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

• Status: Completed
• Trial end date: 2020-03-19
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Algenis SpA

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.