Efficacy and Safety of ETX-018810 in Subjects With Lumbosacral Radicular Pain
- Registration Number
- NCT04778592
- Lead Sponsor
- Eliem Therapeutics (UK) Ltd.
- Brief Summary
Efficacy and Safety of ETX 018810 in Subjects with Lumbosacral Radicular Pain
- Detailed Description
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of ETX 018810 in Subjects with Lumbosacral Radicular Pain
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 149
- The subject has pain consistent with a diagnosis of chronic lumbosacral radiculopathy due to injury of the lumbosacral nerve root(s)
- The subject reports at least moderate pain intensity at screening.
- The subject's onset of leg pain due to LSRP is at least 3 months
- The subject has a magnetic resonance imaging (MRI) scan that is normal or shows incidental lesions
- The subject has a calculated creatinine clearance ≥30 mL/min
- The subject has clinical laboratory values within normal limits or abnormal values that the investigator deems not clinically significant.
- body mass index (BMI) <40 kg/m2.
- The subject has previously undergone back surgery
- The subject is unable to reliably delineate or assess pain by anatomical location/distribution on a body map.
- The subject has a history of peripheral neuropathy, evidence of peripheral neuropathy, or evidence of mononeuropathy in the same limb of LSRP.
- The subject has pain due to infection/abscess, hematoma, or malignancy or other pain that may interfere with the assessment of LSRP in the legs.
- The subject has clinically significant and/or unstable renal, hepatic, hematologic, endocrine, immunologic, inflammatory/rheumatologic, respiratory, or cardiovascular disease that would compromise participation in the study
- The subject has any neurological disease that could interfere with participation in the study (e.g., Huntington's disease, Parkinson's disease, Alzheimer's disease, multiple sclerosis, seizures, epilepsy, stroke).
- The subject has a history or current diagnosis of major psychiatric disorder(s)
- The subject has a has a history of substance abuse or dependence
- The subject has clinically significant abnormal electrocardiogram (ECG) findings
- The subject has received nerve blocks and/or steroid injections for LSRP within the 3 months before screening
- The subject is unwilling or unable to discontinue current medications for LSRP, including topical agents.
- The subject is unable to refrain from using prohibited meds during the study, including: NSAID, antiepileptic drugs, steroids, cannabinoids, or major opioids, antidepressants, muscle relaxants, tramadol, or tapentadol.
- The subject has used prohibited nonpharmacologic therapies, including acupuncture, transcutaneous electrical nerve stimulation, within 30 days the study.
- The subject is currently participating in another or the same clinical study or participated in another clinical study within 3 months before screening
- The subject is pregnant or lactating or not practicing adequate birth control
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ETX-018810 ETX-018810 Drug: ETX-018810 BID for 4 weeks Placebo Placebo Matching Placebo BID for 4 weeks
- Primary Outcome Measures
Name Time Method Change From Baseline to Week 4 in the Weekly Average of the Daily Pain Score as Derived From the Subject's Responses on the Pain Intensity Numerical Rating Scale (PI-NRS) Baseline to Week 4 Change from baseline in the weekly average of the daily pain score as derived from the subject's responses on the Pain Intensity Numerical Rating Scale (PI-NRS), a 10 point scale from 0 being the least (No Pain) to 10 being the most (Worst Possible Pain).
- Secondary Outcome Measures
Name Time Method Number of Subjects With ≥50% Reduction From Baseline to Weeks 1, 2, 3,and 4 in the Weekly Average of the Daily Pain Score Baseline to Weeks 1, 2, 3 and 4 Change in the weekly average of the daily pain score as derived from the subject's responses on the Pain Intensity Numerical Rating Scale (PI-NRS), a 10 point scale from 0 being the least (No Pain) to 10 being the most (Worst Possible Pain).
Change in the Weekly Average of the Daily Pain Score From Baseline to Weeks 1, 2, and 3 Baseline to Weeks 1, 2, and 3 Change in the weekly average of the daily pain score as derived from the subject's responses on the Pain Intensity Numerical Rating Scale (PI-NRS), a 10 point scale from 0 being the least (No Pain) to 10 being the most (Worst Possible Pain).
Change From Baseline to Week 4 for Worst Pain Baseline and Week 4 The Brief Pain Inventory (BPI) includes a 'worst pain' severity scale. Subjects rate their worst pain in the last 24 hours on a scale from 0 (no pain) to 10 (pain as bad as you can imagine).
Change in the Daily Amount of Acetaminophen Use From Baseline to Week 4 Treatment period: 4 weeks The daily amount of acetaminophen (rescue medication) used (mg per day).
Number of Subjects With a ≥30% Reduction From Baseline to Weeks 1, 2, 3, and 4 in the Weekly Average of the Daily Pain Score Baseline to Weeks 1, 2, 3 and 4 Change in the weekly average of the daily pain score as derived from the subject's responses on the Pain Intensity Numerical Rating Scale (PI-NRS), a 10 point scale from 0 being the least (No Pain) to 10 being the most (Worst Possible Pain).
Change in BPI - Interference Scale From Baseline to Week 4 Baseline to Week 4 The Brief Pain Inventory (BPI) interference score measures how much pain has interfered with seven daily activities scored on a scale from 0 (does not interfere) to 10 (completely interferes). It is scored as the mean of the seven interference items.
Number of Subjects With a PGI-C Response (Defined as "Much Improved" or "Very Much Improved") at Week 4 Week 4 The Patient Global Impression - Change (PGI-C) is the patient-reported counterpoint to the CGI-C (Guy, 1976). The qualitative assessment of meaningful change is determined by the patient in response to the question, "Compared to your condition at the beginning of treatment, how much has your condition changed?" Scores are as follows: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; and 7=very much worse.
Change in the Weekly Average of the Daily Sleep Score on the DSIS From Baseline to Weeks 1, 2, 3, and 4 Baseline to Weeks 1, 2, 3 and 4 The Daily Sleep Interference Scale (DSIS) is an 11-point response scale that quantifies sleep interference due to pain. It is a single-item measure that is completed once daily, upon awakening, to accurately capture variability in sleep interference due to pain on a daily basis, thus minimizing recall bias. Patients are asked to select the number that best described how much their pain has interfered with their sleep during the last 24 hours on a scale from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep).
The subjects were to record the value that most closely corresponded to their sleep interference over the last 24 hours in the eDiary once daily, in the morning (when the first dose of investigational medication is taken), during the baseline and 4-week treatment periods.Change in the BPI - Pain Scale From Baseline to Week 4 Baseline to Week 4 The Brief Pain Inventory (BPI) pain score is a composite of 4 items assessing pain severity (worst, least, average and right now). Subjects rate their pain in the last 24 hours on a scale from 0 (no pain) to 10 (pain as bad as you can imagine). It is scored as the mean of the four pain items.
Number of Subjects With a CGI-C Response (Defined as "Much Improved" or "Very Much Improved") at Week 4 Week 4 The Clinical Global Impression - Change (CGI-C) is a 7-point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to the baseline state at the beginning of the intervention. The rater selects one response based on the following question, "Compared to your patient's condition at the beginning of treatment, how much has your patient changed?" Scores are as follows: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; and 7=very much worse.
Change in the RMDQ From Baseline to Week 4 Baseline to Week 4 The modified Roland-Morris Disability Questionnaire (RMDQ) is a self-administered, 24-question physical disability measurement assessment that evaluates the effect of back pain on functioning. Each question requires a "yes" or "no" answer; 1 point is scored for each positive response. The total scores are determined on a scale of 0 ("no disability") to 24 ("severe disability").
Trial Locations
- Locations (24)
Delta Clinical Research
🇺🇸Mobile, Alabama, United States
Drug Studies America
🇺🇸Marietta, Georgia, United States
Chicago Anesthesia Research Specialist
🇺🇸Chicago, Illinois, United States
Cordova Research Institute
🇺🇸Miami, Florida, United States
Advanced Medical Research Institute
🇺🇸Miami, Florida, United States
Arizona Research Center
🇺🇸Phoenix, Arizona, United States
Coral Research Clinic Corp
🇺🇸Miami, Florida, United States
Injury Care Research
🇺🇸Boise, Idaho, United States
Charter Research
🇺🇸Lady Lake, Florida, United States
DBPS Research LLC
🇺🇸Greenwood Village, Colorado, United States
Better Health Clinical Research
🇺🇸Newnan, Georgia, United States
Indiana Spine Group
🇺🇸Carmel, Indiana, United States
Drug Trials America
🇺🇸Hartsdale, New York, United States
Healthcare Research Network
🇺🇸Hazelwood, Missouri, United States
University of Rochester Translational Pain Research
🇺🇸Rochester, New York, United States
Center for Clinical Research
🇺🇸Winston-Salem, North Carolina, United States
Meta Medical Research Institute
🇺🇸Dayton, Ohio, United States
Clinical Investigations LLC
🇺🇸Edmond, Oklahoma, United States
Altoona Center for Clinical Research
🇺🇸Duncansville, Pennsylvania, United States
Clinical Trials of South Carolina
🇺🇸Charleston, South Carolina, United States
Precision Spine care
🇺🇸Tyler, Texas, United States
Northwest Clinical Research center
🇺🇸Bellevue, Washington, United States
Jean Brown Research
🇺🇸Salt Lake City, Utah, United States
Wasatch Clinical Research, LLC
🇺🇸Salt Lake City, Utah, United States