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. 2017 Nov 22;2017(11):CD008929. doi: 10.1002/14651858.CD008929.pub2

EUCTR2011‐005375‐16‐SE.

Methods Randomised controlled trial (completed).
Setting: Norway, Sweden, Denmark, Finland.
Funding: Institut Produits Synthèse (IPSEN) AB.
Participants 88 participants, with upper limb spasticity due to stroke or TBI (unclear what percentage had a TBI).
Interventions Intervention: low‐concentration dilution (100 U/mL) Dysport (abobotulinumtoxinA) injected via the neuromuscular junction targeted technique.
Comparison: high‐concentration dilution (300 U/mL) Dysport (abobotulinumtoxinA) injected via "current clinical practice technique."
Outcomes Outcomes measured as change from baseline at 4 and 12 weeks post‐treatment.
Primary outcomes:
  • spasticity (Modified Ashworth Scale);

  • adverse events.


Secondary outcomes:
  • pain (spasticity related pain measured by visual analogue scale);

  • Global Attainment Scale.

Notes Results available on the EU Clinical Trials Register site but the results for people with TBI are not presented separately, and it is unclear what percentage of participants had a brain injury. The authors reported that "Due to slow recruitment rate it was clear that the study would not be completed in a reasonable time frame, therefore the study was stopped early." Contacted study sponsor in April 2017 but no further information received.