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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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • 80mg/day Ketamine HCl Prolonged Release

    Drug

    Administration of Ketamine HCl Prolonged Release - 40mg BID

  • 160mg/day Ketamine HCl Prolonged Release

    Drug

    Administration of Ketamine HCl Prolonged Release - 80mg BID

Treatment groups

65 Participants
are divided into 1 treatment group
Group A: 80mg Ketamine HCl PRExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Average Daily Pain Numerical Rating Scale (ADP NRS)

Average Daily Pain Numerical Rating Scale is a validated, self-reported instrument used to assess average pain intensity level over the past 24 hours. It uses an 11-point (0-10) scale, with 0 being "no pain" and 10 being "worst pain imaginable."

Time frame
Day 1 to week 12

Secondary outcomes

1

Patient-Reported Outcomes Measurement Information System-2 (PROMIS-29 Profile v2.1)

The PROMIS-29 Profile v2.1 is a validated, self-reported instrument to measure functioning and well-being in 7 categories: physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities and pain interference. There are 4 questions in each of the 7 categories. Each question has five responses with a score from 1 to 5 (1 being best and 5 being worst). For each of these 7 categories, the lowest score is 4; the highest is 20.

Time frame
Day 1 to week 12
2

Complex Regional Pain Syndrome Severity Scale (CSS)

The CSS Questionnaire assesses changes in Complex Regional Pain Syndrome (CRPS) severity by asking for the presence or absence (score of 1 or 0) of 16 clinically assessed signs and symptoms of CRPS. A higher score is worse, indicate greater CRPS severity (range 0-16).

Time frame
Day 1 to week 12
3

Patient Global Impression of Change (PGIC)

Patient Global Impression of Change is a validated, self-reported instrument consisting of a 7-point scale (1 through 7) depicting a patient's rating of overall improvement since a certain point in time. The higher PGIC scores, the greater improvement. We will compare the scores at the end of Cycle 1 (1-4 weeks), 2 (4-8 weeks), and 3 (8-12 weeks).

Time frame
Day 1 to week 12
4

Maximum Plasma concentration [Cmax] of Ketamine

Maximum Plasma concentration \[Cmax\] is the maximum concentration of the drug, Ketamine, in the body, measured in grams/Liter. Blood samples are obtained at Day 2, 4, and 7.

Time frame
Day 1 to Day 7

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Southern California

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: