Botox Injection in Treatment of Chronic Migraine

Phase 1

Completed

• Conditions: Migraine Disorders
• Interventions: Drug: Botulinum Toxin Type A

• Registration Number: NCT02259075
• Lead Sponsor: Norwegian University of Science and Technology

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-10-03
• Study First Submitted QC: 2014-10-03
• Study First Posted: 2014-10-08
• Study Start: 2015-02
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-20
• Last Update Posted: 2016-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Botulinum Toxin	Botulinum Toxin Type A	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.

Primary Outcome Measures

Name	Time	Method
Number of adverse events and number of participants with adverse events	For the follow-up period of 3 months	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.
Number of headache days with moderate or severe intensity	5-8 weeks	measured from week 5 to week 8, in total during 4 weeks

Secondary Outcome Measures

Name	Time	Method
Days with moderate or severe headache per 4 weeks	12 weeks	week 1-4, week 5-8, week 9-12
Number of reponders	12 weeks	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)
Days without headache per 4 weeks	12 weeks	week 1-4, week 5-8, week 9-12
Hours with headache of moderate or severe headache per 4 weeks	12 weeks	week 1-4, week 5-8, week 9-12

Trial Locations

Locations (1)

Department of Neuroscience, Norwegian University of Science and Technology; 🇳🇴 Trondheim, Norway