Botox Injection in Treatment of Cluster Headache

NCT02019017 | Completed Phase 1 DMC

• 2 other identifiers: BTACH20122012-000248-91
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Keywords

Cluster Headache; Botulinum Toxin Type A; Sphenopalatine Ganglion Block; Autonomic Nerve Block

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

Botulinum Toxin Type A 25 IU

EXPERIMENTAL

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

Drug: Botulinum Toxin Type A 25 IU

Botulinum Toxin Type A 50 IU

EXPERIMENTAL

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

Drug: Botulinum Toxin Type A 50 IU

Interventions

Botulinum Toxin Type A 25 IU DRUG

Also known as: Botox

Botulinum Toxin Type A 25 IU

Botulinum Toxin Type A 50 IU DRUG

Also known as: Botox

Botulinum Toxin Type A 50 IU

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• St. Olavs Hospital: collaborator

Study Sites (1)

Department of Neuroscience, Norwegian University of Science and Technology

Trondheim, Norway

Location

Related Publications (1)

• 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.

  PMID: 26232105 RESULT

MeSH Terms

Conditions

Cluster Headache

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Trigeminal Autonomic Cephalalgias; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Daniel F Bratbak, MD

  Norwegian University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2013
• First Posted: December 24, 2013
• Study Start: October 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: August 1, 2014
• Last Updated: March 17, 2017

Record last verified: 2017-03

Locations

NO (1)