Efficacy of M640 in Acute Lumbosacral Musculoskeletal Conditions.
Recruiting
Phase 4
Interventional Study
Sciatica Acute
Lumbar Spinal Stenosis
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 18 – 80
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 50 (estimated)
- Sponsor
- Primus Pharmaceuticals · Industry
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About This Trial
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, be…
Trial Locations
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Eligibility Criteria
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…
Contacts