Back to resultsEfficacy and Safety of ETX-018810 in Subjects With Lumbosacral Radicular Pain
Primary Purpose
Lumbosacral Radiculopathy
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ETX-018810
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Lumbosacral Radiculopathy
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- Delta Clinical Research
- Arizona Research Center
- DBPS Research LLC
- Charter Research
- Cordova Research Institute
- Advanced Medical Research Institute
- Coral Research Clinic Corp
- Drug Studies America
- Better Health Clinical Research
- Injury Care Research
- Chicago Anesthesia Research Specialist
- Indiana Spine Group
- Healthcare Research Network
- Drug Trials America
- University of Rochester Translational Pain Research
- Center for Clinical Research
- Meta Medical Research Institute
- Clinical Investigations LLC
- Altoona Center for Clinical Research
- Clinical Trials of South Carolina
- Precision Spine care
- Jean Brown Research
- Wasatch Clinical Research, LLC
- Northwest Clinical Research center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
ETX-018810
Placebo
Arm Description
Drug: ETX-018810 BID for 4 weeks
Matching Placebo BID for 4 weeks
Outcomes
Primary Outcome Measures
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)
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
Number of Subjects With ≥50% Reduction From Baseline to Weeks 1, 2, 3,and 4 in the Weekly Average of the Daily Pain Score
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).
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
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
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
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).
Number of Subjects With a PGI-C Response (Defined as "Much Improved" or "Very Much Improved") at 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.
Number of Subjects With a CGI-C Response (Defined as "Much Improved" or "Very Much Improved") at 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 Weekly Average of the Daily Sleep Score on the DSIS From 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 BPI - Interference Scale From 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.
Change in the BPI - Pain Scale From 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.
Change in the RMDQ From 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").
Change in the Daily Amount of Acetaminophen Use From Baseline to Week 4
The daily amount of acetaminophen (rescue medication) used (mg per day).
Full Information
NCT ID
NCT04778592
First Posted
February 26, 2021
Last Updated
May 9, 2023
Sponsor
Eliem Therapeutics (UK) Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04778592
Brief Title
Efficacy and Safety of ETX-018810 in Subjects With Lumbosacral Radicular Pain
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of ETX-018810 in Subjects With Lumbosacral Radicular Pain
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 19, 2021 (Actual)
Primary Completion Date
May 16, 2022 (Actual)
Study Completion Date
May 25, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eliem Therapeutics (UK) Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbosacral Radiculopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Placebo Controlled
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
149 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ETX-018810
Arm Type
Experimental
Arm Description
Drug: ETX-018810 BID for 4 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching Placebo BID for 4 weeks
Intervention Type
Drug
Intervention Name(s)
ETX-018810
Intervention Description
Study Drug
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
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)
Description
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).
Time Frame
Baseline to Week 4
Secondary Outcome Measure Information:
Title
Number of Subjects With ≥50% Reduction From Baseline to Weeks 1, 2, 3,and 4 in the Weekly Average of the Daily Pain Score
Description
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).
Time Frame
Baseline to Weeks 1, 2, 3 and 4
Title
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
Description
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).
Time Frame
Baseline to Weeks 1, 2, 3 and 4
Title
Change in the Weekly Average of the Daily Pain Score From Baseline to Weeks 1, 2, and 3
Description
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).
Time Frame
Baseline to Weeks 1, 2, and 3
Title
Change From Baseline to Week 4 for Worst Pain
Description
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).
Time Frame
Baseline and Week 4
Title
Number of Subjects With a PGI-C Response (Defined as "Much Improved" or "Very Much Improved") at Week 4
Description
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.
Time Frame
Week 4
Title
Number of Subjects With a CGI-C Response (Defined as "Much Improved" or "Very Much Improved") at Week 4
Description
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.
Time Frame
Week 4
Title
Change in the Weekly Average of the Daily Sleep Score on the DSIS From Baseline to Weeks 1, 2, 3, and 4
Description
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.
Time Frame
Baseline to Weeks 1, 2, 3 and 4
Title
Change in BPI - Interference Scale From Baseline to Week 4
Description
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.
Time Frame
Baseline to Week 4
Title
Change in the BPI - Pain Scale From Baseline to Week 4
Description
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.
Time Frame
Baseline to Week 4
Title
Change in the RMDQ From Baseline to Week 4
Description
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").
Time Frame
Baseline to Week 4
Title
Change in the Daily Amount of Acetaminophen Use From Baseline to Week 4
Description
The daily amount of acetaminophen (rescue medication) used (mg per day).
Time Frame
Treatment period: 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Facility Information:
Facility Name
Delta Clinical Research
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36606
Country
United States
Facility Name
Arizona Research Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85053
Country
United States
Facility Name
DBPS Research LLC
City
Greenwood Village
State/Province
Colorado
ZIP/Postal Code
80111
Country
United States
Facility Name
Charter Research
City
Lady Lake
State/Province
Florida
ZIP/Postal Code
32159
Country
United States
Facility Name
Cordova Research Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Advanced Medical Research Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33174
Country
United States
Facility Name
Coral Research Clinic Corp
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
Facility Name
Drug Studies America
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Better Health Clinical Research
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30265
Country
United States
Facility Name
Injury Care Research
City
Boise
State/Province
Idaho
ZIP/Postal Code
83713
Country
United States
Facility Name
Chicago Anesthesia Research Specialist
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
Indiana Spine Group
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46032
Country
United States
Facility Name
Healthcare Research Network
City
Hazelwood
State/Province
Missouri
ZIP/Postal Code
63042
Country
United States
Facility Name
Drug Trials America
City
Hartsdale
State/Province
New York
ZIP/Postal Code
10530
Country
United States
Facility Name
University of Rochester Translational Pain Research
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Center for Clinical Research
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Meta Medical Research Institute
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45432
Country
United States
Facility Name
Clinical Investigations LLC
City
Edmond
State/Province
Oklahoma
ZIP/Postal Code
73013
Country
United States
Facility Name
Altoona Center for Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Clinical Trials of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Precision Spine care
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
Jean Brown Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Wasatch Clinical Research, LLC
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Northwest Clinical Research center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy and Safety of ETX-018810 in Subjects With Lumbosacral Radicular Pain
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