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Botox Injection in Treatment of Cluster Headache

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ClinicalTrials.gov Identifier: NCT02019017
Recruitment Status : Completed
First Posted : December 24, 2013
Last Update Posted : March 17, 2017
Sponsor:
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Tracking Information
First Submitted Date  ICMJE November 21, 2013
First Posted Date  ICMJE December 24, 2013
Last Update Posted Date March 17, 2017
Actual Study Start Date  ICMJE October 2013
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 17, 2013)
Safety aspects / Number of adverse events and number of participants with adverse events as a measure of safety [ Time Frame: For the follow-up period of 6 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. Registration of any adverse events categorized by probable relationship to drug, the surgical procedure or anesthesia. Data obtained from the headache diaries as well as open questions during consultations.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 17, 2013)
  • Cluster headache attack frequency [ Time Frame: Average number of attacks of baseline compared to average of week 3 and 4 after injection ]
  • Hours with cluster headache [ Time Frame: Average of baseline compared to average of week 3 and 4 after injection ]
  • Days with cluster headache [ Time Frame: Average of baseline compared to average of week 3 and 4 after injection ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Botox Injection in Treatment of Cluster Headache
Official Title  ICMJE Endoscopic Block of the Sphenopalatine Ganglion With Botulinum Toxin in Intractable Cluster Headache - Safety Issues
Brief Summary

Cluster headache is an intense and powerful, one-sided headache accompanied by involuntary symptoms such as red eye, droopy eyelids, flow of tears, small pupils and one-sided facial sweating. The headache is believed to be the most intense of all headaches and among many is totally disabling and of great personal and social consequences. For a small group of patients with episodic and most chronic form, drug therapy has little effect. For them, surgery can be a solution.

Neuroradiology has found evidence of a possible original activation of cluster headache from the portion of the brain called hypothalamus. Furthermore, an activation of the parasympathetic nervous system through the sphenopalatine ganglion, which may also explain some of the one-sided involuntary symptoms, is suspected in cluster headache. Injection of Botulinum toxin type A (BTA) inhibits secretion of synaptic acetylcholine resulting in nerve signals being blocked. The duration of such a blockade is believed to be 3-9 months.

The purpose of the present study is to develop and evaluate a new surgical procedure with injection of BTA for blocking of the sphenopalatine ganglion. The goal is to relieve the symptoms of refractory cluster headache with a minimal invasive procedure.

The main objective of the project is to determine the safety of BTA injection in the area of the sphenopalatine ganglion of refractory cluster headache and detect the adverse events. Secondary objectives are to identify the changes of headache attacks by the method used.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cluster Headache
Intervention  ICMJE
  • Drug: Botulinum Toxin Type A 25 IU
    Other Name: Botox
  • Drug: Botulinum Toxin Type A 50 IU
    Other Name: Botox
Study Arms  ICMJE
  • Experimental: Botulinum Toxin Type A 25 IU
    The first five patients will be injected 25 IU of Botulinum Toxin Type A
    Intervention: Drug: Botulinum Toxin Type A 25 IU
  • Experimental: Botulinum Toxin Type A 50 IU
    the next five patients will receive 50 IU of Botulinum Toxin Type A
    Intervention: Drug: Botulinum Toxin Type A 50 IU
Publications * Bratbak DF, Nordgård S, Stovner LJ, Linde M, Folvik M, Bugten V, Tronvik E. Pilot study of sphenopalatine injection of onabotulinumtoxinA for the treatment of intractable chronic cluster headache. Cephalalgia. 2016 May;36(6):503-9. doi: 10.1177/0333102415597891. Epub 2015 Jul 31.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 17, 2013)
10
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2014
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Informed and written consent
  • Cluster headaches defined in ICHD-2 criteria, duration of periods of attacks normally more than 2 months and insufficient effect of available prophylactic treatment

Exclusion Criteria:

  • 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 or anesthesia
  • 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
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02019017
Other Study ID Numbers  ICMJE BTACH2012
2012-000248-91 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Norwegian University of Science and Technology
Study Sponsor  ICMJE Norwegian University of Science and Technology
Collaborators  ICMJE St. Olavs Hospital
Investigators  ICMJE
Principal Investigator: Daniel F Bratbak, MD Norwegian University of Science and Technology
PRS Account Norwegian University of Science and Technology
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP