cervical dystonia MedDRA version: 21.0 Level: LLT Classification code 10064124 Term: Cervical dystonia System Organ Class: 100000004859
Conditions
Interventions
Trade Name: Botox(R) 50
Product Name: Botulinumtoxin Type A
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Botulinum Toxin Typ A
CAS Number: 93384-43-1
Other descriptive n
Sponsors
University Hospital Wuerzburg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Diagnosis of primary cervical dystonia = 2 years • Severity of dystonia = 20 points on the TWSTRS total and = 15 points on the TWSTRS motor scale • Age = 18 years and = 75 years • Motor response to BoNT Type A =25% score reduction on the TWSTRS motor scale at 4 weeks after a test injection. • Last injection of BoNT A = 12 weeks before screening • Willingness to undergo pallidal deep brain stimulation surgery • Written informed consent for the participation after written and verbal information by trail physician 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 46 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: • Severity of dystonia 25 ) (earlier episodes of major depression in remission are not excluded) • Dementia or minimal cognitive impairment (Mattis Score = 125) • Acute psychosis (benign hallucinations or earlier psychotic episodes are not excluded) • Any medical or psychological problems which may interfere with a smooth conduction of the study protocol (e.g. cancer with a limited life expectancy) • Analphabetism • Drug or alcohol addiction • Surgical contraindications againt pallidal neurostimulation • Fertile women not using adequate contraceptive methods (hormonal contraception, spiral, surgical sterilisation) • Pregnancy or breast feeding • Simultaneous participation in another clinical treatment trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: neurostimulation is superior to botulinum toxine injections in best clinical practice in controlling the symptoms of cervical dystonia ;Secondary Objective: neurostimulation achieves a better outcome in everyday functioning and a better health-related quality of life than botulinum toxine injections in best clinical practice. With this indication neurostimulation provides sufficient safety. ;Primary end point(s): Difference in TWSTRS total score between baseline and 6 months after stereotactic surgery with bilateral implantation of pallidal stimulation electrodes and generator under optimal therapy;Timepoint(s) of evaluation of this end point: 6 months after baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Difference in Craniocervical Dystonia Questionnaire (CDQ-24) between baseline and 6 months after surgery under optimal therapy • Changes in TWSTRS motor score • Changes in TSUI score • Chenges in SF-36 • Frequency and severity spontaneously reported adverse events/reactions unter BoNT a injections and sham stimulation or neurostimulation and sham injections;Timepoint(s) of evaluation of this end point: 6 months after baseline | — |
Countries
Germany
Contacts
Public ContactNeurology
University Hospital Wuerzburg
Outcome results
None listed