Safety and Efficacy of XT-150 for Treatment of Neuropathic Pain

  • STATUS
    Recruiting
  • End date
    Sep 30, 2022
  • participants needed
    48
  • sponsor
    Xalud Therapeutics, Inc.
Updated on 6 August 2021
analgesia
acupuncture
pain relief
drug test
pain relieving

Summary

Preliminary Evaluation of Safety, Tolerability, and Efficacy of XT-150 for the Treatment of Neuropathic Pain. Intrathecally administered, single injection.

Description

XT-150 has been safe and well tolerated in clinical studies of intra-articular knee injections for osteoarthritis.

This is the initial study of XT-150 for treatment of neuropathic pain. For this indication XT-150 must be administered by intrathecal injection. Doses used in the osteoarthritis studies will be studied for neuropathic pain.

Upon safety reviews, doses will be increased by cohorts.

The study is placebo controlled and blinded.

Details
Condition Peripheral Neuropathy, Neuralgia, Pain, Post-Surgical Pain, Pain (Pediatric), neuropathic pain
Treatment Placebo, XT-150
Clinical Study IdentifierNCT04466410
SponsorXalud Therapeutics, Inc.
Last Modified on6 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Signed Informed Consent Form
Focused Analgesia Selection Test (Analgesic Solutions, Wayland, MA) will be used to determine whether patients can report pain with sufficient consistency to enter the clinical trial
Male or female, between 18 and 80 years of age, inclusive
Clinical indication: Lumbar disk disease with no prior lumbar surgery with radicular pain symptoms and/or signs of compressive neuropathy
Inadequate pain relief (visual analog scale of pain intensity [VASPI] score 60 mm on a 0-100 mm scale) lasting 3 months
Medically stable as determined by the Principal Investigator in consultation with the Sponsor's Medical Monitor, based on pre-study medical history, physical examination, and clinical laboratory tests
In the judgment of the Principal Investigator, acceptable vital signs: blood pressure; resting heart rate; respirations, and oral temperature
Life expectancy >6 months as determined by the Principal Investigator
Female subjects of child-bearing potential, and those <1 year post-menopausal, must be practicing highly effective methods of birth control such as hormonal methods (e.g., combined oral, implantable, injectable, or transdermal contraceptives), double barrier methods (e.g., condoms, sponge, diaphragm, or vaginal ring plus spermicidal jellies or cream), or total abstinence from heterosexual intercourse for a minimum of 1 full menstruation cycle before study drug administration and agree to continue abstinence for 1 full menstruation cycle after the study is completed
Male subjects who are heterosexually active, and not surgically sterile, must agree to use effective contraception for the duration of the study and for 1 month after the study is completed
Stable medical regimen for 2 months before participation
Have suitable lumbar anatomy for intrathecal injection as determined by MRI or X-Ray in the last 6 months
Willing and able to return for the follow-up (FU) visits
Able to read and understand study instructions, and willing and able to comply with all study procedures
Adequately informed of the nature and risks of the study and give written informed consent before receiving any study specific assessments or procedures
Stable use of non-prescription pain therapy, including massage, TENS, physiotherapy osteopathy, chiropractic and acupuncture for 2 months prior and throughout the study period

Exclusion Criteria

Subjects must NOT meet any of the following exclusion criteria
1\. Hypersensitivity, allergy, or significant reaction to any ingredient of the study drug
Any spinal deformity preventing intrathecal injection or making intrathecal injection unsafe
Prior history of lumbar surgery, including fusion and microdiscectomy
History of epidural block or facet block or steroid injection in the last 6 months
Current unstable angina, uncontrolled congestive heart failure, or >1+ pitting edema of lower extremities
History of acute myocardial infarction, transient ischemic attack, stroke, or seizure within 3 months of screening visit
Severe chronic obstructive or restrictive pulmonary disease
Current insulin dependent diabetes mellitus
Current autoimmune conditions or documented immunodeficiency
History of immunosuppressive therapy; high-potency systemic steroids in the last 3 months
Current treatment with systemic immunosuppressive (systemic corticosteroid therapy [equivalent to >10mg/day prednisone] or other strong immunosuppressant)
Current or history of central nervous system cancer
Any malignancy (EXCEPTION: localized non-melanoma skin cancers) within 5 years before the screening visit or currently receiving systemic chemotherapy, radiation therapy, or a surgical stabilization procedure
Significant hepatic disease as indicated by clinical laboratory results for the following: 3 times the upper limit of normal (ULN) for aspartate aminotransferase, alanine aminotransferase, 2.5 time ULN alkaline phosphatase, or 1.5 times ULN for total bilirubin)
Severe anemia (Grade 3; hemoglobin <8.0 g/dL, <4.9 mmol/L, <80 g/L; transfusion indicated), Grade 1 white cell counts (lymphocytes <LLN - 800/mm3; <LLN - 0.8 x 109 /L, neutrophils <LLN - 1500/mm3; <LLN - 1.5 x 109 /L)
Significant renal disease as indicated by creatinine 1.5 times the upper limit of normal or creatinine clearance <80 mL/minute (Cockcroft-Gault formula estimate)
Confirmed positive for human immunodeficiency virus, hepatitis B virus, or hepatitis C virus
Significant psychological conditions; dementia, major depression, or altered mental state that in the opinion of the Investigator will interfere with study participation
Current treatment with systemic antibiotics or antivirals (EXCEPTION: topical treatments)
Current treatment with anticoagulant or antiplatelet medications (EXCEPTION: aspirin and other NSAIDs)
Current use of systemic corticosteroids (equivalent to >10mg/day prednisone)
Known or suspected history of active alcohol or illicit drug abuse within 1 year before the screening visit
Women who are pregnant or nursing
Use of any investigational drug or device within 1 month before randomization or current participation in a trial that included intervention with a drug or device; or currently participating in an investigational drug or device study
Any condition that, in the opinion of the Principal Investigator, could compromise the safety of the subject, the subject's ability to communicate the study staff, or the quality of the data
Presence of an implanted intrathecal infusion system or peripheral neurostimulator
Presence of a generalized pain disorder such as fibromyalgia or complex regional pain syndrome that in the opinion of the PI may impact on evaluation of response to the study drug
Diagnosis of peripheral neuropathy of the lower extremities which in the opinion of the PI, might interfere with the subject's ability to assess the effect of the study drug on the radicular signs and/or symptoms
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