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Botulinum Toxin Type A Blockade of the Sphenopalatine Ganglion in Treatment-refractory Chronic Cluster Headache

Study acronym: BASIC
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated November 19, 2024 (before its estimated September 2025 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Study sites revised (5)
    • Collaborators revised (5)
    v12
  2. Eligibility criteria shortened, about 5 wordsv11
  3. Site details revised at 1 of 5 sitesv10
  4. Re-verified, no change to tracked fieldsv9
  5. Study sites revised (5)
    • Collaborators revised (5)
    v8
Show 6 earlier versionsHide 6 earlier versions
  1. 2 versions Re-verified since Nov 11, 2020, no change to tracked fieldsv6-v7
  2. Site details revised at 3 of 5 sitesv5
  3. Trial status: Not Yet Recruiting to Recruitingv4 Show 6 more changesShow less
    • Primary endpoint revised
    • Enrollment target: 90 to 112
    • Start date changed from estimate of Nov 2019 to Nov 1, 2019
    • Eligibility criteria expanded, about 165 words
    • Secondary endpoints: 14 to 7
    • Site details revised at 5 of 5 sites
  4. Start date: Sep 2019 to Nov 2019
    • Primary and study completion dates: Jul 2025 to Sep 2025
    v3
  5. Start date: May 2019 to Sep 2019
    • Primary and study completion dates: Mar 2025 to Jul 2025
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Cluster headache is a primary headache condition characterized by clusters of one-sided, high-intensity pain attacks. The headache may be episodic or chronic. Treatment options are limited and their effects unsatisfactory. An important nerve pathway involved in the pain attacks has a switching station at the sphenopalatine ganglion (SPG) located in the depth of the facial bones. SPG is a known therapy target for cluster headache. The area can be identified on CT images, but is difficult to access due to its location. Thus, the Multiguide navigation system has been developed to enable precise delivery of the drugs that target SPG activity. In Trondheim, two phase 1 / Phase 2 study have been carried out using botulinum toxin A (Botox®) against SPG in patient with chronic cluster headache and chronic migraine. The results indicate that such a treatment strategy is safe and beneficial. The current study is a randomized, placebo-controlled, triple-blinded study to investigate whether precise single-injection of botulinum toxin A reduces the frequency of attacks in chronic cluster headache .
Trial Details
NCT Number NCT03944876
Lead Sponsor Norwegian University of Science and Technology
Collaborators: St. Olavs Hospital, University College, London, Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta, Catholic University of Valencia, PRAXISKLINIK ULMENHOF
Conditions
(from sponsor)		 Cluster Headache
Related terms Cluster Headache
Enrollment 112 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov