Adults 18 to 75, any sex, with Lumbosacral Radiculopathy. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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)Primary· 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).
Group
Value
95% CI
ETX-018810
-1.49
± 1.735
Placebo
-1.65
± 1.760
Number of Subjects With ≥50% Reduction From Baseline to Weeks 1, 2, 3,and 4 in the Weekly Average of the Daily Pain ScoreSecondary· 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).
Week 1
Group
Value
95% CI
ETX-018810
4
Placebo
3
Week 2
Group
Value
95% CI
ETX-018810
9
Placebo
8
Week 3
Group
Value
95% CI
ETX-018810
12
Placebo
17
Week 4
Group
Value
95% CI
ETX-018810
14
Placebo
17
Number of Subjects With a ≥30% Reduction From Baseline to Weeks 1, 2, 3, and 4 in the Weekly Average of the Daily Pain ScoreSecondary· 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).
Week 1
Group
Value
95% CI
ETX-018810
9
Placebo
17
Week 2
Group
Value
95% CI
ETX-018810
18
Placebo
19
Week 3
Group
Value
95% CI
ETX-018810
22
Placebo
28
Week 4
Group
Value
95% CI
ETX-018810
28
Placebo
29
Change in the Weekly Average of the Daily Pain Score From Baseline to Weeks 1, 2, and 3Secondary· 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).
Week 1
Group
Value
95% CI
ETX-018810
-0.66
± 1.079
Placebo
-0.85
± 0.994
Week 2
Group
Value
95% CI
ETX-018810
-1.04
± 1.479
Placebo
-1.15
± 1.429
Week 3
Group
Value
95% CI
ETX-018810
-1.28
± 1.575
Placebo
-1.49
± 1.606
Change From Baseline to Week 4 for Worst PainSecondary· 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).
Group
Value
95% CI
ETX-018810
-1.73
± 2.206
Placebo
-1.74
± 1.861
Number of Subjects With a PGI-C Response (Defined as "Much Improved" or "Very Much Improved") at Week 4Secondary· 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.
Group
Value
95% CI
ETX-018810
23
Placebo
25
Number of Subjects With a CGI-C Response (Defined as "Much Improved" or "Very Much Improved") at Week 4Secondary· 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.
Group
Value
95% CI
ETX-018810
21
Placebo
24
Change in the Weekly Average of the Daily Sleep Score on the DSIS From Baseline to Weeks 1, 2, 3, and 4Secondary· 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 clo
Week 1
Group
Value
95% CI
ETX-018810
-0.87
± 1.279
Placebo
-0.81
± 1.114
Week 2
Group
Value
95% CI
ETX-018810
-1.14
± 1.576
Placebo
-1.18
± 1.366
Week 3
Group
Value
95% CI
ETX-018810
-1.41
± 1.697
Placebo
-1.51
± 1.520
Week 4
Group
Value
95% CI
ETX-018810
-1.59
± 1.676
Placebo
-1.53
± 1.706
Change in BPI - Interference Scale From Baseline to Week 4Secondary· 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.
Group
Value
95% CI
ETX-018810
-1.68
± 1.967
Placebo
-1.94
± 1.954
Change in the BPI - Pain Scale From Baseline to Week 4Secondary· 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.
Group
Value
95% CI
ETX-018810
-1.70
± 1.974
Placebo
-1.57
± 1.588
Change in the RMDQ From Baseline to Week 4Secondary· 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").
Group
Value
95% CI
ETX-018810
-2.10
± 3.637
Placebo
-2.31
± 4.367
Change in the Daily Amount of Acetaminophen Use From Baseline to Week 4Secondary· Treatment period: 4 weeks
The daily amount of acetaminophen (rescue medication) used (mg per day).
Group
Value
95% CI
ETX-018810
0
-99.4 – 0
Placebo
0
-177.3 – 9.3
Adverse events — posted to ClinicalTrials.gov
Time frame: 9 weeks (up to 4 week screening period, 4 week treatment period, & 1 week follow up period).
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
ETX-018810
Serious: 0/74 (0%)
Deaths: 0/74
Placebo
Serious: 1/74 (1%)
Deaths: 0/74
Serious adverse events (1 terms)
Reaction
System
ETX-018810
Placebo
Colon cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Eliem Therapeutics (UK) Ltd.
Last refreshed: 7 November 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04778592.