Botox injection in treatment of cluster headache

• Conditions: Pharmacological refractory cluster headache with durations of periods of attacks normally more than 2 months; MedDRA version: 14.1Level: LLTClassification code 10009698Term: Cluster headachesSystem Organ Class: 100000004852; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

• Registration Number: EUCTR2012-000248-91-NO
• Lead Sponsor: Institutt for nevromedisin, NT

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-10
• Last Update Posted: 16 November 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified