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Which drug helps stroke recovery more? botox vs baclofen showdown

NCT ID NCT02462317

Symptom relief Sponsor: University Hospital, Toulouse 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 two treatments for muscle stiffness (spasticity) that often occurs after a stroke. 184 people who had a stroke within the past two months received either botulinum toxin injections, oral baclofen, or a placebo. The goal was to see which treatment better helps motor recovery and reduces disability during the early recovery phase.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

184 people

The number who actually took part.

Started

Apr 2015

Finished

Dec 2020

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: * First single stroke ischaemic or haemorrhagic responsible of an hemiplegia * Stoke since less than 2 month * A sufficient understood * A spasticity : a Tardieu score upper or equal to 2 on at least one of the following muscle-triceps surae, flexors of fingers, of wrist and of elbow * A free consent Exclusion Criteria: * Previous antispastic drugs * Contraindication for baclofen or toxin * Antecedent of epileptic seizure * Psychiatric antecedent

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Conditions

The condition(s) this trial relates to.

Muscle Spasticity

As listed by the trial registrant

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

Muscle spasticity

Contacts and locations

Locations

  • CHRU de Brest

    Brest, 29609, France

  • CHU Gui de Chauliac

    Montpellier, 34295, France

  • CHU Jean Minjoz

    Besançon, 25030, France

  • Centre Bouffard- Vercelli

    Cervera de la Marenda, 66290, France

  • Centre de rééducation MARIENIA

    Cambo-les-Bains, 64250, France

  • GH Lariboisière F.Widal

    Paris, 75013, France

  • Groupe Hospitalier Pitié-Salpêtrière

    Paris, 75013, France

  • Groupe Pellegrin, University Hospital Bordeaux

    Bordeaux, 33076, France

  • Hopital Rothschild

    Paris, 75012, France

  • Hôpital J Rebeyrol

    Limoges, 87042, France

  • Hôpital R. Poincarré

    Garches, 92380, France

  • Hôpital Swynghedauw

    Lille, 59000, France

  • Pôle MPR St Hélier

    Rennes, 35000, France

  • University Hospital Carémeau

    Nîmes, 30029, France

  • University Hospital Dijon

    Dijon, 21079, France

  • University Hospital Grenoble

    Échirolles, 38434, France

  • University Hospital, Toulouse

    Toulouse, Haute-Garonne, 31059, France

  • Université Reims Champagne Ardenne

    Reims, 51092, France

  • l'Institut Hélio Marin de la côte d'azur

    Hyères, 67082, France

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