Botox Injection in Treatment of Chronic Migraine
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|ClinicalTrials.gov Identifier: NCT02259075|
Recruitment Status : Completed
First Posted : October 8, 2014
Last Update Posted : May 23, 2016
Chronic migraine is in many cases a most disabling condition. Chronic migraine is defined as headaches for at least 15 days per month, of which 8 days have typical migraine features. In many cases, oral drug treatment has little effect.
The parasympathetic nervous system acting through the sphenopalatine ganglion may be involved in several primary headaches, including migraine, by facilitating release of inflammatory substances in cerebral vessels. Botulinum toxin type A (BTA) inhibits excretion of acetylcholine resulting in blocking of nerve signals in the sphenopalatine ganglion.
The purpose of the present study is to evaluate a new technique with injection of BTA using an minimal invasive image guided procedure, for blocking of the sphenopalatine ganglion. The goal is to relieve the migraine symptoms and develop an alternate treatment for cases where oral drug treatments fail.
The main objective of the project is to determine the safety of this method of BTA injection in the area of the sphenopalatine ganglion by detecting adverse events. Secondary objectives are to measure changes in headache attack parameters with this novel method.
|Condition or disease||Intervention/treatment||Phase|
|Migraine Disorders||Drug: Botulinum Toxin Type A||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Botulinum Toxin Type A Block of the Sphenopalatine Ganglion in Chronic Migraine. Safety Issues.|
|Study Start Date :||February 2015|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||March 2016|
Experimental: Botulinum Toxin
The patients will be injected with 25 IU of Botulinum Toxin Type A towards both the right and left sphenopalatine ganglion, a total of 50 IU.
Drug: Botulinum Toxin Type A
- Number of adverse events and number of participants with adverse events [ Time Frame: For the follow-up period of 3 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 by the method used. Registration of any adverse events categorized by probable relationship to drug or the procedure. Data obtained from the headache diaries as well as open questions during consultations.
- Number of headache days with moderate or severe intensity [ Time Frame: 5-8 weeks ]measured from week 5 to week 8, in total during 4 weeks
- Number of reponders [ Time Frame: 12 weeks ]response is defined as ≥ 50% reduction in number of headache days with moderate or severe intensity per 4 weeks (week 1-4, week 5-8, week 9-12)
- Days with moderate or severe headache per 4 weeks [ Time Frame: 12 weeks ]week 1-4, week 5-8, week 9-12
- Days without headache per 4 weeks [ Time Frame: 12 weeks ]week 1-4, week 5-8, week 9-12
- Hours with headache of moderate or severe headache per 4 weeks [ Time Frame: 12 weeks ]week 1-4, week 5-8, week 9-12
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02259075
|Department of Neuroscience, Norwegian University of Science and Technology|
|Principal Investigator:||Erling A Tronvik, PhD, MD||Norwegian University of Science and Technology|