Migraine Disorders Clinical Trial
Official title:
Botulinum Toxin Type A Block of the Sphenopalatine Ganglion in Chronic Migraine. Safety Issues.
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | March 2016 |
Est. primary completion date | March 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Informed and written consent - Chronic migraine with or without aura defined in International Classification of Headache Disorders (ICHD)-3 criteria - Failed at least 3 oral migraine prophylactic treatments - Duration of migraine at least 1 year before inclusion - Start of migraine before participant turned 50 years - Participant can make a distinction between migraine and other types of headache Exclusion Criteria: - If the criteria for medication-overuse headache (MOH) is fulfilled - 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 - 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 - Anomalies which hinder or impede the used method of injection - 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 |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Norway | Department of Neuroscience, Norwegian University of Science and Technology | Trondheim |
Lead Sponsor | Collaborator |
---|---|
Norwegian University of Science and Technology | St. Olavs Hospital |
Norway,
Bratbak DF, Nordgård S, Stovner LJ, Linde M, Dodick DW, Aschehoug I, Folvik M, Tronvik E. Pilot study of sphenopalatine injection of onabotulinumtoxinA for the treatment of intractable chronic migraine. Cephalalgia. 2016 May 6. pii: 0333102416648328. [Epu — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of adverse events and number of participants with adverse events | 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. | For the follow-up period of 3 months | Yes |
Primary | Number of headache days with moderate or severe intensity | measured from week 5 to week 8, in total during 4 weeks | 5-8 weeks | No |
Secondary | Number of reponders | 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) | 12 weeks | No |
Secondary | Days with moderate or severe headache per 4 weeks | week 1-4, week 5-8, week 9-12 | 12 weeks | No |
Secondary | Days without headache per 4 weeks | week 1-4, week 5-8, week 9-12 | 12 weeks | No |
Secondary | Hours with headache of moderate or severe headache per 4 weeks | week 1-4, week 5-8, week 9-12 | 12 weeks | No |
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