Evaluation of the Effect of Botulinum Toxin on Resting Tremor of the Refractory Upper Limb in Parkinsonians, Cross-over Study, Double Blind and Placebo-controlled (TOX PARK)
2026년 9월 10일 업데이트: University Hospital, Toulouse
Tremor is one of the most common symptoms in Parkinson Disease (PD), affecting almost 60% of patients.
There is currently no specific treatment for tremor in PD, and 30% of patients develop drug-resistant tremor, making its management more complex.
Botulinum toxin (BT) is widely used in neurology, but few studies have been carried out on the effect of BT in parkinsonian tremor without consensus on its management in parkinsonian patients.
In this study, we therefore propose to evaluate the effect of BT injected using precision medicine in the treatment of refractory resting tremor in patients with PD, compared with placebo injection.
연구 개요
상태
아직 모집하지 않음
정황
상세 설명
Parkinson's disease (PD) is the second most common neurodegenerative disease.
Tremor is one of the most common symptoms, affecting almost 60% of patients.
It has a considerable impact on their quality of life, causing psychosocial stress in over 25% of patients.
There is currently no specific treatment for tremor in PD, and 30% of patients develop drug-resistant tremor, making its management more complex.
Botulinum toxin (BT) has been approved in France in 1994 and is widely used in neurology.
To date, few studies have been carried out on the effect of BT in parkinsonian tremor: most have been open-label and have mixed parkinsonian patients and patients with essential tremor.
Therefore, there is no consensus on the management of tremor in patients with PD.
Nevertheless, there is a real need for treatment of refractory tremor, particularly in elderly patients, patients who cannot tolerate high doses of medication or patients who are ineligible for neurostimulation.
In this study, we therefore propose to evaluate the effect of BT injected using precision medicine in the treatment of refractory resting tremor in parkinsonian patients, compared with placebo injection.
We hypothesize that BT treatment improves parkinsonian tremor in a clinically relevant way compared to placebo injection using an optimized and personalized injection technique (doses of toxin and muscles injected).
The drug will be injected intramuscularly into the muscles identified as responsible for the tremor, by an investigator specialising in injections.
PD patients with resistant tremor will be included and followed up in this study for one year.
BT or placebo will be injected at 6 months apart in all patients thanks to the cross over study design.
연구 유형
중재적
등록 (추정된)
39
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Clémence Leung, MD
- 전화번호: +33 05 61 77 61 76
- 이메일: leung.c@chu-toulouse.fr
연구 장소
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Nîmes, 프랑스, 30 029
- Nîmes University Hospital
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연락하다:
- Giovanni Castelnovo, MD
- 전화번호: +33 04 66 68 32 63
- 이메일: giovanni.castelnovo@chu-nimes.fr
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수석 연구원:
- Giovanni Castelnovo, MD
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Toulouse, 프랑스, 31 059
- Pierre Paul Riquet Hospital - Toulouse University Hospital
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연락하다:
- Clémence Leung, MD
- 전화번호: +33 05 61 77 61 76
- 이메일: leung.c@chu-toulouse.fr
-
수석 연구원:
- Clémence Leung, MD
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Patients with PD defined according to UKPDSBB criteria;
- Men and women aged between 40 and 80 years;
- 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).
Exclusion Criteria:
- Patients with tremors related to a pathology other than PD;
- 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, terbutaline, antipsychotics (excluding clozapine) ;
- Patients with hypersensitivity to the active substance or to one of the excipients (human albumin, lactulose);
- patients with atrophy of the target 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 fixed contractures Pregnant or breastfeeding women;
- Women of childbearing age without effective contraception;
- Patients under legal guardianship, tutorship, or curatorship.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Botulinum toxin followed by placebo arm
In this cross-over study, the patient will be his or her own control.
The patient will receive both treatments at 6 months apart: DYSPORT followed by the placebo (the order of injections has been randomly assigned).
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Both treatments, first DYSPORT 500UI for 6 months then placebo, also for 6 months, will be administered intramuscularly using the same schedule and procedures thus allowing the blind to be maintained.
The two injections will be carried at 6 months apart: the drug will be injected intramuscularly, into the muscles identified as responsible for the tremor, by an investigator specialized in carrying out injections.
The doses injected will depend on the severity of the tremor and the number of muscles injected, which is conditioned by the tremor phenotype.
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실험적: Placebo followed by botulinum toxin arm
In this cross-over study, the patient will be his or her own control.
The patient will receive both treatments at 6 months apart: placebo followed by DYSPORT (the order of injections has been randomly assigned).
|
Both treatments, first placebo for 6 months then DYSPORT 500UI, also for 6 months, will be administered intramuscularly using the same schedule and procedures thus allowing the blind to be maintained.
The two injections will be carried at 6 months apart: the drug will be injected intramuscularly, into the muscles identified as responsible for the tremor, by an investigator specialized in carrying out injections.
The doses injected will depend on the severity of the tremor and the number of muscles injected, which is conditioned by the tremor phenotype.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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The effect of botulinum toxin on the resting tremor of the upper limb refractory to treatments
기간: 7,5 months
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It will be assessed by the PGI-C (Patient Global Impression-Change) score completed by the patient six weeks after injection and compared between treatments.
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7,5 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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The effect of botulinum toxin on the resting tremor: evolution evaluated by the investigator
기간: 7,5 months
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It will be assessed by the CGI-C (Clinician Global Impression-Change) investigator-level change score, six weeks after injection.
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7,5 months
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The effect of botulinum toxin on the resting tremor: severity evaluated by the investigator
기간: 7,5 months
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It will be assessed by the delta of severity scores at the CGI-S (Clinician Global Impression-Severity) investigator level between injection and six weeks post-injection.
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7,5 months
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The effect of botulinum toxin on the resting tremor: amplitude evaluated by the investigator
기간: 7,5 months
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It will be assessed by the delta of the item score 3.17 (amplitude) at the MDS-UPDRS III investigator level between injection and six weeks post-injection.
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7,5 months
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The effect of botulinum toxin on the resting tremor: patient-assessed severity
기간: 7,5 months
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It will be assessed by the delta of severity scores at the patient scale PGI-S (Patient Global Impression-Severity) between injection and six weeks post-injection.
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7,5 months
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The effect of botulinum toxin on the postural tremor: evolution evaluated by the investigator
기간: 7,5 months
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It will be assessed by the change score at the CGI-C investigator scale, at six weeks post-injection.
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7,5 months
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The effect of botulinum toxin on the postural tremor: severity evaluated by the investigator
기간: 7,5 months
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It will be assessed by the delta of severity scores at the CGI-S investigator level between injection and six weeks post-injection.
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7,5 months
|
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The effect of botulinum toxin on the postural tremor: amplitude evaluated by the investigator
기간: 7,5 months
|
It will be assessed by the delta of item 3.21 (amplitude) at the MDS-UPDRS III investigator level between injection and six weeks post-injection.
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7,5 months
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The effect of botulinum toxin on the postural tremor: patient-assessed change
기간: 7,5 months
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It will be assessed by the PGI-C scale score completed by the patient six weeks after injection and compared between groups.
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7,5 months
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The effect of botulinum toxin on the postural tremor: patient-assessed severity
기간: 7,5 months
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It will be assessed by the delta of severity scores on the PGI-S (Patient Global Impression-Severity) scale completed by the patient between the injection and six weeks post-injection.
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7,5 months
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The effect of botulinum toxin on the Parkinsonian tremor (at rest and postural): duration
기간: 12 months
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It will be assessed by the proportion of time the patient has a tremor, measured using an actimeter for 7 days prior to the assessment visit.
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12 months
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The effect of botulinum toxin on the Parkinsonian tremor (at rest and postural): amplitude
기간: 7,5 months
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It will be assessed by the mean angular amplitude measured using motion sensors placed on the hand and arm at six weeks post-injection.
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7,5 months
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The effect of botulinum toxin on the Parkinsonian tremor (at rest and postural): frequency
기간: 7,5 months
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It will be assessed by the mean frequency in Hertz (Hz) measured using motion sensors placed on the hand and arm at six weeks post-injection.
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7,5 months
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The effect of botulinum toxin on the patient's experience: life quality
기간: 7,5 months
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It will be assessed by the delta of the patient's quality of life score on the PDQ-39 self-administered questionnaire between injection and six weeks post-injection.
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7,5 months
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The effect of botulinum toxin on the patient's experience: daily life activities
기간: 7,5 months
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It will be assessed by the delta of the daily life activities score by the MDS-UPDRS scale, parts one and two between injection and six weeks post-injection.
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7,5 months
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The safety of use for botulinum toxin: muscle weakness (1)
기간: 7,5 months
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It will be assessed by the delta of the measurement in Newton of the manual dynamometer, for the treated hand, between injection and six weeks after injection.
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7,5 months
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The safety of use for botulinum toxin: muscle weakness (2)
기간: 7,5 months
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It will be assessed by the delta of the severity scores for muscle weakness in the treated hand, on the PGI-S (Patient Global Impression Severity) scale, completed by the patient between the injection and six weeks after the injection.
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7,5 months
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The safety of use for botulinum toxin: adverse events
기간: 12 months
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It will be assessed by all the adverse events collected during the study.
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12 months
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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The factors associated with good response to botulinum toxin treatment
기간: 12 months
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The correct response to treatment will be determined from the scores of the PGI-S patient scale on the severity of the tremor and on the severity of the muscle weakness.
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12 months
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Clémence Leung, MD, University Hospital, Toulouse
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 10월 1일
기본 완료 (추정된)
2029년 10월 1일
연구 완료 (추정된)
2029년 10월 1일
연구 등록 날짜
최초 제출
2026년 9월 10일
QC 기준을 충족하는 최초 제출
2026년 9월 10일
처음 게시됨 (실제)
2026년 9월 16일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 16일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 10일
마지막으로 확인됨
2026년 9월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- RC31/25/0444
- PHRC 24-79 (기타 보조금/기금 번호: French Ministry of Health)
- 2026-525862-23-00 (기타 식별자: ID-RCB)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
미정
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .