Trial Outcomes & Findings for Safety and Efficacy of SX600 Administered by Lumbosacral Transforaminal Epidural Injection for Radicular Pain (NCT NCT03952377)

NCT ID: NCT03952377

Last Updated: 2024-01-10

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

56 participants

Primary outcome timeframe

Baseline to 60 days

Results posted on

2024-01-10

Participant Flow

Participant milestones

Participant milestones
Measure	0.9% Sodium Chloride for Injection Placebo: Transforaminal Epidural Injection	12.5 mg SX600 Low Dose SX600: Transforaminal Epidural Injection	25.0 mg SX600 High Dose SX600: Transforaminal Epidural Injection
Overall Study STARTED	18	21	17
Overall Study COMPLETED	16	19	16
Overall Study NOT COMPLETED	2	2	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy of SX600 Administered by Lumbosacral Transforaminal Epidural Injection for Radicular Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	0.9% Sodium Chloride for Injection n=18 Participants Placebo: Transforaminal Epidural Injection	12.5 mg SX600 n=21 Participants Low Dose SX600: Transforaminal Epidural Injection	25.0 mg SX600 n=17 Participants High Dose SX600: Transforaminal Epidural Injection	Total n=56 Participants Total of all reporting groups
Age, Continuous	45.1 years STANDARD_DEVIATION 6.77 • n=5 Participants	47.7 years STANDARD_DEVIATION 7.25 • n=7 Participants	52.0 years STANDARD_DEVIATION 4.86 • n=5 Participants	48.1 years STANDARD_DEVIATION 6.93 • n=4 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants	19 Participants n=4 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	16 Participants n=7 Participants	10 Participants n=5 Participants	37 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	5 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants	17 Participants n=7 Participants	14 Participants n=5 Participants	44 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	6 Participants n=4 Participants
Region of Enrollment Australia	18 participants n=5 Participants	21 participants n=7 Participants	17 participants n=5 Participants	56 participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline to 60 days

Population: mITT population, denominator (# of participants analyzed) is number of non-missing values at 60 days

Outcome measures

Outcome measures
Measure	0.9% Sodium Chloride for Injection n=16 Participants Placebo: Transforaminal Epidural Injection	12.5 mg SX600 n=19 Participants Low Dose SX600: Transforaminal Epidural Injection	25.0 mg SX600 n=14 Participants High Dose SX600: Transforaminal Epidural Injection
The Proportion of Subjects With a 50% or Greater Improvement in Mean Worst Daily Leg Pain (Responders).	2 Participants	10 Participants	10 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	0.9% Sodium Chloride for Injection n=18 Participants Placebo: Transforaminal Epidural Injection	12.5 mg SX600 n=21 Participants Low Dose SX600: Transforaminal Epidural Injection	25.0 mg SX600 n=16 Participants High Dose SX600: Transforaminal Epidural 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	42.1 percentage of participants	43.8 percentage of participants
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	38.9 percentage of participants	66.7 percentage of participants
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	52.6 percentage of participants	66.7 percentage of participants
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	46.7 percentage of participants	64.3 percentage of participants
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	46.7 percentage of participants	71.4 percentage of participants
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	46.7 percentage of participants	69.2 percentage of participants

SECONDARY outcome

Timeframe: 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

Very much improved, or much improved from baseline

Outcome measures

Outcome measures
Measure	0.9% Sodium Chloride for Injection n=18 Participants Placebo: Transforaminal Epidural Injection	12.5 mg SX600 n=21 Participants Low Dose SX600: Transforaminal Epidural Injection	25.0 mg SX600 n=16 Participants High Dose SX600: Transforaminal Epidural Injection
Change in Functional Outcomes as Measured by Patient's Global Impression of Change Baseline to 30 days	23.5 percentage of participants	45 percentage of participants	53.3 percentage of participants
Change in Functional Outcomes as Measured by Patient's Global Impression of Change Baseline to 60 days	23.2 percentage of participants	45 percentage of participants	60 percentage of participants
Change in Functional Outcomes as Measured by Patient's Global Impression of Change Baseline to 14 days	16.7 percentage of participants	36.8 percentage of participants	56.3 percentage of participants
Change in Functional Outcomes as Measured by Patient's Global Impression of Change Baseline to 90 days	50 percentage of participants	38.9 percentage of participants	60 percentage of participants
Change in Functional Outcomes as Measured by Patient's Global Impression of Change Baseline to 120 days	46.2 percentage of participants	46.7 percentage of participants	57.1 percentage of participants
Change in Functional Outcomes as Measured by Patient's Global Impression of Change Baseline to 150 days	58.3 percentage of participants	46.7 percentage of participants	57.1 percentage of participants
Change in Functional Outcomes as Measured by Patient's Global Impression of Change Baseline to 180 days	66.6 percentage of participants	50.1 percentage of participants	71.5 percentage of participants

SECONDARY outcome

Timeframe: 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

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

Outcome measures

Outcome measures
Measure	0.9% Sodium Chloride for Injection n=18 Participants Placebo: Transforaminal Epidural Injection	12.5 mg SX600 n=21 Participants Low Dose SX600: Transforaminal Epidural Injection	25.0 mg SX600 n=16 Participants High Dose SX600: Transforaminal Epidural 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	15 score on scale of 0% to 100% Standard Deviation 13.779	9.74 score on scale of 0% to 100% Standard Deviation 8.781
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	35.21 score on scale of 0% to 100% Standard Deviation 12.844	32.83 score on scale of 0% to 100% Standard Deviation 16.113
Change in Functional Outcomes as Measured by the Oswestry Disability Index 14 days	22.97 score on scale of 0% to 100% Standard Deviation 12.730	21.04 score on scale of 0% to 100% Standard Deviation 14.463	19.72 score on scale of 0% to 100% Standard Deviation 19.506
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	21.12 score on scale of 0% to 100% Standard Deviation 16.464	16.89 score on scale of 0% to 100% Standard Deviation 19.427
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	16.50 score on scale of 0% to 100% Standard Deviation 13.839	15.31 score on scale of 0% to 100% Standard Deviation 19.237
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	14.67 score on scale of 0% to 100% Standard Deviation 10.847	16.95 score on scale of 0% to 100% Standard Deviation 22.502
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	16.53 score on scale of 0% to 100% Standard Deviation 12.794	19.59 score on scale of 0% to 100% Standard Deviation 24.574
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	14.13 score on scale of 0% to 100% Standard Deviation 11.426	12.74 score on scale of 0% to 100% Standard Deviation 11.994

SECONDARY outcome

Timeframe: Baseline, 14, 30, 60, 90, 120, 150, and 180 days

Population: mITT population

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.

Outcome measures

Outcome measures
Measure	0.9% Sodium Chloride for Injection n=18 Participants Placebo: Transforaminal Epidural Injection	12.5 mg SX600 n=21 Participants Low Dose SX600: Transforaminal Epidural Injection	25.0 mg SX600 n=16 Participants High Dose SX600: Transforaminal Epidural Injection
Change From Baseline in Short Form 36 Questionnaire (SF-36) Baseline	61.03 score on a scale Interval 0.0 to 100.0	51.04 score on a scale Interval 0.0 to 100.0	48.40 score on a scale Interval 0.0 to 100.0
Change From Baseline in Short Form 36 Questionnaire (SF-36) 14 days	60.85 score on a scale Interval 0.0 to 100.0	63.73 score on a scale Interval 0.0 to 100.0	61.89 score on a scale Interval 0.0 to 100.0
Change From Baseline in Short Form 36 Questionnaire (SF-36) 30 days	64.02 score on a scale Interval 0.0 to 100.0	63.28 score on a scale Interval 0.0 to 100.0	67.93 score on a scale Interval 0.0 to 100.0
Change From Baseline in Short Form 36 Questionnaire (SF-36) 60 days	66.17 score on a scale Interval 0.0 to 100.0	73.26 score on a scale Interval 0.0 to 100.0	69.29 score on a scale Interval 0.0 to 100.0
Change From Baseline in Short Form 36 Questionnaire (SF-36) 90 days	69.07 score on a scale Interval 0.0 to 100.0	73.22 score on a scale Interval 0.0 to 100.0	68.8 score on a scale Interval 0.0 to 100.0
Change From Baseline in Short Form 36 Questionnaire (SF-36) 120 days	77.32 score on a scale Interval 0.0 to 100.0	69.49 score on a scale Interval 0.0 to 100.0	68 score on a scale Interval 0.0 to 100.0
Change From Baseline in Short Form 36 Questionnaire (SF-36) 150 days	73.92 score on a scale Interval 0.0 to 100.0	76 score on a scale Interval 0.0 to 100.0	72.44 score on a scale Interval 0.0 to 100.0
Change From Baseline in Short Form 36 Questionnaire (SF-36) 180 days	77.83 score on a scale Interval 0.0 to 100.0	72.57 score on a scale Interval 0.0 to 100.0	77.29 score on a scale Interval 0.0 to 100.0

SECONDARY outcome

Timeframe: Baseline to 14, 30, 60, 90, 120, 150, and 180 days

Population: mITT population

Outcome measures

Outcome measures
Measure	0.9% Sodium Chloride for Injection n=18 Participants Placebo: Transforaminal Epidural Injection	12.5 mg SX600 n=21 Participants Low Dose SX600: Transforaminal Epidural Injection	25.0 mg SX600 n=16 Participants High Dose SX600: Transforaminal Epidural 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	52.6 percentage of participants	68.8 percentage of participants
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	61.1 percentage of participants	80 percentage of participants
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	73.7 percentage of participants	78.6 percentage of participants
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	60 percentage of participants	66.7 percentage of participants
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	50 percentage of participants	71.4 percentage of participants
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	62.5 percentage of participants	71.4 percentage of participants
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	50 percentage of participants	76.9 percentage of participants

SECONDARY outcome

Timeframe: Baseline through 180 days

Population: ITT population

Outcome measures

Outcome measures
Measure	0.9% Sodium Chloride for Injection n=18 Participants Placebo: Transforaminal Epidural Injection	12.5 mg SX600 n=21 Participants Low Dose SX600: Transforaminal Epidural Injection	25.0 mg SX600 n=17 Participants High Dose SX600: Transforaminal Epidural Injection
Proportion of Subjects Who Required Rescue Medication, as Reported in Patient Diary	7 Participants	3 Participants	3 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	0.9% Sodium Chloride for Injection n=4 Participants Placebo: Transforaminal Epidural Injection	12.5 mg SX600 n=8 Participants Low Dose SX600: Transforaminal Epidural Injection	25.0 mg SX600 n=7 Participants High Dose SX600: Transforaminal Epidural 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	40.8 days Standard Error 6.19	103.3 days Standard Error 2.24

OTHER_PRE_SPECIFIED outcome

Timeframe: From baseline through 180 days

Population: This endpoint was not included in the final SAP, thus this analysis was not conducted.

Outcome measures

Outcome data not reported

Adverse Events

0.9% Sodium Chloride for Injection

Serious events: 3 serious events

Other events: 15 other events

Deaths: 0 deaths

12.5 mg SX600

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

25.0 mg SX600

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	0.9% Sodium Chloride for Injection n=18 participants at risk Placebo: Transforaminal Epidural Injection	12.5 mg SX600 n=21 participants at risk Low Dose SX600: Transforaminal Epidural Injection	25.0 mg SX600 n=16 participants at risk High Dose SX600: Transforaminal Epidural Injection
Gastrointestinal disorders Small Intestinal Obstruction	5.6% 1/18 • 180 days 1 of the 17 subjects in the 25 mg SX600 group did not receive the study drug due to the inability to complete the TF-EI procedure due to unsure transitional anatomy, thus was not included in the safety population. Participants at risk in this group is thus, 16 (not 17 as listed in participant flow).	0.00% 0/21 • 180 days 1 of the 17 subjects in the 25 mg SX600 group did not receive the study drug due to the inability to complete the TF-EI procedure due to unsure transitional anatomy, thus was not included in the safety population. Participants at risk in this group is thus, 16 (not 17 as listed in participant flow).	0.00% 0/16 • 180 days 1 of the 17 subjects in the 25 mg SX600 group did not receive the study drug due to the inability to complete the TF-EI procedure due to unsure transitional anatomy, thus was not included in the safety population. Participants at risk in this group is thus, 16 (not 17 as listed in participant flow).
Musculoskeletal and connective tissue disorders Back Pain	5.6% 1/18 • 180 days 1 of the 17 subjects in the 25 mg SX600 group did not receive the study drug due to the inability to complete the TF-EI procedure due to unsure transitional anatomy, thus was not included in the safety population. Participants at risk in this group is thus, 16 (not 17 as listed in participant flow).	0.00% 0/21 • 180 days 1 of the 17 subjects in the 25 mg SX600 group did not receive the study drug due to the inability to complete the TF-EI procedure due to unsure transitional anatomy, thus was not included in the safety population. Participants at risk in this group is thus, 16 (not 17 as listed in participant flow).	0.00% 0/16 • 180 days 1 of the 17 subjects in the 25 mg SX600 group did not receive the study drug due to the inability to complete the TF-EI procedure due to unsure transitional anatomy, thus was not included in the safety population. Participants at risk in this group is thus, 16 (not 17 as listed in participant flow).
Nervous system disorders Radiculopathy	5.6% 1/18 • 180 days 1 of the 17 subjects in the 25 mg SX600 group did not receive the study drug due to the inability to complete the TF-EI procedure due to unsure transitional anatomy, thus was not included in the safety population. Participants at risk in this group is thus, 16 (not 17 as listed in participant flow).	0.00% 0/21 • 180 days 1 of the 17 subjects in the 25 mg SX600 group did not receive the study drug due to the inability to complete the TF-EI procedure due to unsure transitional anatomy, thus was not included in the safety population. Participants at risk in this group is thus, 16 (not 17 as listed in participant flow).	0.00% 0/16 • 180 days 1 of the 17 subjects in the 25 mg SX600 group did not receive the study drug due to the inability to complete the TF-EI procedure due to unsure transitional anatomy, thus was not included in the safety population. Participants at risk in this group is thus, 16 (not 17 as listed in participant flow).
Renal and urinary disorders Renal Colic	0.00% 0/18 • 180 days 1 of the 17 subjects in the 25 mg SX600 group did not receive the study drug due to the inability to complete the TF-EI procedure due to unsure transitional anatomy, thus was not included in the safety population. Participants at risk in this group is thus, 16 (not 17 as listed in participant flow).	0.00% 0/21 • 180 days 1 of the 17 subjects in the 25 mg SX600 group did not receive the study drug due to the inability to complete the TF-EI procedure due to unsure transitional anatomy, thus was not included in the safety population. Participants at risk in this group is thus, 16 (not 17 as listed in participant flow).	6.2% 1/16 • 180 days 1 of the 17 subjects in the 25 mg SX600 group did not receive the study drug due to the inability to complete the TF-EI procedure due to unsure transitional anatomy, thus was not included in the safety population. Participants at risk in this group is thus, 16 (not 17 as listed in participant flow).

Other adverse events

Additional Information

Jeff Missling, CEO

SpineThera

Phone: +1(612)-508-4795

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place