Lumbosacral Radicular PainPhase 2NCT03613662

A Research Study to Characterize the Pharmacodynamics and Safety of Repeat Dose SP-102

A Phase 2 study testing SP-102 in people with Lumbosacral Radicular Pain, run by Semnur Pharmaceuticals, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This is an open-label, single-arm, repeat dose study to characterize the pharmacodynamics and safety/tolerability of SP-102 administered by epidural injection. 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?: No, everyone receives an active treatment
How many people: 19 participants
Where: 1 siteUnited States
Study dates: 13 Jul 2018to 15 Mar 2019
Phase: Phase 2
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

1 site in 1 country.

United States1 site

Semnur Research Site 1
Boise, Idaho, 83713

Other trials in United States

About this study

Official title: An Open-label, Single-arm Study to Characterize the Pharmacodynamics and Safety of Repeat Dose SP-102 Administered by Epidural Injection in Subjects With Lumbosacral Radiculopathy

This is an open-label, single-arm, repeat dose study to characterize the pharmacodynamics and safety/tolerability of SP-102 administered by epidural injection.

Conditions: Lumbosacral Radicular Pain
Being tested: SP-102
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

Study groups in NCT03613662
Study group	Role	What they receive
SP-102	Experimental	SP-102 Receives: Drug: SP-102

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Plasma Cortisol Concentrations From Baseline
Dexamethasone-induced hypothalamic-pituitary-adrenal (HPA) suppression is evaluated by monitoring SP-102 induced changes in plasma cortisol levels from Baseline.
The T1 (index) and T2 (repeat) injections of SP-102 are separated by 4-8 weeks
Measured: 12 Weeks
Change in Blood Glucose Levels From Baseline
Dexamethasone-induced hypothalamic-pituitary-adrenal (HPA) suppression is evaluated by monitoring SP-102 induced changes in blood glucose levels from Baseline.
The T1 (index) and T2 (repeat) injections of SP-102 are separated by 4-8 weeks
Measured: 12 Weeks
Change in White Blood Cell (WBC) Levels From Baseline
Dexamethasone-induced hypothalamic-pituitary-adrenal (HPA) suppression is evaluated by monitoring SP-102 induced changes in WBC levels from Baseline.
The T1 (index) and T2 (repeat) injections of SP-102 are separated by 4-8 weeks
Measured: 12 Weeks

Secondary outcomes (3)

Change in Numeric Pain Rating Scale (NPRS) Scores for Leg Pain From Baseline
The NPRS is an 11-point scale (0- to 10-point scale where 0 is no pain and 10 is worst pain imaginable) that allows subjects to rate the severity of their pain intensity at various points in time (Turk et al., 2003). Subjects used the NPRS to record their current pain, average pain over 24 hours, and worst pain over 24 hours for both affected leg(s) and back pain. NPRS average leg pain scores over 24 hours are presented.
Measured: 12 weeks
Change in Numeric Pain Rating Scale (NPRS) Scores for Back Pain From Baseline
The NPRS is an 11-point scale (0- to 10-point scale where 0 is no pain and 10 is worst pain imaginable) that allows subjects to rate the severity of their pain intensity at various points in time (Turk et al., 2003). Subjects used the NPRS to record their current pain, average pain over 24 hours, and worst pain over 24 hours for both affected leg(s) and back pain. NPRS average back pain scores over 24 hours are presented.
Measured: 12 weeks
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Incidence of treatment-emergent AEs (TEAEs) related to study drug.
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Jul 201815 Mar 2019

First posted3 Aug 2018
Study start13 Jul 2018
Primary completion15 Mar 2019
Study completion15 Mar 2019

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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03613662
Sponsor's protocol ID: SP-102-03
Status last verified: Jan 2022
First submitted: 9 Jul 2018
Last updated: 13 Jan 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Radnovich R, Heinz J, Ambrose C, Stannard E, Lissin D. Repeat Epidural Injections of SP-102 (Dexamethasone Sodium Phosphate Injectable Gel) in Subjects with Lumbosacral Radiculopathy. J Pain Res. 2021 May 5;14:1231-1239. doi: 10.2147/JPR.S303282. eCollection 2021.
PubMed 33981160

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1
Study to Evaluate Safety of C-1101 Versus Sterile Saline in Adults With Chronic Painful Lumbosacral Radiculopathy
Lumbosacral Radicular Pain, Sciatic Radiculopathy
Not yet recruitingPhase 4
Comparing Three Epidural Steroid Injection Approaches for Lumbar Radicular Pain
Lumbar Disc Herniation, Lumbosacral Radiculopathy
Not yet recruitingPhase 3
Corticosteroid Lumbar Epidural Analgesia for Radicular Pain 2
Lumbosacral Radicular Pain
Recruiting
TFESI and Neuropathic Pain in Lumbosacral Radiculopathy
Lumbosacral Radiculopathy, Neuropathic Pain From Lumbosacral Radiculopathy
RecruitingObservational study
Determination of Sensitivity and Specificity of Straight Leg Raise Test Via Transforaminal Nerve Root Block
Lumbosacral Radicular Pain, Lumbar Radiculopathy

All Lumbosacral Radicular Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Single-arm Study to Characterize the Pharmacodynamics and Safety of Repeat Dose SP-102 Administered by Epidural Injection in Subjects With Lumbosacral Radiculopathy
ClinicalTrials.gov ID: NCT03613662
Acronym / sponsor ID: SP-102-03
Conditions: Lumbosacral Radicular Pain
Keywords: lumbosacral radicular pain, sciatica, leg pain
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 19 participants (actual)
Lead sponsor: Semnur Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Collaborators: Worldwide Clinical Trials, Scilex Pharmaceuticals, Inc.
Study start: 13 Jul 2018 (actual)
Primary completion: 15 Mar 2019 (actual)
Study completion: 15 Mar 2019 (actual)
First posted: 3 Aug 2018 (actual)
Results: Posted 13 Jan 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 an open-label, single-arm, repeat dose study to characterize the pharmacodynamics and safety/tolerability of SP-102 administered by epidural injection.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
SP-102	Experimental	Drug: SP-102SP-102

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

Primary outcome

Change in Plasma Cortisol Concentrations From Baseline
Time frame: 12 Weeks
Dexamethasone-induced hypothalamic-pituitary-adrenal (HPA) suppression is evaluated by monitoring SP-102 induced changes in plasma cortisol levels from Baseline. The T1 (index) and T2 (repeat) injections of SP-102 are separated by 4-8 weeks
Change in Blood Glucose Levels From Baseline
Time frame: 12 Weeks
Dexamethasone-induced hypothalamic-pituitary-adrenal (HPA) suppression is evaluated by monitoring SP-102 induced changes in blood glucose levels from Baseline. The T1 (index) and T2 (repeat) injections of SP-102 are separated by 4-8 weeks
Change in White Blood Cell (WBC) Levels From Baseline
Time frame: 12 Weeks
Dexamethasone-induced hypothalamic-pituitary-adrenal (HPA) suppression is evaluated by monitoring SP-102 induced changes in WBC levels from Baseline. The T1 (index) and T2 (repeat) injections of SP-102 are separated by 4-8 weeks

3 secondary outcomes

Change in Numeric Pain Rating Scale (NPRS) Scores for Leg Pain From Baseline
Time frame: 12 weeks
Change in Numeric Pain Rating Scale (NPRS) Scores for Back Pain From Baseline
Time frame: 12 weeks
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: 12 weeks

Results and safety

Results posted to the registry on 13 Jan 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SP-102	19	19

Primary outcome: Change in Plasma Cortisol Concentrations From Baseline

Time frame: 12 Weeks. Mean (Standard Deviation). Unit: nmol/L

Measure	SP-102 n = 19
T1: Day 1 (predose)	36.62 (31.81)
T1: Day 2	0.64 (0.27)
T1: Day 3	6.26 (9.00)
T1: Day 4	29.77 (2.60)
T1: Day 5	39.91 (40.53)
T1: Day 8	39.71 (28.97)
T1: Day 15	44.28 (33.55)
T1: Day 28	25.08 (21.34)

Population analysed: 19 subjects were enrolled and received an index (T1) injection of SP-102. 15 subjects received a (T2) injection of SP-102. Data was not recorded for all subjects at each time point.

Primary outcome: Change in Blood Glucose Levels From Baseline

Time frame: 12 Weeks. Mean (Standard Deviation). Unit: nmol/L

Measure	SP-102 n = 19
T1: Day 1 (predose)	4.993 (0.5216)
T1: Day 2	6.155 (0.9009)
T1: Day 3	4.528 (0.4451)
T1: Day 4	4.676 (0.5509)
T1: Day 5	4.958 (0.4362)
T1: Day 8	5.059 (0.6597)
T1: Day 15	5.254 (0.8143)
T1: Day 28	4.963 (0.7116)

Primary outcome: Change in White Blood Cell (WBC) Levels From Baseline

Time frame: 12 Weeks. Mean (Standard Deviation). Unit: cell count × 10^9/L

Measure	SP-102 n = 19
T1: Day 1 (predose)	6.65 (2.051)
T1: Day 2	13.43 (3.726)
T1: Day 3	9.33 (2.336)
T1: Day 4	7.38 (1.863)
T1: Day 5	6.81 (1.771)
T1: Day 8	6.91 (2.212)
T1: Day 15	7.26 (1.873)
T1: Day 28	6.15 (1.339)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SP-102	0 of 19 (0%)	13 of 19 (68.4%)	0 of 19

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 33981160Radnovich R, Heinz J, Ambrose C, Stannard E, Lissin D. Repeat Epidural Injections of SP-102 (Dexamethasone Sodium Phosphate Injectable Gel) in Subjects with Lumbosacral Radiculopathy. J Pain Res. 2021 May 5;14:1231-1239. doi: 10.2147/JPR.S303282. eCollection 2021.
Individual participant dataSharing planned: No

Related trials for Lumbosacral Radicular Pain

RecruitingPhase 1
Study to Evaluate Safety of C-1101 Versus Sterile Saline in Adults With Chronic Painful Lumbosacral Radiculopathy
Lumbosacral Radicular Pain, Sciatic Radiculopathy
Not yet recruitingPhase 4
Comparing Three Epidural Steroid Injection Approaches for Lumbar Radicular Pain
Lumbar Disc Herniation, Lumbosacral Radiculopathy
Not yet recruitingPhase 3
Corticosteroid Lumbar Epidural Analgesia for Radicular Pain 2
Lumbosacral Radicular Pain
Recruiting
TFESI and Neuropathic Pain in Lumbosacral Radiculopathy
Lumbosacral Radiculopathy, Neuropathic Pain From Lumbosacral Radiculopathy
RecruitingObservational study
Determination of Sensitivity and Specificity of Straight Leg Raise Test Via Transforaminal Nerve Root Block
Lumbosacral Radicular Pain, Lumbar Radiculopathy

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.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SP-102 in people with Lumbosacral Radicular Pain, run by Semnur Pharmaceuticals, Inc. at 1 site 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 13 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 13 Jan 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?

Change in Plasma Cortisol Concentrations From Baseline (time frame: 12 Weeks). The study lists 3 primary outcomes in all. 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 NCT03613662, 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 13 Jan 2022.