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)
2026年9月10日 更新者：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.
調査の概要
状態
まだ募集していません
条件
詳細な説明
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.
研究の種類
介入
入学 (推定)
39
段階
- フェーズ 3
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Clémence Leung, MD
- 電話番号：+33 05 61 77 61 76
- メール：leung.c@chu-toulouse.fr
研究場所
-
-
-
Nîmes、フランス、30 029
- Nîmes University Hospital
-
コンタクト：
- Giovanni Castelnovo, MD
- 電話番号：+33 04 66 68 32 63
- メール：giovanni.castelnovo@chu-nimes.fr
-
主任研究者：
- Giovanni Castelnovo, MD
-
Toulouse、フランス、31 059
- Pierre Paul Riquet Hospital - Toulouse University Hospital
-
コンタクト：
- Clémence Leung, MD
- 電話番号：+33 05 61 77 61 76
- メール：leung.c@chu-toulouse.fr
-
主任研究者：
- Clémence Leung, MD
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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).
|
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.
|
|
実験的：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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The effect of botulinum toxin on the resting tremor of the upper limb refractory to treatments
時間枠：7,5 months
|
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.
|
7,5 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The effect of botulinum toxin on the resting tremor: evolution evaluated by the investigator
時間枠：7,5 months
|
It will be assessed by the CGI-C (Clinician Global Impression-Change) investigator-level change score, six weeks after injection.
|
7,5 months
|
|
The effect of botulinum toxin on the resting tremor: severity evaluated by the investigator
時間枠：7,5 months
|
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.
|
7,5 months
|
|
The effect of botulinum toxin on the resting tremor: amplitude evaluated by the investigator
時間枠：7,5 months
|
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.
|
7,5 months
|
|
The effect of botulinum toxin on the resting tremor: patient-assessed severity
時間枠：7,5 months
|
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.
|
7,5 months
|
|
The effect of botulinum toxin on the postural tremor: evolution evaluated by the investigator
時間枠：7,5 months
|
It will be assessed by the change score at the CGI-C investigator scale, at six weeks post-injection.
|
7,5 months
|
|
The effect of botulinum toxin on the postural tremor: severity evaluated by the investigator
時間枠：7,5 months
|
It will be assessed by the delta of severity scores at the CGI-S investigator level between injection and six weeks post-injection.
|
7,5 months
|
|
The effect of botulinum toxin on the postural tremor: amplitude evaluated by the investigator
時間枠：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.
|
7,5 months
|
|
The effect of botulinum toxin on the postural tremor: patient-assessed change
時間枠：7,5 months
|
It will be assessed by the PGI-C scale score completed by the patient six weeks after injection and compared between groups.
|
7,5 months
|
|
The effect of botulinum toxin on the postural tremor: patient-assessed severity
時間枠：7,5 months
|
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.
|
7,5 months
|
|
The effect of botulinum toxin on the Parkinsonian tremor (at rest and postural): duration
時間枠：12 months
|
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.
|
12 months
|
|
The effect of botulinum toxin on the Parkinsonian tremor (at rest and postural): amplitude
時間枠：7,5 months
|
It will be assessed by the mean angular amplitude measured using motion sensors placed on the hand and arm at six weeks post-injection.
|
7,5 months
|
|
The effect of botulinum toxin on the Parkinsonian tremor (at rest and postural): frequency
時間枠：7,5 months
|
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.
|
7,5 months
|
|
The effect of botulinum toxin on the patient's experience: life quality
時間枠：7,5 months
|
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.
|
7,5 months
|
|
The effect of botulinum toxin on the patient's experience: daily life activities
時間枠：7,5 months
|
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.
|
7,5 months
|
|
The safety of use for botulinum toxin: muscle weakness (1)
時間枠：7,5 months
|
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.
|
7,5 months
|
|
The safety of use for botulinum toxin: muscle weakness (2)
時間枠：7,5 months
|
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.
|
7,5 months
|
|
The safety of use for botulinum toxin: adverse events
時間枠：12 months
|
It will be assessed by all the adverse events collected during the study.
|
12 months
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The factors associated with good response to botulinum toxin treatment
時間枠：12 months
|
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.
|
12 months
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Clémence Leung, MD、University Hospital, Toulouse
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年10月1日
一次修了 (推定)
2029年10月1日
研究の完了 (推定)
2029年10月1日
試験登録日
最初に提出
2026年9月10日
QC基準を満たした最初の提出物
2026年9月10日
最初の投稿 (実際)
2026年9月16日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月16日
QC基準を満たした最後の更新が送信されました
2026年9月10日
最終確認日
2026年9月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- RC31/25/0444
- PHRC 24-79 (その他の助成金/資金番号：French Ministry of Health)
- 2026-525862-23-00 (その他の識別子：ID-RCB)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
未定
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。