Table 3.
Prospective clinical trials with incobotulinumtoxinA in spasticity
| Study design | Patients | Treatment cycles/study duration | Dose | Key efficacy outcomes |
|---|---|---|---|---|
| Randomized, double-blind, placebo-controlled, multicenter trial19 followed by an open-label, repeat-treatment extension.20 | Adults patients ≥6 months post-stroke. Wrist and finger flexor AS score ≥2 and moderate disability (DAS ≥2 in the principal therapeutic target). Main period: n=l48. Open-label extension period: n=l45. |
Injections permitted every ≥12 weeks. Main period: one treatment with incobotulinumtoxinA or placebo. Observation period: ≤20 weeks. Extension period: ≤5 incobotulinumtoxinA treatments. Total study duration: ≤89 weeks. |
≤400 U | Responder rates at 4 weeks post-treatment (defined as improvement of ≥1 point in AS score of wrist flexors): 68.5% for incobotulinumtoxinA versus 37.3% for placebo (P<0.00l). AS responder rates in all muscle groups 48.8%–80.6% after each injection session in the open-label phase. |
| Randomized, observer-blind, multicenter trial.21 | Adult patients. Focal spasticity of wrist flexors or wrist flexors AS score ≥2. n=l92. |
One treatment with incobotulinumtoxinA. Observation period: ≤20 weeks. |
≤400 U total dose 20 or 50 U/mL dilutions. | At 4 weeks post-injection, response defined as ≥1-point reduction on the DAS or a ≥1-point reduction on the AS occurred in 57.6% and 62.2% of patients, respectively. The 20 U/mL dilution was noninferior to the 50 U/mL dilution. |
| Prospective, open-label study.27 | Adult patients. Upper-limb post-stroke spasticity. n=20. |
Multiple treatments with retreatment permitted at 12 weeks after prior treatment. Study duration: 1 year. |
Total dose for first treatment: 160–450 U; total dose for last treatment: 120–350 U. | MAS scores, DAS scores, and spasm frequency were significantly reduced at all time points assessed (P≤0.001 for all). |
| Prospective, open-label study.28 | Adult patients. Lower-limb post-stroke spasticity. MAS=2 for ankle plantar flexor muscles. No previous botulinum toxin treatment. n=7l. |
One treatment. Assessments at 30 and 90 days after treatment. |
25–100 U per muscle | MAS was statistically reduced at 30 days and 90 days post-treatment (P=0.0000 for all). |
| Prospective, open-label, nonrandomized study.29 | Adult patients. Upper- and lower-limb post-stroke spasticity. AS score ≥2 for elbow, wrist, finger, and ankle flexors. n=25. |
One treatment. Assessments at 30 and 90 days after treatment. |
Total ≤840 U | Spasticity (AS) and pain (Visual Analog Scale) and disability (DAS) were significantly reduced at 30 days and at 90 days after injections versus baseline (P=0.0000 for all). |
Abbreviations: AS, Ashworth Scale; DAS, Disability Assessment Scale; MAS, modified Ashworth Scale.