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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04466410
Ethics application status
Date submitted
24/06/2020
Date registered
10/07/2020
Date last updated
20/01/2021

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
XT-150-1-0102
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

Intervention/exposure
Study type
Interventional
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
Placebo

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

Outcomes
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

Eligibility
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
period
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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
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 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
Treatment
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
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

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

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

Ethics approval
Ethics application status

Summary
Brief summary
Preliminary Evaluation of Safety, Tolerability, and Efficacy of XT-150 for the Treatment of
Neuropathic Pain. Intrathecally administered, single injection.
Trial website
https://clinicaltrials.gov/show/NCT04466410
Trial related presentations / publications
Public notes

Contacts
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
elspeth.hutton@monash.edu
Contact person for scientific queries

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