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:
Secondary outcomes:
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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. |