Botox Injection in Treatment of Cluster Headache

• Sponsor: Norwegian University of Science and Technology (Other)
• Overall Status: Completed
• CT.gov ID: NCT02019017
• Collaborator: St. Olavs Hospital (Other)
• Enrollment: 10
• Location: 1
• Arms: 2
• Actual Duration (Months): 10
• Patients Per Site Per Month: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cluster Headache	Drug: Botulinum Toxin Type A 25 IU; Drug: Botulinum Toxin Type A 50 IU	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Endoscopic Block of the Sphenopalatine Ganglion With Botulinum Toxin in Intractable Cluster Headache - Safety Issues
• Actual Study Start Date: Oct 1, 2013
• Actual Primary Completion Date: Feb 1, 2014
• Actual Study Completion Date: Aug 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. Cluster headache attack frequency [Average number of attacks of baseline compared to average of week 3 and 4 after injection]

2. Hours with cluster headache [Average of baseline compared to average of week 3 and 4 after injection]

3. Days with cluster headache [Average of baseline compared to average of week 3 and 4 after injection]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Neuroscience, Norwegian University of Science and Technology	Trondheim		Norway

Sponsors and Collaborators

• Norwegian University of Science and Technology
• St. Olavs Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Norwegian University of Science and Technology
• ClinicalTrials.gov Identifier: NCT02019017
• Other Study ID Numbers: BTACH2012; 2012-000248-91
• First Posted: Dec 24, 2013
• Last Update Posted: Mar 17, 2017
• Last Verified: Mar 1, 2017

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Norwegian University of Science and Technology: Cluster Headache; Botulinum Toxin Type A; Sphenopalatine Ganglion Block; Autonomic Nerve Block
• Additional relevant MeSH terms: Cluster Headache; Headache; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA

Study Results

No Results Posted as of Mar 17, 2017