Gonyautoxin 2/3 in the Treatment of Acute Back Pain: A Clinical Proof-of-concept Study

NCT04799041 | Completed Phase 1

• 1 other identifier: CLN 17-032 (Chilean Number)
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Back Pain; Acute Pain

Keywords

Low Back Pain; Acute Pain; Gonyautoxin; Paralytic Shellfish Poison; Muscle Relaxants

Outcome Measures

Primary Outcomes (1)

• Efficacy of GTX 2/3 in the treatment of acute back pain after 4 days of administration.

  Change of pain (0- to 10-point on a Visual Analog Scale (VAS), 0 meaning no pain and 10 the worst pain) and/or functional improvement (0- to 24-point on the Roland-Morris Disability Questionnaire (RMDQ). Each question is one point so scores can range from 0 (no disability) to 24 (severe disability)) in patients with acute back pain without radiculopathy from baseline to day 4 day after one local administration of GTX 2/3 or placebo.

  4 days after one local administration

Secondary Outcomes (7)

• Efficacy of GTX 2/3 in the treatment of acute back pain after 7 days of administration.

  7 days after one local administration

• Pain evaluation after 2 hours of GTX 2/3 administration (Discharge of the hospital)

  2 hours after one local administration

• Pain evaluation on day 1 after GTX 2/3 administration.

  1 day after one local administration

• Pain evaluation on day 2 after GTX 2/3 administration.

  2 day after one local administration

• Pain evaluation on day 3 after GTX 2/3 administration.

  3 day after one local administration

Study Arms (2)

GTX 2/3

ACTIVE COMPARATOR

Dose level administered of GTX 2/3 was 80 mcg. Dose was administered as IM paravertebral injections, 1 mL per site. Total of 2 mL of GTX 2/3 was injected. 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).

Drug: GTX 2/3

Placebo

PLACEBO COMPARATOR

Placebo was of identical appearance to the IMP, and was administered as IM paravertebral injections, 1 mL per site. Total of 2 mL of placebo was injected.

Drug: Placebo

Interventions

GTX 2/3 DRUG

There were 15 patients in this group. Each one received only one treatment.

Also known as: NAVX-010 (drug internal name), Gonyautoxin 2/3

GTX 2/3

Placebo DRUG

There were 15 patients in this group. Each one received only one treatment.

Also known as: Placebo of NAVX-010

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Man or woman patients between 18 and 75 years old.
• Acute back pain episode without radiculopathy asociated and no red flags.
• Back pain related pain bigger than 4 in VAS.
• Patients with no severe illnesses or conditions that would be inappropriate to enroll in this study or patients with no chronic pain.
• Signed informed consent.

You may not qualify if:

• Pregnant women or breastfeeding.
• Hyper acute back pain that requires emergency hospitalization.
• Chronic back pain or complicated (red flags).
• Patients that have received previous analgesic therapy of long half life, like corticoids, for current back pain or other pathology (inhalers are excluded).
• Associated neuromuscular diseases, inflammatory diseases in the spine (Musculoskeletal Disorders 2017, 18; 454: 2-12), inability to stand up, tumoral diseases, terminal disease.
• Ongoing local treatment with calcium antagonists or trinitroglycerin.
• Treatment with anti-vitamins K or another anticoagulant.
• Patients with adverse psychosomatic, work or social factors.
• Known or suspected allergy to any component of the study drug.
• Current participation in another clinical study or 30 days prior to enrollment.
• Another condition that in the opinion of the PI prevents participation in the study (physical or mental) or that cannot attend controls or answer the patient's survey / diary.

Sponsors & Collaborators

• Algenis SpA: lead

Study Sites (1)

Hospital San José SSMN

Santiago, Santiago Metropolitan, Chile

Location

MeSH Terms

Conditions

Back Pain; Acute Pain; Low Back Pain; Muscle Hypotonia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neuromuscular Manifestations; Nervous System Diseases

Study Officials

• Francisco Bravo, MD

  Hospital San José

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 5, 2021
• First Posted: March 16, 2021
• Study Start: October 11, 2019
• Primary Completion: March 19, 2020
• Study Completion: March 19, 2020
• Last Updated: March 16, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)