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Tests treatment safety and results for Chronic Neuropathic Pain
Official title Safety and Tolerability Study of ST-503 for Refractory Pain Due to Peripheral Neuropathy (Small Fiber Predominant, SFN)
ClinicalTrials.gov ID: NCT06980948
What this study is testing
What is ST-503?
ST-503 is an investigational medicine, being studied as a potential treatment for chronic neuropathic pain.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This research is being done to study a possible treatment for refractory pain due to small fiber neuropathy (SFN). ST-503 is intended to deliver a modified copy of the gene which will ideally repress Nav1.7 tissue-related pain signals reaching the brain, which should reduce the refractory pain due to small fiber neuropathy (SFN).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Diagnostic characterization of Small Fiber Neuropathy (SFN) according to the Analgesic, Anesthetic, and Addiction Clinical Trial Translations...
- Medical record documentation that pain is refractory to 2 of 3 categories of first line medical therapy for at ≥ 6 months prior to screening.
- Serum sample negative for pre-existing anti-AAV9 antibodies determined by assay detection limit
You likely can't join if
- Drug- and alcohol-related:
- Persons using opioid analgesics for under 3 months or persons who are not on a stable dose of opioids; if on a stable dose, the dose may decrease...
- History of known alcohol abuse, opioid analgesic abuse, or illicit drug abuse within 2 years of Screening.
- Positive urine test for drugs of abuse (including opiates, benzodiazepines, amphetamines, cocaine, barbiturates, and phencyclidine) without...
- Use of cannabinoids is not permitted.
- Persons with Fabry's disease, with erythromelalgia, with peripheral neuropathies due to alcohol or drug toxicity, or with diagnosed channelopathies
See the full eligibility criteria
- Diagnostic characterization of Small Fiber Neuropathy (SFN) according to the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities and Networks (ACTTION) criteria.
- Medical record documentation that pain is refractory to 2 of 3 categories of first line medical therapy for at ≥ 6 months prior to screening.
- Serum sample negative for pre-existing anti-AAV9 antibodies determined by assay detection limit
- Drug- and alcohol-related:
- Persons using opioid analgesics for under 3 months or persons who are not on a stable dose of opioids; if on a stable dose, the dose may decrease over the course of the study but should not be increased.
- History of known alcohol abuse, opioid analgesic abuse, or illicit drug abuse within 2 years of Screening.
- Positive urine test for drugs of abuse (including opiates, benzodiazepines, amphetamines, cocaine, barbiturates, and phencyclidine) without prescription and investigator approval, at Screening and Day -1.
- Use of cannabinoids is not permitted.
- Persons with Fabry's disease, with erythromelalgia, with peripheral neuropathies due to alcohol or drug toxicity, or with diagnosed channelopathies
- Procedure-related:
- Contraindications to LP, general anesthesia or sedation
- Any medical disorders that, in the opinion of the Investigator, could interfere with LP including but not limited to evidence for a pressure gradient between supratentorial and infratentorial compartments, Arnold-Chiari...
- Infectious disease-related:
- Active viral infection or bacterial
- A severe infection (e.g., pneumonia, septicemia, central nervous system infections [e.g., meningitis, encephalitis]) within 12 weeks prior to Screening
- Hepatic disease- and hepatotoxic medication-related:
- Presence of clinically relevant liver disease
- Hepatic dysfunction as indicated by one or more of the following: i. Albumin ≤ 3.5 g/dL ii. Total bilirubin \> 1.5 x ULN and direct bilirubin ≥0.5 mg/dL iii. Alkaline phosphatase (ALP) \> 2 x ULN iv. Alanine...
- Hepatotoxic medications should be avoided during the study period including acetaminophen exceeding 4 gm/day unless essential to patient's treatment, approved by investigator, and hepatic dysfunction is not identified
- Hepatotoxic supplement use during the study period
- Cancer-related: a. History of cancer, including B-cell cancers, within 5 years of Screening i. Exceptions to this exclusion are fully excised non-melanoma skin cancers, non-metastatic prostate cancer, and fully treated...
- Previously received gene or cellular therapy
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- Little Rock, Arkansas, United States
- La Jolla, California, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Lebanon, New Hampshire, United States
- New York, New York, United States
- Chapel Hill, North Carolina, United States
- Nashville, Tennessee, United States
- Salt Lake City, Utah, United States
- Richmond, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States; Little Rock, Arkansas, United States; La Jolla, California, United States; Baltimore, Maryland, United States; Boston, Massachusetts, United States; Lebanon, New Hampshire, United States and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.