Lumbar Radiculopathy
Conditions
Keywords
Sciatica, Low Back Pain, Lumbosacral Radiculopathy, Leg Pain
Brief summary
This is a Phase I/II, double-blind, parallel-group, randomized, placebo-controlled multi-centre trial in 180 patients randomized 1:1:1 to receive the IMP (Dexamethasone acetate microspheres for extended-release injectable micro-suspension, SX600 at 12.5 mg or 25.0 mg) or Placebo (0.9% Sodium Chloride for Injection, BP) via transforaminal epidural injection to the lumbosacral epidural space.
Interventions
DRUGSX600
Transforaminal Epidural Injection
DRUGPlacebo
Transforaminal Epidural Injection
Sponsors
SpineThera Australia PTY LTD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Double-Blind
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria: * Adult aged 18 to 65 years, capable of providing informed consent, capable of complying with the outcome instruments, and meeting the attendance requirements for review as defined in the study * Presenting with a history of radicular pain of duration of 4 weeks to 6 months, having failed conservative therapy. * Mean Worst Daily Leg Pain score of ≥5.0 and ≤9.0 * Women of child-bearing potential must use a medically accepted method of contraception for the duration of the study plus 30 days and register a negative pregnancy test prior to dosing Main
Exclusion criteria
* Documented history of allergy or intolerance to components of the Investigational Medicinal Product, relevant radiologic contrast media, or local anaesthetics * Is pregnant or lactating * Has been taking corticosteroid medications routinely in the past 6 months or has received an epidural corticosteroid injection within 12 weeks of screening * Has a BMI greater than 40 kg/m2 * Has radiological evidence of clinically significant foraminal stenosis at L4-L5 or L5-S1 or of clinically significant spinal stenosis, or spondylolisthesis (Grade 2 or higher). (Note, asymptomatic foraminal stenosis at other spinal levels is not excluded). * Has Diabetes Mellitus (Type 1 or Type 2)- prior confirmed HbA1c or OGTT * Has a history of significant leg pain unrelated to disc herniation that would significantly compromise assessment of back or leg radicular pain * Has had lumbar back surgery * Has received an implantable device for pain management
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Proportion of Subjects With a 50% or Greater Improvement in Mean Worst Daily Leg Pain (Responders). | Baseline to 60 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Proportion of Subjects Who Are Responders (Defined as Having a 50% or Greater Improvement in Mean Worst Daily Leg Pain) | Baseline to 14, 30, 60, 90, 120, 150, and 180 days | — |
| Change in Functional Outcomes as Measured by Patient's Global Impression of Change | Baseline, 14, 30, 60, 90, 120, 150, and 180 days | Very much improved, or much improved from baseline |
| Change in Functional Outcomes as Measured by the Oswestry Disability Index | Baseline, 14, 30, 60, 90, 120, 150, and 180 days | 0 - 20%: Minimal disability 21% - 40%: Moderate disability 41% - 60%: Severe disability 61% - 80%: Crippling back pain 81% - 100%: Bed-bound or exaggerating their symptoms |
| The Proportion of Subjects Who Are Responders (Defined as Having a 30% or Greater Improvement in Mean Worst Daily Leg Pain) | Baseline to 14, 30, 60, 90, 120, 150, and 180 days | — |
| Proportion of Subjects Who Required Rescue Medication, as Reported in Patient Diary | Baseline through 180 days | — |
| Time to Loss of Response in the Subset of Patients Who Are Responders at Day 14 (50% or Greater Improvement in Mean Worst Daily Leg Pain) | Day 14 through 180 days | — |
| Change From Baseline in Short Form 36 Questionnaire (SF-36) | Baseline, 14, 30, 60, 90, 120, 150, and 180 days | SF-36 is a self-administered, generic health status questionnaire consisting of 36 questions that measure 8 health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Each health concept has a range of possible total scores from 0 to 100. A high score defines a more favorable health state. The mean overall total score will be reported. |
Other
| Measure | Time frame |
|---|---|
| Proportion of Subjects Who Reduce Utilization of Supportive Health Services From Baseline, as Reported in Patient Diary | From baseline through 180 days |
Countries
Australia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 0.9% Sodium Chloride for Injection Placebo: Transforaminal Epidural Injection | 18 |
| 12.5 mg SX600 Low Dose
SX600: Transforaminal Epidural Injection | 21 |
| 25.0 mg SX600 High Dose
SX600: Transforaminal Epidural Injection | 17 |
| Total | 56 |
Baseline characteristics
| Characteristic | 0.9% Sodium Chloride for Injection | Total | 25.0 mg SX600 | 12.5 mg SX600 |
|---|---|---|---|---|
| Age, Continuous | 45.1 years STANDARD_DEVIATION 6.77 | 48.1 years STANDARD_DEVIATION 6.93 | 52.0 years STANDARD_DEVIATION 4.86 | 47.7 years STANDARD_DEVIATION 7.25 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 5 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 6 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) White | 13 Participants | 44 Participants | 14 Participants | 17 Participants |
| Region of Enrollment Australia | 18 participants | 56 participants | 17 participants | 21 participants |
| Sex: Female, Male Female | 7 Participants | 19 Participants | 7 Participants | 5 Participants |
| Sex: Female, Male Male | 11 Participants | 37 Participants | 10 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 21 | 0 / 16 |
| other Total, other adverse events | 15 / 18 | 16 / 21 | 14 / 16 |
| serious Total, serious adverse events | 3 / 18 | 0 / 21 | 1 / 16 |
Outcome results
Primary
The Proportion of Subjects With a 50% or Greater Improvement in Mean Worst Daily Leg Pain (Responders).
Time frame: Baseline to 60 days
Population: mITT population, denominator (# of participants analyzed) is number of non-missing values at 60 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 0.9% Sodium Chloride for Injection | The Proportion of Subjects With a 50% or Greater Improvement in Mean Worst Daily Leg Pain (Responders). | 2 Participants |
| 12.5 mg SX600 | The Proportion of Subjects With a 50% or Greater Improvement in Mean Worst Daily Leg Pain (Responders). | 10 Participants |
| 25.0 mg SX600 | The Proportion of Subjects With a 50% or Greater Improvement in Mean Worst Daily Leg Pain (Responders). | 10 Participants |
Secondary
Change From Baseline in Short Form 36 Questionnaire (SF-36)
SF-36 is a self-administered, generic health status questionnaire consisting of 36 questions that measure 8 health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Each health concept has a range of possible total scores from 0 to 100. A high score defines a more favorable health state. The mean overall total score will be reported.
Time frame: Baseline, 14, 30, 60, 90, 120, 150, and 180 days
Population: mITT population
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| 0.9% Sodium Chloride for Injection | Change From Baseline in Short Form 36 Questionnaire (SF-36) | 30 days | 64.02 score on a scale |
| 0.9% Sodium Chloride for Injection | Change From Baseline in Short Form 36 Questionnaire (SF-36) | Baseline | 61.03 score on a scale |
| 0.9% Sodium Chloride for Injection | Change From Baseline in Short Form 36 Questionnaire (SF-36) | 60 days | 66.17 score on a scale |
| 0.9% Sodium Chloride for Injection | Change From Baseline in Short Form 36 Questionnaire (SF-36) | 180 days | 77.83 score on a scale |
| 0.9% Sodium Chloride for Injection | Change From Baseline in Short Form 36 Questionnaire (SF-36) | 14 days | 60.85 score on a scale |
| 0.9% Sodium Chloride for Injection | Change From Baseline in Short Form 36 Questionnaire (SF-36) | 90 days | 69.07 score on a scale |
| 0.9% Sodium Chloride for Injection | Change From Baseline in Short Form 36 Questionnaire (SF-36) | 150 days | 73.92 score on a scale |
| 0.9% Sodium Chloride for Injection | Change From Baseline in Short Form 36 Questionnaire (SF-36) | 120 days | 77.32 score on a scale |
| 12.5 mg SX600 | Change From Baseline in Short Form 36 Questionnaire (SF-36) | 14 days | 63.73 score on a scale |
| 12.5 mg SX600 | Change From Baseline in Short Form 36 Questionnaire (SF-36) | 120 days | 69.49 score on a scale |
| 12.5 mg SX600 | Change From Baseline in Short Form 36 Questionnaire (SF-36) | Baseline | 51.04 score on a scale |
| 12.5 mg SX600 | Change From Baseline in Short Form 36 Questionnaire (SF-36) | 150 days | 76 score on a scale |
| 12.5 mg SX600 | Change From Baseline in Short Form 36 Questionnaire (SF-36) | 180 days | 72.57 score on a scale |
| 12.5 mg SX600 | Change From Baseline in Short Form 36 Questionnaire (SF-36) | 30 days | 63.28 score on a scale |
| 12.5 mg SX600 | Change From Baseline in Short Form 36 Questionnaire (SF-36) | 60 days | 73.26 score on a scale |
| 12.5 mg SX600 | Change From Baseline in Short Form 36 Questionnaire (SF-36) | 90 days | 73.22 score on a scale |
| 25.0 mg SX600 | Change From Baseline in Short Form 36 Questionnaire (SF-36) | 60 days | 69.29 score on a scale |
| 25.0 mg SX600 | Change From Baseline in Short Form 36 Questionnaire (SF-36) | Baseline | 48.40 score on a scale |
| 25.0 mg SX600 | Change From Baseline in Short Form 36 Questionnaire (SF-36) | 14 days | 61.89 score on a scale |
| 25.0 mg SX600 | Change From Baseline in Short Form 36 Questionnaire (SF-36) | 30 days | 67.93 score on a scale |
| 25.0 mg SX600 | Change From Baseline in Short Form 36 Questionnaire (SF-36) | 180 days | 77.29 score on a scale |
| 25.0 mg SX600 | Change From Baseline in Short Form 36 Questionnaire (SF-36) | 90 days | 68.8 score on a scale |
| 25.0 mg SX600 | Change From Baseline in Short Form 36 Questionnaire (SF-36) | 120 days | 68 score on a scale |
| 25.0 mg SX600 | Change From Baseline in Short Form 36 Questionnaire (SF-36) | 150 days | 72.44 score on a scale |
Secondary
Change in Functional Outcomes as Measured by Patient's Global Impression of Change
Very much improved, or much improved from baseline
Time frame: Baseline, 14, 30, 60, 90, 120, 150, and 180 days
Population: % based on number of non-missing values at the time of visit in mITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 0.9% Sodium Chloride for Injection | Change in Functional Outcomes as Measured by Patient's Global Impression of Change | Baseline to 60 days | 23.2 percentage of participants |
| 0.9% Sodium Chloride for Injection | Change in Functional Outcomes as Measured by Patient's Global Impression of Change | Baseline to 180 days | 66.6 percentage of participants |
| 0.9% Sodium Chloride for Injection | Change in Functional Outcomes as Measured by Patient's Global Impression of Change | Baseline to 120 days | 46.2 percentage of participants |
| 0.9% Sodium Chloride for Injection | Change in Functional Outcomes as Measured by Patient's Global Impression of Change | Baseline to 90 days | 50 percentage of participants |
| 0.9% Sodium Chloride for Injection | Change in Functional Outcomes as Measured by Patient's Global Impression of Change | Baseline to 30 days | 23.5 percentage of participants |
| 0.9% Sodium Chloride for Injection | Change in Functional Outcomes as Measured by Patient's Global Impression of Change | Baseline to 14 days | 16.7 percentage of participants |
| 0.9% Sodium Chloride for Injection | Change in Functional Outcomes as Measured by Patient's Global Impression of Change | Baseline to 150 days | 58.3 percentage of participants |
| 12.5 mg SX600 | Change in Functional Outcomes as Measured by Patient's Global Impression of Change | Baseline to 120 days | 46.7 percentage of participants |
| 12.5 mg SX600 | Change in Functional Outcomes as Measured by Patient's Global Impression of Change | Baseline to 14 days | 36.8 percentage of participants |
| 12.5 mg SX600 | Change in Functional Outcomes as Measured by Patient's Global Impression of Change | Baseline to 30 days | 45 percentage of participants |
| 12.5 mg SX600 | Change in Functional Outcomes as Measured by Patient's Global Impression of Change | Baseline to 60 days | 45 percentage of participants |
| 12.5 mg SX600 | Change in Functional Outcomes as Measured by Patient's Global Impression of Change | Baseline to 90 days | 38.9 percentage of participants |
| 12.5 mg SX600 | Change in Functional Outcomes as Measured by Patient's Global Impression of Change | Baseline to 150 days | 46.7 percentage of participants |
| 12.5 mg SX600 | Change in Functional Outcomes as Measured by Patient's Global Impression of Change | Baseline to 180 days | 50.1 percentage of participants |
| 25.0 mg SX600 | Change in Functional Outcomes as Measured by Patient's Global Impression of Change | Baseline to 120 days | 57.1 percentage of participants |
| 25.0 mg SX600 | Change in Functional Outcomes as Measured by Patient's Global Impression of Change | Baseline to 30 days | 53.3 percentage of participants |
| 25.0 mg SX600 | Change in Functional Outcomes as Measured by Patient's Global Impression of Change | Baseline to 180 days | 71.5 percentage of participants |
| 25.0 mg SX600 | Change in Functional Outcomes as Measured by Patient's Global Impression of Change | Baseline to 150 days | 57.1 percentage of participants |
| 25.0 mg SX600 | Change in Functional Outcomes as Measured by Patient's Global Impression of Change | Baseline to 14 days | 56.3 percentage of participants |
| 25.0 mg SX600 | Change in Functional Outcomes as Measured by Patient's Global Impression of Change | Baseline to 90 days | 60 percentage of participants |
| 25.0 mg SX600 | Change in Functional Outcomes as Measured by Patient's Global Impression of Change | Baseline to 60 days | 60 percentage of participants |
Secondary
Change in Functional Outcomes as Measured by the Oswestry Disability Index
0 - 20%: Minimal disability 21% - 40%: Moderate disability 41% - 60%: Severe disability 61% - 80%: Crippling back pain 81% - 100%: Bed-bound or exaggerating their symptoms
Time frame: Baseline, 14, 30, 60, 90, 120, 150, and 180 days
Population: % based on number of non-missing values at the time of the visit for the mITT population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.9% Sodium Chloride for Injection | Change in Functional Outcomes as Measured by the Oswestry Disability Index | 120 days | 12.8 score on scale of 0% to 100% | Standard Deviation 8.193 |
| 0.9% Sodium Chloride for Injection | Change in Functional Outcomes as Measured by the Oswestry Disability Index | 150 days | 11.89 score on scale of 0% to 100% | Standard Deviation 6.578 |
| 0.9% Sodium Chloride for Injection | Change in Functional Outcomes as Measured by the Oswestry Disability Index | Baseline | 27.99 score on scale of 0% to 100% | Standard Deviation 9.525 |
| 0.9% Sodium Chloride for Injection | Change in Functional Outcomes as Measured by the Oswestry Disability Index | 180 days | 12.23 score on scale of 0% to 100% | Standard Deviation 7.208 |
| 0.9% Sodium Chloride for Injection | Change in Functional Outcomes as Measured by the Oswestry Disability Index | 60 days | 17.64 score on scale of 0% to 100% | Standard Deviation 11.306 |
| 0.9% Sodium Chloride for Injection | Change in Functional Outcomes as Measured by the Oswestry Disability Index | 30 days | 19.22 score on scale of 0% to 100% | Standard Deviation 10.341 |
| 0.9% Sodium Chloride for Injection | Change in Functional Outcomes as Measured by the Oswestry Disability Index | 90 days | 17.06 score on scale of 0% to 100% | Standard Deviation 12.841 |
| 0.9% Sodium Chloride for Injection | Change in Functional Outcomes as Measured by the Oswestry Disability Index | 14 days | 22.97 score on scale of 0% to 100% | Standard Deviation 12.73 |
| 12.5 mg SX600 | Change in Functional Outcomes as Measured by the Oswestry Disability Index | 30 days | 21.12 score on scale of 0% to 100% | Standard Deviation 16.464 |
| 12.5 mg SX600 | Change in Functional Outcomes as Measured by the Oswestry Disability Index | 120 days | 16.53 score on scale of 0% to 100% | Standard Deviation 12.794 |
| 12.5 mg SX600 | Change in Functional Outcomes as Measured by the Oswestry Disability Index | 14 days | 21.04 score on scale of 0% to 100% | Standard Deviation 14.463 |
| 12.5 mg SX600 | Change in Functional Outcomes as Measured by the Oswestry Disability Index | Baseline | 35.21 score on scale of 0% to 100% | Standard Deviation 12.844 |
| 12.5 mg SX600 | Change in Functional Outcomes as Measured by the Oswestry Disability Index | 150 days | 14.13 score on scale of 0% to 100% | Standard Deviation 11.426 |
| 12.5 mg SX600 | Change in Functional Outcomes as Measured by the Oswestry Disability Index | 90 days | 14.67 score on scale of 0% to 100% | Standard Deviation 10.847 |
| 12.5 mg SX600 | Change in Functional Outcomes as Measured by the Oswestry Disability Index | 60 days | 16.50 score on scale of 0% to 100% | Standard Deviation 13.839 |
| 12.5 mg SX600 | Change in Functional Outcomes as Measured by the Oswestry Disability Index | 180 days | 15 score on scale of 0% to 100% | Standard Deviation 13.779 |
| 25.0 mg SX600 | Change in Functional Outcomes as Measured by the Oswestry Disability Index | 60 days | 15.31 score on scale of 0% to 100% | Standard Deviation 19.237 |
| 25.0 mg SX600 | Change in Functional Outcomes as Measured by the Oswestry Disability Index | Baseline | 32.83 score on scale of 0% to 100% | Standard Deviation 16.113 |
| 25.0 mg SX600 | Change in Functional Outcomes as Measured by the Oswestry Disability Index | 14 days | 19.72 score on scale of 0% to 100% | Standard Deviation 19.506 |
| 25.0 mg SX600 | Change in Functional Outcomes as Measured by the Oswestry Disability Index | 30 days | 16.89 score on scale of 0% to 100% | Standard Deviation 19.427 |
| 25.0 mg SX600 | Change in Functional Outcomes as Measured by the Oswestry Disability Index | 180 days | 9.74 score on scale of 0% to 100% | Standard Deviation 8.781 |
| 25.0 mg SX600 | Change in Functional Outcomes as Measured by the Oswestry Disability Index | 90 days | 16.95 score on scale of 0% to 100% | Standard Deviation 22.502 |
| 25.0 mg SX600 | Change in Functional Outcomes as Measured by the Oswestry Disability Index | 120 days | 19.59 score on scale of 0% to 100% | Standard Deviation 24.574 |
| 25.0 mg SX600 | Change in Functional Outcomes as Measured by the Oswestry Disability Index | 150 days | 12.74 score on scale of 0% to 100% | Standard Deviation 11.994 |
Secondary
Proportion of Subjects Who Required Rescue Medication, as Reported in Patient Diary
Time frame: Baseline through 180 days
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 0.9% Sodium Chloride for Injection | Proportion of Subjects Who Required Rescue Medication, as Reported in Patient Diary | 7 Participants |
| 12.5 mg SX600 | Proportion of Subjects Who Required Rescue Medication, as Reported in Patient Diary | 3 Participants |
| 25.0 mg SX600 | Proportion of Subjects Who Required Rescue Medication, as Reported in Patient Diary | 3 Participants |
Secondary
The Proportion of Subjects Who Are Responders (Defined as Having a 30% or Greater Improvement in Mean Worst Daily Leg Pain)
Time frame: Baseline to 14, 30, 60, 90, 120, 150, and 180 days
Population: mITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 0.9% Sodium Chloride for Injection | The Proportion of Subjects Who Are Responders (Defined as Having a 30% or Greater Improvement in Mean Worst Daily Leg Pain) | 30 days | 29.4 percentage of participants |
| 0.9% Sodium Chloride for Injection | The Proportion of Subjects Who Are Responders (Defined as Having a 30% or Greater Improvement in Mean Worst Daily Leg Pain) | 120 days | 53.3 percentage of participants |
| 0.9% Sodium Chloride for Injection | The Proportion of Subjects Who Are Responders (Defined as Having a 30% or Greater Improvement in Mean Worst Daily Leg Pain) | 90 days | 50 percentage of participants |
| 0.9% Sodium Chloride for Injection | The Proportion of Subjects Who Are Responders (Defined as Having a 30% or Greater Improvement in Mean Worst Daily Leg Pain) | 14 days | 27.8 percentage of participants |
| 0.9% Sodium Chloride for Injection | The Proportion of Subjects Who Are Responders (Defined as Having a 30% or Greater Improvement in Mean Worst Daily Leg Pain) | 180 days | 46.7 percentage of participants |
| 0.9% Sodium Chloride for Injection | The Proportion of Subjects Who Are Responders (Defined as Having a 30% or Greater Improvement in Mean Worst Daily Leg Pain) | 150 days | 46.2 percentage of participants |
| 0.9% Sodium Chloride for Injection | The Proportion of Subjects Who Are Responders (Defined as Having a 30% or Greater Improvement in Mean Worst Daily Leg Pain) | 60 days | 50 percentage of participants |
| 12.5 mg SX600 | The Proportion of Subjects Who Are Responders (Defined as Having a 30% or Greater Improvement in Mean Worst Daily Leg Pain) | 90 days | 60 percentage of participants |
| 12.5 mg SX600 | The Proportion of Subjects Who Are Responders (Defined as Having a 30% or Greater Improvement in Mean Worst Daily Leg Pain) | 14 days | 52.6 percentage of participants |
| 12.5 mg SX600 | The Proportion of Subjects Who Are Responders (Defined as Having a 30% or Greater Improvement in Mean Worst Daily Leg Pain) | 30 days | 61.1 percentage of participants |
| 12.5 mg SX600 | The Proportion of Subjects Who Are Responders (Defined as Having a 30% or Greater Improvement in Mean Worst Daily Leg Pain) | 60 days | 73.7 percentage of participants |
| 12.5 mg SX600 | The Proportion of Subjects Who Are Responders (Defined as Having a 30% or Greater Improvement in Mean Worst Daily Leg Pain) | 120 days | 50 percentage of participants |
| 12.5 mg SX600 | The Proportion of Subjects Who Are Responders (Defined as Having a 30% or Greater Improvement in Mean Worst Daily Leg Pain) | 150 days | 62.5 percentage of participants |
| 12.5 mg SX600 | The Proportion of Subjects Who Are Responders (Defined as Having a 30% or Greater Improvement in Mean Worst Daily Leg Pain) | 180 days | 50 percentage of participants |
| 25.0 mg SX600 | The Proportion of Subjects Who Are Responders (Defined as Having a 30% or Greater Improvement in Mean Worst Daily Leg Pain) | 120 days | 71.4 percentage of participants |
| 25.0 mg SX600 | The Proportion of Subjects Who Are Responders (Defined as Having a 30% or Greater Improvement in Mean Worst Daily Leg Pain) | 30 days | 80 percentage of participants |
| 25.0 mg SX600 | The Proportion of Subjects Who Are Responders (Defined as Having a 30% or Greater Improvement in Mean Worst Daily Leg Pain) | 180 days | 76.9 percentage of participants |
| 25.0 mg SX600 | The Proportion of Subjects Who Are Responders (Defined as Having a 30% or Greater Improvement in Mean Worst Daily Leg Pain) | 150 days | 71.4 percentage of participants |
| 25.0 mg SX600 | The Proportion of Subjects Who Are Responders (Defined as Having a 30% or Greater Improvement in Mean Worst Daily Leg Pain) | 90 days | 66.7 percentage of participants |
| 25.0 mg SX600 | The Proportion of Subjects Who Are Responders (Defined as Having a 30% or Greater Improvement in Mean Worst Daily Leg Pain) | 60 days | 78.6 percentage of participants |
| 25.0 mg SX600 | The Proportion of Subjects Who Are Responders (Defined as Having a 30% or Greater Improvement in Mean Worst Daily Leg Pain) | 14 days | 68.8 percentage of participants |
Secondary
The Proportion of Subjects Who Are Responders (Defined as Having a 50% or Greater Improvement in Mean Worst Daily Leg Pain)
Time frame: Baseline to 14, 30, 60, 90, 120, 150, and 180 days
Population: Denominator for % is the number of non-missing values for each treatment group at the visit of interest for the mITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 0.9% Sodium Chloride for Injection | The Proportion of Subjects Who Are Responders (Defined as Having a 50% or Greater Improvement in Mean Worst Daily Leg Pain) | Baseline to 14 days | 22.2 percentage of participants |
| 0.9% Sodium Chloride for Injection | The Proportion of Subjects Who Are Responders (Defined as Having a 50% or Greater Improvement in Mean Worst Daily Leg Pain) | Baseline to 30 days | 17.6 percentage of participants |
| 0.9% Sodium Chloride for Injection | The Proportion of Subjects Who Are Responders (Defined as Having a 50% or Greater Improvement in Mean Worst Daily Leg Pain) | Baseline to 90 days | 43.8 percentage of participants |
| 0.9% Sodium Chloride for Injection | The Proportion of Subjects Who Are Responders (Defined as Having a 50% or Greater Improvement in Mean Worst Daily Leg Pain) | Baseline to 120 days | 46.7 percentage of participants |
| 0.9% Sodium Chloride for Injection | The Proportion of Subjects Who Are Responders (Defined as Having a 50% or Greater Improvement in Mean Worst Daily Leg Pain) | Baseline to 150 days | 41.7 percentage of participants |
| 0.9% Sodium Chloride for Injection | The Proportion of Subjects Who Are Responders (Defined as Having a 50% or Greater Improvement in Mean Worst Daily Leg Pain) | Baseline to 180 days | 38.5 percentage of participants |
| 12.5 mg SX600 | The Proportion of Subjects Who Are Responders (Defined as Having a 50% or Greater Improvement in Mean Worst Daily Leg Pain) | Baseline to 180 days | 46.7 percentage of participants |
| 12.5 mg SX600 | The Proportion of Subjects Who Are Responders (Defined as Having a 50% or Greater Improvement in Mean Worst Daily Leg Pain) | Baseline to 14 days | 42.1 percentage of participants |
| 12.5 mg SX600 | The Proportion of Subjects Who Are Responders (Defined as Having a 50% or Greater Improvement in Mean Worst Daily Leg Pain) | Baseline to 120 days | 46.7 percentage of participants |
| 12.5 mg SX600 | The Proportion of Subjects Who Are Responders (Defined as Having a 50% or Greater Improvement in Mean Worst Daily Leg Pain) | Baseline to 150 days | 46.7 percentage of participants |
| 12.5 mg SX600 | The Proportion of Subjects Who Are Responders (Defined as Having a 50% or Greater Improvement in Mean Worst Daily Leg Pain) | Baseline to 30 days | 38.9 percentage of participants |
| 12.5 mg SX600 | The Proportion of Subjects Who Are Responders (Defined as Having a 50% or Greater Improvement in Mean Worst Daily Leg Pain) | Baseline to 90 days | 52.6 percentage of participants |
| 25.0 mg SX600 | The Proportion of Subjects Who Are Responders (Defined as Having a 50% or Greater Improvement in Mean Worst Daily Leg Pain) | Baseline to 30 days | 66.7 percentage of participants |
| 25.0 mg SX600 | The Proportion of Subjects Who Are Responders (Defined as Having a 50% or Greater Improvement in Mean Worst Daily Leg Pain) | Baseline to 90 days | 66.7 percentage of participants |
| 25.0 mg SX600 | The Proportion of Subjects Who Are Responders (Defined as Having a 50% or Greater Improvement in Mean Worst Daily Leg Pain) | Baseline to 180 days | 69.2 percentage of participants |
| 25.0 mg SX600 | The Proportion of Subjects Who Are Responders (Defined as Having a 50% or Greater Improvement in Mean Worst Daily Leg Pain) | Baseline to 120 days | 64.3 percentage of participants |
| 25.0 mg SX600 | The Proportion of Subjects Who Are Responders (Defined as Having a 50% or Greater Improvement in Mean Worst Daily Leg Pain) | Baseline to 14 days | 43.8 percentage of participants |
| 25.0 mg SX600 | The Proportion of Subjects Who Are Responders (Defined as Having a 50% or Greater Improvement in Mean Worst Daily Leg Pain) | Baseline to 150 days | 71.4 percentage of participants |
Secondary
Time to Loss of Response in the Subset of Patients Who Are Responders at Day 14 (50% or Greater Improvement in Mean Worst Daily Leg Pain)
Time frame: Day 14 through 180 days
Population: Time to loss of response was analyzed in the subset of patients who had a 50% or greater improvement in mean WDLP score (i.e., 50% Responders) at Day 14 compared to Baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 0.9% Sodium Chloride for Injection | Time to Loss of Response in the Subset of Patients Who Are Responders at Day 14 (50% or Greater Improvement in Mean Worst Daily Leg Pain) | 40.8 days | Standard Error 7.54 |
| 12.5 mg SX600 | Time to Loss of Response in the Subset of Patients Who Are Responders at Day 14 (50% or Greater Improvement in Mean Worst Daily Leg Pain) | 40.8 days | Standard Error 6.19 |
| 25.0 mg SX600 | Time to Loss of Response in the Subset of Patients Who Are Responders at Day 14 (50% or Greater Improvement in Mean Worst Daily Leg Pain) | 103.3 days | Standard Error 2.24 |
Other Pre-specified
Proportion of Subjects Who Reduce Utilization of Supportive Health Services From Baseline, as Reported in Patient Diary
Time frame: From baseline through 180 days
Population: This endpoint was not included in the final SAP, thus this analysis was not conducted.