Efficacy of M640 in Acute Lumbosacral Musculoskeletal Conditions.

Primus Pharmaceuticals

Status and phase: Enrolling; Phase 4

Conditions: Lumbar Spinal Stenosis; Sciatica Acute

Treatments: Drug: Metaxalone 640 mg Oral Tablet

Study type: Interventional

Funder types: NETWORK; Industry

Identifiers

NCT06157177

PMMSS-01

Details and patient eligibility

About

The goal of this clinical trial is to learn if a modification to metaxalone 640 mg can reduce low back and leg pain. The participants will be 18 to 80 years old, healthy with newly occurring back or leg pain. The main question aims to compare a group taking active treatment and a group taking a look-alike substance containing no active treatment. All participants will answer questions on Day 1, before treatment, and on 7-day after treatment, about:

• Amount and quality of pain
• Interference with physical activity
• Interference with sleep

Full description

Double-blind, randomized, placebo-controlled, multi-center study of metaxalone 640 mg plus standard of care for patients with acute lumbo sacral musculoskeletal conditions with spinal stenosis and sciatica. Participants will be randomized 1:1. Following the initial pilot-study a second study will randomize a larger population of patients with appropriate power.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• No clinically significant conditions impacting quality or quantity of pain
• Baseline Numeric Pain Scale ≥ 6
• Capable of answering text or email survey reminders
• Low back pain with or without sciatica

Exclusion criteria

• Current use of other skeletal relaxants
• Current use of other pain relievers
• Current use of cimetidine or monoamine oxidase inhibitors

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups, including a placebo group

Active M640

Active Comparator group

Description:

Metaxalone micronized 640 mg over encapsulated tablet Taken orally every 6 hours for 7 days

Treatment:

Drug: Metaxalone 640 mg Oral Tablet

Placebo

Placebo Comparator group

Description:

Inactive placebo capsule 640 mg Taken orally every 6 hours for 7 days

Treatment:

Drug: Metaxalone 640 mg Oral Tablet