Gonyautoxin 2/3 in the Treatment of Acute Back Pain: A Clinical Proof-of-concept Study
Condition: Back Pain; Acute Pain
MeSH terms: Back Pain; Acute Pain
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This was an interventional, double-blind, placebo controlled, randomized, single dose,
      proof-of-concept study. It was a single-center clinical trial.

      The purpose of the study was to explore the clinical efficacy and safety of a single local IM
      injection of gonyautoxin 2/3 (GTX 2/3) compared to placebo in decreasing pain and improving
      lumbar functionality at short term follow-up in adult patients with acute low back pain,
      without radiculopathy.
    

Detailed description: 
      This was an interventional, double-blind, placebo controlled, randomized, single dose,
      proof-of-concept study. It was a single-center clinical trial.

      The primary objective was to determine the clinical efficacy of GTX 2/3 in the decrease of
      pain and in the functional improvement of adults patients with acute back pain with no
      associated radiculopathy. The secondary objective was to determine the safety of a local
      intramuscular injection of GTX 2/3 in adults patients with acute back pain.

      Thirty subjects were studied in 2 groups, each consisting of 15 subjects. One group received
      the Investigational Medicinal Product (IMP) and the other group received placebo.

      The eligible patients were adults, from both sex, aged between 18 and 70 years, with an
      episode of acute back pain without radiculopathy, with a pain intensity higher than 4 in the
      VAS scale, with no chronic pain and without any severe pathology.

      Each subject participated in 1 treatment group only. All subjects received IV administration
      of 100 mg Ketoprofen before the IMP injection. All patients returned for a follow-up visit at
      day 4 after dose administration and at day 7 for discharge. Follow up telephone calls were
      done on day 1, 2 and 3 after the administration.

      Each subject received only a single dose of GTX 2/3 or placebo during the study. Doses were
      administered as IM paravertebral injections, 1 mL per site. Total of 2 mL of GTX 2/3 or
      placebo. The IMP was supplied in glass vials containing 1.2 mL solution at a total GTX 2 and
      GTX 3 concentration of 40 mcg/mL (at a relative epimer ratio of 62% GTX 2:38% GTX 3). The
      total concentration of drug administrated was 80 mcg. Placebo was of identical appearance to
      the IMP.

      Patients that participated in the study had the possibility of using rescue medication. As a
      first line medication was Ketoprofen (maximum of 200 mg per day) and as a second line
      analgesia was Tramadol®.

      The primary efficacy endpoints were the mean change in pain intensity and lumbar function
      from baseline to day 4, as measured by VAS and RMDQ scores, respectively. Secondary outcomes
      were: 1) the mean change in pain intensity and lumbar function from baseline to day 7 as
      measured by VAS and RMDQ scores, respectively, 2) the frequency of use of rescue pain drugs
      during Days 1 to 3, and 3) the occurrence of adverse events during the 7 days of the study
      period.
    

Intervention name(s): GTX 2/3; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): There were 15 patients in this group. Each one received only one treatment.; There were 15 patients in this group. Each one received only one treatment.
Other intervention name(s): NAVX-010 (drug internal name); Gonyautoxin 2/3; Placebo of NAVX-010
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This was a double-blind, placebo-controlled, randomized study in patients with acute back pain. This was a proof of concept study to determine efficacy and safety in two groups: active and placebo. Each patient participated in only one group. This was a single-center clinical trial.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Low Back Pain; Acute Pain; Gonyautoxin; Paralytic Shellfish Poison; Muscle Relaxants