We are experiencing 4 week turn-around time in review of submissions and resubmissions. We recommend commencing this process concurrently with your ethics submission and allowing at least 8 weeks for registration to be completed from date of first submission. We currently do not have the capacity to expedite reviews.

Note also there are delays to review of updates. We appreciate your patience.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04466410

Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
Safety and Efficacy of XT-150 for Treatment of Neuropathic Pain
Scientific title
A Double Blind, Placebo Controlled, Preliminary Evaluation of Safety, Tolerability, and Efficacy of XT-150 for the Treatment of Neuropathic Pain
Secondary ID [1] 0 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neuropathic Pain 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders

Study type
Description of intervention(s) / exposure
Other interventions - XT-150
Other interventions - Placebo

Experimental: Low Dose XT-150 - Lowest dose of XT-150. Cohort 1 of the study

Experimental: Middle dose XT-150 - Middle dose of XT-150. Cohort 2 of the study

Experimental: High Dose XT-150 - Highest dose of XT-150. Cohort 3 of the study

Placebo Comparator: Placebo - PBS for injection. 4 of 16 subjects randomly assigned in each experimental drug cohort

Other interventions: XT-150
Single bolus intrathecal injection

Other interventions: Placebo

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Primary outcome [1] 0 0
Incidence of Treatment-Emergent Adverse Events - Adverse events
Timepoint [1] 0 0
6 months
Primary outcome [2] 0 0
Visual Analog Scale of Pain Intensity - Change from Baseline score, 0 to 100 worst pain
Timepoint [2] 0 0
6 months
Secondary outcome [1] 0 0
West Haven-Yale Multidimensional Pain Inventory (WHYMPI/MPI) - measures the impact of pain on patients' lives
Timepoint [1] 0 0
6 months
Secondary outcome [2] 0 0
Multidimensional Pain Scale (MPS) - Changes from baseline in pain
Timepoint [2] 0 0
6 months
Secondary outcome [3] 0 0
Neuropathic Pain Symptom Inventory (NPSI) - Evaluates the relative component of neuropathic and nociceptive pain symptoms
Timepoint [3] 0 0
6 months

Key inclusion criteria
1. Signed Informed Consent Form

2. 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

3. Male or female, between 18 and 80 years of age, inclusive

4. Clinical indication: Lumbar disk disease with no prior lumbar surgery with radicular
pain symptoms and/or signs of compressive neuropathy

5. Inadequate pain relief (visual analog scale of pain intensity [VASPI] score =70 mm on
a 0-100 mm scale) lasting =3 months

6. 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

7. In the judgment of the Principal Investigator, acceptable vital signs: blood pressure;
resting heart rate; respirations, and oral temperature

8. Body mass index of 18 to 35 kg/m2 , (maximum weight 250kg, maximum girth 420cm)

9. Life expectancy >6 months as determined by the Principal Investigator

10. 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

11. 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

12. Stable medical regimen for =2 months before participation

13. Have suitable lumbar anatomy for intrathecal injection as determined by MRI or X-Ray
in the last 6 months.

14. Willing and able to return for the follow-up (FU) visits

15. Able to read and understand study instructions, and willing and able to comply with
all study procedures

16. Adequately informed of the nature and risks of the study and give written informed
consent before receiving any study specific assessments or procedures

17. Stable use of non-prescription pain therapy, including massage, TENS, physiotherapy
osteopathy, chiropractic and acupuncture for 2 months prior and throughout the study
Minimum age
18 Years
Maximum age
80 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Subjects must NOT meet any of the following exclusion criteria:

1. 1. Hypersensitivity, allergy, or significant reaction to any ingredient of the study

2. Any spinal deformity preventing intrathecal injection or making intrathecal injection

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

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

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

20. Current treatment with anticoagulant or antiplatelet medications (EXCEPTION: aspirin
and other NSAIDs)

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 subject, the subject'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 subject's ability to assess the effect of the study
drug on the radicular signs and/or symptoms

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Alfred Health - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Xalud Therapeutics, Inc.

Ethics approval
Ethics application status

Brief summary
Preliminary Evaluation of Safety, Tolerability, and Efficacy of XT-150 for the Treatment of
Neuropathic Pain. Intrathecally administered, single injection.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Stephen Collins, MD/PhD
Address 0 0
Xalud Therapeutics, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Elspeth Hutton, MBBS,PhD,FRACP
Address 0 0
Country 0 0
Phone 0 0
+61 3 9903 0781?
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04466410