BridgeMD
New treatment option for Focal Hand Dystonia
Official title IncobotulinumtoxinA (Xeomin) to Treat Focal Hand Dystonia
ClinicalTrials.gov ID: NCT03977493
What this study is testing
What is Xeomin?
Xeomin is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for focal hand dystonia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is a multicenter, double-blind, randomized placebo controlled, parallel group, superiority trial in order to test the superiority of intramuscular injections of IncobotulinumtoxinA against placebo using a 1:1 allocation ratio.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Informed Consent as documented by signature
- Age ≥ 18 years
- Focal hand dystonia (FHD). Diagnosis must be made by a neurologist specialized in movement disorder (at least 2 years specific training, all partners...
- Both idiopathic and secondary FHD are allowed
- Both drug naive people and people previously treated with other BoNT-A will be included
You likely can't join if
- Presence of spasticity, or other central sensorimotor lesion of motor system other than dystonia in the affected limb
- Peripheral nerve lesion (diagnosis either clinical or electrophysiological) in the affected limb, for example with a muscle weakness at baseline
- Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to BoNT-A toxins including IncobotulinumtoxinA
- Doses and schedules of any ongoing treatment with potential confounding drugs such as muscle relaxants (for example Tolperison, Tizinadid, Baclofen...
- Previous treatment with other BoNT-A less than 3 months before the inclusion in this study
- Women who are pregnant or breast feeding,
See the full eligibility criteria
- Informed Consent as documented by signature
- Age ≥ 18 years
- Focal hand dystonia (FHD). Diagnosis must be made by a neurologist specialized in movement disorder (at least 2 years specific training, all partners listed have at least 2 years training)
- Both idiopathic and secondary FHD are allowed
- Both drug naive people and people previously treated with other BoNT-A will be included
- Patients must be willing and able to comply with the study procedures
- Female patients of childbearing potential must agree to use an effective method of contraception during the treatment period
- Presence of spasticity, or other central sensorimotor lesion of motor system other than dystonia in the affected limb
- Peripheral nerve lesion (diagnosis either clinical or electrophysiological) in the affected limb, for example with a muscle weakness at baseline
- Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to BoNT-A toxins including IncobotulinumtoxinA
- Doses and schedules of any ongoing treatment with potential confounding drugs such as muscle relaxants (for example Tolperison, Tizinadid, Baclofen, Mestinon, Dantrolen), benzodiazepine, neuroleptics or antidepressants...
- Previous treatment with other BoNT-A less than 3 months before the inclusion in this study
- 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 days preceding and during the present study
- Previous enrolment into the current study
- Enrolment of the investigator, his/her family members, employees and other dependent persons
- Severe depression (\>29 as measured with the Beck Depression Inventory, see Appendix 8) or other relevant psychiatric disorder
- INR \> 2 on the day of injection if the patient is anticoagulated. If INR \> 2, the study injection will be delayed until the return to a safer INR.
The study team makes the final eligibility decision.
Where it's taking place
- Bern, Switzerland
- Lausanne, Switzerland
- Lugano, Switzerland
- Sankt Gallen, Switzerland
- Zurich, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bern, Switzerland; Lausanne, Switzerland; Lugano, Switzerland; Sankt Gallen, Switzerland; Zurich, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.