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| Name | Class |
|---|---|
| Illumination Health | NETWORK |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active M640 | Active Comparator | Metaxalone micronized 640 mg over encapsulated tablet Taken orally every 6 hours for 7 days |
|
| Placebo | Placebo Comparator | Inactive placebo capsule 640 mg Taken orally every 6 hours for 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metaxalone 640 mg Oral Tablet | Drug | Metaxalone 640 mg used for the treatment of discomforts associated with acute, musculoskeletal pain. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 1 to Day 7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| S Sodhi | Contact | 205-202-0739 | simi@illumination.health |
| Name | Affiliation | Role |
|---|---|---|
| S Sodhi | Illumination Health | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| East Alabama Arthritis Center | Active, not recruiting | Auburn | Alabama | 36830 | United States | |
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|
| Sean Wollaston, MD |
| Active, not recruiting |
| Valley Village |
| California |
| 91607 |
| United States |
| Arthritis and Osteoporosis Center | Active, not recruiting | Aventura | Florida | 33180 | United States |
| William Sunshine, MD | Active, not recruiting | Boca Raton | Florida | 33431 | United States |
| Robert Levin, MD | Recruiting | Clearwater | Florida | 33765 | United States |
|
| 5. CZ Rheumatology | Recruiting | Coral Springs | Florida | 33065 | United States |
|
| 4. Palm Beach Rheumatology and Wellness | Active, not recruiting | Jupiter | Florida | 33458 | United States |
| Family Arthritis Center | Active, not recruiting | Loxahatchee Groves | Florida | 33458 | United States |
| Arthritis and Rheumatology Center of South Florida | Active, not recruiting | Margate | Florida | 33063 | United States |
| Arthritis and Osteoporosis Treatment and ResearchCenter | Recruiting | Miami | Florida | 33180 | United States |
|
| CZ Rheumatology | Recruiting | Miami Beach | Florida | 33140 | United States |
|
| Bay Area Rheumatology | Recruiting | Oldsmar | Florida | 34677 | United States |
|
| Arthritis and Rheumatic Care Center | Active, not recruiting | South Miami | Florida | 33143 | United States |
| Arthritis Research and Treatment Center | Active, not recruiting | Stockbridge | Georgia | 30281 | United States |
| Arthritis and Rheumatology Center of MI | Recruiting | Sterling Heights | Michigan | 48310 | United States |
|
| Jayashree Sinha, MD 1 | Active, not recruiting | Clovis | New Mexico | 88101 | United States |
| Carolina Rheumatology | Active, not recruiting | Fayetteville | North Carolina | 28304 | United States |
| Ohio Arthritis and Osteoporosis Center of Southwest Ohio | Active, not recruiting | Springboro | Ohio | 45066 | United States |
| Cumberland Rheumatology | Recruiting | Crossville | Tennessee | 38555 | United States |
|
| Heritage Rheumatology & Arthritis Care | Recruiting | Colleyville | Texas | 76034 | United States |
|
| Integrative Rheumatology of South Texas | Active, not recruiting | Harlingen | Texas | 78550 | United States |
| Southwest Research Group | Active, not recruiting | Mesquite | Texas | 75150 | United States |
| DFW Rheumatology | Active, not recruiting | Red Oak | Texas | 75154 | United States |
| Northern Virginia Center for Arthritis | Active, not recruiting | Annandale | Virginia | 22003 | United States |
| ID | Term |
|---|---|
| D013130 | Spinal Stenosis |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| C011301 | metaxalone |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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