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Can a common toxin calm Parkinson's shaking hands?

NCT ID NCT07822893

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time

Summary

Many people with Parkinson's disease develop hand tremor that standard drugs cannot control. This Phase 3 trial tests whether botulinum toxin injections, guided by each patient's tremor pattern, can reduce that shaking. Participants receive either the toxin or a placebo injection into the specific arm muscles causing the tremor, then switch to the other treatment after six months. Researchers measure change in tremor severity six weeks after each injection.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
botulinum toxin type A (Dysport)
What this could lead to
If it works, botulinum toxin injections could become a targeted option for Parkinson's patients whose hand tremor does not respond to standard drugs.
What could go wrong
The trial is small, with 39 participants, and botulinum toxin injections into tremor muscles can cause temporary weakness in the treated arm. Results may not apply to all Parkinson's tremor types.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 39 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Oct 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Nîmes University Hospital

    Nîmes, 30 029, France

  • Pierre Paul Riquet Hospital - Toulouse University Hospital

    Toulouse, 31 059, France

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