabotulinumtoxinA
Pain
Norway
Outpatients
Safety

Keywords

  • botulinum toxin
  • pterygopalatine ganglion
  • sensitization
  • sphenopalatine ganglion
  • trigeminal neuralgia

ASJC Scopus subject areas

  • Neurology
  • Clinical Neurology

Cite this

Pilot Study of Injection of OnabotulinumtoxinA Toward the Sphenopalatine Ganglion for the Treatment of Classical Trigeminal Neuralgia. / Crespi, Joan; Bratbak, Daniel; Dodick, David William; Matharu, Manjit; Jamtøy, Kent Are; Tronvik, Erling.

In: Headache, Vol. 59, No. 8, 01.09.2019, p. 1229-1239.

Research output: Contribution to journalArticle

Crespi, Joan ; Bratbak, Daniel ; Dodick, David William ; Matharu, Manjit ; Jamtøy, Kent Are ; Tronvik, Erling. / Pilot Study of Injection of OnabotulinumtoxinA Toward the Sphenopalatine Ganglion for the Treatment of Classical Trigeminal Neuralgia. In: Headache. 2019 ; Vol. 59, No. 8. pp. 1229-1239.
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abstract = "BACKGROUND: The sphenopalatine ganglion (SPG) has previously been targeted in trigeminal neuralgia (TN), but its role in this condition has not been established. OBJECTIVE: To investigate the safety of injecting onabotulinumtoxinA (BTA) toward the SPG using the MultiGuide{\circledR} in 10 patients with refractory classical TN, and collect preliminary efficacy data. METHODS: Twenty-five international units (IU) of BTA were injected toward the SPG in a prospective, open-label study in 10 patients with refractory classical TN. All patients were recruited and treated on an out-patient basis at St. Olav's University Hospital in Trondheim (Norway). PRIMARY OUTCOME: adverse events (AEs). Primary efficacy outcome: number of TN attacks at weeks 5-8 after injection compared to baseline. A treatment responder was predefined as at least 50{\%} reduction in the median number of attacks per day between baseline and weeks 5-8. Other efficacy outcomes were intensity of attacks (numeric rating scale, 0 to 10) and functional level (1 to 4; 1 best and 4 worst) at weeks 5-8 after injection compared to baseline. Percentage of the day with concomitant persistent pain was registered at baseline and at weeks 1-4, 6, 8, and 12 after injection. Patient global impression of change (PGIC) was ascertained at month 3. RESULTS: For the primary endpoint, we analyzed data for all 10 patients. For efficacy outcomes we analyzed data for 9 patients (1 patient violated protocol). We registered 13 AEs, none of which were serious. The median number of TN attacks during the 4-week baseline and weeks 5-8 after injection was 5.5 (range: 1.0-51.5) and 5 (range: 0-225.0), respectively (P = .401). Four patients were treatment responders. The median intensity of attacks at baseline and weeks 5-8 after injection was 6 (range: 3.0-8.5) and 3 (range: 0.0-9.0) respectively (P = .024). The median functional level at baseline was 2 (range: 1.0-3.3) and at month 2, 1 (range 1.0-4.0; P = .750). Median percentage of the day with concomitant persistent pain was 75{\%} (minimum 37.5{\%}, maximum 100{\%}) at baseline and 18.75{\%} (minimum 0{\%}, maximum 100{\%}) at week 8 (P = .023). CONCLUSIONS: Injection of BTA toward the SPG using the MultiGuide{\circledR} in patients with TN appears to be safe and well tolerated. This study was negative for the main efficacy endpoint (reduction in the number of attacks from baseline to weeks 5-8). Further studies examining the role of the SPG in TN are necessary.",
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TY - JOUR

T1 - Pilot Study of Injection of OnabotulinumtoxinA Toward the Sphenopalatine Ganglion for the Treatment of Classical Trigeminal Neuralgia

AU - Crespi, Joan

AU - Bratbak, Daniel

AU - Dodick, David William

AU - Matharu, Manjit

AU - Jamtøy, Kent Are

AU - Tronvik, Erling

PY - 2019/9/1

Y1 - 2019/9/1

N2 - BACKGROUND: The sphenopalatine ganglion (SPG) has previously been targeted in trigeminal neuralgia (TN), but its role in this condition has not been established. OBJECTIVE: To investigate the safety of injecting onabotulinumtoxinA (BTA) toward the SPG using the MultiGuide® in 10 patients with refractory classical TN, and collect preliminary efficacy data. METHODS: Twenty-five international units (IU) of BTA were injected toward the SPG in a prospective, open-label study in 10 patients with refractory classical TN. All patients were recruited and treated on an out-patient basis at St. Olav's University Hospital in Trondheim (Norway). PRIMARY OUTCOME: adverse events (AEs). Primary efficacy outcome: number of TN attacks at weeks 5-8 after injection compared to baseline. A treatment responder was predefined as at least 50% reduction in the median number of attacks per day between baseline and weeks 5-8. Other efficacy outcomes were intensity of attacks (numeric rating scale, 0 to 10) and functional level (1 to 4; 1 best and 4 worst) at weeks 5-8 after injection compared to baseline. Percentage of the day with concomitant persistent pain was registered at baseline and at weeks 1-4, 6, 8, and 12 after injection. Patient global impression of change (PGIC) was ascertained at month 3. RESULTS: For the primary endpoint, we analyzed data for all 10 patients. For efficacy outcomes we analyzed data for 9 patients (1 patient violated protocol). We registered 13 AEs, none of which were serious. The median number of TN attacks during the 4-week baseline and weeks 5-8 after injection was 5.5 (range: 1.0-51.5) and 5 (range: 0-225.0), respectively (P = .401). Four patients were treatment responders. The median intensity of attacks at baseline and weeks 5-8 after injection was 6 (range: 3.0-8.5) and 3 (range: 0.0-9.0) respectively (P = .024). The median functional level at baseline was 2 (range: 1.0-3.3) and at month 2, 1 (range 1.0-4.0; P = .750). Median percentage of the day with concomitant persistent pain was 75% (minimum 37.5%, maximum 100%) at baseline and 18.75% (minimum 0%, maximum 100%) at week 8 (P = .023). CONCLUSIONS: Injection of BTA toward the SPG using the MultiGuide® in patients with TN appears to be safe and well tolerated. This study was negative for the main efficacy endpoint (reduction in the number of attacks from baseline to weeks 5-8). Further studies examining the role of the SPG in TN are necessary.

AB - BACKGROUND: The sphenopalatine ganglion (SPG) has previously been targeted in trigeminal neuralgia (TN), but its role in this condition has not been established. OBJECTIVE: To investigate the safety of injecting onabotulinumtoxinA (BTA) toward the SPG using the MultiGuide® in 10 patients with refractory classical TN, and collect preliminary efficacy data. METHODS: Twenty-five international units (IU) of BTA were injected toward the SPG in a prospective, open-label study in 10 patients with refractory classical TN. All patients were recruited and treated on an out-patient basis at St. Olav's University Hospital in Trondheim (Norway). PRIMARY OUTCOME: adverse events (AEs). Primary efficacy outcome: number of TN attacks at weeks 5-8 after injection compared to baseline. A treatment responder was predefined as at least 50% reduction in the median number of attacks per day between baseline and weeks 5-8. Other efficacy outcomes were intensity of attacks (numeric rating scale, 0 to 10) and functional level (1 to 4; 1 best and 4 worst) at weeks 5-8 after injection compared to baseline. Percentage of the day with concomitant persistent pain was registered at baseline and at weeks 1-4, 6, 8, and 12 after injection. Patient global impression of change (PGIC) was ascertained at month 3. RESULTS: For the primary endpoint, we analyzed data for all 10 patients. For efficacy outcomes we analyzed data for 9 patients (1 patient violated protocol). We registered 13 AEs, none of which were serious. The median number of TN attacks during the 4-week baseline and weeks 5-8 after injection was 5.5 (range: 1.0-51.5) and 5 (range: 0-225.0), respectively (P = .401). Four patients were treatment responders. The median intensity of attacks at baseline and weeks 5-8 after injection was 6 (range: 3.0-8.5) and 3 (range: 0.0-9.0) respectively (P = .024). The median functional level at baseline was 2 (range: 1.0-3.3) and at month 2, 1 (range 1.0-4.0; P = .750). Median percentage of the day with concomitant persistent pain was 75% (minimum 37.5%, maximum 100%) at baseline and 18.75% (minimum 0%, maximum 100%) at week 8 (P = .023). CONCLUSIONS: Injection of BTA toward the SPG using the MultiGuide® in patients with TN appears to be safe and well tolerated. This study was negative for the main efficacy endpoint (reduction in the number of attacks from baseline to weeks 5-8). Further studies examining the role of the SPG in TN are necessary.

KW - botulinum toxin

KW - pterygopalatine ganglion

KW - sensitization

KW - sphenopalatine ganglion

KW - trigeminal neuralgia

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