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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04778592
Recruitment Status : Completed
First Posted : March 3, 2021
Last Update Posted : June 30, 2022
Sponsor:
Information provided by (Responsible Party):
Eliem Therapeutics (UK) Ltd.

Study Description
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Brief Summary:
Efficacy and Safety of ETX 018810 in Subjects with Lumbosacral Radicular Pain

Condition or disease Intervention/treatment Phase
Lumbosacral Radiculopathy Drug: ETX-018810 Drug: Placebo Phase 2

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
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Placebo Controlled, Parallel-group
Masking: Double (Participant, Investigator)
Masking Description: Double Blind Placebo Controlled
Primary Purpose: Treatment
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
Actual Study Start Date : February 5, 2021
Actual Primary Completion Date : May 16, 2022
Actual Study Completion Date : May 23, 2022
Arms and Interventions
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Arm Intervention/treatment
Experimental: ETX-018810
Drug: ETX-018810 bid
 Drug: ETX-018810
Study Drug
Placebo Comparator: Placebo
Matching Placebo bid
 Drug: Placebo
Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline to Week 4 in the weekly average of the daily pain score [ Time Frame: Week 4 ]
    Efficacy of ETX 018810 for the treatment of lumbosacral radicular pain will be assessed from change from baseline to Week 4 in the weekly average of the daily pain score on the 11 point Pain Intensity Numerical Rating Scale (PI NRS) from 0 being the least (No Pain) to 10 being the most (Worst Possible Pain).


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04778592


Locations
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United States, Alabama
Delta Clinical Research
Mobile, Alabama, United States, 36606
Sponsors and Collaborators
Eliem Therapeutics (UK) Ltd.
More Information
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Responsible Party: Eliem Therapeutics (UK) Ltd.
ClinicalTrials.gov Identifier: NCT04778592    
Other Study ID Numbers: ETX-018810-201
First Posted: March 3, 2021    Key Record Dates
Last Update Posted: June 30, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Radiculopathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases