Diabetic Peripheral Neuropathic Pain, Diabetic Peripheral Neuropathy
Conditions
Brief summary
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Study to Evaluate the Efficacy and Safety of ETX 018810 in Subjects with Diabetic Peripheral Neuropathic Pain.
Detailed description
ETX-018810 is a new chemical entity that is under development as a non-opioid treatment for chronic pain syndromes. ETX-018810 is a prodrug of palmitoylethanolamide (PEA), an endogenous bioactive lipid that has shown efficacy in a broad range of nonclinical inflammatory and neuropathic pain models and in clinical trials in chronic pain indications, including diabetic peripheral neuropathic pain (DPNP).
Interventions
DRUGETX-018810
Study Drug
DRUGPlacebo
Matching Placebo
Sponsors
Eliem Therapeutics (UK) Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double-Blind
Intervention model description
Placebo-Controlled, Parallel-Group
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* The subject is ≥18 and ≤75 years of age at the time of signing ICF. * The subject has a diagnosis of type 1 or 2 diabetes mellitus. * The subject has diabetic neuropathy of a symmetrical nature in the lower extremities for ≥6 months to ≤10 years * The subject reports at least moderate pain intensity * The subject's onset of neuropathic pain is at least 3 months before the screening visit. * The subject has used a stable regimen of antidiabetic agents for at least 1 month before the baseline visit or has achieved adequate glycemic control through diet and exercise. * The subject has clinical laboratory values within normal limits or abnormal values that the investigator deems not clinically significant. * Sexually active male subjects with female partners of childbearing potential and sexually active female subjects of childbearing potential must agree to practice effective contraception or to remain abstinent during the study and for 4 weeks after the last dose of investigational product * The subject is capable of giving signed informed consent and agrees to provide authorization for use and release of health records.
Exclusion criteria
* The subject has pain that cannot be clearly differentiated from or that could interfere with the assessment of DPNP. * The subject has neurologic and/or circulatory disorders that are unrelated to diabetic neuropathy * The subject has a history of hypoglycemia that disturbed consciousness or ketoacidosis that required hospitalization within the 3 months before screening. * The subject has clinically significant and/or unstable renal, hepatic, hematologic, immunologic, inflammatory/rheumatologic, respiratory, or cardiovascular disease that would compromise participation in the study in the judgment of the investigator. * The subject has any neurological disease that could interfere with participation in the study (eg, Huntington's disease, Parkinson's disease, Alzheimer's disease, multiple sclerosis, seizures, epilepsy, stroke). * The subject has an amputation of a lower extremity. Toe amputation is allowed. * The subject has clinically significant abnormal electrocardiogram (ECG) findings at screening or baseline. * The subject is likely to require major surgery during the study. * The subject is pregnant or lactating. * The subject is unwilling or unable to discontinue current medications for neuropathic pain, including topical agents. * The subject is unable to refrain from using nonsteroidal anti-inflammatory drugs (NSAIDs); antiepileptic drugs, steroids, cannabinoids, or major opioids, muscle relaxants, tramadol, or tapentadol throughout the study. * The subject has used prohibited nonpharmacologic therapies, including acupuncture, transcutaneous electrical nerve stimulation, etc, within 30 days before baseline/Day 1 or anticipates use of such therapies during the study.
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). |
| 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 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 ≥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 the BPI - Interference Scale From Baseline to Week 4 | Baseline to Week 4 | The BPI Interference scale 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 BPI pain scale is a composite of 4 items assessing pain severity (worst, least, average, and right now). Subjects rate their pain in 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 Daily Amount of Acetaminophen Use From Baseline to Week 4 | Baseline to week 4 | The daily amount of acetaminophen (rescue medication) that was 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 describes 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ETX-018810 ETX-018810: Study Drug | 83 |
| Placebo Placebo: Matching Placebo | 84 |
| Total | 167 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 1 |
| Overall Study | Lack of Efficacy | 1 | 1 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 1 |
Baseline characteristics
| Characteristic | ETX-018810 | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 26 Participants | 29 Participants | 55 Participants |
| Age, Categorical Between 18 and 65 years | 57 Participants | 55 Participants | 112 Participants |
| Age, Continuous | 60.4 years STANDARD_DEVIATION 9.33 | 60.3 years STANDARD_DEVIATION 9.87 | 60.4 years STANDARD_DEVIATION 9.57 |
| Body Mass Index (BMI) | 31.9 kg/m^2 STANDARD_DEVIATION 4.33 | 30.9 kg/m^2 STANDARD_DEVIATION 4.77 | 31.4 kg/m^2 STANDARD_DEVIATION 4.57 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 4 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 13 Participants | 23 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 70 Participants | 65 Participants | 135 Participants |
| Region of Enrollment United States | 83 participants | 84 participants | 167 participants |
| Sex: Female, Male Female | 25 Participants | 34 Participants | 59 Participants |
| Sex: Female, Male Male | 58 Participants | 50 Participants | 108 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 83 | 0 / 84 |
| other Total, other adverse events | 22 / 83 | 11 / 84 |
| serious Total, serious adverse events | 1 / 83 | 0 / 84 |
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; 78 and 81 subjects for the ETX-018810 and Placebo groups, respectively. All subjects in this population were included in the statistical analysis comparing the groups. However, the descriptive summary for Week 4 only included those subjects who had measurements at Baseline and Week 4 (74 and 78 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) | -1.79 score on a scale | Standard Deviation 2.099 |
| 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) | -1.91 score on a scale | Standard Deviation 1.781 |
p-value: 0.560590% CI: [-0.32, 0.68]Mixed Models Analysis
Secondary
Change in the BPI - Interference Scale From Baseline to Week 4
The BPI Interference scale 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; 83 and 84 subjects for the ETX-018810 and Placebo groups, respectively. Not all subjects had a BPI assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ETX-018810 | Change in the BPI - Interference Scale From Baseline to Week 4 | -1.60 score on a scale | Standard Deviation 2.142 |
| Placebo | Change in the BPI - Interference Scale From Baseline to Week 4 | -1.78 score on a scale | Standard Deviation 2.202 |
Secondary
Change in the BPI-Pain Scale From Baseline to Week 4
The BPI pain scale is a composite of 4 items assessing pain severity (worst, least, average, and right now). Subjects rate their pain in 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; 83 and 84 subjects for the ETX-018810 and Placebo groups, respectively. Not all subjects had a BPI assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ETX-018810 | Change in the BPI-Pain Scale From Baseline to Week 4 | -1.39 score on a scale | Standard Deviation 1.833 |
| Placebo | Change in the BPI-Pain Scale From Baseline to Week 4 | -1.78 score on a scale | Standard Deviation 1.809 |
Secondary
Change in the Daily Amount of Acetaminophen Use From Baseline to Week 4
The daily amount of acetaminophen (rescue medication) that was used (mg per day).
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; 78 and 81 subjects for the ETX-018810 and Placebo groups, respectively.
| 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 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; 78 and 81 subjects for the ETX-018810 and Placebo groups, respectively. 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 | -0.67 score on a scale | Standard Deviation 1.294 |
| ETX-018810 | Change in the Weekly Average of the Daily Pain Score From Baseline to Weeks 1, 2, and 3 | Week 3 | -1.60 score on a scale | Standard Deviation 1.945 |
| ETX-018810 | Change in the Weekly Average of the Daily Pain Score From Baseline to Weeks 1, 2, and 3 | Week 2 | -1.39 score on a scale | Standard Deviation 1.879 |
| Placebo | Change in the Weekly Average of the Daily Pain Score From Baseline to Weeks 1, 2, and 3 | Week 1 | -0.51 score on a scale | Standard Deviation 1.009 |
| Placebo | Change in the Weekly Average of the Daily Pain Score From Baseline to Weeks 1, 2, and 3 | Week 2 | -1.16 score on a scale | Standard Deviation 1.42 |
| Placebo | Change in the Weekly Average of the Daily Pain Score From Baseline to Weeks 1, 2, and 3 | Week 3 | -1.56 score on a scale | Standard Deviation 1.682 |
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 describes 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).
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; 78 and 81 subjects for the ETX-018810 and Placebo groups, respectively. 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 2 | -1.36 score on a scale | Standard Deviation 1.967 |
| 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 | -1.70 score on a scale | Standard Deviation 2.144 |
| 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 | -1.65 score on a scale | Standard Deviation 2.087 |
| 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 | -0.86 score on a scale | Standard Deviation 1.554 |
| 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 | -1.73 score on a scale | Standard Deviation 1.72 |
| 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 | -0.67 score on a scale | Standard Deviation 1.133 |
| 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 | -1.95 score on a scale | Standard Deviation 1.9 |
| 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 | -1.34 score on a scale | Standard Deviation 1.48 |
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; 78 and 81 subjects for the ETX-018810 and Placebo groups, respectively. 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 | 11 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 | 21 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 | 26 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 | 25 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 | 42 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 | 9 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 | 26 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 | 38 Participants |
Secondary
Number of Subjects With a ≥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; 78 and 81 subjects for the ETX-018810 and Placebo groups, respectively. Not all subjects had assessments at each week.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ETX-018810 | Number of Subjects With a ≥50% Reduction From Baseline to Weeks 1, 2, 3, and 4 in the Weekly Average of the Daily Pain Score | Week 1 | 5 Participants |
| ETX-018810 | Number of Subjects With a ≥50% Reduction From Baseline to Weeks 1, 2, 3, and 4 in the Weekly Average of the Daily Pain Score | Week 4 | 16 Participants |
| ETX-018810 | Number of Subjects With a ≥50% Reduction From Baseline to Weeks 1, 2, 3, and 4 in the Weekly Average of the Daily Pain Score | Week 3 | 16 Participants |
| ETX-018810 | Number of Subjects With a ≥50% Reduction From Baseline to Weeks 1, 2, 3, and 4 in the Weekly Average of the Daily Pain Score | Week 2 | 15 Participants |
| Placebo | Number of Subjects With a ≥50% Reduction From Baseline to Weeks 1, 2, 3, and 4 in the Weekly Average of the Daily Pain Score | Week 3 | 18 Participants |
| Placebo | Number of Subjects With a ≥50% Reduction From Baseline to Weeks 1, 2, 3, and 4 in the Weekly Average of the Daily Pain Score | Week 4 | 25 Participants |
| Placebo | Number of Subjects With a ≥50% Reduction From Baseline to Weeks 1, 2, 3, and 4 in the Weekly Average of the Daily Pain Score | Week 2 | 7 Participants |
| Placebo | Number of Subjects With a ≥50% Reduction From Baseline to Weeks 1, 2, 3, and 4 in the Weekly Average of the Daily Pain Score | Week 1 | 1 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; 83 and 84 subjects for the ETX-018810 and Placebo groups, respectively. 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 | 26 Participants |
| Placebo | Number of Subjects With a CGI-C Response (Defined as Much Improved or Very Much Improved) at Week 4 | 34 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; 83 and 84 subjects for the ETX-018810 and Placebo groups, respectively. Not all subjects in the population 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. | 27 Participants |
| Placebo | Number of Subjects With a PGI-C Response (Defined as Much Improved or Very Much Improved) at Week 4. | 37 Participants |