Botox Injection in Treatment of Cluster Headache

Cluster Headache Clinical Trial

Official title:

Endoscopic Block of the Sphenopalatine Ganglion With Botulinum Toxin in Intractable Cluster Headache - Safety Issues

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02019017
• Other study ID #: BTACH2012
• Secondary ID: 2012-000248-91
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 21, 2013
• Last updated: March 16, 2017
• Start date: October 2013
• Est. completion date: August 2014

Study information

• Verified date: March 2017
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Cluster headache is an intense and powerful, one-sided headache accompanied by involuntary symptoms such as red eye, droopy eyelids, flow of tears, small pupils and one-sided facial sweating. The headache is believed to be the most intense of all headaches and among many is totally disabling and of great personal and social consequences. For a small group of patients with episodic and most chronic form, drug therapy has little effect. For them, surgery can be a solution.

Neuroradiology has found evidence of a possible original activation of cluster headache from the portion of the brain called hypothalamus. Furthermore, an activation of the parasympathetic nervous system through the sphenopalatine ganglion, which may also explain some of the one-sided involuntary symptoms, is suspected in cluster headache. Injection of Botulinum toxin type A (BTA) inhibits secretion of synaptic acetylcholine resulting in nerve signals being blocked. The duration of such a blockade is believed to be 3-9 months.

The purpose of the present study is to develop and evaluate a new surgical procedure with injection of BTA for blocking of the sphenopalatine ganglion. The goal is to relieve the symptoms of refractory cluster headache with a minimal invasive procedure.

The main objective of the project is to determine the safety of BTA injection in the area of the sphenopalatine ganglion of refractory cluster headache and detect the adverse events. Secondary objectives are to identify the changes of headache attacks by the method used.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Informed and written consent

• Cluster headaches defined in ICHD-2 criteria, duration of periods of attacks normally more than 2 months and insufficient effect of available prophylactic treatment

Exclusion Criteria:

• Heart or lung disease

• Any kind of systematic or local disease or illness that may significantly increase the risk of complications for the procedure, related to injection or anesthesia

• Psychiatric illness that hinders participation in the study

• Known pregnancy or breast feeding

• Inadequate use of contraceptives

• Overuse or abuse of opioids

• Abuse of medications, narcotics or alcohol

• Allergy or any other hypersensitivity reactions against marcain, lidocaine, xylocain or adrenalin, botulinum toxin type A, Botox or any of it's constituents or any other related medication

• Treatment with medication that can interact with botulinum toxin type A

Related Conditions & MeSH terms

• Cluster Headache
• Headache

Intervention

Drug:
• Botulinum Toxin Type A 25 IU

• Botulinum Toxin Type A 50 IU

Locations

Country	Name	City	State
Norway	Department of Neuroscience, Norwegian University of Science and Technology	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Bratbak DF, Nordgård S, Stovner LJ, Linde M, Folvik M, Bugten V, Tronvik E. Pilot study of sphenopalatine injection of onabotulinumtoxinA for the treatment of intractable chronic cluster headache. Cephalalgia. 2016 May;36(6):503-9. doi: 10.1177/0333102415 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety aspects / Number of adverse events and number of participants with adverse events as a measure of safety	Number of adverse events and number of participants with adverse events after BTA injection in the area of the sphenopalatine ganglion and severity of adverse events. Registration of any adverse events categorized by probable relationship to drug, the surgical procedure or anesthesia. Data obtained from the headache diaries as well as open questions during consultations.	For the follow-up period of 6 months
Secondary	Cluster headache attack frequency		Average number of attacks of baseline compared to average of week 3 and 4 after injection
Secondary	Hours with cluster headache		Average of baseline compared to average of week 3 and 4 after injection
Secondary	Days with cluster headache		Average of baseline compared to average of week 3 and 4 after injection