Lumbosacral RadiculopathyPhase 3EXPANDNCT06956014
Efficacy and Safety of VER-01 in the Treatment of Participants With Chronic Painful Lumbosacral Radiculopathy
A Phase 3 study testing VER-01 in people with Lumbosacral Radiculopathy, run by Vertanical GmbH at 32 sites in United States.
Trial summary
The aim of the trial is to prove the efficacy and safety of VER-01 compared to placebo in patients with chronic painful lumbosacral radiculopathy (PLSR) for whom drug treatment is indicated and previous optimized treatments with non-opioid analgesics have not led to sufficient pain relief or were unsuitable due to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbosacral Radiculopathy
- What is being tested?
- VER-01
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 810 participants
- Where
- 32 sitesUnited States
- Study dates
- 22 Sep 2026to Sep 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
32 sites in 1 country. Contact the study team or a site near you to ask about taking part.
32 sites in 1 country
United States32 sites, 32 recruiting
- Recruiting
Central Texas Clinical Research, LLC
Austin, Texas, 78705
Melissa Frampton, 402-934-0044, melissa.frampton@qcrnetwork.com
- Recruiting
Bradenton Research Center
Bradenton, Florida, 34205
Eric Folkens, 941-708-0005, info@bradentonresearch.com
- Recruiting
DFW Clinical Trials
Carrollton, Texas, 75010
Forbes Hewitt, 585-301-8686, fhewitt@eliteclinicalnetwork.com
- Recruiting
Clinitiative - Clinical Trials of South Carolina - Charleston
Charleston, South Carolina, 29406
Rhiannon Crump, 843-789-3707, rhenderson@clinicaltrialssc.com
- Recruiting
Epic Medical Research - Chickasha
Chickasha, Oklahoma, 73018
Daniel Duncan, 512-480-9660, dduncan@ctcrcorp.com
- Recruiting
Velocity Clinical Research - Cleveland
Cleveland, Ohio, 44122
Elizabeth Schneider, 216-682-0320, eschneider@velocityclinical.com
- Recruiting
Innovare Research Group I
Friendswood, Texas, 77456
Kevin Maldonado, 832-841-1475, k.maldonado@innovareresearch.com
- Recruiting
AGA Clinical Trials
Hialeah, Florida, 33012
Linzandra Castillo, 305-819-1551, lcastillo@agaclinicaltrials.com
- Recruiting
Synergy Groups Medical - Southeast Houston
Houston, Texas, 77036
Shamim Memon, 832 500 5185, admin@synergygroupus.com
- Recruiting
Green Leaf Clinical Trials
Jacksonville, Florida, 32258
Nicole Gilyard, 904-680-2818, ngilyard@greenleafclinicaltrials.com
- Recruiting
R & H Clinical Research
Katy, Texas, 77494
Esmeralda Aguirre, 832-345-5316, esmeralda@rhclinicalresearch.com
Denise Rodriguez, 832-886-3275, denise@rhclinicalresearch.com
- Recruiting
Alliance for Multispecialty Research - Knoxville
Knoxville, Tennessee, 37920
William Smith, 865-305-9100, william.smith@amr-clinical.com
- Recruiting
Epic Clinical Research - Lewisville
Lewisville, Texas, 75057
Jessica Powell, 469-361-8007, jpowell@allianceclinicalnetwork.com
- Recruiting
Central Medical Research Institute
Long Beach, California, 90802
Kyle Tent, 562-455-6767, kyle@cmrillc.com
- Recruiting
Tekton Research - Longmont
Longmont, Colorado, 80501
Don Hales, 303-345-6994, don.hales@tektonresearch.com
- Recruiting
K2 Medical Research - Maitland II
Maitland, Florida, 32751
Alfonso Gonzalez, 407-500-5252, Alfonso.Gonzalez@k2med.com
- Recruiting
Velocity Clinical Research - Medford
Medford, Oregon, 97504
Danuel Hamlin, 541-858-1018, dhamlin@velocityclinical.com
- Recruiting
Floridian Research Institute LLC I
Miami, Florida, 33179
Jose Fidalgo, 786-391-1137, jmfidalgo@floridianresearch.com
- Recruiting
Alma Clinical Research
Miami, Florida, 33184
Rogelio B Rodriguez, 786-762-2922, rbardinas@almaresearch1.com
- Recruiting
AMR Mobile
Mobile, Alabama, 36608
Harry Studdard, 251-414-1984, harry.studdard@amr-clinical.com
- Recruiting
Monroe Biomedical Research - Monroe
Monroe, North Carolina, 28112
MBR Recruitment Team, 704-290-3556, JoinUs@MonroeResearch.com
- Recruiting
Conquest Research - Lake Nona
Orlando, Florida, 32832
Kendra Tandeski, 407-916-0060, info@conquestresearch.com
- Recruiting
Alfa Medical Research - Pembroke Pines
Pembroke Pines, Florida, 33029
Claudia Ramirez, 754-263-3626, cramirez@alfamedicalgroups.com
- Recruiting
United Medical Research
Port Orange, Florida, 32738
Tasha Brocato, 386-304-7070, tashab@progressivemedicalresearch.com
- Recruiting
Boeson Research
Provo, Utah, 84604
Melissa Loosli, 385-392-2200, pvustaff@boesonresearch.com
- Recruiting
CenExel JBR - Salt Lake City
Salt Lake City, Utah, 84107
Todd Bertoch, 801-261-2000, t.bertoch@cenexel.com
- Recruiting
Elixia Clinical Research Collaborative
Springfield, Massachusetts, 01103
Brittany Perreault, 413-305-1142, Brittany.Perreault@voltaireresearch.com
- Recruiting
Alliance for Multispecialty Research - Tempe I
Tempe, Arizona, 85281
William Reedy, 602-910-3343, William.Reedy@amr-clinical.com
- Recruiting
Alliance for Multispecialty Research - Wichita East
Wichita, Kansas, 67226
Terry Klein, 316-689-6635, terry.klein@amr-clinical.com
- Recruiting
Grayline Research Center
Wichita Falls, Texas, 76309
Kathy Castro, 940-322-1131, kcastro@graylinecdt.com
- Recruiting
Progressive Medicine of the Triad, LLC
Winston-Salem, North Carolina, 27103
Donna Rice, 336-768-3456, drice@progressivemedicineofthetriad.com
- Recruiting
Conquest Research - Winter Park
Winter Park, Florida, 32789
James Kelly, 407-916-0060, james.kelly@conquestresearch.com
About this study
Official title: Multicenter, Double-blind, Randomized, Placebo-controlled Phase III Trial to Evaluate the Efficacy and Safety of the Full-spectrum Cannabis Extract VER-01 in Participants With Chronic Painful Lumbosacral Radiculopathy
The aim of the trial is to prove the efficacy and safety of VER-01 compared to placebo in patients with chronic painful lumbosacral radiculopathy (PLSR) for whom drug treatment is indicated and previous optimized treatments with non-opioid analgesics have not led to sufficient pain relief or were unsuitable due to contraindications or intolerance.
- Conditions
- Lumbosacral Radiculopathy
- Being tested
- VER-01, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VER-01Drug
Standardized soft extract from Cannabis sativa DKJ127 L., cannabis flos (Cannabis flower), corresponding to 19 mg Δ9-Tetrahydrocannabinol (THC) per ml drug product
PlaceboOther
Comparator without active ingredient
| Study group | Role | What they receive |
|---|---|---|
| VER-01 Dose 1 | Experimental | Not described Receives: Drug: VER-01 |
| VER-01 Dose 2 | Experimental | Not described Receives: Drug: VER-01 |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy based on pain reduction
The primary endpoint is the absolute change in mean leg pain intensity in the index leg measured on an 11-point numerical rating scale (NRS) at Treatment Week 12 compared to Baseline.
Measured: From Baseline to Treatment Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2025
- Study start22 Sep 2026
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbosacral RadiculopathyStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 810 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vertanical GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06956014
- Sponsor's protocol ID
- VER-CLBP-003
- Acronym
- EXPAND
- Status last verified
- Oct 2026
- First submitted
- 24 Apr 2025
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Double-blind, Randomized, Placebo-controlled Phase III Trial to Evaluate the Efficacy and Safety of the Full-spectrum Cannabis Extract VER-01 in Participants With Chronic Painful Lumbosacral Radiculopathy
- ClinicalTrials.gov ID
- NCT06956014
- Acronym / sponsor ID
- EXPAND / VER-CLBP-003
- Conditions
- Lumbosacral Radiculopathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 810 participants (estimated)
- Lead sponsor
- Vertanical GmbHIndustry (pharma, biotech, devices)
- Study start
- 22 Sep 2026 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 2 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the trial is to prove the efficacy and safety of VER-01 compared to placebo in patients with chronic painful lumbosacral radiculopathy (PLSR) for whom drug treatment is indicated and previous optimized treatments with non-opioid analgesics have not led to sufficient pain relief or were unsuitable due to contraindications or intolerance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| VER-01 Dose 1 | Experimental | Drug: VER-01 |
| VER-01 Dose 2 | Experimental | Drug: VER-01 |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| VER-01Standardized soft extract from Cannabis sativa DKJ127 L., cannabis flos (Cannabis flower), corresponding to 19 mg Δ9-Tetrahydrocannabinol (THC) per ml drug product | Drug | VER-01 Dose 1, VER-01 Dose 2 |
| PlaceboComparator without active ingredient | Other | Placebo |
Primary outcome
Efficacy based on pain reduction
Time frame: From Baseline to Treatment Week 12
The primary endpoint is the absolute change in mean leg pain intensity in the index leg measured on an 11-point numerical rating scale (NRS) at Treatment Week 12 compared to Baseline.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No
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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.
32 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 VER-01 in people with Lumbosacral Radiculopathy, run by Vertanical GmbH at 32 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?
The sponsor lists 3 inclusion and 3 exclusion criteria. 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: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vertanical GmbH (+49 (0)89 787 97 90 - 0202, regulatory@vertanical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy based on pain reduction (time frame: From Baseline to Treatment Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2026.