Lumbosacral Radiculopathy
Conditions
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
Interventions
DRUGETX-018810
Study Drug
DRUGPlacebo
Placebo
Sponsors
Eliem Therapeutics (UK) Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Placebo Controlled
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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). |
| Change in the Weekly Average of the Daily Pain Score From Baseline to Weeks 1, 2, and 3 | 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). |
| Change From Baseline to Week 4 for Worst Pain | 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). |
| Number of Subjects With a PGI-C Response (Defined as Much Improved or Very Much Improved) at Week 4 | 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. |
| Number of Subjects With a CGI-C Response (Defined as Much Improved or Very Much Improved) at Week 4 | 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. |
| Number of Subjects With ≥50% Reduction From Baseline to Weeks 1, 2, 3,and 4 in the Weekly Average of the Daily Pain Score | 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). |
| Change in BPI - Interference Scale From Baseline to Week 4 | 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. |
| Change in the BPI - Pain Scale From Baseline to Week 4 | 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. |
| Change in the RMDQ From Baseline to Week 4 | 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). |
| Change in the Daily Amount of Acetaminophen Use From Baseline to Week 4 | Treatment period: 4 weeks | The daily amount of acetaminophen (rescue medication) used (mg per day). |
| Change in the Weekly Average of the Daily Sleep Score on the DSIS From Baseline to Weeks 1, 2, 3, and 4 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ETX-018810 Drug: ETX-018810 bid
ETX-018810: Study Drug | 74 |
| Placebo Matching Placebo bid
Placebo: Placebo | 74 |
| Total | 148 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | Placebo | Total | ETX-018810 |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 13 Participants | 30 Participants | 17 Participants |
| Age, Categorical Between 18 and 65 years | 61 Participants | 118 Participants | 57 Participants |
| Age, Continuous | 53.8 years STANDARD_DEVIATION 10.67 | 54.8 years STANDARD_DEVIATION 11.51 | 55.8 years STANDARD_DEVIATION 12.29 |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants | 30 Participants | 16 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) White | 55 Participants | 111 Participants | 56 Participants |
| Region of Enrollment United States | 74 participants | 148 participants | 74 participants |
| Sex: Female, Male Female | 36 Participants | 82 Participants | 46 Participants |
| Sex: Female, Male Male | 38 Participants | 66 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 74 | 0 / 74 |
| other Total, other adverse events | 11 / 74 | 15 / 74 |
| serious Total, serious adverse events | 0 / 74 | 1 / 74 |
Outcome results
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).
Time frame: Baseline to Week 4
Population: The modified ITT population included all randomized subjects who received at least one dose of study treatment and had at least four post-baseline PI-NRS measurements; 73 subjects in both the ETX-018810 and Placebo groups. All subjects in this population were included in the statistical analysis comparing the groups. However, the descriptive statistics for Week 4 only include those subjects who had measurements at Baseline and Week 4 (72 and 70 subjects, respectively).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ETX-018810 | 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) | -1.49 units on a scale | Standard Deviation 1.735 |
| Placebo | 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) | -1.65 units on a scale | Standard Deviation 1.76 |
p-value: 0.454995% CI: [-0.36, 0.79]Mixed Models Analysis
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).
Time frame: Baseline and Week 4
Population: The ITT population included all randomized subjects who received at least one dose of study treatment; 74 subjects in both the ETX-018810 and Placebo groups. Not all subjects had a BPI assessment at Week 4.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ETX-018810 | Change From Baseline to Week 4 for Worst Pain | -1.73 score on a scale | Standard Deviation 2.206 |
| Placebo | Change From Baseline to Week 4 for Worst Pain | -1.74 score on a scale | Standard Deviation 1.861 |
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.
Time frame: Baseline to Week 4
Population: The ITT population included all randomized subjects who received at least one dose of study treatment; 74 subjects in both the ETX-018810 and Placebo groups. Not all subjects had a BPI assessment at Week 4.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ETX-018810 | Change in BPI - Interference Scale From Baseline to Week 4 | -1.68 score on a scale | Standard Deviation 1.967 |
| Placebo | Change in BPI - Interference Scale From Baseline to Week 4 | -1.94 score on a scale | Standard Deviation 1.954 |
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.
Time frame: Baseline to Week 4
Population: The ITT population included all randomized subjects who received at least one dose of study treatment; 74 subjects in both the ETX-018810 and Placebo groups. Not all subjects had a BPI assessment at Week 4.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ETX-018810 | Change in the BPI - Pain Scale From Baseline to Week 4 | -1.70 score on a scale | Standard Deviation 1.974 |
| Placebo | Change in the BPI - Pain Scale From Baseline to Week 4 | -1.57 score on a scale | Standard Deviation 1.588 |
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).
Time frame: Treatment period: 4 weeks
Population: The modified ITT population included all randomized subjects who received at least one dose of study treatment and had at least four post-baseline PI-NRS measurements; 73 subjects in both the ETX-018810 and Placebo groups. Three subjects were excluded due to implausible records in the subject's diary.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ETX-018810 | Change in the Daily Amount of Acetaminophen Use From Baseline to Week 4 | 0 mg per day |
| Placebo | Change in the Daily Amount of Acetaminophen Use From Baseline to Week 4 | 0 mg per day |
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).
Time frame: Baseline to Week 4
Population: The ITT population included all randomized subjects who received at least one dose of study treatment; 74 subjects in both the ETX-018810 and Placebo groups. Not all subjects had a RMDQ assessment at Week 4.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ETX-018810 | Change in the RMDQ From Baseline to Week 4 | -2.10 score on a scale | Standard Deviation 3.637 |
| Placebo | Change in the RMDQ From Baseline to Week 4 | -2.31 score on a scale | Standard Deviation 4.367 |
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).
Time frame: Baseline to Weeks 1, 2, and 3
Population: The modified ITT population included all randomized subjects who received at least one dose of study treatment and had at least four post-baseline PI-NRS measurements; 73 subjects in both the ETX-018810 and Placebo groups. Not all subjects had assessments at each week.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ETX-018810 | Change in the Weekly Average of the Daily Pain Score From Baseline to Weeks 1, 2, and 3 | Week 1 | -0.66 score on a scale | Standard Deviation 1.079 |
| ETX-018810 | Change in the Weekly Average of the Daily Pain Score From Baseline to Weeks 1, 2, and 3 | Week 2 | -1.04 score on a scale | Standard Deviation 1.479 |
| ETX-018810 | Change in the Weekly Average of the Daily Pain Score From Baseline to Weeks 1, 2, and 3 | Week 3 | -1.28 score on a scale | Standard Deviation 1.575 |
| Placebo | Change in the Weekly Average of the Daily Pain Score From Baseline to Weeks 1, 2, and 3 | Week 1 | -0.85 score on a scale | Standard Deviation 0.994 |
| Placebo | Change in the Weekly Average of the Daily Pain Score From Baseline to Weeks 1, 2, and 3 | Week 2 | -1.15 score on a scale | Standard Deviation 1.429 |
| Placebo | Change in the Weekly Average of the Daily Pain Score From Baseline to Weeks 1, 2, and 3 | Week 3 | -1.49 score on a scale | Standard Deviation 1.606 |
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.
Time frame: Baseline to Weeks 1, 2, 3 and 4
Population: The modified ITT population included all randomized subjects who received at least one dose of study treatment and had at least four post-baseline PI-NRS measurements; 73 subjects in both the ETX-018810 and Placebo groups. Not all subjects had assessments at each week.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ETX-018810 | Change in the Weekly Average of the Daily Sleep Score on the DSIS From Baseline to Weeks 1, 2, 3, and 4 | Week 1 | -0.87 score on a scale | Standard Deviation 1.279 |
| ETX-018810 | Change in the Weekly Average of the Daily Sleep Score on the DSIS From Baseline to Weeks 1, 2, 3, and 4 | Week 2 | -1.14 score on a scale | Standard Deviation 1.576 |
| ETX-018810 | Change in the Weekly Average of the Daily Sleep Score on the DSIS From Baseline to Weeks 1, 2, 3, and 4 | Week 3 | -1.41 score on a scale | Standard Deviation 1.697 |
| ETX-018810 | Change in the Weekly Average of the Daily Sleep Score on the DSIS From Baseline to Weeks 1, 2, 3, and 4 | Week 4 | -1.59 score on a scale | Standard Deviation 1.676 |
| Placebo | Change in the Weekly Average of the Daily Sleep Score on the DSIS From Baseline to Weeks 1, 2, 3, and 4 | Week 4 | -1.53 score on a scale | Standard Deviation 1.706 |
| Placebo | Change in the Weekly Average of the Daily Sleep Score on the DSIS From Baseline to Weeks 1, 2, 3, and 4 | Week 1 | -0.81 score on a scale | Standard Deviation 1.114 |
| Placebo | Change in the Weekly Average of the Daily Sleep Score on the DSIS From Baseline to Weeks 1, 2, 3, and 4 | Week 3 | -1.51 score on a scale | Standard Deviation 1.52 |
| Placebo | Change in the Weekly Average of the Daily Sleep Score on the DSIS From Baseline to Weeks 1, 2, 3, and 4 | Week 2 | -1.18 score on a scale | Standard Deviation 1.366 |
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).
Time frame: Baseline to Weeks 1, 2, 3 and 4
Population: The modified ITT population included all randomized subjects who received at least one dose of study treatment and had at least four post-baseline PI-NRS measurements; 73 subjects in both the ETX-018810 and Placebo groups. Not all subjects had assessments at each week.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ETX-018810 | Number of Subjects With ≥50% Reduction From Baseline to Weeks 1, 2, 3,and 4 in the Weekly Average of the Daily Pain Score | Week 1 | 4 Participants |
| ETX-018810 | Number of Subjects With ≥50% Reduction From Baseline to Weeks 1, 2, 3,and 4 in the Weekly Average of the Daily Pain Score | Week 2 | 9 Participants |
| ETX-018810 | Number of Subjects With ≥50% Reduction From Baseline to Weeks 1, 2, 3,and 4 in the Weekly Average of the Daily Pain Score | Week 3 | 12 Participants |
| ETX-018810 | Number of Subjects With ≥50% Reduction From Baseline to Weeks 1, 2, 3,and 4 in the Weekly Average of the Daily Pain Score | Week 4 | 14 Participants |
| Placebo | Number of Subjects With ≥50% Reduction From Baseline to Weeks 1, 2, 3,and 4 in the Weekly Average of the Daily Pain Score | Week 4 | 17 Participants |
| Placebo | Number of Subjects With ≥50% Reduction From Baseline to Weeks 1, 2, 3,and 4 in the Weekly Average of the Daily Pain Score | Week 1 | 3 Participants |
| Placebo | Number of Subjects With ≥50% Reduction From Baseline to Weeks 1, 2, 3,and 4 in the Weekly Average of the Daily Pain Score | Week 3 | 17 Participants |
| Placebo | Number of Subjects With ≥50% Reduction From Baseline to Weeks 1, 2, 3,and 4 in the Weekly Average of the Daily Pain Score | Week 2 | 8 Participants |
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).
Time frame: Baseline to Weeks 1, 2, 3 and 4
Population: The modified ITT population included all randomized subjects who received at least one dose of study treatment and had at least four post-baseline PI-NRS measurements; 73 subjects in both the ETX-018810 and Placebo groups. Not all subjects had assessments at each week.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ETX-018810 | 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 | Week 1 | 9 Participants |
| ETX-018810 | 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 | Week 2 | 18 Participants |
| ETX-018810 | 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 | Week 3 | 22 Participants |
| ETX-018810 | 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 | Week 4 | 28 Participants |
| Placebo | 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 | Week 4 | 29 Participants |
| Placebo | 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 | Week 1 | 17 Participants |
| Placebo | 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 | Week 3 | 28 Participants |
| Placebo | 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 | Week 2 | 19 Participants |
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.
Time frame: Week 4
Population: The ITT population included all randomized subjects who received at least one dose of study treatment; 74 subjects in both the ETX-018810 and Placebo groups. Not all subjects had a CGI-C assessment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ETX-018810 | Number of Subjects With a CGI-C Response (Defined as Much Improved or Very Much Improved) at Week 4 | 21 Participants |
| Placebo | Number of Subjects With a CGI-C Response (Defined as Much Improved or Very Much Improved) at Week 4 | 24 Participants |
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.
Time frame: Week 4
Population: The ITT population included all randomized subjects who received at least one dose of study treatment; 74 subjects in both the ETX-018810 and Placebo groups. Not all subjects had a PGI-C assessment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ETX-018810 | Number of Subjects With a PGI-C Response (Defined as Much Improved or Very Much Improved) at Week 4 | 23 Participants |
| Placebo | Number of Subjects With a PGI-C Response (Defined as Much Improved or Very Much Improved) at Week 4 | 25 Participants |