Botox Injection in Treatment of Cluster Headache

Phase 1

Completed

• Conditions: Cluster Headache
• Interventions: Drug: Botulinum Toxin Type A 50 IU; Drug: Botulinum Toxin Type A 25 IU

• Registration Number: NCT02019017
• Lead Sponsor: Norwegian University of Science and Technology

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-11-21
• Study First Submitted QC: 2013-12-17
• Study First Posted: 2013-12-24
• Primary Completion: 2014-02
• Study Completion: 2014-08
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-16
• Last Update Posted: 2017-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Botulinum Toxin Type A 50 IU	Botulinum Toxin Type A 50 IU	the next five patients will receive 50 IU of Botulinum Toxin Type A
Botulinum Toxin Type A 25 IU	Botulinum Toxin Type A 25 IU	The first five patients will be injected 25 IU of Botulinum Toxin Type A

Primary Outcome Measures

Name	Time	Method
Safety aspects / Number of adverse events and number of participants with adverse events as a measure of safety	For the follow-up period of 6 months	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.

Secondary Outcome Measures

Name	Time	Method
Cluster headache attack frequency	Average number of attacks of baseline compared to average of week 3 and 4 after injection
Hours with cluster headache	Average of baseline compared to average of week 3 and 4 after injection
Days with cluster headache	Average of baseline compared to average of week 3 and 4 after injection

Trial Locations

Locations (1)

Department of Neuroscience, Norwegian University of Science and Technology; 🇳🇴 Trondheim, Norway