PMID- 33262641
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220418
IS  - 1178-7090 (Print)
IS  - 1178-7090 (Electronic)
IS  - 1178-7090 (Linking)
VI  - 13
DP  - 2020
TI  - Tolperisone for the Treatment of Acute Muscle Spasm of the Back: Results from the 
      Dose-Ranging Phase 2 STAR Study (NCT03802565).
PG  - 3059-3069
LID - 10.2147/JPR.S278857 [doi]
AB  - OBJECTIVE: Use of skeletal muscle relaxants (SMRs) for acute muscle spasm is 
      confounded by central nervous system adverse events (AEs), including somnolence. 
      Tolperisone is an SMR that does not appear to be associated with somnolence. The 
      aim of this study was to assess the safety and efficacy of tolperisone versus 
      placebo in subjects with acute muscle spasm of the back. METHODS: STAR 
      (NCT03802565) was a double-blind, randomized, placebo-controlled phase 2 study in 
      subjects with back pain due to acute muscle spasm. Subjects were randomized 
      1:1:1:1:1 to tolperisone 50, 100, 150, or 200 mg three times daily (TID) or 
      placebo for 14 days. The primary efficacy endpoint was subject-rated pain "right 
      now" using a numeric rating scale on day 14. RESULTS: Subjects (tolperisone, 
      n=337; placebo, n=78) were enrolled at 38 US clinical sites. Tolperisone was well 
      tolerated, with AEs in 18.1% of subjects receiving tolperisone versus 14.1% of 
      subjects receiving placebo. Headache (7.1%) and diarrhea (2.4%) were the most 
      frequent AEs in tolperisone-treated subjects versus 3.8% and 0%, respectively, in 
      placebo-treated subjects. Somnolence was reported in 1.2% and 2.6% of subjects 
      treated with tolperisone and placebo, respectively. Mean change from baseline in 
      numeric rating scale score of pain "right now" on day 14 was -3.5 for placebo 
      versus -4.2, -4.0, -3.7, and -4.4 for tolperisone 50, 100, 150, and 200 mg TID, 
      respectively (linear test of trend on the least-squares mean difference 
      [treatment-placebo]; p=0.0539). In an analysis of pairwise estimates 
      (treatment-placebo), the greatest numerical difference and significance were 
      observed for tolperisone 200 mg TID (p=0.0040). Several secondary endpoints 
      trended toward significance for tolperisone 200 mg TID versus placebo. 
      CONCLUSION: Tolperisone 200 mg TID may be a promising treatment for acute muscle 
      spasm, without the somnolence associated with SMRs. The safety and efficacy of 
      tolperisone should be evaluated in a phase 3 trial.
CI  - (c) 2020 Nalamachu et al.
FAU - Nalamachu, Srinivas
AU  - Nalamachu S
AD  - Mid America PolyClinic, Overland Park, KS, USA.
FAU - Pergolizzi, Joseph
AU  - Pergolizzi J
AUID- ORCID: 0000-0001-5658-1471
AD  - NEMA Research, Naples, FL, USA.
FAU - Kaye, Randall
AU  - Kaye R
AD  - Neurana Pharmaceuticals, Inc., San Diego, CA, USA.
LA  - eng
PT  - Journal Article
DEP - 20201123
PL  - New Zealand
TA  - J Pain Res
JT  - Journal of pain research
JID - 101540514
PMC - PMC7695600
OTO - NOTNLM
OT  - *acute muscle spasm
OT  - *skeletal muscle relaxant
OT  - *somnolence
OT  - *tolperisone
COIS- S. Nalamachu is a consultant for Neurana Pharmaceuticals, Pfizer, and Lilly. J. 
      Pergolizzi is a consultant/speaker and researcher for US WorldMeds, BDSI, Salix, 
      Enalare, Scilex, Pfizer, Lilly, Teva, Regeneron, RedHill, Grunenthal, and 
      Neumentum. R. Kaye is an employee of and owns stock in Neurana Pharmaceuticals. 
      The authors report no other conflicts of interest in this work.
EDAT- 2020/12/03 06:00
MHDA- 2020/12/03 06:01
PMCR- 2020/11/23
CRDT- 2020/12/02 05:32
PHST- 2020/08/29 00:00 [received]
PHST- 2020/10/28 00:00 [accepted]
PHST- 2020/12/02 05:32 [entrez]
PHST- 2020/12/03 06:00 [pubmed]
PHST- 2020/12/03 06:01 [medline]
PHST- 2020/11/23 00:00 [pmc-release]
AID - 278857 [pii]
AID - 10.2147/JPR.S278857 [doi]
PST - epublish
SO  - J Pain Res. 2020 Nov 23;13:3059-3069. doi: 10.2147/JPR.S278857. eCollection 2020.