A Phase 3 interventional study of SP-102 and Placebo in Lumbosacral Radicular Pain, sponsored by Scilex Pharmaceuticals, Inc.. Completed at 37 sites in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-09-19.
Sponsored by Scilex Pharmaceuticals, Inc. · Phase 3, Interventional, and Treatment
This is a research study of SP-102, an experimental medication designed to relieve pain in patients with a specific type of leg pain. The medication is given once by your healthcare professional, with a possibility of a second injection as early as about 1 month after the first treatment.
The purpose of the study is to measure how well a single injection of the experimental medication, SP-102, relieves pain. The study will also investigate the side effects of SP-102.
149 studies on the registry are indexed under Sciatica; 31 are open to participants now.
This study's enrollment of 401 is above the median of 68 across 122 interventional studies indexed under Sciatica.
Browse Sciatica studies →Scilex Pharmaceuticals, Inc. is the lead sponsor of 13 studies on the registry; none are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Main Inclusion Criteria:
Main Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
SP-102
Drug: SP-102
Placebo
Drug: Placebo
injection
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
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.
Time frame: Baseline, 4 Weeks
Mean Change From Baseline (Day 1) to Week 4 in the Oswestry Disability Index Score (ODI)
The 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.
Time frame: Baseline, 4 Weeks
| Milestone | SP-102 | Placebo |
|---|---|---|
| Started | 202 | 199 |
| Completed | 193 | 192 |
| Not completed | 9 | 7 |
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.
| Change in score on a scale from baseline | SP-102 | Placebo |
|---|---|---|
| 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 ± 1.842 | -1.16 ± 1.723 |
The 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.
| Change in score on a scale from baseline | SP-102 | Placebo |
|---|---|---|
| Mean Change From Baseline (Day 1) to Week 4 in the Oswestry Disability Index Score (ODI) | -10.89 ± 14.906 | -4.76 ± 12.896 |
Collected over 4 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| SP-102 | 0/202 (0%) | 0/202 (0%) | 60/202 (29.7%) |
| Placebo | 1/199 (0.5%) | 2/199 (1%) | 42/199 (21.1%) |
| Event | SP-102 | Placebo |
|---|---|---|
| Cardiac arrestCardiac disorders | 0/202 | 1/199 |
| COVID-19 pneumoniaInfections and infestations | 0/202 | 1/199 |
| Event | SP-102 | Placebo |
|---|---|---|
| HeadacheNervous system disorders | 13/202 | 11/199 |
| Upper respiratory tract infectionInfections and infestations | 2/202 | 4/199 |
| Injection site painGeneral disorders | 4/202 | 0/199 |
| SinusitisInfections and infestations | 4/202 | 0/199 |
| HypertensionVascular disorders | 4/202 | 1/199 |
| Urinary tract infectionInfections and infestations | 2/202 | 3/199 |
| NauseaGastrointestinal disorders | 3/202 | 1/199 |
| VomitingGastrointestinal disorders | 3/202 | 0/199 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 3/202 | 1/199 |
| MigraineNervous system disorders | 3/202 | 0/199 |
| Age, Continuous(years) | SP-102 | Placebo | Total |
|---|---|---|---|
| Mean | 51.2 ± 9.83 | 51.7 ± 10.36 | 51.4 ± 10.09 |
| Sex: Female, Male(Participants) | SP-102 | Placebo | Total |
|---|---|---|---|
| Female | 116 | 122 | 238 |
| Male | 86 | 77 | 163 |
| Ethnicity (NIH/OMB)(Participants) | SP-102 | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 34 | 35 | 69 |
| Not Hispanic or Latino | 168 | 164 | 332 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | SP-102 | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 4 | 3 | 7 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 37 | 33 | 70 |
| White | 160 | 162 | 322 |
| More than one race | 1 | 1 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: SP-102
Scilex Pharmaceuticals, Inc.