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Efficacy and Safety of ETX 018810 in Subjects with Lumbosacral Radicular Pain
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of ETX 018810 in Subjects with Lumbosacral Radicular Pain
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ETX-018810 | Experimental | Drug: ETX-018810 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 ≥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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Delta Clinical Research | Mobile | Alabama | 36606 | United States | ||
| Arizona Research Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | ETX-018810 | Drug: ETX-018810 bid ETX-018810: Study Drug |
| FG001 | Placebo | Matching Placebo bid Placebo: Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 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 | May 24, 2021 |
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Placebo Controlled
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| Drug |
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 |
| 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). | Baseline and 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 |
| 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 |
| 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. | Baseline to Weeks 1, 2, 3 and 4 |
| 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. | Baseline to Week 4 |
| 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. | Baseline to Week 4 |
| 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"). | Baseline to Week 4 |
| Change in the Daily Amount of Acetaminophen Use From Baseline to Week 4 | The daily amount of acetaminophen (rescue medication) used (mg per day). | Treatment period: 4 weeks |
| Phoenix |
| Arizona |
| 85053 |
| United States |
| DBPS Research LLC | Greenwood Village | Colorado | 80111 | United States |
| Charter Research | Lady Lake | Florida | 32159 | United States |
| Cordova Research Institute | Miami | Florida | 33155 | United States |
| Advanced Medical Research Institute | Miami | Florida | 33174 | United States |
| Coral Research Clinic Corp | Miami | Florida | 33186 | United States |
| Drug Studies America | Marietta | Georgia | 30060 | United States |
| Better Health Clinical Research | Newnan | Georgia | 30265 | United States |
| Injury Care Research | Boise | Idaho | 83713 | United States |
| Chicago Anesthesia Research Specialist | Chicago | Illinois | 60657 | United States |
| Indiana Spine Group | Carmel | Indiana | 46032 | United States |
| Healthcare Research Network | Hazelwood | Missouri | 63042 | United States |
| Drug Trials America | Hartsdale | New York | 10530 | United States |
| University of Rochester Translational Pain Research | Rochester | New York | 14618 | United States |
| Center for Clinical Research | Winston-Salem | North Carolina | 27103 | United States |
| Meta Medical Research Institute | Dayton | Ohio | 45432 | United States |
| Clinical Investigations LLC | Edmond | Oklahoma | 73013 | United States |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | United States |
| Clinical Trials of South Carolina | Charleston | South Carolina | 29406 | United States |
| Precision Spine care | Tyler | Texas | 75701 | 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 |
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| NOT COMPLETED |
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The ITT population included all randomized subjects who received at least one dose of study treatment. One subject randomized to ETX-018810 withdrew consent to participate in the study before receiving their first dose of study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | ETX-018810 | Drug: ETX-018810 bid ETX-018810: Study Drug |
| BG001 | Placebo | Matching Placebo bid Placebo: 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 |
|
| 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; 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). | Posted | Mean | Standard Deviation | units on a scale | Baseline to Week 4 |
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| 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). | 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. | Posted | Count of Participants | Participants | Baseline to Weeks 1, 2, 3 and 4 |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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; 73 subjects in both the ETX-018810 and Placebo groups. Not all subjects had assessments at each week. | Posted | Count of Participants | Participants | Baseline to Weeks 1, 2, 3 and 4 |
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| 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; 73 subjects in both the ETX-018810 and Placebo groups. Not all subjects had assessments at each week. | Posted | Mean | Standard Deviation | score on a scale | Baseline to Weeks 1, 2, and 3 |
|
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| 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). | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 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; 74 subjects in both the ETX-018810 and Placebo groups. Not all subjects had a PGI-C assessment. | Posted | Count of Participants | Participants | Week 4 |
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| 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; 74 subjects in both the ETX-018810 and Placebo groups. Not all subjects had a CGI-C assessment. | Posted | Count of Participants | Participants | Week 4 |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline to Weeks 1, 2, 3 and 4 |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline to Week 4 |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline to Week 4 |
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| 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"). | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline to Week 4 |
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| 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). | 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. | Posted | Median | Inter-Quartile Range | mg per day | Treatment period: 4 weeks |
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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 | Drug: ETX-018810 bid ETX-018810: Study Drug | 0 | 74 | 0 | 74 | 11 | 74 |
| EG001 | Placebo | Matching Placebo bid Placebo: Placebo | 0 | 74 | 1 | 74 | 15 | 74 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colon cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | MedDRA (23.0) | Non-systematic Assessment |
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| Haematocrit decreased | Investigations | MedDRA (23.0) | Non-systematic Assessment |
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| SARS-CoV-2 test positive | Investigations | MedDRA (23.0) | Non-systematic Assessment |
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| Weight increased | Investigations | MedDRA (23.0) | Non-systematic Assessment |
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| Asthenia | General disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Chest discomfort | General disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Peripheral swelling | General disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (23.0) | Non-systematic Assessment |
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| Otitis media | Infections and infestations | MedDRA (23.0) | Non-systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Blister | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Lethargy | Nervous system disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Restless legs syndrome | Nervous system disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Sciatica | Nervous system disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Hepatomegaly | Hepatobiliary disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Abnormal dreams | Psychiatric disorders | MedDRA (23.0) | Non-systematic Assessment |
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| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Non-systematic Assessment |
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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 |
| May 9, 2023 |
| Prot_SAP_000.pdf |
| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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