Effect of Botulinum Toxin on Resting Tremor of the Refractory Upper Limb in Parkinsonians

NCT07822893 | Not Yet Recruiting Phase 3

• 3 other identifiers: RC31/25/0444PHRC 24-792026-525862-23-00
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 2

Brief Summary

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, the investigators 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.

Conditions

PARKINSON DISEASE (Disorder)

Keywords

parkinson disease; resistant tremor; botulinic toxin; precision medicine

Outcome Measures

Primary Outcomes (1)

• The effect of botulinum toxin on the resting tremor of the upper limb refractory to treatments

  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

Secondary Outcomes (17)

• The effect of botulinum toxin on the resting tremor: evolution evaluated by the investigator

  7,5 months

• The effect of botulinum toxin on the resting tremor: severity evaluated by the investigator

  7,5 months

• The effect of botulinum toxin on the resting tremor: amplitude evaluated by the investigator

  7,5 months

• The effect of botulinum toxin on the resting tremor: patient-assessed severity

  7,5 months

• The effect of botulinum toxin on the postural tremor: evolution evaluated by the investigator

  7,5 months

Other Outcomes (1)

• The factors associated with good response to botulinum toxin treatment

  12 months

Study Arms (2)

Botulinum toxin followed by placebo arm

EXPERIMENTAL

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).

Drug: Injection of Dysport then placebo

Placebo followed by botulinum toxin arm

EXPERIMENTAL

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).

Drug: Injection of placebo then Dysport

Interventions

Injection of Dysport then placebo DRUG

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.

Botulinum toxin followed by placebo arm

Injection of placebo then Dysport DRUG

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.

Placebo followed by botulinum toxin arm

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Person affiliated with or beneficiary of a social security scheme;

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (2)

Nîmes University Hospital

Nîmes, 30 029, France

Location

Pierre Paul Riquet Hospital - Toulouse University Hospital

Toulouse, 31 059, France

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Clémence Leung, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clémence Leung, MD

CONTACT

05 61 77 61 76; leung.c@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2026
• First Posted: September 16, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): October 1, 2029
• Last Updated: September 22, 2026

Record last verified: 2026-09

Locations

FR (2)