Ketamine HCl Prolonged Release Oral Tablets for CRPS
ConditionComplex Regional Pain Syndromes
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-64
SponsorUniversity of Southern California
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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).
Known or suspected psychotic illness or neurologic disease.
Known or suspected elevated intraocular and/or intracranial pressure.
Trial design
Treatments tested in this trial
- 80mg/day Ketamine HCl Prolonged Release
- 160mg/day Ketamine HCl Prolonged Release
Treatment groups
65 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov