Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ETX-018810 | Experimental | 1000 mg BID for 4 weeks |
|
| Placebo | Placebo Comparator | matching placebo BID for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ETX-018810 | Drug | Study Drug |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | baseline to Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline to Weeks 1, 2, 3 and 4 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Delta Clinical Research | Mobile | Alabama | 36609 | United States | ||
| Arizona Research Center |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | ETX-018810 | ETX-018810: Study Drug |
| FG001 | Placebo | Placebo: Matching Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 7, 2020 |
Not provided
Not provided
Placebo-Controlled, Parallel-Group
Not provided
Not provided
Double-Blind
| Drug |
Matching 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 | 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). | Baseline to Weeks 1, 2, 3 and 4 |
| 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). | Baseline to Weeks 1, 2 and 3 |
| 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. | Week 4 |
| 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. | Week 4 |
| 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). | Baseline to Weeks 1, 2, 3 and 4 |
| 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. | Baseline to Week 4 |
| 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. | Baseline to Week 4 |
| 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). | Baseline to week 4 |
| Phoenix |
| Arizona |
| 85053 |
| United States |
| Neuro-Pain Medical Cneter | Fresno | California | 93710 | United States |
| Encompass Clinical Research | Spring Valley | California | 91978 | United States |
| Diabetes Research Center | Tustin | California | 92780 | United States |
| Chase Medical Research LLC | Hamden | Connecticut | 06517 | United States |
| Charter Research | Lady Lake | Florida | 32159 | United States |
| Cordova Research Institute | Miami | Florida | 33155 | United States |
| Coral Research Clinic Corp | Miami | Florida | 33186 | United States |
| Better Health Clinical Reseach | Newnan | Georgia | 30265 | United States |
| Medisphere Medical Research Center | Evansville | Indiana | 47714 | United States |
| StudyMetrix Research LLC | City of Saint Peters | Missouri | 65810 | United States |
| Alliance for Multispeciality Research LLC | Las Vegas | Nevada | 89119 | United States |
| Hassman Research Institute | Berlin | New Jersey | 08009 | United States |
| IMA Clinical Research | New York | New York | 10036 | United States |
| Upstate Clinical Research Associates | Williamsville | New York | 14221 | United States |
| Midwest Clinical Research Center | Dayton | Ohio | 45417 | United States |
| FutureSearch Trials of Neurology | Austin | Texas | 78731 | United States |
| Alpine Research Organization | Clinton | Utah | 84015 | United States |
| Jean Brown Research | Salt Lake City | Utah | 84107 | United States |
| Wasatch Clinical Research LLC | Salt Lake City | Utah | 84107 | United States |
| Northwest Clinical Research Center | Bellevue | Washington | 98007 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ETX-018810 | ETX-018810: Study Drug |
| BG001 | Placebo | Placebo: Matching Placebo |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | 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). | Posted | Mean | Standard Deviation | score on a scale | baseline to Week 4 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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). | 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. | Posted | Count of Participants | Participants | Baseline to Weeks 1, 2, 3 and 4 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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). | 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. | Posted | Count of Participants | Participants | Baseline to Weeks 1, 2, 3 and 4 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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). | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline to Weeks 1, 2 and 3 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Count of Participants | Participants | Week 4 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Count of Participants | Participants | Week 4 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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). | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline to Weeks 1, 2, 3 and 4 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline to Week 4 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline to Week 4 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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). | 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. | Posted | Median | Inter-Quartile Range | mg per day | Baseline to week 4 |
|
|
9 weeks (up to 4 week screening period, 4 week treatment period, & 1 week follow up period)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ETX-018810 | ETX-018810: Study Drug | 0 | 83 | 1 | 83 | 22 | 83 |
| EG001 | Placebo | Placebo: Matching Placebo | 0 | 84 | 0 | 84 | 11 | 84 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial ischaemia | Cardiac disorders | MedDRA (23.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Oesophageal pain | Gastrointestinal disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| cellulitis | Infections and infestations | MedDRA (23.0) | Non-systematic Assessment |
| |
| Gastroenteritis astroviral | Infections and infestations | MedDRA (23.0) | Non-systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA (23.0) | Non-systematic Assessment |
| |
| Diabetic foot infection | Infections and infestations | MedDRA (23.0) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (23.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (23.0) | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Nasal pruritus | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA (23.0) | Non-systematic Assessment |
| |
| Liver function test increased | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Non-systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Non-systematic Assessment |
|
The only disclosure restriction on the PI is that the PI will provide the sponsor with a copy of any proposed communication at least 90 days in advance of the proposed submission or presentation date. Within this 90 day period, the sponsor will review the communication to determine whether it contains any sponsor Confidential Information, or whether the sponsor desires to file patent applications on subject matter contained therein, and to ensure the accuracy of the information.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Operations | Eliem Therapeutics | +1-888-506-2573 | studyinfo@eliemtx.com |
| Apr 21, 2023 |
| Prot_SAP_001.pdf |
Not provided
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
|
|
| Participants |
|
|
|
|
|