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Trial record 93 of 720 for:    Botulinum Toxins, Type A

Botox Injection in Treatment of Chronic Migraine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02259075
Recruitment Status : Completed
First Posted : October 8, 2014
Last Update Posted : May 23, 2016
Sponsor:
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Migraine Disorders Drug: Botulinum Toxin Type A Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Botulinum Toxin Type A Block of the Sphenopalatine Ganglion in Chronic Migraine. Safety Issues.
Study Start Date : February 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Drug: Botulinum Toxin Type A
Other Names:
  • Botox
  • BTA




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02259075


Locations
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Norway
Department of Neuroscience, Norwegian University of Science and Technology
Trondheim, Norway
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Investigators
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Principal Investigator: Erling A Tronvik, PhD, MD Norwegian University of Science and Technology

Publications of Results:
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Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT02259075     History of Changes
Other Study ID Numbers: BTACM2014
2014-001852-43 ( EudraCT Number )
First Posted: October 8, 2014    Key Record Dates
Last Update Posted: May 23, 2016
Last Verified: May 2016

Keywords provided by Norwegian University of Science and Technology:
Migraine with aura
Migraine without aura
Headache disorders
Botulinum Toxin Type A
Sphenopalatine Ganglion Block
Autonomic Nerve Block

Additional relevant MeSH terms:
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Botulinum Toxins
Botulinum Toxins, Type A
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents