Efficacy and Safety of ETX-018810 in Subjects With Lumbosacral Radicular Pain

Lumbosacral Radiculopathy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04778592
• Other study ID #: ETX-018810-201
• Status: Completed
• Phase: Phase 2
• Start date: January 19, 2021
• Est. completion date: May 25, 2022

Study information

• Verified date: November 2023
• Source: Eliem Therapeutics (UK) Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Efficacy and Safety of ETX 018810 in Subjects with Lumbosacral Radicular Pain

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 information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: May 25, 2022
• Est. primary completion date: May 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Lumbosacral Radiculopathy
• Radiculopathy

Intervention

Drug:
• ETX-018810
Study Drug
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Northwest Clinical Research center	Bellevue	Washington
United States	Injury Care Research	Boise	Idaho
United States	Indiana Spine Group	Carmel	Indiana
United States	Clinical Trials of South Carolina	Charleston	South Carolina
United States	Chicago Anesthesia Research Specialist	Chicago	Illinois
United States	Meta Medical Research Institute	Dayton	Ohio
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania
United States	Clinical Investigations LLC	Edmond	Oklahoma
United States	DBPS Research LLC	Greenwood Village	Colorado
United States	Drug Trials America	Hartsdale	New York
United States	Healthcare Research Network	Hazelwood	Missouri
United States	Charter Research	Lady Lake	Florida
United States	Drug Studies America	Marietta	Georgia
United States	Advanced Medical Research Institute	Miami	Florida
United States	Coral Research Clinic Corp	Miami	Florida
United States	Cordova Research Institute	Miami	Florida
United States	Delta Clinical Research	Mobile	Alabama
United States	Better Health Clinical Research	Newnan	Georgia
United States	Arizona Research Center	Phoenix	Arizona
United States	University of Rochester Translational Pain Research	Rochester	New York
United States	Jean Brown Research	Salt Lake City	Utah
United States	Wasatch Clinical Research, LLC	Salt Lake City	Utah
United States	Precision Spine care	Tyler	Texas
United States	Center for Clinical Research	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Eliem Therapeutics (UK) Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Baseline to Week 4
Secondary	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).	Baseline to Weeks 1, 2, 3 and 4
Secondary	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).	Baseline to Weeks 1, 2, 3 and 4
Secondary	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).	Baseline to Weeks 1, 2, and 3
Secondary	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).	Baseline and Week 4
Secondary	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.	Week 4
Secondary	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.	Week 4
Secondary	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.	Baseline to Weeks 1, 2, 3 and 4
Secondary	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.	Baseline to Week 4
Secondary	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.	Baseline to Week 4
Secondary	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").	Baseline to Week 4
Secondary	Change in the Daily Amount of Acetaminophen Use From Baseline to Week 4	The daily amount of acetaminophen (rescue medication) used (mg per day).	Treatment period: 4 weeks