A Phase 1 interventional study of BRC-002 and BRC-002 Placebo in Complex Regional Pain Syndrome, sponsored by University of California, San Diego. Recruiting at 2 sites in United States. Open to participants aged 21 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-06-07.
Sponsored by University of California, San Diego · Phase 1, Interventional, and Treatment
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Among 88 studies in Complex Regional Pain Syndromes with a site in United States — 20 open to participants now, 22 under way, 2 of them phase 3. Complex Regional Pain Syndromes · United States.
Among the 88 studies in Complex Regional Pain Syndromes with a site in United States, this one is the 22nd largest by planned enrollment of the 67 interventional ones that give a count, is one of 3 that started in 2024, is one of 5 in phase 1, reaches primary completion later than 20 of the 21 other live ones, and was the 80th registered.
206 studies on the registry are indexed under Complex Regional Pain Syndromes; 55 are open to participants now.
Browse Complex Regional Pain Syndromes studies →20 of the 88 studies in Complex Regional Pain Syndromes with a site in United States are open now. Recruiting first, the newest first:
Ambros Therapeutics, Inc. · Sites in United States
Ages 18+
The Cleveland Clinic · Sites in United States
Ages 18+
Ambros Therapeutics, Inc. · Sites in United States
Ages 18+
Ambros Therapeutics, Inc. · Sites in United States
Ages 18+
Scripps Health · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 39 Complex Regional Pain Syndromes studies recruiting now, 17 (44%) set no upper age limit and 16 (41%) stop at 75 or younger; 3 take children under 18; 5 take healthy volunteers.
This study: 21 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
88 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 6 · Phase 2 10 · Phase 3 13 · Phase 4 4
First in 2000; this study’s year is marked. 3 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 52 is above the median of 40 across 152 interventional studies indexed under Complex Regional Pain Syndromes.
Median enrollment 30 across the 67 interventional studies, 60 across the 21 observational. Of the 56 that completed or were terminated, 29 (52%) have results posted.
This tab as a report to print or save as PDF → With an account.
20 of 88 have an industry lead sponsor. The 10 most frequent:
University of California, San Diego is the lead sponsor of 980 studies on the registry; 195 are open to participants now.
Of its 113 completed or terminated interventional studies of FDA-regulated products, 71 (63%) have results posted.
University of California, San Diego has 1 study filed under Complex Regional Pain Syndromes — fewer than ten, so there is no comparison to draw.
8 of the studies in Complex Regional Pain Syndromes with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06798493Hospital for Special Surgery, New YorkCSS-SR Validation Study | 2026-12-29 |
| NCT05593237University of California, San FranciscoTranscranial Magnetic Stimulation for Chronic Neuropathic Pain | 2026-12-30 |
| NCT05477004Theresa LiiObservational Study of Ketamine Infusions for the Treatment of Chronic Pain | 2026-12-31 |
| NCT05777889Hospital for Special Surgery, New YorkInfrared Images for Spinal Cord Stimulation in Complex Regional Pain Syndrome Patients | 2027-02 |
| NCT05814497Children's Hospital Medical Center, CincinnatiSupraspinal Processing of Sensory Aspects of Pain | 2027-06-30 |
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Among the 88 studies in Complex Regional Pain Syndromes with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The aim of this trial is to determine the potential effects and mechanisms of cannabinoid-induced pain relief in complex regional pain syndrome (CRPS). Multiple psychophysical approaches will be conducted in conjunction with psychological and inflammatory marker testing to determine if and how cannabinoids produce stabilized improvement in CRPS-related pain and comorbidities.
The trial consisted of a pre-treatment screening period, six-week treatment period and a two-week follow-up.
Complex Regional Pain Syndrome (CRPS) is a debilitating and perplexing chronic pain condition that produces incalculable suffering to millions of individuals worldwide. The enigmatic nature of CRPS has left it difficult to treat. CRPS is characterized by a constellation of pain, sensory, autonomic, and motor symptoms that is difficult to pinpoint the source of injury/inflammation. Although unclear, a common cause of CRPS are radial fractures that demonstrate aberrant processing 4-6 weeks after injury.
The aim of this trial is to determine the potential effects and mechanisms of cannabinoid-induced pain relief in complex regional pain syndrome (CRPS). Multiple psychophysical approaches will be conducted in conjunction with psychological and inflammatory marker testing to determine if and how cannabinoids produce stabilized improvement in CRPS-related pain and comorbidities.
The trial consisted of a pre-treatment screening period, six-week treatment period and a two-week follow-up.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Half of the patients will receive PO placebo
Drug: BRC-002 Placebo
Drug: BRC-002 (High Cannabidiol Botanical Extract) 100 mg/mL
Drug: BRC-002
BRC-002 is a non-scheduled cannabidiolic (CBD) formulation (\<.3% THC). The cannabinoids in BRC-002 are naturally biosynthesized within the Cannabis sativa L. plant as acidic forms of CBD (cannabidiolic acid; CBDA), THC (tetrahydrocannabinolic acid; THCA) and other minor cannabinoids.
Oral solution of mono-, di-, and triglycerides
Change in complex regional pain syndrome pain and heat pain measured with VAS
Change from baseline in pain intensity and unpleasantness ratings using an 11-point Visual Analog Scale in response to heat and ongoing CRPS pain
Time frame: Day 1 - Day 42
Pain Inventory Measure
Change from baseline in The Brief Pain Inventory
Time frame: Day 1 - Day 42
Depression Measure
Change from baseline in Beck Depression
Time frame: Day 1 - Day 42
Sleep Measure
Change from baseline in Pittsburgh Sleep Quality Index
Time frame: Day 1 - Day 42
Interleukin 6
Change from baseline in Interleukin 6
Time frame: Day 1 - Day 42
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jun 2024; primary completion for Jun 2029, 60 months later.
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Studies of the drug tested here: BRC-002
Complex Regional Pain Syndromes →
University of California, San Diego →