Neuropathic Pain
Conditions
Keywords
XT-150, Plasmid Gene Therapy, IL-10
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.
Interventions
BIOLOGICALXT-150
Single bolus intrathecal injection
BIOLOGICALPlacebo
Placebo is a sterile phosphate-buffered saline
Sponsors
Xalud Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, 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.
Intervention model description
Dose escalation by cohort following safety reviews
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with Treatment-Emergent Adverse Events and Serious Adverse Events | 6 months |
| Number of participants with abnormal vital signs | 6 months |
| Number of participants with clinically significant abnormal physical examination findings | 6 months |
| Number of participants with anti-interleukin (IL)-10 antibodies | 6 months |
| Number of participants with IL-10 Protein | 6 months |
| Number of participants with abnormal clinical and hematology parameters | 6 months |
| Number of participants with plasmid DNA present in whole blood | 6 months |
| Number of participants with cytokines in Cerebrospinal fluid | 6 months |
Countries
Australia
Outcome results
None listed