Botox for the treatment of facial pain, provoked by an extremely painful irritation of the fifth cranial nerve

• Conditions: Trigeminal neuralgia; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2014-001959-24-DE
• Lead Sponsor: niversity Hospital Essen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06-27
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Male and female patients of 18 years of age,
• Patients of legal competence,
• Sufficient knowledge of written and spoken German,
• Diagnosis of classical trigeminal neuralgia according to the International Classification of Headache Disorders, third edition
• Min. three bouts per day between Screening and Baseline
• Unmodified prophylactic medication for TN (anti-epileptic drugs / Baclofen) during the last four weeks before study participation
• Unmodified dosing of medication which may have an influence on the frequence and intensity of bouts of TN (tricyclic antidepressants, opiods)
• Min. one therapeutic attempt of TN with Carbamazepin and in appropriate dose (min. 600 mg / d) either inadequate efficacy or intolerance during therapy
• Patient willing and capable of attending regular examination and follow-up visits and completing patient questionnaires accurately

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 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Intolerance or contraindications against Botox® according to SmPC:
o known intolerance/hypersensitivity against BoTN-A
o local inflammation / sign of infection at allocated injection site
• Pre-existing diseases with special warning notices according to SmPC:
• Known periphal motor neuropathic disease (e.g. amyotrophic lateral sclerosis)
• Known dysphagia, history of aspiration
• Known corneal ulceration
• History of neuromuscular disease (e.g. myasthenia gravis, Duchenne muscular dystrophy, Lambert-Eaton-Syndrome)
• Severe allergic diathesis
• Symptomatic cause of trigeminal complaints in terms of trigeminal neuropathic pain (e.g. associated with Herpes zoster, MSPlaque, post-traumatic or caused by local spherical mass)
• Trigeminal autonomic syndroms (SUNCT/SUNA, paroxysmal hemicrania, cluster headache)
• Ongoing substance/alcohol/medication abuse/dependence
• Known dysfunction of haemostasis (anamnesis, laboratory)
• Medical history, which induces an effective anticoagulation (e.g. atrial fibrillation)
• Severe or terminal diesease (e.g. cancer or tuberculosis)
• Chronic disease which causes impairment of absorption, metabolism, secretion of study medication
• Chronic hepatic disease or 3 fold increase in transaminases above normal
• Positive HIV-testing (anamnestic survey)
• Nursing women
• Pregnancy (pregnacy testing in fertile women)
• Fertile women with insufficient contraception
• Participation in a different clinical trial less than 30 days before inclusion
• Previous inclusion into BoTN-study
• Parallel participation in a different clinical trial

Study & Design

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