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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04466410
Recruitment Status : Recruiting
First Posted : July 10, 2020
Last Update Posted : August 26, 2022
Sponsor:
Information provided by (Responsible Party):
Xalud Therapeutics, Inc.

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

Condition or disease Intervention/treatment Phase
Neuropathic Pain Biological: XT-150 Biological: Placebo Phase 1

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Dose escalation by cohort following safety reviews
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Placebo and active drug are identical in appearance. Randomization will be provided to an unblinded pharmacist. Dosing and clinical assessments will be blinded.
Primary Purpose: Treatment
Official Title: A Double Blind, Placebo Controlled, Preliminary Evaluation of Safety, Tolerability, and Efficacy of XT-150 for the Treatment of Neuropathic Pain
Actual Study Start Date : April 14, 2021
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : April 2023

Arm Intervention/treatment
Experimental: 15 microgram (µg) XT-150
15 µg of XT-150. Cohort 1 of the study
Biological: XT-150
Single bolus intrathecal injection
Other Name: IL-10 transgene plasmid DNA injected intrathecally

Experimental: 150 µg XT-150
150 µg of XT-150. Cohort 2 of the study
Biological: XT-150
Single bolus intrathecal injection
Other Name: IL-10 transgene plasmid DNA injected intrathecally

Experimental: 450 µg XT-150
450 µg of XT-150. Cohort 3 of the study
Biological: XT-150
Single bolus intrathecal injection
Other Name: IL-10 transgene plasmid DNA injected intrathecally

Placebo Comparator: Placebo
PBS for injection.
Biological: Placebo
Placebo




Primary Outcome Measures :
  1. Number of participants with Treatment-Emergent Adverse Events and Serious Adverse Events [ Time Frame: 6 months ]
  2. Number of participants with abnormal vital signs [ Time Frame: 6 months ]
  3. Number of participants with clinically significant abnormal physical examination findings [ Time Frame: 6 months ]
  4. Number of participants with anti-interleukin (IL)-10 antibodies [ Time Frame: 6 months ]
  5. Number of participants with IL-10 Protein [ Time Frame: 6 months ]
  6. Number of participants with abnormal clinical and hematology parameters [ Time Frame: 6 months ]
  7. Number of participants with plasmid DNA present in whole blood [ Time Frame: 6 months ]
  8. Number of participants with cytokines in Cerebrospinal fluid [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed Informed Consent Form
  2. Male or female, between 18 and 80 years of age, inclusive
  3. Clinical indication: Lumbar disk disease with no prior lumbar surgery with radicular pain symptoms and/or signs of compressive neuropathy
  4. At screening and baseline, a pain intensity score > 60 using the visual analog scale of pain intensity [VASPI] (0-100 mm scale) and a participant reported history of pain in the past 3 or more months
  5. 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
  6. In the judgment of the Principal Investigator, acceptable vital signs: blood pressure; resting heart rate; respirations, and oral temperature
  7. Life expectancy >6 months as determined by the Principal Investigator
  8. Female participants 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
  9. Male participants 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
  10. Stable medical regimen for ≥1 month before screening assessments
  11. Have suitable lumbar anatomy for intrathecal injection as determined by MRI or X-Ray in the last 6 months.
  12. Willing and able to return for the follow-up (FU) visits
  13. Able to read and understand study instructions, and willing and able to comply with all study procedures
  14. Adequately informed of the nature and risks of the study and give written informed consent before receiving any study specific assessments or procedures
  15. 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:

Participants must NOT meet any of the following exclusion criteria:

  1. Hypersensitivity, allergy, or significant reaction to any ingredient of the study drug
  2. Any spinal deformity preventing intrathecal injection or making intrathecal injection unsafe
  3. Prior history of lumbar surgery, including fusion and microdiscectomy
  4. History of epidural block or facet block or steroid injection in the last 6 months
  5. Current unstable angina, uncontrolled congestive heart failure, or >1+ pitting edema of lower extremities
  6. History of acute myocardial infarction, transient ischemic attack, stroke, or seizure within 3 months of screening visit
  7. Severe chronic obstructive or restrictive pulmonary disease
  8. Current insulin dependent diabetes mellitus
  9. Current autoimmune conditions or documented immunodeficiency
  10. History of immunosuppressive therapy; high-potency systemic steroids in the last 3 months
  11. Current treatment with systemic immunosuppressive (systemic corticosteroid therapy [equivalent to >10mg/day prednisone] or other strong immunosuppressant)
  12. Current or history of central nervous system cancer
  13. 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
  14. 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)
  15. 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)
  16. 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)
  17. Confirmed positive for human immunodeficiency virus, hepatitis B virus, or hepatitis C virus
  18. Significant psychological conditions; dementia, major depression, or altered mental state that in the opinion of the Investigator will interfere with study participation
  19. Current treatment with systemic antibiotics or antivirals (EXCEPTION: topical treatments)
  20. Current treatment with anticoagulants /antiplatelet medications except for low dose aspirin or low dose aspirin-containing compounds. Participants, if medically feasible, can interrupt anticoagulant therapy by following local medical practice protocol for intrathecal injections for participants on anticoagulant, antiplatelet therapy.
  21. Current use of systemic corticosteroids (equivalent to >10mg/day prednisone)
  22. Known or suspected history of active alcohol or illicit drug abuse within 1 year before the screening visit
  23. Women who are pregnant or nursing
  24. 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
  25. Any condition that, in the opinion of the Principal Investigator, could compromise the safety of the participants, the participant's ability to communicate the study staff, or the quality of the data
  26. Presence of an implanted intrathecal infusion system or peripheral neurostimulator
  27. 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
  28. Diagnosis of peripheral neuropathy of the lower extremities which in the opinion of the PI, might interfere with the participant's ability to assess the effect of the study drug on the radicular signs and/or symptoms

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04466410


Contacts
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Contact: Elspeth Hutton, MBBS,PhD,FRACP +61 3 9903 0781‬ elspeth.hutton@monash.edu
Contact: Mahima Kapoor M.Kapoor@alfred.org.au

Locations
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Australia, New South Wales
Genesis Research Services Recruiting
Newcastle, New South Wales, Australia, 2292
Contact: Marc Russo, MD    +61 2 4985 1860    reception@genesisresearchservices.com   
Principal Investigator: Marc Russo, MD         
Australia, South Australia
CerCare Not yet recruiting
Wayville, South Australia, Australia, 5034
Contact: Matthew Green    +61 8 8340 7733    matthew.green@painmedsa.com   
Principal Investigator: Matthew Green         
Australia, Victoria
Metro Pain Group Recruiting
Clayton, Victoria, Australia, 3168
Contact: Bruce Mitchell    +61 3 9595 6111    b.mitchell@metropain.com.au   
Principal Investigator: Bruce Mitchell, MD         
Alfred Health Recruiting
Melbourne, Victoria, Australia, 3004
Contact: Jack Germaine    +61 3 9076 2029    j.germaine@alfred.org.au   
Principal Investigator: Elspeth Hutton, MBBS PhD FRACP         
Sub-Investigator: Mahima Kapoor         
Sponsors and Collaborators
Xalud Therapeutics, Inc.
Investigators
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Study Director: Howard Rutman, MD,MBA Xalud Therapeutics, Inc.
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Responsible Party: Xalud Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04466410    
Other Study ID Numbers: XT-150-1-0102
First Posted: July 10, 2020    Key Record Dates
Last Update Posted: August 26, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xalud Therapeutics, Inc.:
XT-150
Plasmid Gene Therapy
IL-10
Additional relevant MeSH terms:
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Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations