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

NCT02052024.

Methods Randomised controlled trial (complete; final data collection August 2015).
Setting: US.
Funding: Georgetown University (Solstice Neurosciences, a pharmaceutical company, listed as a collaborator).
Participants People aged ≥ 18 years with spasticity due to a disorder or trauma (e.g. spinal cord injury, brain injury, tumour, stroke, multiple sclerosis or peripheral nerve injury).
Interventions Intervention: botulinum toxin A (Botox), 100 U per injection, 1‐3 injections per muscle at each visit.
Comparator: botulinum toxin B (Myobloc), 5000 U per injection, 1‐3 injections per muscle at each visit.
Number of visits per week not reported but treatment administered for 36 weeks.
Outcomes Primary outcomes:
  • adverse events (muscle atrophy, measured by volume and cross‐sectional area of muscle) at 36 weeks;

  • spasticity (Modified Ashworth Scale), measured before, during and after treatment at every visit, up to 36 weeks.

Notes We are unable to find any published results for this trial. As such, it was unclear what percentage of participants had TBI, or whether the results for this group is (or could be) presented separately.

TBI: traumatic brain injury.