Botox Injection in Treatment of Cluster Headache
|ClinicalTrials.gov Identifier: NCT02019017|
Recruitment Status : Completed
First Posted : December 24, 2013
Last Update Posted : March 17, 2017
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Endoscopic Block of the Sphenopalatine Ganglion With Botulinum Toxin in Intractable Cluster Headache - Safety Issues|
|Actual Study Start Date :||October 2013|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||August 2014|
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 Name: 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 Name: Botox
- 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.
- Cluster headache attack frequency [ Time Frame: 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 ]
- Days with cluster headache [ Time Frame: Average of baseline compared to average of week 3 and 4 after injection ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02019017
|Department of Neuroscience, Norwegian University of Science and Technology|
|Principal Investigator:||Daniel F Bratbak, MD||Norwegian University of Science and Technology|