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Botox block of the sphenopalatine ganglion in treatment of chronic migraine

Botulinum toxin type A block of the sphenopalatine ganglion in chronic migraine. Safety issues

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2014-001852-43-NO
Enrollment
10
Registered
2014-06-12
Start date
2014-08-11
Completion date
Unknown
Last updated
2022-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic migraine MedDRA version: 17.0 Level: LLT Classification code 10066636 Term: Chronic migraine System Organ Class: 100000004852

Interventions

Sponsors

Department of Neuroscience, NTNU
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Informed and written consent Person from 18 to 65 years old Refractory chronic migraine Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 8 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2

Exclusion criteria

Exclusion criteria: Medication overuse headache Co-morbidity that significantly increases the risk of the procedure Pregnancy Inadequate use of prevention or lactancy Allergies to local anesthetics or IMP

Design outcomes

Primary

MeasureTime frame
Main Objective: To evaluate the safety;Secondary Objective: To evaluate the effect of the treatment;Primary end point(s): Adverse events;Timepoint(s) of evaluation of this end point: For the follow-up period of 3 months

Secondary

MeasureTime frame
Secondary end point(s): Headache days with moderate or severe headache Migraine attacks ;Timepoint(s) of evaluation of this end point: Average from baseline compared to week 4, 8, and 12.

Countries

Norway

Contacts

Public ContactLars Jacob Stovner

Department of Neuroscience, NTNU

lars.stovner@ntnu.no

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026