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

NCT ID: NCT04466410

Last Updated: 2023-01-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-14
• Study Completion Date: 2022-09-27

Brief Summary

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

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.

Conditions

Neuropathic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

0.015 milligram (mg) XT-150

0.015 mg of XT-150. Cohort 1 of the study

Group Type: EXPERIMENTAL

XT-150

Intervention Type: BIOLOGICAL

Single bolus intrathecal injection

0.15 mg XT-150

0.15 mg of XT-150. Cohort 2 of the study

Group Type: EXPERIMENTAL

XT-150

Intervention Type: BIOLOGICAL

Single bolus intrathecal injection

0.45 mg XT-150

0.45 mg of XT-150. Cohort 3 of the study

Group Type: EXPERIMENTAL

XT-150

Intervention Type: BIOLOGICAL

Single bolus intrathecal injection

Placebo

PBS for injection.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Placebo is a sterile phosphate-buffered saline

Interventions

XT-150

Single bolus intrathecal injection

Intervention Type: BIOLOGICAL

Placebo

Placebo is a sterile phosphate-buffered saline

Intervention Type: BIOLOGICAL

Other Intervention Names

IL-10 transgene plasmid DNA injected intrathecally

Eligibility 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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xalud Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Howard Rutman, MD,MBA

Role: STUDY_DIRECTOR

Xalud Therapeutics, Inc.

Locations

Genesis Research Services

Newcastle, New South Wales, Australia

CerCare

Wayville, South Australia, Australia

Metro Pain Group

Clayton, Victoria, Australia

Alfred Health

Melbourne, Victoria, Australia

Countries

Australia

Other Identifiers

XT-150-1-0102

Identifier Type: -

Identifier Source: org_study_id