Table 1 Completed Trials for Sialorrhea
From: RimabotulinumtoxinB in sialorrhea: systematic review of clinical trials
| Study | Design/Duration | Objective | N | Patient Population | Intervention | Glands injected | Efficacy Outcomes | Safety Outcomes |
|---|---|---|---|---|---|---|---|---|
| Chinnapongse R, et al; 2012 [24] | Multicenter, randomized, double-blind, sequential-dose escalation design | Evaluate safety, tolerability and efficacy of three BoNT-B doses subjects with sialorrhea | N = 54 | PD subjects with troublesome sialorrhea |
BoNT-B doses: 1500 units; 2500 units; or 3500 units or placebo | PG and SMG |
4 weeks post injection-significant improvement in DFSS and USFR. placebo (p ≤ 0.0009) | No serious AEs attributed to BoNT-B |
| Guidubaldi A, et al; 2011 [25] | Prospective, randomized, double-blind, crossover pilot study | Evaluate efficacy and tolerability of BoNT-A versus BoNT-B for the treatment of sialorrhea | N = 27 |
Patients with ALS or PD (n = 15 ALS; n = 12 PD) enrolled, |
250 units BoNT-A 2500 units BoNT-B Ultrasound-guided injections into parotid and submandibular glands performed | B/L PG and SMG |
Subjective and objective improvements in all patients Shorter latency to response with BoNT-B Similar mean benefit duration similar | Only toxin-related side effect was a change in saliva thickness |
| Jackson CE, et all; 2009 [26] | Double-blind, randomized study | Determine patient perception of benefit of BoNT-B treatment for sialorrhea in ALS patients | N = 20 | ALS patients with sialorrhea refractory to medical therapy | 2500 units of BoNT-B | B/L PG and SMG |
Global impression of improvement of 82% at 2 weeks vs. 38% placebo group (p < 0.05) Significant effect sustained at 4 weeks, with continued improvement at 12 wees (in 50% of patients) | No significant AEs (including dysphagia) reported |
| Ondo, et al; 2004 [27] | Double-blind placebo-controlled | Determine whether BoNT-B is safe and effective for sialorrhea in patients with PD | N = 16 | PD subjects with problematic sialorrhea | 1000 units BoNT-B into each parotid gland and 250 units into each submandibular gland) or placebo | PG and SMG | Improvement on the Visual Analogue Scale,global impressions of change, Drooling Rating Scale and DSFS in BoNT-B | Adverse events were considered mild |
| Lagalla G, et al; 2009 [28] | Double-blind, randomized, placebo-controlled study | Investigate safety, efficacy and effectiveness of BoNT-B into the parotid glands to reduce drooling in PD subjects | N = 36 | Advanced phase PD subjects who complained of disabling drooling | 4000 units BoNT-B or placebo | PG |
BTX-B patients showed a significant improvement in almost all subjective outcomes All BTX-B subjects reported sialorrhea reduction (moderate in 44.4%, and marked in 33.3%), vs 61.1% controls who denied benefit Benefits lasted on average 19.2 +/- 6.3 weeks in the BTX-B) |
Three BoNT-B patients complained of mild, transient swallowing difficulties starting 10 days after the injections and recovering within 2 weeks One BoNT-B patient showed a transient mild weakness of chewing. |
| Steinlechner, et al; 2010 [29] |
Double-blind placebo-controlled Patients were followed over 16 weeks | To evaluate the treatment effects, tolerance, and duration of BoNT-B in neuroleptic-induced (group 1) and PD-associated sialorrhea (group 2) | N = 9 |
Group 1: 4 patients Group 2: 5 patients | 2500 units BoNT-B) injected under ultrasound control | PG and SMG | “Large effect sizes* for improvement of sialorrhea” in patients treated with BoNT-B compared to placebo. Reduction of sialorrhea lasted for 8 to 16 weeks after a single injection. | No patient reported side effects. |