This is a clinical trial to assess the efficacy of botox treatment of the sphenopalatine ganglion as an add-on treatment in drug resistant migraine. An injection targeting the ganglion is made possible by an image-guided device developed specifically for this purpose (MultiGuide) Study participants will be randomized to either placebo or botox after a 4 week run-in period. First, one injection will be given towards both the right and the left ganglion. After that there will be a follow-up of 12 weeks for efficacy and safety evaluation. The main efficacy measure is change in number of moderate to severe headache days before and after injection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
170
Botulinum toxin 25 Allergan units in 0.5 ml Sodium Chloride (NaCl) 0.9 % Braun. Two injections, one in each side of the face, and targeting the sphenopalatine ganglion.
0.5 ml Sodium Chloride (NaCl) 0.9% Braun. Two injections, one in each side of the face, and targeting the sphenopalatine ganglion.
Haukeland University Hospital, department of Neurology
Bergen, Norway
Nordland Hospital, department of Neurology
Bodø, Norway
Nevroklinikken Universitetet i Oslo, Oslo Universitetssykehus HF
Oslo, Norway
St Olavs Hospital, Trondheim University Hospital
Trondheim, Norway
Change from baseline in the mean monthly headache days at weeks 5 - 8 post intervention
Change from baseline to week 5-8 post-intervention in frequency of moderate to severe headache days. Headache episodes that qualify is in the study defined as headache pain duration of ≥4 hours with a peak severity of moderate or severe intensity, or of any severity or duration if the subject takes and responds to rescue medication.
Time frame: week 5 through week 8 in the post-injection period
Occurrence of adverse events and serious adverse events in the treatment
All adverse events and serious adverse events occurring in the 3 months follow up are registered in an electronic CRF. Frequency of AE and SAE are compared between the placebo group and the treatment group
Time frame: week 1 through week 12 in the post-injection period
Change from baseline in the mean monthly migraine days in the treatment
A migraine day is defined as one day with headache pain fulfilling the ICHD3-criteria for migraine or probable migraine. However, a headache duration of less than 4 hours is allowed if the subject takes and responds to triptans. The frequency of headache days in the baseline period are compared to the frequency in week 5-8 post-intervention
Time frame: week 5 through week 8 in the post-injection period
number of treatment responders (≥ 30% reduction in mean monthly headache days)
A 30% treatment response is defined as a patient with a ≥ 30% reduction in frequency of headache days during weeks 5 - 8 post-intervention compared to baseline. Headache is defined as in the primary outcome, i.e. moderate to severe headache days. The number of responders is compared between the intervention and the placebo group
Time frame: week 5 through week 8 in the post-injection period
Change from baseline in the mean monthly headache intensity in the treatment
Attack intensity is reported daily on a 11-point numerical response scale (NRS) in the electronic headache diary. The mean attack intensity in week 5 - 8 post-intervention is compared to baseline in the active group versus the placebo group.
Time frame: week 1 through week 4, week 5 through week 8 and week 9 through week 12 in the post-injection period
Change from baseline in the mean monthly occurrence of cumulative hours per 28 days of moderate/severe pain in the treatment
The difference in hours with NRS ≥4 in the baseline period and weeks 1-4, 5-8 and 9-12 post injection are compared between the active group and the placebo group
Time frame: : week 1 through week 4, week 5 through week 8 and week 9 through week 12 in the post-injection period
Change from baseline in the mean monthly number of days with rescue medication in the treatment
Any use of rescue medication is reported in the headache diary every day. The number of days with registered use of any headache related rescue medication in weeks 1-4, 5-8 and 9-12 post-intervention is compared to the baseline period
Time frame: : week 1 through week 4, week 5 through week 8 and week 9 through week 12 in the post-injection period
Migraine specific quality of life questionnaire
Study participants will fill in the 6-question Headache impact test (HIT-6) at visit 1 (at inclusion) and at week 8 and week 12 postintervention. Scores are compared between the placebo and the treatment group
Time frame: week 8 and week 12 post-injection
Migraine specific quality of life questionnaire
Study participants will fill in the 14-question Migraine-Specific Quality-of-Life Questionnaire Version 2.1 (MSQ) at visit 1 (at inclusion) and at week 8 and week 12 postintervention. Scores are compared between the placebo and the treatment group
Time frame: week 8 and week 12 post-injection
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