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. 2021 Jan 8;13(1):42. doi: 10.3390/toxins13010042

Table 10.

Lists the two RCTs identified with RLS and BoNT.

Study Study Design Method Results
Mittal, 2018 [275] Double-blinded, placebo-controlled crossover randomized controlled trial (RCT)
Formulation used: incobotulinumtoxinA
Sample size (N): 24
40 units each for tibialis anterior (TA), gastrocnemius (GCS) and 20 units in biceps femoris bilaterally
Controls were injected with saline
International restless legs syndrome score improved at Week 4 (p = 0.0036) and Week 6 (p = 0.0325). No significant improvement at Week 8 (p = 0.067)
They concluded that incobotulinumtoxinA injected improved RLS severity without adverse events
Nahab, 2008 [279] Double-blinded, placebo-controlled crossover RCT
Formulation used: onabotulinumtoxinA
n = 6
40 mU Quadriceps femoris (QF), 20 mU TA, 20 mU GCS, and 10 mU soleus (SOL) under EMG guidance
Max dose: 90 mU/leg
Controls were injected with saline
A statistically significant benefit was not noted, and adverse effects were similar with both groups

Abbreviations: EMG—Electromyography; GCS—Gastrocnemius; QF—Quadriceps femoris; RLS—Restless leg syndrome; RCT—Randomized controlled trial; SO—Soleus; TA—Tibialis anterior.