New sciatica shot could offer lasting pain relief

NCT ID NCT07579351

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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First seen Jun 27, 2026 · Last updated Sep 09, 2026 · Updated 1 time

Summary

This study tests an experimental drug called SP-102 for people with moderate to severe sciatica (leg and back pain). About 755 adults will receive a single injection of SP-102, a placebo, or an active comparator. The goal is to see how well SP-102 reduces pain and improves daily function compared to the other options.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 755 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Feb 2027

An estimate. Start dates often move.

Expected to finish

Apr 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 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 75 years (inclusive) at the Screening Visit. * A diagnosis of lumbosacral radicular pain (sciatica) present for at least 6 weeks and not more than 9 months prior to the Screening Visit. * Clinical symptoms consistent with the imaging (MRI) * 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. Day 1 Inclusion: As calculated by the eDiary system, during the 7 days (D-7 to D-1) immediately prior to the Baseline Visit, the participant: 1. Completed the current, worst, and daily average NPRS scores (in the affected leg, non-affected leg, and lower back) in the eDiary on at least 6 out of the 7 days during the Baseline Period. 2. Meets the NPRS average daily pain score criteria, 3. Has a mean (at Baseline Visit) NPRS worst pain score in the affected leg that is greater than the mean worst pain score in lower back. Participant continues to demonstrate a clear understanding of how to complete the eDiary. Participant remains an appropriate candidate for trial participation in the opinion of the Investigator. Participant continues to meet all the screening inclusion criteria and none of the exclusion criteria. - Exclusion Criteria: * Has a body mass index ≥40 kg/m2. * Has radiologic evidence of a condition that would compromise study outcomes: Spinal cord tumor (intra- or extradural) or hematoma. Epidural or intrathecal abscess. Systemic infection. * 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 any contradiction to performing MRI (such as coronary pacemakers and implantable cardioverter-defibrillators \[ICDs\], metallic foreign bodies, neuro and spinal cord stimulators). * Has history of malignancy or evidence of malignancy, within 5 years of Screening Visit. * Has significant motor impairment * Has regular use of opioid doses \> 30 mg morphine equivalents per day for more than 2 days per week in the 30 days prior to the Screening Visit. * Involvement in an ongoing worker's compensation claim, disability claim, or litigation related to any pain problem, receiving payments for a settled claim, awaiting pending payment for a settled claim, or any potential secondary gain in the opinion of the Investigator.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The official record

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