Botox Injection in Treatment of Cluster Headache

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

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Trondheim, Norway
        • Department of Neuroscience, Norwegian University of Science and Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Botulinum Toxin Type A 25 IU
The first five patients will be injected 25 IU of Botulinum Toxin Type A
Other Names:
  • Botox
Experimental: Botulinum Toxin Type A 50 IU
the next five patients will receive 50 IU of Botulinum Toxin Type A
Other Names:
  • Botox

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety aspects / Number of adverse events and number of participants with adverse events as a measure of safety
Time Frame: 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.
For the follow-up period of 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Cluster headache attack frequency
Time Frame: Average number of attacks of baseline compared to average of week 3 and 4 after injection
Average number of attacks of baseline compared to average of week 3 and 4 after injection
Hours with cluster headache
Time Frame: Average of baseline compared to average of week 3 and 4 after injection
Average of baseline compared to average of week 3 and 4 after injection
Days with cluster headache
Time Frame: Average of baseline compared to average of week 3 and 4 after injection
Average of baseline compared to average of week 3 and 4 after injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Daniel F Bratbak, MD, Norwegian University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2013

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

November 21, 2013

First Submitted That Met QC Criteria

December 17, 2013

First Posted (Estimate)

December 24, 2013

Study Record Updates

Last Update Posted (Actual)

March 17, 2017

Last Update Submitted That Met QC Criteria

March 16, 2017

Last Verified

March 1, 2017

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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