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Completed

NCT Number: NCT04778592

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

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

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Key information

Conditions

Lumbosacral Radiculopathy

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Delta Clinical Research, Mobile, Alabama, United States

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About this study

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of ETX 018810 in Subjects with Lumbosacral Radicular Pain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ETX-018810

Drug

Study Drug

Placebo

Drug

Placebo

Primary outcomes

  1. 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)

    Time frame: 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 outcomes

  1. Number of Subjects With ≥50% Reduction From Baseline to Weeks 1, 2, 3,and 4 in the Weekly Average of the Daily Pain Score

    Time frame: 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).

  2. 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

    Time frame: 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).

  3. Change in the Weekly Average of the Daily Pain Score From Baseline to Weeks 1, 2, and 3

    Time frame: 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).

  4. Change From Baseline to Week 4 for Worst Pain

    Time frame: 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).

  5. Number of Subjects With a PGI-C Response (Defined as "Much Improved" or "Very Much Improved") at Week 4

    Time frame: 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.

  6. Number of Subjects With a CGI-C Response (Defined as "Much Improved" or "Very Much Improved") at Week 4

    Time frame: 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.

  7. Change in the Weekly Average of the Daily Sleep Score on the DSIS From Baseline to Weeks 1, 2, 3, and 4

    Time frame: 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.

  8. Change in BPI - Interference Scale From Baseline to Week 4

    Time frame: 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.

  9. Change in the BPI - Pain Scale From Baseline to Week 4

    Time frame: 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.

  10. Change in the RMDQ From Baseline to Week 4

    Time frame: 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").

  11. Change in the Daily Amount of Acetaminophen Use From Baseline to Week 4

    Time frame: Treatment period: 4 weeks

    The daily amount of acetaminophen (rescue medication) used (mg per day).

Sponsors and collaborators

Lead sponsor

Eliem Therapeutics (UK) Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 3, 2021
Registry last updated
Nov 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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