IncobotulinumtoxinA (Xeomin) to Treat Focal Hand Dystonia: a Double-blind Placebo-controlled Randomized Multicenter Study: The "SwissHandSpasm" Study
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Alain Kaelin
- 入组人数
- 48
- 试验地点
- 5
- 主要终点
- Evaluation of the efficacy of IncobotulinumtoxinA on focal hand dystonia (FHD)
研究概览
简要总结
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.
详细描述
After a baseline evaluation, each patient will receive a first injection of IncobotulinumtoxinA or placebo (50:50 randomization) in a double blinding setting. Assessment of the Focal hand dystonia (FHD) will be done at each site by an investigator blinded to the treatment.
A first evaluation of the efficacy will be performed after 6 weeks. After 6 weeks, patients unsatisfied with treatment and wishing to continue the treatment will receive an injection of IncobotulinumtoxinA regardless of the treatment arm they were initially assigned to at baseline. These patients will subsequently be excluded from the study.
A second assessment will be performed after 12 weeks (only for patients not receiving a second injection of IncobotulinumtoxinA at week 6).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 subjects and subjects 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
排除标准
- •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 have to be kept unchanged throughout the study and no changes should be made between the first trial injection and the end of study visit at week
- •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.
研究组 & 干预措施
Xeomin®
Intramuscular IncobotulinumtoxinA (Xeomin®) injection under guidance (EMG and/or sonographic monitoring), 2.5 to 40 U in each muscle (max. 5 forearm- and/or hand muscles).
干预措施: Xeomin (Drug)
Placebo concentrate
Intramuscular Placebo injection under guidance (EMG and/or sonographic monitoring), in each muscle (max. 5 forearm- and/or hand muscles).
干预措施: Placebo - Concentrate (Drug)
结局指标
主要结局
Evaluation of the efficacy of IncobotulinumtoxinA on focal hand dystonia (FHD)
时间窗: 6 weeks
To evaluate patient's subjective impairment due to FHD on VAS for handwriting. The VAS for handwriting is a self-assessment scale drawn by the patients on a 10-cm line, on which 0 indicates the worst possible situation and 10 the best possible situation.
次要结局
- Evaluation of the effect of IncobotulinumtoxinA on writing pressure(6 and 12 weeks)
- Evaluation of the effect of IncobotulinumtoxinA on disease improvement(6 and 12 weeks)
- Evaluation of the effect of IncobotulinumtoxinA on writing speed(6 and 12 weeks)
- Evaluation of the effect of IncobotulinumtoxinA on muscle strength(6 and 12 weeks)
- Evaluation of the responders to IncobotulinumtoxinA treatment(6 and 12 weeks)
- Evaluation of the effect of IncobotulinumtoxinA on FHD symptoms severity(6 and 12 weeks)
- Evaluation of the effect of IncobotulinumtoxinA on functional status(6 and 12 weeks)
- Evaluation of the overall satisfaction of the patients following IncobotulinumtoxinA treatment(6 weeks)
- Need of re-injection(6 weeks)
- Safety outcomes: adverse events(6 and 12 weeks)
- Evaluation of the efficacy of IncobotulinumtoxinA on FHD(12 weeks)
- Evaluation of the effect of IncobotulinumtoxinA on writer's cramp improvement(6 and 12 weeks)
- Safety outcomes: pain(6 and 12 weeks)
- Safety outcomes: weakness(6 and 12 weeks)
- Evaluation of the effect of IncobotulinumtoxinA on depressive symptoms(6 and 12 weeks)
研究者
Alain Kaelin
Director of the Neurocenter of Southern Switzerland
Ente Ospedaliero Cantonale, Bellinzona