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Lumbosacral RadiculopathyPhase 2NCT04778592

Efficacy and Safety of ETX-018810 in Subjects With Lumbosacral Radicular Pain

A Phase 2 study testing ETX-018810 in people with Lumbosacral Radiculopathy, run by Eliem Therapeutics (UK) Ltd. at 24 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Efficacy and Safety of ETX 018810 in Subjects with Lumbosacral Radicular Pain Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Lumbosacral Radiculopathy
What is being tested?
ETX-018810
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
149 participants
Where
24 sitesUnited States
Study dates
19 Jan 2021to 25 May 2022
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).
Show all 15Show fewer
  • 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

Trial locations and contacts

24 sites in 1 country.

24 sites in 1 country

United States24 sites

  • Northwest Clinical Research center

    Bellevue, Washington, 98007

  • Injury Care Research

    Boise, Idaho, 83713

  • Indiana Spine Group

    Carmel, Indiana, 46032

  • Clinical Trials of South Carolina

    Charleston, South Carolina, 29406

  • Chicago Anesthesia Research Specialist

    Chicago, Illinois, 60657

  • Meta Medical Research Institute

    Dayton, Ohio, 45432

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania, 16635

  • Clinical Investigations LLC

    Edmond, Oklahoma, 73013

  • DBPS Research LLC

    Greenwood Village, Colorado, 80111

  • Drug Trials America

    Hartsdale, New York, 10530

  • Healthcare Research Network

    Hazelwood, Missouri, 63042

  • Charter Research

    Lady Lake, Florida, 32159

  • Drug Studies America

    Marietta, Georgia, 30060

  • Cordova Research Institute

    Miami, Florida, 33155

  • Advanced Medical Research Institute

    Miami, Florida, 33174

  • Coral Research Clinic Corp

    Miami, Florida, 33186

  • Delta Clinical Research

    Mobile, Alabama, 36606

  • Better Health Clinical Research

    Newnan, Georgia, 30265

  • Arizona Research Center

    Phoenix, Arizona, 85053

  • University of Rochester Translational Pain Research

    Rochester, New York, 14618

  • Jean Brown Research

    Salt Lake City, Utah, 84107

  • Wasatch Clinical Research, LLC

    Salt Lake City, Utah, 84107

  • Precision Spine care

    Tyler, Texas, 75701

  • Center for Clinical Research

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of ETX-018810 in Subjects With Lumbosacral Radicular Pain

Efficacy and Safety of ETX 018810 in Subjects with Lumbosacral Radicular Pain

Read the 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

Being tested
ETX-018810, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ETX-018810Drug

    Study Drug

  • PlaceboDrug

    Placebo

Study groups in NCT04778592
Study groupRoleWhat they receive
ETX-018810ExperimentalDrug: ETX-018810 BID for 4 weeks
Receives: Drug: ETX-018810
PlaceboPlacebo comparatorMatching Placebo BID for 4 weeks
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Baseline to Week 4

Secondary outcomes (11)

  1. 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).

    Measured: Baseline to Weeks 1, 2, 3 and 4

  2. 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).

    Measured: Baseline to Weeks 1, 2, 3 and 4

  3. 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).

    Measured: Baseline to Weeks 1, 2, and 3

  4. 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).

    Measured: Baseline and Week 4

  5. 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.

    Measured: Week 4

  6. 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.

    Measured: Week 4

  7. 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.

    Measured: Baseline to Weeks 1, 2, 3 and 4

  8. 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.

    Measured: Baseline to Week 4

  9. 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.

    Measured: Baseline to Week 4

  10. 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").

    Measured: Baseline to Week 4

  11. Change in the Daily Amount of Acetaminophen Use From Baseline to Week 4

    The daily amount of acetaminophen (rescue medication) used (mg per day).

    Measured: Treatment period: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2021
  2. Study start19 Jan 2021
  3. Primary completion16 May 2022
  4. Study completion25 May 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Placebo Controlled
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
149 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04778592
Sponsor's protocol ID
ETX-018810-201
Status last verified
Nov 2023
First submitted
26 Feb 2021
Last updated
7 Nov 2023
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ETX-018810 in people with Lumbosacral Radiculopathy, run by Eliem Therapeutics (UK) Ltd. at 24 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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) (time frame: Baseline to Week 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04778592.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.

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