Trial Outcomes & Findings for Corticosteroid Lumbar Epidural Analgesia for Radiculopathy (NCT NCT03372161)
NCT ID: NCT03372161
Last Updated: 2022-09-19
Results Overview
The NPRS is an 11-point scale (0 to 10-point scale where 0 was no pain and 10 was worst pain imaginable) that allowed the subject to rate the severity of their pain intensity at various points in time.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
401 participants
Primary outcome timeframe
Baseline, 4 Weeks
Results posted on
2022-09-19
Participant Flow
Participant milestones
| Measure |
SP-102
SP-102
SP-102: injection
|
Placebo
Placebo
Placebo: injection
|
|---|---|---|
|
Overall Study
STARTED
|
202
|
199
|
|
Overall Study
COMPLETED
|
193
|
192
|
|
Overall Study
NOT COMPLETED
|
9
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Corticosteroid Lumbar Epidural Analgesia for Radiculopathy
Baseline characteristics by cohort
| Measure |
SP-102
n=202 Participants
SP-102
SP-102: injection
|
Placebo
n=199 Participants
Placebo
Placebo: injection
|
Total
n=401 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.2 years
STANDARD_DEVIATION 9.83 • n=5 Participants
|
51.7 years
STANDARD_DEVIATION 10.36 • n=7 Participants
|
51.4 years
STANDARD_DEVIATION 10.09 • n=5 Participants
|
|
Sex: Female, Male
Female
|
116 Participants
n=5 Participants
|
122 Participants
n=7 Participants
|
238 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
86 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
163 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
34 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
168 Participants
n=5 Participants
|
164 Participants
n=7 Participants
|
332 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
37 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
160 Participants
n=5 Participants
|
162 Participants
n=7 Participants
|
322 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 4 WeeksThe NPRS is an 11-point scale (0 to 10-point scale where 0 was no pain and 10 was worst pain imaginable) that allowed the subject to rate the severity of their pain intensity at various points in time.
Outcome measures
| Measure |
SP-102
n=148 Participants
SP-102: injection
|
Placebo
n=184 Participants
Placebo: injection
|
|---|---|---|
|
Mean Change From Baseline (Day 1) to Week 4 in the Mean Numeric Pain Rating Scale (NPRS) Average Pain Score in the Affected Leg
|
-2.34 Change in score on a scale from baseline
Standard Deviation 1.842
|
-1.16 Change in score on a scale from baseline
Standard Deviation 1.723
|
SECONDARY outcome
Timeframe: Baseline, 4 WeeksThe ODI is the gold standard for measuring degree of disability and estimating quality of life in a person with low back pain. The ODI is a questionnaire completed by the subject that assesses10 topics: intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Each question was scored on a scale of 0-5 with 0 indicating the least amount of disability and 5 indicating the most severe disability. The scores for all questions answered were summed, then multiplied by 2 to obtain the index (range 0 to 100). Zero was equated with no disability and 100 was the maximum disability possible.
Outcome measures
| Measure |
SP-102
n=147 Participants
SP-102: injection
|
Placebo
n=177 Participants
Placebo: injection
|
|---|---|---|
|
Mean Change From Baseline (Day 1) to Week 4 in the Oswestry Disability Index Score (ODI)
|
-10.89 Change in score on a scale from baseline
Standard Deviation 14.906
|
-4.76 Change in score on a scale from baseline
Standard Deviation 12.896
|
Adverse Events
SP-102
Serious events: 0 serious events
Other events: 60 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 42 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
SP-102
n=202 participants at risk
SP-102: injection
|
Placebo
n=199 participants at risk
Placebo: injection
|
|---|---|---|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/202 • 4 weeks
|
0.50%
1/199 • 4 weeks
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/202 • 4 weeks
|
0.50%
1/199 • 4 weeks
|
Other adverse events
| Measure |
SP-102
n=202 participants at risk
SP-102: injection
|
Placebo
n=199 participants at risk
Placebo: injection
|
|---|---|---|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/202 • 4 weeks
|
0.50%
1/199 • 4 weeks
|
|
Cardiac disorders
Cardiomyopathy
|
0.50%
1/202 • 4 weeks
|
0.00%
0/199 • 4 weeks
|
|
Cardiac disorders
Palpitations
|
0.50%
1/202 • 4 weeks
|
0.50%
1/199 • 4 weeks
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.50%
1/202 • 4 weeks
|
0.00%
0/199 • 4 weeks
|
|
Eye disorders
Vision blurred
|
0.50%
1/202 • 4 weeks
|
0.00%
0/199 • 4 weeks
|
|
Gastrointestinal disorders
Abdominal distension
|
0.50%
1/202 • 4 weeks
|
0.00%
0/199 • 4 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/202 • 4 weeks
|
0.50%
1/199 • 4 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
0.99%
2/202 • 4 weeks
|
0.00%
0/199 • 4 weeks
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.50%
1/202 • 4 weeks
|
0.00%
0/199 • 4 weeks
|
|
Gastrointestinal disorders
Nausea
|
1.5%
3/202 • 4 weeks
|
0.50%
1/199 • 4 weeks
|
|
Gastrointestinal disorders
Toothache
|
0.99%
2/202 • 4 weeks
|
0.50%
1/199 • 4 weeks
|
|
Gastrointestinal disorders
Vomiting
|
1.5%
3/202 • 4 weeks
|
0.00%
0/199 • 4 weeks
|
|
General disorders
Chills
|
0.00%
0/202 • 4 weeks
|
0.50%
1/199 • 4 weeks
|
|
General disorders
Fatigue
|
0.50%
1/202 • 4 weeks
|
0.00%
0/199 • 4 weeks
|
|
General disorders
Feeling hot
|
0.50%
1/202 • 4 weeks
|
0.50%
1/199 • 4 weeks
|
|
General disorders
Gait disturbance
|
0.50%
1/202 • 4 weeks
|
0.00%
0/199 • 4 weeks
|
|
General disorders
Injection site pain
|
2.0%
4/202 • 4 weeks
|
0.00%
0/199 • 4 weeks
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/202 • 4 weeks
|
0.50%
1/199 • 4 weeks
|
|
General disorders
Pain
|
0.50%
1/202 • 4 weeks
|
0.00%
0/199 • 4 weeks
|
|
General disorders
Peripheral swelling
|
0.00%
0/202 • 4 weeks
|
0.50%
1/199 • 4 weeks
|
|
Infections and infestations
Abscess
|
0.50%
1/202 • 4 weeks
|
0.00%
0/199 • 4 weeks
|
|
Infections and infestations
Bronchitis
|
0.50%
1/202 • 4 weeks
|
1.0%
2/199 • 4 weeks
|
|
Infections and infestations
COVID-19
|
0.50%
1/202 • 4 weeks
|
0.50%
1/199 • 4 weeks
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/202 • 4 weeks
|
0.50%
1/199 • 4 weeks
|
|
Infections and infestations
Dacryocystitis
|
0.50%
1/202 • 4 weeks
|
0.00%
0/199 • 4 weeks
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/202 • 4 weeks
|
0.50%
1/199 • 4 weeks
|
|
Infections and infestations
Influenza
|
0.00%
0/202 • 4 weeks
|
0.50%
1/199 • 4 weeks
|
|
Infections and infestations
Labyrinthitis
|
0.50%
1/202 • 4 weeks
|
0.00%
0/199 • 4 weeks
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/202 • 4 weeks
|
0.50%
1/199 • 4 weeks
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/202 • 4 weeks
|
0.50%
1/199 • 4 weeks
|
|
Infections and infestations
Respiratory tract infection
|
0.50%
1/202 • 4 weeks
|
0.00%
0/199 • 4 weeks
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/202 • 4 weeks
|
0.50%
1/199 • 4 weeks
|
|
Infections and infestations
Sinusitis
|
2.0%
4/202 • 4 weeks
|
0.00%
0/199 • 4 weeks
|
|
Infections and infestations
Tooth abscess
|
0.50%
1/202 • 4 weeks
|
0.50%
1/199 • 4 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
0.99%
2/202 • 4 weeks
|
2.0%
4/199 • 4 weeks
|
|
Infections and infestations
Urinary tract infection
|
0.99%
2/202 • 4 weeks
|
1.5%
3/199 • 4 weeks
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.50%
1/202 • 4 weeks
|
0.00%
0/199 • 4 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/202 • 4 weeks
|
0.50%
1/199 • 4 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/202 • 4 weeks
|
0.50%
1/199 • 4 weeks
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.50%
1/202 • 4 weeks
|
0.50%
1/199 • 4 weeks
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.50%
1/202 • 4 weeks
|
0.00%
0/199 • 4 weeks
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.99%
2/202 • 4 weeks
|
0.50%
1/199 • 4 weeks
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.00%
0/202 • 4 weeks
|
0.50%
1/199 • 4 weeks
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.99%
2/202 • 4 weeks
|
0.00%
0/199 • 4 weeks
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.00%
0/202 • 4 weeks
|
0.50%
1/199 • 4 weeks
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/202 • 4 weeks
|
0.50%
1/199 • 4 weeks
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.50%
1/202 • 4 weeks
|
0.50%
1/199 • 4 weeks
|
|
Investigations
Blood pressure increased
|
0.99%
2/202 • 4 weeks
|
0.00%
0/199 • 4 weeks
|
|
Investigations
Cardiac murmur
|
0.00%
0/202 • 4 weeks
|
0.50%
1/199 • 4 weeks
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/202 • 4 weeks
|
0.50%
1/199 • 4 weeks
|
|
Investigations
Hepatic enzyme increased
|
0.50%
1/202 • 4 weeks
|
0.00%
0/199 • 4 weeks
|
|
Investigations
SARS-CoV-2 test positive
|
0.50%
1/202 • 4 weeks
|
0.00%
0/199 • 4 weeks
|
|
Investigations
Weight increased
|
0.00%
0/202 • 4 weeks
|
0.50%
1/199 • 4 weeks
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.50%
1/202 • 4 weeks
|
0.00%
0/199 • 4 weeks
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.50%
1/202 • 4 weeks
|
0.00%
0/199 • 4 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.5%
3/202 • 4 weeks
|
0.50%
1/199 • 4 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.50%
1/202 • 4 weeks
|
0.00%
0/199 • 4 weeks
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.50%
1/202 • 4 weeks
|
0.00%
0/199 • 4 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.50%
1/202 • 4 weeks
|
0.00%
0/199 • 4 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/202 • 4 weeks
|
0.50%
1/199 • 4 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.99%
2/202 • 4 weeks
|
1.0%
2/199 • 4 weeks
|
|
Nervous system disorders
Burning sensation
|
0.50%
1/202 • 4 weeks
|
0.00%
0/199 • 4 weeks
|
|
Nervous system disorders
Dizziness
|
0.99%
2/202 • 4 weeks
|
0.00%
0/199 • 4 weeks
|
|
Nervous system disorders
Dysgeusia
|
0.50%
1/202 • 4 weeks
|
0.00%
0/199 • 4 weeks
|
|
Nervous system disorders
Formication
|
0.00%
0/202 • 4 weeks
|
0.50%
1/199 • 4 weeks
|
|
Nervous system disorders
Headache
|
6.4%
13/202 • 4 weeks
|
5.5%
11/199 • 4 weeks
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/202 • 4 weeks
|
0.50%
1/199 • 4 weeks
|
|
Nervous system disorders
Lethargy
|
0.00%
0/202 • 4 weeks
|
0.50%
1/199 • 4 weeks
|
|
Nervous system disorders
Migraine
|
1.5%
3/202 • 4 weeks
|
0.00%
0/199 • 4 weeks
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/202 • 4 weeks
|
0.50%
1/199 • 4 weeks
|
|
Nervous system disorders
Presyncope
|
0.50%
1/202 • 4 weeks
|
0.00%
0/199 • 4 weeks
|
|
Nervous system disorders
Radicular pain
|
0.50%
1/202 • 4 weeks
|
0.50%
1/199 • 4 weeks
|
|
Nervous system disorders
Syncope
|
0.50%
1/202 • 4 weeks
|
0.00%
0/199 • 4 weeks
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.50%
1/202 • 4 weeks
|
0.00%
0/199 • 4 weeks
|
|
Psychiatric disorders
Anxiety
|
0.99%
2/202 • 4 weeks
|
0.50%
1/199 • 4 weeks
|
|
Psychiatric disorders
Depression
|
0.00%
0/202 • 4 weeks
|
0.50%
1/199 • 4 weeks
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/202 • 4 weeks
|
0.50%
1/199 • 4 weeks
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/202 • 4 weeks
|
0.50%
1/199 • 4 weeks
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.50%
1/202 • 4 weeks
|
0.00%
0/199 • 4 weeks
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/202 • 4 weeks
|
0.50%
1/199 • 4 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/202 • 4 weeks
|
1.0%
2/199 • 4 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.50%
1/202 • 4 weeks
|
0.00%
0/199 • 4 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.50%
1/202 • 4 weeks
|
0.00%
0/199 • 4 weeks
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/202 • 4 weeks
|
0.50%
1/199 • 4 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.50%
1/202 • 4 weeks
|
0.00%
0/199 • 4 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.50%
1/202 • 4 weeks
|
0.00%
0/199 • 4 weeks
|
|
Vascular disorders
Accelerated hypertension
|
0.00%
0/202 • 4 weeks
|
0.50%
1/199 • 4 weeks
|
|
Vascular disorders
Flushing
|
0.50%
1/202 • 4 weeks
|
0.00%
0/199 • 4 weeks
|
|
Vascular disorders
Hot flush
|
0.50%
1/202 • 4 weeks
|
0.00%
0/199 • 4 weeks
|
|
Vascular disorders
Hypertension
|
2.0%
4/202 • 4 weeks
|
0.50%
1/199 • 4 weeks
|
Additional Information
Associate Director Clinical Operations
Scilex Pharmaceuticals, Inc.
Phone: (650) 386-6709
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor has the right to first publication of the results of the study. Following the first publication, PIs may publish study data or results; however, the proposed publication must be submitted to the Sponsor for review and approval in writing at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study Data.
- Publication restrictions are in place
Restriction type: OTHER