University of Southern California
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.
This study will enroll patients (age 18 to 64 years old) with history of CRPS (diagnosis greater than 6 months prior) at a single academic medical institution in the United States. All participants will be informed about the study and potential risks and will provided written informed consents prior to undergoing any study-related procedures. Health status assessments including physical exams, blood work, urinalysis, EKG and questionnaires to assess quality of life and pain scale measurement will be conducted at the clinic visits. The participants will also keep a daily diary throughout the s…
Inclusion Criteria: 1. Male and female participants between 18 and 64 years of age, inclusive, at Screening Visit. 2. Participants with a documented history of CRPS of at least 6 months at Visit 1. 3. At least one sign in two of the categories of The Budapest Criteria for CRPS to support the diagnosis of CRPS. 4. 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. 5. No surgery, denervation procedures or neural blockade within 1 m…
Administration of Ketamine HCl Prolonged Release - 40mg BID
Administration of Ketamine HCl Prolonged Release - 80mg BID
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