Clinical trial NCT04778592: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lumbosacral Radiculopathy
Lead sponsor: Eliem Therapeutics (UK) Ltd.
Sponsor class: INDUSTRY
First posted: 2021-03-03
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Placebo Controlled
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: 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)
timeFrame: Baseline to Week 4
Secondary outcomes:
measure: Number of Subjects With ≥50% Reduction From Baseline to Weeks 1, 2, 3,and 4 in the Weekly Average of the Daily Pain Score
timeFrame: Baseline to Weeks 1, 2, 3 and 4
measure: 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
timeFrame: Baseline to Weeks 1, 2, 3 and 4
measure: Change in the Weekly Average of the Daily Pain Score From Baseline to Weeks 1, 2, and 3
timeFrame: Baseline to Weeks 1, 2, and 3
measure: Change From Baseline to Week 4 for Worst Pain
timeFrame: Baseline and Week 4
measure: Number of Subjects With a PGI-C Response (Defined as "Much Improved" or "Very Much Improved") at Week 4
timeFrame: Week 4
measure: Number of Subjects With a CGI-C Response (Defined as "Much Improved" or "Very Much Improved") at Week 4
timeFrame: Week 4
measure: Change in the Weekly Average of the Daily Sleep Score on the DSIS From Baseline to Weeks 1, 2, 3, and 4
timeFrame: Baseline to Weeks 1, 2, 3 and 4
measure: Change in BPI - Interference Scale From Baseline to Week 4
timeFrame: Baseline to Week 4
measure: Change in the BPI - Pain Scale From Baseline to Week 4
timeFrame: Baseline to Week 4
measure: Change in the RMDQ From Baseline to Week 4
timeFrame: Baseline to Week 4
measure: Change in the Daily Amount of Acetaminophen Use From Baseline to Week 4
timeFrame: Treatment period: 4 weeks
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Delta Clinical Research
state: Alabama
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Greenwood Village
country: United States
facility: DBPS Research LLC
state: Colorado
city: Lady Lake
country: United States
facility: Charter Research
state: Florida
city: Miami
country: United States
facility: Cordova Research Institute
state: Florida
city: Miami
country: United States
facility: Advanced Medical Research Institute
state: Florida
city: Miami
country: United States
facility: Coral Research Clinic Corp
state: Florida
city: Marietta
country: United States
facility: Drug Studies America
state: Georgia
city: Newnan
country: United States
facility: Better Health Clinical Research
state: Georgia
city: Boise
country: United States
facility: Injury Care Research
state: Idaho
city: Chicago
country: United States
facility: Chicago Anesthesia Research Specialist
state: Illinois
city: Carmel
country: United States
facility: Indiana Spine Group
state: Indiana
city: Hazelwood
country: United States
facility: Healthcare Research Network
state: Missouri
city: Hartsdale
country: United States
facility: Drug Trials America
state: New York
city: Rochester
country: United States
facility: University of Rochester Translational Pain Research
state: New York
city: Winston-Salem
country: United States
facility: Center for Clinical Research
state: North Carolina
city: Dayton
country: United States
facility: Meta Medical Research Institute
state: Ohio
city: Edmond
country: United States
facility: Clinical Investigations LLC
state: Oklahoma
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Charleston
country: United States
facility: Clinical Trials of South Carolina
state: South Carolina
city: Tyler
country: United States
facility: Precision Spine care
state: Texas
city: Salt Lake City
country: United States
facility: Jean Brown Research
state: Utah
city: Salt Lake City
country: United States
facility: Wasatch Clinical Research, LLC
state: Utah
city: Bellevue
country: United States
facility: Northwest Clinical Research center
state: Washington
Study officials:
References: