Phase
Condition
Dyskinesias
Dystonia
Treatment
Xeomin
Placebo - Concentrate
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Informed Consent as documented by signature
Age ≥ 18 years
Focal hand dystonia (FHD). Diagnosis must be made by a neurologist specialized inmovement disorder (at least 2 years specific training, all partners listed have atleast 2 years training)
Both idiopathic and secondary FHD are allowed
Both drug naive subjects and subjects previously treated with other BoNT-A will beincluded
Patients must be willing and able to comply with the study procedures
Female patients of childbearing potential must agree to use an effective method ofcontraception during the treatment period
Exclusion
Exclusion Criteria:
Presence of spasticity, or other central sensorimotor lesion of motor system otherthan dystonia in the affected limb
Peripheral nerve lesion (diagnosis either clinical or electrophysiological) in theaffected limb, for example with a muscle weakness at baseline
Contraindications to the class of drugs under study, e.g. known hypersensitivity orallergy to BoNT-A toxins including IncobotulinumtoxinA
Doses and schedules of any ongoing treatment with potential confounding drugs suchas muscle relaxants (for example Tolperison, Tizinadid, Baclofen, Mestinon,Dantrolen), benzodiazepine, neuroleptics or antidepressants have to be keptunchanged throughout the study and no changes should be made between the first trialinjection and the end of study visit at week 12.
Previous treatment with other BoNT-A less than 3 months before the inclusion in thisstudy
Women who are pregnant or breast feeding,
Inability to follow the procedures of the study, e.g. due to language problems,psychological disorders, dementia, etc. of the participant
Participation in another study with investigational drug within the 30 dayspreceding and during the present study
Previous enrolment into the current study
Enrolment of the investigator, his/her family members, employees and other dependentpersons
Severe depression (>29 as measured with the Beck Depression Inventory, see Appendix
- or other relevant psychiatric disorder
- INR > 2 on the day of injection if the patient is anticoagulated. If INR > 2, thestudy injection will be delayed until the return to a safer INR.
Study Design
Study Description
Connect with a study center
Inselspital - University Hospital Berne
Berne, 3010
SwitzerlandSite Not Available
Centre hospitalier universitaire vaudois (CHUV)
Lausanne, 1001
SwitzerlandSite Not Available
Neurocentro della Svizzera Italiana
Lugano, 6900
SwitzerlandSite Not Available
Neurocenter of St. Gallen
St.Gallen, 9007
SwitzerlandSite Not Available
USZ- Univerity Hospital Zurich
Zurich, 8091
SwitzerlandSite Not Available
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