Botox Injection in Treatment of Cluster Headache

NCT ID: NCT02019017

Last Updated: 2017-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2014-08-31

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.

Conditions

Cluster Headache

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Botulinum Toxin Type A 25 IU

The first five patients will be injected 25 IU of Botulinum Toxin Type A

Group Type: EXPERIMENTAL

Botulinum Toxin Type A 25 IU

Intervention Type: DRUG

Botulinum Toxin Type A 50 IU

the next five patients will receive 50 IU of Botulinum Toxin Type A

Group Type: EXPERIMENTAL

Botulinum Toxin Type A 50 IU

Intervention Type: DRUG

Interventions

Botulinum Toxin Type A 25 IU

Intervention Type: DRUG

Botulinum Toxin Type A 50 IU

Intervention Type: DRUG

Other Intervention Names

Botox; Botox

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Olavs Hospital

OTHER

Sponsor Role: collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel F Bratbak, MD

Role: PRINCIPAL_INVESTIGATOR

Norwegian University of Science and Technology

Locations

Department of Neuroscience, Norwegian University of Science and Technology

Trondheim, , Norway

Countries

Norway

References

Bratbak DF, Nordgard 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: 10.1177/0333102415597891. Epub 2015 Jul 31.

Reference Type: RESULT

PMID: 26232105 (View on PubMed)

Other Identifiers

2012-000248-91

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BTACH2012

Identifier Type: -

Identifier Source: org_study_id