Botox Injection in Treatment of Chronic Migraine

• Register: ClinicalTrials.gov
• Last refreshed on: 30 May 2016
• Main ID: NCT02259075
• Date of registration: 03/10/2014
• Prospective Registration: Yes
• Primary sponsor: Norwegian University of Science and Technology
• Public title: Botox Injection in Treatment of Chronic Migraine
• Scientific title: Botulinum Toxin Type A Block of the Sphenopalatine Ganglion in Chronic Migraine. Safety Issues.
• Date of first enrolment: February 2015
• Target sample size: 10
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02259075
• Study type: Interventional
• Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1/Phase 2

Countries of recruitment

Norway

Contacts

• Name: Erling A Tronvik, PhD, MD
• Affiliation: Norwegian University of Science and Technology

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Migraine Disorders

Intervention(s)

Drug: Botulinum Toxin Type A

Primary Outcome(s)

Number of adverse events and number of participants with adverse events [Time Frame: For the follow-up period of 3 months]

Number of headache days with moderate or severe intensity [Time Frame: 5-8 weeks]

Secondary Outcome(s)

Days with moderate or severe headache per 4 weeks [Time Frame: 12 weeks]

Number of reponders [Time Frame: 12 weeks]

Days without headache per 4 weeks [Time Frame: 12 weeks]

Hours with headache of moderate or severe headache per 4 weeks [Time Frame: 12 weeks]

Secondary ID(s)

2014-001852-43

BTACM2014

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

St. Olavs Hospital