Trigeminal neuralgia
Conditions
Interventions
Trade Name: BOTOX®
Product Name: BOTOX®
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Onabotulinumtoxin A
CAS Number: 93384-43-1
Other descriptive name: BOTULINUM TOXIN T
Sponsors
University Hospital Essen
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assessment of the clinical efficacy and safety of local injection of Onabotulinumtoxin A compared to placebo in the therapy of classical trigeminal neuralgia;Secondary Objective: Additional assessment of neurophysiological alterations of pain processing under BoTN-A therapy by pain-evoking potential and derivation of the nociceptive blink reflex;Primary end point(s): average number of cases of TN bouts during week four (= week 16 of therapy) after double-blind intervention in V2 of BoTN-A / Placebo injection;Timepoint(s) of evaluation of this end point: week 16 of therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Alteration of average frequency of bouts in week 4 after double-blind intervention (week 16 of therapy) compared to Baseline (days 1-7 before V0) and week 12 of therapy. 2. Alteration of average frequency of bouts in week 14, 18, 20 and 24 of therapy compared to Baseline and week 12 of therapy. 3. Intensity of bouts on a numerical rating scale (NRS) in week 14, 16, 18, 20 and 24 of therapy compared to Baseline and week 12 of therapy. 4. Cases of bouts compared to Baseline and V1. 5. Adverse events 6. Rescue-medication required compared to Placebo and run-in-phase 7. Number of days with TN bouts after V2 8. Therapy-Response (reduction of cases/day of bouts about = 30 %) in week 4, 8, and 12 of therapy compared to Baseline and in week 16, 20 und 24 of therapy compared to Baseline and week 12 of therapy. 9. Quality of life / Degree of impairment in daily living, scaled at V0, V2 and V4 by: a) SF-12, b) HIT-6, c) ADS 10. Questionnaires for adverse events (documented continuously): •Results of neurological examination (diagnostic finding of effective pathological value (yes/no) at V1, V2, V3 and V4 (compared to Baseline); • Results of physical examination (diagnostic finding of effective pathological value (yes/no)) at V1, V2, V3 and V4 • Clinical Global Impression at V1, V2, V3 and V4 ;Timepoint(s) of evaluation of this end point: see E.5.2 | — |
Countries
Germany
Contacts
Public ContactPrincipal Investigator
University Hospital Essen
Outcome results
None listed