2026-525862-23-00招募中2 期
Evaluation of the effect of botulinum toxin on refractory upper limb rest tremor in parkinsonian patients, double-blind, placebo-controlled cross-over study : TOX PARK
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- The primary endpoint is the Patient Global Impression-Change (PGI-C) score completed by the patient compared between botulinum toxin injection and placebo injection at 6weeks after the injection on treatment-refractory resting tremor of the upper limb, in patients with PD
研究概览
简要总结
The primary endpoint is the Patient Global Impression-Change (PGI-C) score completed by the patient compared between botulinum toxin injection and placebo injection at 6weeks after the injection on treatment-refractory resting tremor of the upper limb, in patients with Parkinson Disease.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patients with PD defined according to UKPDSBB criteria;
- •‐ Hommes et femmes âgés entre 40 et 80 ans
- •Patients with troublesome rest tremor assessed by the CGI-S scale ≥ 3 and persistent despite the initiation of ≥ two anti-parkinsonian treatments (levodopa, dopaminergic agonist, anticholinergic), which defines drug-resistant parkinsonian tremor;
- •Patients naïve to botulinum toxin treatment
- •Patients whose antiparkinsonian treatment has been stable for at least 4 weeks prior to inclusion and for the duration of the study
- •Person affiliated with or beneficiary of a social security scheme
- •Free, informed, and written consent signed by the participant and the investigator (no later than the day of inclusion and before any examination required by the research).
排除标准
- •Patients with tremors related to a pathology other than PD
- •Patients under legal guardianship, tutorship, or curatorship
- •Patients with atrophy of the targeted muscle
- •patients with a urinary tract infection at the time of treatment if the patient suffers from urinary incontinence due to neurological detrusor overactivity
- •patients with a history of swallowing or respiratory disorders
- •patients with marked clinical or subclinical neuromuscular transmission deficits (e.g., myasthenia gravis);
- •patients with a fixed contracture
- •Patients with atypical parkinsonian syndrome
- •Patients treated with drugs which have the adverse effect of causing the appearance or aggravation of tremors: lithium, sodium valproate, levetiracetam, benzodiazepines, corticosteroids, thyroid hormones, ciclosporin, alcohol, tricyclic antidepressants, theophillyne, terbutalineantipsychotics (excluding clozapine) ;
- •Patients with hypersensitivity to the active substance or to one of the excipients (human albumin, lactulose);
- •Pregnant or breastfeeding women
- •Women of childbearing age without effective contraception
研究组 & 干预措施
Dysport 500 U, poudre pour solution injectable
Test
干预措施: Dysport 500 U, poudre pour solution injectable (Drug)
NaCl
Placebo
干预措施: NaCl (Drug)
Entonox 50%/50% gaz medicinal comprimat
Auxiliary
干预措施: Entonox 50%/50% gaz medicinal comprimat (Drug)
结局指标
主要结局
The primary endpoint is the Patient Global Impression-Change (PGI-C) score completed by the patient compared between botulinum toxin injection and placebo injection at 6weeks after the injection on treatment-refractory resting tremor of the upper limb, in patients with PD
The primary endpoint is the Patient Global Impression-Change (PGI-C) score completed by the patient compared between botulinum toxin injection and placebo injection at 6weeks after the injection on treatment-refractory resting tremor of the upper limb, in patients with PD
次要结局
- 1. The effect of botulinum toxin: a. on resting tremor will be measured by: i. The change score on the CGI-C (Clinician Global Impression-Change) investigator scale, at six weeks post-injection; ° The delta of the severity scores on the CGI-S (Clinician Global Impression-Severity) investigator scale between injection and six weeks post-injection; ° The delta of the score of item 3.17 (amplitude) on the MDS-UPDRS III investigator scale between injection and six weeks post-injection; ii. The de
- The effect of botulinum toxin on the patient's experience will be measured by: a. The delta of the patient's quality of life score on the PDQ-39 self-questionnaire between the injection and six weeks post-injection b. The delta of the activities of daily living score using the MDS-UPDRS part two scale between injection and six weeks post-injection
- Safety of use will be measured by: a. The delta of the measurement in Newtons of the manual dynamometer, for the treated hand, between the injection and six weeks post-injection The delta of the scores for severity of muscle weakness in the treated hand, using the PGI-S scale (Patient Global Impression-Severity) completed by the patient between the injection and six weeks post-injection Collection of adverse events throughout the duration of the study
研究者
Clemence Leung
Scientific
Centre Hospitalier Universitaire De Toulouse
研究点 (2)
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