Lumbosacral Radicular PainPhase 3NCT03372161
Corticosteroid Lumbar Epidural Analgesia for Radiculopathy
A Phase 3 study testing SP-102 in people with Lumbosacral Radicular Pain, run by Scilex Pharmaceuticals, Inc. at 37 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lumbosacral Radicular Pain
- What is being tested?
- SP-102
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 401 participants
- Where
- 37 sitesUnited States
- Study dates
- 8 Dec 2017to 6 Jan 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Main Inclusion Criteria:
- Able and willing to read, write, and understand the English language and provide English language written informed consent prior to beginning any study procedures.
- Age 18 to 70 years (inclusive) at the Screening Visit.
- A diagnosis of lumbosacral radicular pain (sciatica).
- Agrees to follow study-specific medication requirements.
- If sexually active and a female of child-bearing potential or a male capable of bearing a child, agrees to use an effective method of birth control during the study.
- Has reviewed all study specific materials and has, in the opinion of the Investigator, the abilities to understand and appropriately complete all study procedures.
Main Exclusion Criteria:
- Has radiologic evidence of a condition that would compromise study outcomes.
- Has ever had lumbosacral back surgery or plans to undergo spine surgical intervention while in the study.
- Has been diagnosed with insulin dependent diabetes mellitus.
- Presence of any other disorder, condition or circumstance (including secondary gain) that, in the opinion of the Investigator, has the potential to prevent study completion and/or to have a confounding effect on outcome assessments.
- Use of any investigational drug and/or device within 30 days, or is scheduled to receive an investigational drug other than blinded study drug during this study.
- Has a body mass index ≥40 kg/m2.
Trial locations and contacts
37 sites in 1 country.
37 sites in 1 country
United States37 sites
Semnur Research Site 40
Bloomington, Illinois, 61704
Semnur Research Site 38
Boise, Idaho, 83704
Semnur Research Site 51
Burlington, Massachusetts, 01805
Semnur Research Site 48
Charleston, South Carolina, 29406
Semnur Research Site 63
Chicago, Illinois, 60607
Semnur Research Site 12
Chicago, Illinois, 60612
Semnur Research Site 19
Chicago, Illinois, 60657
Semnur Research Site 46
Cleveland, Ohio, 44106
Semnur Research Site 43
Cuyahoga Falls, Ohio, 44223
Semnur Research Site 59
Draper, Utah, 84020
Semnur Research Site 11
Durham, North Carolina, 27710
Semnur Research Site 56
Fernandina Beach, Florida, 32024
Semnur Research Site 42
Greenfield, Wisconsin, 53220
Semnur Research Site 77
Greenville, South Carolina, 29615
Semnur Research Site 15
Houston, Texas, 77004
Semnur Research Site 81
Jacksonville, Florida, 32224
Semnur Research Site 18
La Jolla, California, 92037
Semnur Research Site 47
Laguna Woods, California, 92637
Semnur Research Site 60
Las Vegas, Nevada, 89129
Semnur Research Site 70
Los Gatos, California, 95032
Semnur Research Site 28
Marietta, Georgia, 30060
Semnur Research Site 64
Marietta, Georgia, 30060
Semnur Research Site 75
Mobile, Alabama, 36605
Semnur Research Site 10
Newnan, Georgia, 30265
Semnur Research Site 36
Oklahoma City, Oklahoma, 73109
Semnur Research Site 65
Omaha, Nebraska, 68118
Semnur Reseach Site 62
Overland Park, Kansas, 66210
Semnur Research Site 52
Phoenix, Arizona, 85053
Semnur Research Site 54
Plano, Texas, 75093
Semnur Research Site 30
Shrewsbury, New Jersey, 07702
Semnur Research Site 49
St. Petersburg, Florida, 33709
Semnur Research Site 13
Tampa, Florida, 33603
Semnur Research Site 61
Tampa, Florida, 33603
Semnur Research Site 58
Tempe, Arizona, 85284
Semnur Research Site 35
Tyler, Texas, 75701
Semnur Research Site 20
Winston-Salem, North Carolina, 27103
Semnur Research Site 53
Winter Park, Florida, 32789
About this study
Official title: Corticosteroid Lumbar Epidural Analgesia for Radiculopathy (C.L.E.A.R.)
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.
- Conditions
- Lumbosacral Radicular Pain
- Being tested
- SP-102, Placebo
- Keywords
- lumbosacral radicular pain, sciatica, leg pain
- Medical subject headings
- Sciatica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SP-102Drug
injection
PlaceboDrug
injection
| Study group | Role | What they receive |
|---|---|---|
| SP-102 | Experimental | SP-102 Receives: Drug: SP-102 |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 4 Weeks
Secondary outcomes (1)
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.
Measured: Baseline, 4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2017
- Study start8 Dec 2017
- Primary completion20 Aug 2021
- Study completion6 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lumbosacral Radicular PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 401 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scilex Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Worldwide Clinical Trials, Semnur Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Dmitri Lissin, MD, Study director, Scilex Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03372161
- Sponsor's protocol ID
- SP-102-02
- Status last verified
- Aug 2022
- First submitted
- 8 Dec 2017
- Last updated
- 19 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Miller A, Candido KD, Knezevic NN, Rivera J, Lunseth P, Levinson DJ, Formoso F, Solanki D, Tavel E, Krull A, Radnovich R, Burkhead D, Souza D, Helm S, Katz N, Dworkin RH, Cohen SP, Rathmell JP, Buvanendran A, Levin J, Stannard E, Ambrose C, Jaros M, Vought K, Lissin D. A randomized, placebo-controlled trial of long-acting dexamethasone viscous gel delivered by transforaminal injection for lumbosacral radicular pain. Pain. 2024 Dec 1;165(12):2762-2773. doi: 10.1097/j.pain.0000000000003287. Epub 2024 Jun 14.
PubMed 38875121
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corticosteroid Lumbar Epidural Analgesia for Radiculopathy (C.L.E.A.R.)
- ClinicalTrials.gov ID
- NCT03372161
- Acronym / sponsor ID
- SP-102-02
- Conditions
- Lumbosacral Radicular Pain
- Keywords
- lumbosacral radicular pain, sciatica, leg pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 401 participants (actual)
- Lead sponsor
- Scilex Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Worldwide Clinical Trials, Semnur Pharmaceuticals, Inc.
- Study start
- 8 Dec 2017 (actual)
- Primary completion
- 20 Aug 2021 (actual)
- Study completion
- 6 Jan 2022 (actual)
- First posted
- 13 Dec 2017 (actual)
- Results
- Posted 19 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SP-102 | Experimental | Drug: SP-102SP-102 |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SP-102injection | Drug | SP-102 |
| Placeboinjection | Drug | Placebo |
Primary outcome
Mean Change From Baseline (Day 1) to Week 4 in the Mean Numeric Pain Rating Scale (NPRS) Average Pain Score in the Affected Leg
Time frame: Baseline, 4 Weeks
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.
1 secondary outcome
Mean Change From Baseline (Day 1) to Week 4 in the Oswestry Disability Index Score (ODI)
Time frame: Baseline, 4 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38875121Miller A, Candido KD, Knezevic NN, Rivera J, Lunseth P, Levinson DJ, Formoso F, Solanki D, Tavel E, Krull A, Radnovich R, Burkhead D, Souza D, Helm S, Katz N, Dworkin RH, Cohen SP, Rathmell JP, Buvanendran A, Levin J, Stannard E, Ambrose C, Jaros M, Vought K, Lissin D. A randomized, placebo-controlled trial of long-acting dexamethasone viscous gel delivered by transforaminal injection for lumbosacral radicular pain. Pain. 2024 Dec 1;165(12):2762-2773. doi: 10.1097/j.pain.0000000000003287. Epub 2024 Jun 14.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dmitri Lissin, MD study director
Scilex Pharmaceuticals, Inc.
37 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SP-102 in people with Lumbosacral Radicular Pain, run by Scilex Pharmaceuticals, Inc. at 37 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change From Baseline (Day 1) to Week 4 in the Mean Numeric Pain Rating Scale (NPRS) Average Pain Score in the Affected Leg (time frame: Baseline, 4 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03372161, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2022.