Pharmacological refractory cluster headache with durations of periods of attacks normally more than 2 months MedDRA version: 14.1 Level: LLT Classification code 10009698 Term: Cluster headaches System Organ Class: 100000004852
Conditions
Interventions
Trade Name: Botox
Product Name: Botox
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: OnabotulinumtoxinA
CAS Number: 93384-43-1
Other descriptive name: BOTULINUM TOXIN TYPE
Sponsors
Institutt for nevromedisin, NTNU
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - informed and written consent - man or woman from 18 to 65 years old - cluster headacheas defined in ICHD-2 criteria, durations of periods of attacks normally more than 2 months and insufficient effect of available prophylactic treatment 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 10 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - heart or lung disease - any kind of systemic or local disease or illness that may significantly increase the risk of complications for the procedure, related to the injections or anesthesia - phsyciatric illness that hinder participation in the study - known pregnacy - overuse or abuse of opiodes - abuse of medications, narcotics or alcohol. - allergy or any other hypersensitivity reactions against marcain, lidocain, xylocain or adrenalin, botulinum toxin type A, Botox or any of its constituents or any other related medications. - treatment with medication that can interact with botulinum toxin typeA.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety of injections of botulinum toxin towards the sphenopalatine ganglion in cluster headache;Secondary Objective: To evaluate the effect of the treatment;Primary end point(s): Safety aspects;Timepoint(s) of evaluation of this end point: For the follow-up period of 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Cluster headache intensity - Hours with cluster headache - Days with cluster headache;Timepoint(s) of evaluation of this end point: Average of baseline compared to average of week 3 and 4 after injection. | — |
Countries
Norway
Contacts
Public ContactLars Jacob Stovner
Institutt for nevromedisin, NTNU
Outcome results
None listed