Lumbosacral Radicular Pain: Do you have pain in the lower back and hip that radiates down the back of your thigh into the leg that is due to nerve damage?

  • STATUS
    Recruiting
  • End date
    Aug 23, 2022
  • sponsor
    Elium
Updated on 2 September 2021
body mass index
leg pain

Summary

Eliem Therapeutics has begun a 9 week study of an investigational drug (also known as the “study drug”) as a possible treatment for pain due to lumbosacral radiculopathy (pain in the lower back and hip that radiates down the back of the thigh into the leg). 

Description

The purpose of this study is to Evaluate the Efficacy and Safety of the study medication in Subjects with Lumbosacral Radicular Pain.

Details
Condition Radiculopathy
Clinical Study IdentifierTX281508
SponsorElium
Last Modified on2 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

The subject is ≥18 and ≤75 years of age at the time of signing ICF
The subject has unilateral pain consistent with a diagnosis of chronic lumbosacral radiculopathy due to injury of the lumbosacral nerve root(s) by degenerative disease of the vertebrae or associated soft tissues, including the intervertebral discs, or secondary to spinal injury
The subject’s onset of leg pain due to LSRP is at least 3 months before the screening visit
The subject has a body mass index (BMI) <40 kg/m2

Exclusion Criteria

The subject has previously undergone back surgery for pain at the same level as the current pain or has planned surgical intervention for LSRP during the study
The subject has a history of peripheral neuropathy (due to diabetes, alcohol consumption, other causes, or idiopathic) or evidence of peripheral neuropathy upon neurological examination
The subject has a history or any evidence of mononeuropathy in the same limb of LSRP
The subject has pain due to infection/abscess, hematoma, or malignancy
The subject has other pain that may interfere with the assessment of LSRP
The subject has history of malignancy in the 5 years before screening except for basal or squamous cell skin carcinoma or carcinoma in situ of the cervix
The subject has a positive test result for human immunodeficiency virus (HIV)
The subject has a history or positive test result for hepatitis C virus antibody, indicating ongoing infection, at screening
The subject has a history or evidence of hepatitis B virus (HBV) infection at screening
The subject has a history or current diagnosis of major psychiatric disorder(s) as defined by: a). A current diagnosis of schizophrenia, bipolar disorder, or panic disorder; b.) Use of antipsychotic agents or mood stabilizers (e.g., lithium, carbamazepine, valproate) within 12 months before screening; c.) Occurrence of major depressive episode in the 6 months before screening
The subject is pregnant or lactating
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Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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