NCT02662972

Botulinum Toxin Type A Block of the Sphenopalatine Ganglion in Trigeminal Neuralgia. Safety Issues.

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Norwegian University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Trigeminal neuralgia is one of the strongest pains known to humans. Some patients do not have enough effect with the available pharmaceutical treatments and are offered surgery. There are different types of procedures and most of them are complex with a risk for complications. The researchers want to start a pilot study on 10 patients with a new surgical technique using neuronavigation. The target will be a neural structure (sphenopalatine ganglion) which has an important role in facial pain. There have been a few trials trying to block this structure in trigeminal neuralgia, but none using this new approach with botulinum toxin. The researchers technique requires local anesthesia only (awake patient). The researchers believe that this treatment can become a "low threshold"-treatment for patients who do not have enough effect with pharmacological treatment and a better alternative to other complex surgical approaches. Using this new neuronavigation system the researchers can reach this neural structure with high precision.

Conditions

• Trigeminal Neuralgia
• Headache Disorders

Interventions

Type	Name	Description
DRUG	Botulinum Toxin Type A

Timeline

• Start date: 2016-05-01
• Primary completion: 2018-11-01
• Completion: 2018-11-01
• First posted: 2016-01-26
• Last updated: 2019-07-29

Locations

1 site across 1 country: Norway