NCT06157177 Efficacy of M640 in Acute Lumbosacral Musculoskeletal Conditions.
| NCT ID | NCT06157177 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Primus Pharmaceuticals |
| Condition | Sciatica Acute |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2023-11-15 |
| Primary Completion | 2026-11-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 50 participants in total. It began in 2023-11-15 with a primary completion date of 2026-11-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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 use of other pain relievers * Current use of cimetidine or monoamine oxidase inhibitors
Contact & Investigator
S Sodhi
STUDY DIRECTOR
Illumination Health
Frequently Asked Questions
Who can join the NCT06157177 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Sciatica Acute. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06157177 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06157177 currently recruiting?
Yes, NCT06157177 is actively recruiting participants. Contact the research team at simi@illumination.health for enrollment information.
Where is the NCT06157177 trial being conducted?
This trial is being conducted at Auburn, United States, Valley Village, United States, Aventura, United States, Boca Raton, United States and 11 additional locations.
Who is sponsoring the NCT06157177 clinical trial?
NCT06157177 is sponsored by Primus Pharmaceuticals. The principal investigator is S Sodhi at Illumination Health. The trial plans to enroll 50 participants.