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Effect of Botulinum Toxin on Resting Tremor of the Refractory Upper Limb in Parkinsonians
Sponsor: University Hospital, Toulouse
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.
Official title: 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
Key Details
Gender
All
Age Range
40 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
39
Start Date
2026-10
Completion Date
2029-10
Last Updated
2026-09-22
Healthy Volunteers
No
Conditions
Interventions
Injection of Dysport then placebo
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.
Injection of placebo then Dysport
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.
Locations (2)
Nîmes University Hospital
Nîmes, France
Pierre Paul Riquet Hospital - Toulouse University Hospital
Toulouse, France