VER-01 for chronic painful lumbosacral radiculopathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, blinded trial compares VER-01 to placebo in adults with chronic painful lumbosacral radiculopathy who have not achieved adequate pain relief with optimized non-opioid analgesics. Participants will receive VER-01 or placebo and will be monitored for safety and changes in pain and function. The study involves scheduled visits and the use of an electronic diary to capture outcomes. Eligible participants must consent, be willing to adhere to the treatment plan, and have no excluded cardiovascular or severe psychiatric conditions. The trial is conducted at several sites in the United States and is sponsored by Vertanical GmbH.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Participants ≥ 18 years of age, all sexes
* Participant voluntarily provided written informed consent
* Participant is willing and able to comply with scheduled visits, treatment plan, eDiary, and other trial-related procedures throughout trial participation

Exclusion Criteria:

* Pregnant or breastfeeding female patients
* Known history of previous or current severe psychiatric disorder as per DSM-5 (e.g., schizophrenia, bipolar disorder, severe anxiety disorder, psychotic disorder, post-traumatic stress disorder), or currently taking antipsychotic medication
* Cardiovascular event or clinically significant cardiac dysfunction (e.g., congestive heart failure, myocardial ischemia, arrhythmias, poorly controlled high blood pressure, congenital long QT syndrome) within 12 months or a cardiac disorder that, in the opinion of the investigator, would put the patient at risk of a clinically significant arrhythmia or myocardial infarction

Where it's running

• AMR Mobile
  Mobile, Alabama, United States Recruiting
• Alliance for Multispecialty Research - Tempe I
  Tempe, Arizona, United States Recruiting
• Central Medical Research Institute
  Long Beach, California, United States Recruiting
• Tekton Research - Longmont
  Longmont, Colorado, United States Recruiting
• Bradenton Research Center
  Bradenton, Florida, United States Recruiting
• AGA Clinical Trials
  Hialeah, Florida, United States Recruiting

Study contacts

• Study coordinator: Vertanical GmbH
• Email: regulatory@vertanical.com
• Phone: +49 (0)89 787 97 90 - 0202

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Move-MORE: Online mindfulness, gentle movement, and motivational coaching for lumbosacral radiculopathy

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.