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Completed

NCT Number: NCT02259075

Botox Injection in Treatment of Chronic Migraine

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.

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Key information

Conditions

Migraine Disorders Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine with Aura Migraine without Aura Nervous System Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Department of Neuroscience, Norwegian University of Science and Technology

Trondheim, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Botulinum Toxin Type A

Drug

Other names: Botox, BTA

Primary outcomes

  1. Number of adverse events and number of participants with adverse events

    Time frame: 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.

  2. Number of headache days with moderate or severe intensity

    Time frame: 5-8 weeks

    measured from week 5 to week 8, in total during 4 weeks

Secondary outcomes

  1. Number of reponders

    Time frame: 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)

  2. Days with moderate or severe headache per 4 weeks

    Time frame: 12 weeks

    week 1-4, week 5-8, week 9-12

  3. Days without headache per 4 weeks

    Time frame: 12 weeks

    week 1-4, week 5-8, week 9-12

  4. Hours with headache of moderate or severe headache per 4 weeks

    Time frame: 12 weeks

    week 1-4, week 5-8, week 9-12

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • St. Olavs Hospital

Registry information

Official study title

Botulinum Toxin Type A Block of the Sphenopalatine Ganglion in Chronic Migraine. Safety Issues.

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 8, 2014
Registry last updated
May 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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