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Botox for shaky heads? new study tests relief

NCT ID NCT02555982

Symptom relief Sponsor: University Hospital, Clermont-Ferrand Source: ClinicalTrials.gov ↗

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether botulinum toxin (Botox) injections can reduce head shaking in people with essential head tremor, a condition that often doesn't respond to standard medicines or surgery. About 120 adults with troublesome head tremor received either Botox or a placebo shot, and researchers measured improvement using a standard rating scale. The goal was to see if Botox could safely ease symptoms and improve quality of life.

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

120 people

The number who actually took part.

Started

Jun 2016

Finished

Sep 2022

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

18 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 suffering from a head tremor without (isolated) or with associated * tremor in any other body parts. * The HT must be troublesome for the patients (TRS 2 for the head tremor * severity item). * Patients never treated with botulinum toxin or not treated with botulinum toxin for this indication for at least 4 months. * Men or women aged from 18 to 80 years old. * Social security coverage. * Ability to provide informed consent. Exclusion Criteria: * Patients with tremor from cerebellar syndrome (multiple sclerosis, etc.). * Patients with a predominant dystonic jerky or myoclonic head tremor using * the Tsui scale (\>1). * Oral treatments for HT are allowed but must be stable during the study. * Any contra-indication to Botulinum toxin. * Women without efficient contraception. * Patients under supervision or (legal) guardianship.

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Conditions

The condition(s) this trial relates to.

essential tremor

As listed by the trial registrant

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

Essential head tremor

Contacts and locations

Locations

  • AP-HP

    Paris, France

  • CH Narbonne

    Narbonne, France

  • CHU d'Amiens

    Amiens, France

  • CHU de Clermont-Ferrand

    Clermont-Ferrand, 63003, France

  • CHU de Poitiers

    Poitiers, France

  • CHU de Toulouse

    Toulouse, France

  • Centre Hospitalier Pays D'Aix

    Aix-en-Provence, France

  • Fondation Rothschild

    Paris, France

  • Hopital Lariboisière

    Paris, France

  • Hôpital Caremeau

    Nîmes, France

  • Hôpital Haut-Levêque

    Bordeaux, France

  • Hôpital Jean Minjoz

    Besançon, France

  • Hôpital R Salendro

    Lille, France

  • Hôpital de Hautepierre

    Strasbourg, France

  • Hôpital de la Timone

    Marseille, France

  • Hôpital neurologique

    Lyon, France

  • Hôptal Avicenne de Bobigny

    Paris, France