Sciatica AcutePhase 4NCT06157177
Efficacy of M640 in Acute Lumbosacral Musculoskeletal Conditions.
A Phase 4 study testing Metaxalone 640 mg Oral Tablet in people with Sciatica Acute and Lumbar Spinal Stenosis, run by Primus Pharmaceuticals at 24 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Sciatica Acute, Lumbar Spinal Stenosis
- What is being tested?
- Metaxalone 640 mg Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 24 sitesUnited States
- Study dates
- 15 Nov 2023to 15 Nov 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Current use of other skeletal relaxants
- Current use of other pain relievers
- Current use of cimetidine or monoamine oxidase inhibitors
Trial locations and contacts
24 sites in 1 country. Contact the study team or a site near you to ask about taking part.
24 sites in 1 country
United States24 sites, 8 recruiting
- Active, not recruiting
Northern Virginia Center for Arthritis
Annandale, Virginia, 22003
- Active, not recruiting
East Alabama Arthritis Center
Auburn, Alabama, 36830
- Active, not recruiting
Arthritis and Osteoporosis Center
Aventura, Florida, 33180
- Active, not recruiting
William Sunshine, MD
Boca Raton, Florida, 33431
- Recruiting
Robert Levin, MD
Clearwater, Florida, 33765
simi@illumination.health
- Active, not recruiting
Jayashree Sinha, MD 1
Clovis, New Mexico, 88101
- Recruiting
Heritage Rheumatology & Arthritis Care
Colleyville, Texas, 76034
simi@illumination.health
- Recruiting
5. CZ Rheumatology
Coral Springs, Florida, 33065
simi@illumination.health
- Recruiting
Cumberland Rheumatology
Crossville, Tennessee, 38555
Sivalingam Kanagasegar, MD, simi@illumination.health
- Active, not recruiting
Carolina Rheumatology
Fayetteville, North Carolina, 28304
- Active, not recruiting
Integrative Rheumatology of South Texas
Harlingen, Texas, 78550
- Active, not recruiting
4. Palm Beach Rheumatology and Wellness
Jupiter, Florida, 33458
- Active, not recruiting
Family Arthritis Center
Loxahatchee Groves, Florida, 33458
- Active, not recruiting
Arthritis and Rheumatology Center of South Florida
Margate, Florida, 33063
- Active, not recruiting
Southwest Research Group
Mesquite, Texas, 75150
- Recruiting
Arthritis and Osteoporosis Treatment and ResearchCenter
Miami, Florida, 33180
George Munoz, MD, simi@illumination.health
- Recruiting
CZ Rheumatology
Miami Beach, Florida, 33140
Conrad Ziembinski, DO, simi@illumination.health
- Recruiting
Bay Area Rheumatology
Oldsmar, Florida, 34677
Rodney Daniel,, MD, simi@illumination.health
- Active, not recruiting
DFW Rheumatology
Red Oak, Texas, 75154
- Active, not recruiting
Arthritis and Rheumatic Care Center
South Miami, Florida, 33143
- Active, not recruiting
Ohio Arthritis and Osteoporosis Center of Southwest Ohio
Springboro, Ohio, 45066
- Recruiting
Arthritis and Rheumatology Center of MI
Sterling Heights, Michigan, 48310
Srijana Bakshi, MD, simi@illumination.health
- Active, not recruiting
Arthritis Research and Treatment Center
Stockbridge, Georgia, 30281
- Active, not recruiting
Sean Wollaston, MD
Valley Village, California, 91607
About this study
Official title: Efficacy of Modified Release Metaxalone 640 mg in Acute Lumbosacral Musculoskeletal Conditions With Spinal Stenosis and Sciatica
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
Read the detailed 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.
- Conditions
- Sciatica Acute, Lumbar Spinal Stenosis
- Being tested
- Metaxalone 640 mg Oral Tablet
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metaxalone 640 mg Oral TabletDrug
Also called Skelaxin un-micronized, M640, metaxalone micronized
Metaxalone 640 mg used for the treatment of discomforts associated with acute, musculoskeletal pain.
| Study group | Role | What they receive |
|---|---|---|
| Active M640 | Active comparator | Metaxalone micronized 640 mg over encapsulated tablet Taken orally every 6 hours for 7 days Receives: Drug: Metaxalone 640 mg Oral Tablet |
| Placebo | Placebo comparator | Inactive placebo capsule 640 mg Taken orally every 6 hours for 7 days Receives: Drug: Metaxalone 640 mg Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Numeric Pain Scale
Change from Baseline in low back pain and leg pain as measured by the Numeric Pain Rating Scale (NPRS) at Day 7
Measured: Day 1 to Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start15 Nov 2023
- Primary completion15 Nov 2026 (estimated)
- Study completion15 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sciatica AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Primus Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Illumination Health
- Responsible party
- Sponsor
- Investigators
- S Sodhi, Study director, Illumination Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06157177
- Sponsor's protocol ID
- PMMSS-01
- Status last verified
- Sep 2026
- First submitted
- 27 Nov 2023
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Modified Release Metaxalone 640 mg in Acute Lumbosacral Musculoskeletal Conditions With Spinal Stenosis and Sciatica
- ClinicalTrials.gov ID
- NCT06157177
- Acronym / sponsor ID
- PMMSS-01
- Conditions
- Sciatica Acute, Lumbar Spinal Stenosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Primus PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Illumination Health
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 15 Nov 2026 (estimated)
- Study completion
- 15 Nov 2026 (estimated)
- First posted
- 5 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active M640 | Active comparator | Drug: Metaxalone 640 mg Oral TabletMetaxalone micronized 640 mg over encapsulated tablet Taken orally every 6 hours for 7 days |
| Placebo | Placebo comparator | Drug: Metaxalone 640 mg Oral TabletInactive placebo capsule 640 mg Taken orally every 6 hours for 7 days |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Current use of other skeletal relaxants
- Current use of other pain relievers
- Current use of cimetidine or monoamine oxidase inhibitors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metaxalone 640 mg Oral TabletAlso: Skelaxin un-micronized, M640, metaxalone micronizedMetaxalone 640 mg used for the treatment of discomforts associated with acute, musculoskeletal pain. | Drug | Active M640, Placebo |
Primary outcome
Change of Numeric Pain Scale
Time frame: Day 1 to Day 7
Change from Baseline in low back pain and leg pain as measured by the Numeric Pain Rating Scale (NPRS) at Day 7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
S Sodhi study director
Illumination Health
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metaxalone 640 mg Oral Tablet in people with Sciatica Acute and Lumbar Spinal Stenosis, run by Primus Pharmaceuticals at 24 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact S Sodhi (205-202-0739, simi@illumination.health), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Numeric Pain Scale (time frame: Day 1 to Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.