Ketamine HCl Prolonged Release Oral Tablets for CRPS
United States65 participantsStarted 2026-07
Plain-language summary
The purpose of this study is to evaluate the efficacy of Ketamine HCl Prolonged Release (PR) tablets in participants with pain due to complex regional pain syndrome (CRPS).
Additionally, this trial will explore the feasibility of the trial design through dosing compliance, clinical instruments for safety and quality of life measurements, and pharmacokinetic profile.
Who can participate
Age range18 Years – 64 Years
SexALL
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Inclusion criteria
✓. Male and female participants between 18 and 64 years of age, inclusive, at Screening Visit.
✓. Participants with a documented history of CRPS of at least 6 months at Visit 1.
✓. At least one sign in two of the categories of The Budapest Criteria for CRPS to support the diagnosis of CRPS.
✓. Stable individual regular standard treatment regimen for CRPS pain, i.e., no change in drug and non-drug treatments for at least 4 weeks prior to Screening Visit and anticipated to remain stable throughout the study.
✓. No surgery, denervation procedures or neural blockade within 1 month of Screening Visit.
✓. Participants on ketamine therapy at Screening Visit must agree to discontinue use for at least 14 days prior to the Baseline Observation Period.
✓. Agree to discontinue any prohibited medications within prior to 14 days of the Baseline Observation Period and for the duration of the study.
✓. Average daily CRPS pain intensity score in the affected limb of ≥5 and ≤9 on an 11-point (0-10) NRS averaged over 7 days prior to Baseline Visit (Visit 1). This will be based on completion of at least 5 daily pain diary entries during the week prior to Visit 1, with no more than one 24-hour pain intensity score of zero or more than one 24-hour pain intensity score of 10.
Exclusion criteria
✕. Known or suspected cardiovascular disease, arrythmias, and/or respiratory issues.
✕. Abnormal EKG results, abnormal blood pressure (SBP \<90 or ≥ 140; DBP \<50 or ≥ 90) and/or heart rates (\<50 or \>110).
What they're measuring
1
Average Daily Pain Numerical Rating Scale (ADP NRS)
✕. Known or suspected psychotic illness or neurologic disease.
✕. Known or suspected elevated intraocular and/or intracranial pressure.
✕. Known or suspected renal or urologic conditions or symptoms (i.e., bladder pain syndrome, interstitial cystitis), and/or abnormal baseline urinalysis results.
✕. Known or suspected hyperthyroidism.
✕. Allergy, hypersensitivity, or intolerance to ketamine or any of the investigational product excipients.
✕. Participants receiving opioids ≥30 mg/day morphine milligram equivalents (MME), whether as part of their individual standard treatment regimen for CRPS pain or in context with any other indication, within the last two weeks prior to Visit 1.