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abobotulinumtoxinA

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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.

Botulinum toxin type A

0.5 ml Sodium Chloride (NaCl) 0.9% Braun. Two injections, one in each side of the face, and targeting the sphenopalatine ganglion.

placebo

Tore Wergeland Meisingset, Md phd

Erling Tronvik, md phd

Marte-Helene Bjørk, MD phd

Karl Bjørnar Alstadhaug, md prof

John-Anker Zwart, MD prof

Geir Bråthen, md phd

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.

Botulinum Toxin Type A Blockade of the Sphenopalatine Ganglion in Treatment-refractory Chronic Migraine

all IPD that underlie results in a publication will be shared within 6 months after study results publication

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.

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

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

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

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.

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

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

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

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

Norwegian University of Science and Technology

Oslo University Hospital

Haukeland University Hospital

Nordlandssykehuset HF

St. Olavs Hospital

Cluster Headache

Pain

Neurologic Manifestations

Trigeminal Autonomic Cephalalgias

Botulinum toxin 25 Allergan units in 0.5 ml Sodium Chloride (NaCl) 0.9 % Braun. One injection in the headache side of the face, targeted at the sphenopalatine ganglion (SPG)

0.5 ml Sodium Chloride (NaCl) 0.9% Braun. One injection in the headache side of the face, targeted at the sphenopalatine ganglion (SPG)

Tore Wergeland Meisingset, md phd

Alexandre Thomas Assaf, dr

Massimo Leone, md prof

Miguel Lainez, md prof

Manjit Matharu, MD phd

Cluster headache is a primary headache condition characterized by clusters of one-sided, high-intensity pain attacks. The headache may be episodic or chronic. Treatment options are limited and their effects unsatisfactory. An important nerve pathway involved in the pain attacks has a switching station at the sphenopalatine ganglion (SPG) located in the depth of the facial bones. SPG is a known therapy target for cluster headache. The area can be identified on CT images, but is difficult to access due to its location. Thus, the Multiguide navigation system has been developed to enable precise delivery of the drugs that target SPG activity. In Trondheim, two phase 1 / Phase 2 study have been carried out using botulinum toxin A (Botox®) against SPG in patient with chronic cluster headache and chronic migraine. The results indicate that such a treatment strategy is safe and beneficial. The current study is a randomized, placebo-controlled, triple-blinded study to investigate whether precise single-injection of botulinum toxin A reduces the frequency of attacks in chronic cluster headache .

Botulinum Toxin Type A Blockade of the Sphenopalatine Ganglion in Treatment-refractory Chronic Cluster Headache

Change from baseline to weeks 5-8 post-intervention in number of cluster headache attacks per week in the active group versus the placebo group. The number of cluster headache attacks is collected in a headache diary.

All adverse events and serious adverse events occurring in the 3 months follow up are registered in an electronic case report form (CRF). Frequency of AE and SAE are compared between the placebo group and the treatment group

Change from baseline to weeks 9-12 post-intervention in number of cluster headache attacks per week in the active group versus the placebo group. The number of cluster headache attacks is collected in a headache diary

Change from baseline to weeks 5 - 8 post-intervention in number of cluster headache attacks per week comparing high versus low attack frequency and low versus high attack frequency variation in the entire baseline period. Comparisons are done between the active and the placebo group. The number of cluster headache attacks is collected in a headache diary

Change from baseline to weeks 9-12 post-intervention in number of cluster headache attacks per week comparing high versus low attack frequency and high versus low attack frequency variation in the entire baseline period. Comparisons are done between the active and the placebo group. The number of cluster headache attacks is collected in a headache diary

Number of therapeutic responders as defined as a ≥ 30% reduction in attack frequency, intensity or both during weeks 5 - 8 post-intervention compared to baseline week 5-8. The number in the placebo and intervention group are compared

Number of attack frequency responders as defined as a ≥ 30% reduction in attack frequency during weeks 5-8 post-intervention compared to baseline. The number in the placebo and intervention group are compared

Mean attack intensity (10-point numerical response scale - NRS) week 5-8 post intervention compared to baseline in the intervention group versus the placebo group.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Botulinum Toxin Type A Blockade of the Sphenopalatine Ganglion in Treatment-refractory Chronic Migraine	NCT04069897	Migraine Disord...	Botulinum toxin... placebo	18 Years - 70 Years	St. Olavs Hospital
Botulinum Toxin Type A Blockade of the Sphenopalatine Ganglion in Treatment-refractory Chronic Cluster Headache	NCT03944876	Cluster Headach...	Botulinum toxin... placebo	18 Years - 85 Years	Norwegian University of Science and Technology

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