Botox Injection in Treatment of Chronic Migraine
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Fase 2
- Fase 1
Kontakter og plasseringer
Studiesteder
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Trondheim, Norge
- Department of Neuroscience, Norwegian University of Science and Technology
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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.
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Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Number of adverse events and number of participants with adverse events
Tidsramme: For the follow-up period of 3 months
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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.
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For the follow-up period of 3 months
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Number of headache days with moderate or severe intensity
Tidsramme: 5-8 weeks
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measured from week 5 to week 8, in total during 4 weeks
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5-8 weeks
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Number of reponders
Tidsramme: 12 weeks
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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)
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12 weeks
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Days with moderate or severe headache per 4 weeks
Tidsramme: 12 weeks
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week 1-4, week 5-8, week 9-12
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12 weeks
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Days without headache per 4 weeks
Tidsramme: 12 weeks
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week 1-4, week 5-8, week 9-12
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12 weeks
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Hours with headache of moderate or severe headache per 4 weeks
Tidsramme: 12 weeks
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week 1-4, week 5-8, week 9-12
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12 weeks
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Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Erling A Tronvik, PhD, MD, Norwegian University of Science and Technology
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Hjernesykdommer
- Sykdommer i sentralnervesystemet
- Sykdommer i nervesystemet
- Hodepinelidelser, Primær
- Hodepine lidelser
- Migrene lidelser
- Fysiologiske effekter av legemidler
- Nevrotransmittere agenter
- Molekylære mekanismer for farmakologisk virkning
- Agenter fra det perifere nervesystemet
- Kolinerge midler
- Membrantransportmodulatorer
- Acetylkolinfrigjøringshemmere
- Nevromuskulære midler
- Botulinum toksiner
- Botulinumtoksiner, type A
- abobotulinumtoksinA
Andre studie-ID-numre
- BTACM2014
- 2014-001852-43 (EudraCT-nummer)
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