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2024-518147-37-00Not yet recruitingPhase 2

Upper-limb Active Function and Botulinum Toxin A

Source: EU CTIS (euclinicaltrials.eu) · Last updated 31 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open

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Brief summary (registry, in English)

Evaluer l’effet d’injections de toxine botulique A dans les fléchisseurs du coude sur la réduction des cocontractions spastiques au cours d’un mouvement d’extension active de coude chez des patients hémiplégiques vasculaires chroniques.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
80 (estimated)
First submitted
4 Oct 2024
Start date
18 Dec 2020
Lead sponsor
Centre Hospitalier Universitaire De Toulouse
Diseases
Stroke
EU CT number
2024-518147-37-00
EudraCT number
2018-000941-38

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 80
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

AI-kivonat: who the study is looking for

Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults who had a stroke more than 6 months ago and need botulinum toxin A injections in the elbow flexor muscles. A control group of adults without arm problems also takes part.

Age
Over 18 years
Sex
All sexes
Disease stage
Patient group: ischemic or hemorrhagic stroke more than 6 months ago. Active elbow extension of at least 20°, limited by at least 15° or done with a speed reduced by 50%.
Earlier treatment
Patient group: no earlier botulinum toxin A (TBA) injection, or more than 4 months since a first TBA injection in the elbow flexors. The doctor prescribes abobotulinumtoxinA (DYSPORT®).

Main reasons for not taking part

  • Passive limitation of elbow extension of more than 30°
  • Pain during active elbow bending or stretching
  • Unstable epilepsy, or progressive or decompensated neurological disease
  • Contraindication to botulinum toxin, such as myasthenia, swallowing disorders or skin infection at the injection site
  • Pregnant or breastfeeding women

Read by machine on 9 Nov 2026.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Patient group: Cognitive disorder limiting the understanding of three basic instructions (test type of the 3 MMS papers test)
  • Patient group: Unstable epilepsy
  • Patient group: Anticoagulant treatment at curative dose or haemostasis disorder (prolonged bleeding time) contraindicating intramuscular injections

Lab values

  • Patient group: General contraindication to the use of botulinum toxin: hypersensitivity to the active substance (toxin-haemagglutinin complex BoTX-A) or to one of the excipients (albumin solution), history of myasthenia, Lambert Eaton syndrome, history of neuromuscular disease, surgery with curarization for less than 1 month, treatment with aminoglycosides, aminoquinolines, cyclosporine or anticholinesterases, History or presence of swallowing disorders (choking on solids or liquids), History or presence of chronic respiratory disorders (known respiratory failure), presence of a skin infection or inflammation at the injection site

Other

  • Patient group: Passive limitation of elbow extension > 30°
  • Patient group: Legal incapacity (judicial protection, curatorship, guardianship)
  • Patient group: Pregnant or breastfeeding women
  • Patient group: Women who want to become pregnant within 18 months
  • Patient group: Premenopausal women (menopause being defined by an absence of menstruation for at least 12 months without medical intervention) not using one of the following methods of contraception considered to be very reliable: intrauterine device, estrogen-progestin or progestin contraception inhibiting ovulation delivered by an implanted subcutaneous device, or tubal ligation.
  • Control group: History or progressive orthopedic or neurological damage to the upper limbs
  • Control group: Subject expert in a sport requiring intensive use of the upper limbs (competition, at least departmental level)
  • Control group: Legal incapacity (judicial protection, curatorship, guardianship).
  • Patient group: Pain when performing active elbow flexion/extension movements
  • Patient group: Boston Diagnostic Severity Aphasia Examination score ≤3
  • Patient group: Progressive or decompensated neurological pathology
  • Patient group: Claustrophobia or metallic foreign bodies contraindicating the performance of an MRI

Who the study is looking for

  • Patient group: Ischemic or hemorrhagic stroke of more than 6 months, of cortical and/or subcortical location
  • Control group: Age > 18 years
  • Control group: Signing of informed consent.
  • Patient group: Indication for performing a TBA injection in the elbow flexor muscles according to the usual clinical criteria: presence of a functional or aesthetic complaint expressed by the patient, linked to muscular hyperactivity (spasticity or co-contraction) on the elbow flexor muscles, and requiring focal treatment by injection of botulinum toxin
  • Patient group: Being prescribed the molecule abobotulinumtoxinA (DYSPORT®, Ipsen-Pharma)
  • Patient group: Possibility of active elbow extension of at least 20°
  • Patient group: Limitation of active elbow extension movement by at least 15° or performance of a complete movement with a speed reduced by 50%
  • Patient group: TBA-naïve patients or more than 4 months after a first TBA injection, targeting the elbow flexors
  • Patient group: Age > 18 years
  • Patient group: Signing of informed consent
  • Patient group: Patient affiliated to a social security scheme.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (2)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Centre Hospitalier De St Amand Les EauxSt Amand Les EauxFranceNot yet recruiting
Centre Hospitalier Universitaire de ToulouseToulouseFranceNot yet recruiting

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This page is information, not medical advice. Discuss any trial with your doctor.