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Neuropathic PainPhase 1NCT04466410

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

A Phase 1 study testing XT-150 in people with Neuropathic Pain, run by Xalud Therapeutics, Inc. at 4 sites in Australia.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Neuropathic Pain
What is being tested?
XT-150
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
5 participants
Where
4 sitesAustralia
Study dates
14 Apr 2021to 27 Sep 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed Informed Consent Form
  • 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
  • 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
  • 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
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  • Life expectancy >6 months as determined by the Principal Investigator
  • 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
  • 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
  • Stable medical regimen for ≥1 month before screening assessments
  • 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

Who cannot join

  • Participants must NOT meet any of the following exclusion criteria:
  • 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
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  • 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 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.
  • 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 participants, the participant'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 participant's ability to assess the effect of the study drug on the radicular signs and/or symptoms

Trial locations and contacts

4 sites in 1 country.

Australia4 sites

  • Metro Pain Group

    Clayton, Victoria, 3168

  • Alfred Health

    Melbourne, Victoria, 3004

  • Genesis Research Services

    Newcastle, New South Wales, 2292

  • CerCare

    Wayville, South Australia, 5034

Other trials in Australia

About this study

Official title: A Double Blind, Placebo Controlled, Preliminary Evaluation of Safety, Tolerability, and Efficacy of XT-150 for the Treatment of Neuropathic Pain

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

Read the 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.

Being tested
XT-150, Placebo
Keywords
XT-150, Plasmid Gene Therapy, IL-10
Medical subject headings
Neuralgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • XT-150Biological

    Also called IL-10 transgene plasmid DNA injected intrathecally

    Single bolus intrathecal injection

  • PlaceboBiological

    Placebo is a sterile phosphate-buffered saline

Study groups in NCT04466410
Study groupRoleWhat they receive
0.015 milligram (mg) XT-150Experimental0.015 mg of XT-150. Cohort 1 of the study
Receives: Biological: XT-150
0.15 mg XT-150Experimental0.15 mg of XT-150. Cohort 2 of the study
Receives: Biological: XT-150
0.45 mg XT-150Experimental0.45 mg of XT-150. Cohort 3 of the study
Receives: Biological: XT-150
PlaceboPlacebo comparatorPBS for injection.
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with Treatment-Emergent Adverse Events and Serious Adverse Events

    Measured: 6 months

  2. Number of participants with abnormal vital signs

    Measured: 6 months

  3. Number of participants with clinically significant abnormal physical examination findings

    Measured: 6 months

  4. Number of participants with anti-interleukin (IL)-10 antibodies

    Measured: 6 months

  5. Number of participants with IL-10 Protein

    Measured: 6 months

  6. Number of participants with abnormal clinical and hematology parameters

    Measured: 6 months

  7. Number of participants with plasmid DNA present in whole blood

    Measured: 6 months

  8. Number of participants with cytokines in Cerebrospinal fluid

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2020
  2. Study start14 Apr 2021
  3. Primary completion27 Sep 2022
  4. Study completion27 Sep 2022

Why it stopped: Failure to enroll a sufficient number of patients.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
Dose escalation by cohort following safety reviews
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04466410
Sponsor's protocol ID
XT-150-1-0102
Status last verified
Jan 2023
First submitted
24 Jun 2020
Last updated
23 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kanao-Kanda M, Kanda H, Liu S, Kawamata T, Candiotti KA, Hao S. Viral vector-mediated interleukin 10 for gene therapy on chronic pain. Mol Pain. 2025 Jan-Dec;21:17448069251390266. doi: 10.1177/17448069251390266. Epub 2025 Oct 15.

    PubMed 41090674

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing XT-150 in people with Neuropathic Pain, run by Xalud Therapeutics, Inc. at 4 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Failure to enroll a sufficient number of patients.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with Treatment-Emergent Adverse Events and Serious Adverse Events (time frame: 6 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04466410, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2023.

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