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Study of the Effects on Motor Recovery of Early Post-stroke Spasticity Treatment (BacloTox)

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ClinicalTrials.gov Identifier: NCT02462317
Recruitment Status : Recruiting
First Posted : June 4, 2015
Last Update Posted : December 3, 2018
Sponsor:
Collaborator:
Merz Pharmaceuticals GmbH
Information provided by (Responsible Party):
University Hospital, Toulouse

Brief Summary:
Stroke is the first cause of motor impairment and disability in adults. Then the main objective of rehabilitation during the first six months following stroke is to facilitate motor recovery. Many post-stroke hemiplegics develop spasticity which is responsible for an increase of disability. Then antispastic drugs are frequently prescribed to the patients even during the post-stroke recovery phase. Until recently most of french patients were treated by oral tablets of baclofen. Now the number of patients receiving intramuscular injections of botulinum A toxin is increasing. However in the literature, these drugs have been tested in post-stroke spasticity during the chronicle phase, after the sixth month and their action on motor recovery remain largely unknown. Then it is necessary to evaluate more accurately the effects of its drugs on motor recovery. The main criterion of its study is the time course of Fugl-Meyer Motor Assessment (FMA). Spastic patients with a single stroke, since less than two months, will be included in the try. They receive at the same time oral tablets for five months and intramuscular injections. Patients are randomized in three arms planned with a distribution balanced by group of 5 patients with a 2 -2- 1 model: botulinum toxin and placebo baclofen (120 patients), oral baclofen and placebo botulinum toxin (120 patients), placebo baclofen and placebo botulinum toxin (60 patients). The FMA score will be assessed before treatment start, one month and three months later. Spasticity, functional abilities, capacity in the activities of daily life, pain and quality of life will be also assessed during the study with Tardieu score, Rivermead Motor Assessment scale, Barthel index, Rankin score, Visual Analogic Scale and Reintegration to Normal Life Index respectively. A positive difference of 12 points in the time course of FMA in the botulinum toxin group in comparison with the baclofen group will be considered as the minimum relevant effect. 300 patients have been planned to be included in 20 centers during the 2 years of trial.

Condition or disease Intervention/treatment Phase
Muscle Spasticity Drug: botulinum A toxin Drug: Baclofen Drug: Placebo toxin Drug: placebo baclofen Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Study of the Effects on Motor Recovery of Early Post-stroke Spasticity Treatment: Double Blinded Comparison Between Botulinum Toxin and Baclofen.
Study Start Date : April 2015
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Baclofen

Arm Intervention/treatment
Active Comparator: botulinum A toxin
Patients are injected with botulinum toxin in a standardized protocol and received placebo baclofen tablets (120 patients)
Drug: botulinum A toxin
botulinum toxin injection
Other Name: Drug injection

Drug: placebo baclofen
placebo oral tablet
Other Name: placebo drug

Active Comparator: Baclofen
Patients are injected with placebo in a standardized protocol and received baclofen tablets (120 patients)
Drug: Baclofen
baclofen oral tablet
Other Name: Drug

Drug: Placebo toxin
placebo injection
Other Name: placebo injection

Placebo Comparator: double Placebo
Patients are injected with placebo in a standardized protocol and received placebo baclofen tablets (60 patients)
Drug: Placebo toxin
placebo injection
Other Name: placebo injection

Drug: placebo baclofen
placebo oral tablet
Other Name: placebo drug




Primary Outcome Measures :
  1. Motor recovery with time course of Fugl-Meyer Assessment scale [ Time Frame: month 3 ]
    A positive difference of 12 points in the time of course of Fugl-Meyer motor Assessment scale (FMA) from inclusion to the third month, between the results obtained in the botulinum toxin group and those of the baclofen group will be considered as the minimum relevant effect.


Secondary Outcome Measures :
  1. none inferiority of motor recovery with time course of Fugl-Meyer Assessment scale [ Time Frame: month 3 ]
    A none inferiority of the FMA time course between the results of the botulinum toxin group and the placebo group will be researched.

  2. Spasticity with Tardieu scale [ Time Frame: Month 1 and 3 ]
    A comparison of efficacy of the two treatments on spastic symptoms using Tardieu scale.

  3. Function with Rivermead Motor Assessment score, [ Time Frame: month 3 ]
    Functional impact of early treatment of post-stroke spasticity: comparison of changes in the Rivermead Motor Assessment score during the three months of protocol between all groups.

  4. Quality of life : Reintegration to Normal Life Index [ Time Frame: month 3 ]
  5. Pain : Visual Analogic Scale [ Time Frame: Month 1 and 3 ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02462317


Contacts
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Contact: Philippe MARQUE, MD, PhD 5 61 32 28 01 ext 33 marque.ph@chu-toulouse.fr

Locations
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France
University Hospital, Toulouse Recruiting
Toulouse, Haute-Garonne, France, 31059
Contact: Philippe MARQUE, MD PHD    5 61 32 28 01 ext 33    marque.ph@chu-toulouse.fr   
Principal Investigator: Philippe MARQUE, MD PHD         
CHU Jean Minjoz Not yet recruiting
Besançon, France, 25030
Contact: Bernard PARRATTE, MD PHD    3 63 08 25 51 ext 33    bernard.parratte@univfcomte.fr   
Groupe Pellegrin, University Hospital Bordeaux Not yet recruiting
Bordeaux, France, 33076
Contact: Patrick DEHAIL, PHD MD    556796006 ext 33    patrick.dehail@chubordeaux.fr   
Centre de rééducation MARIENIA Not yet recruiting
Cambo Les Bains, France, 64250
Contact: Michel BEGUE, MD    559936801 ext 33    m.begue@marienia.fr   
Centre Bouffard- Vercelli Not yet recruiting
Cerbere, France, 66290
Contact: Michel ENJALBERT, MD    4 68 88 75 00 ext 33    michel.enjalbert@wanadoo.fr   
University Hospital Dijon Not yet recruiting
Dijon, France, 21079
Contact: Charles BENAIM, MD PHD    380293643 ext 33    charles.benaim@chu-dijon.fr   
University Hospital Grenoble Not yet recruiting
Echirolles, France, 38434
Contact: Dominic PERENNOU, MD PHD    4 76 76 60 83 ext 33    DPerennou@chu-grenoble.fr   
Hôpital R. Poincarré Not yet recruiting
Garches, France, 92380
Contact: Alexis SCHNITZER, MD    1 47 10 77 26 ext 33    alexis.schnitzler@rpc.aphp.fr   
Hôpital Swynghedauw Not yet recruiting
Lille, France, 59000
Contact: Etienne ALLART, MD    3-20-44-58-32 ext 33    Etienne.ALLART@CHRU-LILLE.FR   
Hôpital J Rebeyrol Not yet recruiting
Limoges, France, 87042
Contact: Jean- Christophe DAVIET, MD PHD    5 55 05 65 13 ext 33    jean-Christophe.Daviet@chu-limoges.fr   
CHU Gui de Chauliac Not yet recruiting
Montpellier, France, 34295
Contact: Isabelle LAFFOND, MD    4 67 33 87 17 ext 33    i-laffont@chu-montpellier.fr   
University Hospital Carémeau Not yet recruiting
Nimes, France, 30029
Contact: Frédéric PELLAS, MD PHD    4 66 68 34 59 ext 33    frederic.pellas@chu-nimes.fr   
Hopital Rothschild Not yet recruiting
Paris, France, 75012
Contact: Gilberte ROBAIN, MD PHD    1 49 59 46 97 ext 33    gilberte.robain@rth.aphp.fr   
GH Lariboisière F.Widal Not yet recruiting
Paris, France, 75013
Contact: Alain YELNIK, MD PHD    1 40 05 48 51 ext 33    alain.yelnik@lrb.aphp.fr   
Groupe Hospitalier Pitié-Salpêtrière Not yet recruiting
Paris, France, 75013
Contact: Dominique MAZEVET, MD    1 42 16 11 48 ext 33    dominique.mazevet@psl.aphp.fr   
Université Reims Champagne Ardenne Not yet recruiting
Reims, France, 51092
Contact: François BOYER, MD PHD    3 26 78 44 80 ext 33    fboyer@chu-reims.fr   
Pôle MPR St Hélier Not yet recruiting
Rennes, France, 35000
Contact: Philippe GALLIEN, MD    2 99 29 50 80 ext 33    philippe.gallien@polesthelier.com   
Sponsors and Collaborators
University Hospital, Toulouse
Merz Pharmaceuticals GmbH
Investigators
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Principal Investigator: Philippe MARQUE, MD, PhD University Hospital, Toulouse

Publications:

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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT02462317     History of Changes
Other Study ID Numbers: 10 140 01
2010-022881-28 ( EudraCT Number )
First Posted: June 4, 2015    Key Record Dates
Last Update Posted: December 3, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by University Hospital, Toulouse:
Spasticity
Post stroke motor recovery
Botulinum toxin
Baclofen
Pharmacological modulation

Additional relevant MeSH terms:
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Muscle Spasticity
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents