Pregabalin in CIPN

April 25, 2019 updated by: simon.haroutounian, Washington University School of Medicine

Investigation of Somatosensory Predictors of Response to Pregabalin in Painful Chemotherapy-induced Peripheral Neuropathy (CIPN)

The investigators seek to investigate certain patient characteristics that would predict the response to a currently approved analgesic, pregabalin, in patients with chronic pain due to nerve damage caused by chemotherapy. Patients with this painful condition, called chemotherapy-induced peripheral neuropathy (CIPN) have a current or recent history of chemotherapy with particular chemotherapy agents called taxanes or oxaliplatin. The investigators will recruit potential subjects from both the Siteman Cancer Center and the Washington University Pain Management Center. Those patients who meet the inclusion and satisfy the exclusion criteria will be enrolled. Subjects will undergo mechanical and thermal sensitivity testing on their extremities, will provide quality of life information by completing questionnaires and will receive pregabalin followed by placebo, or placebo followed by pregabalin [crossover design] in order to assess how well the sensory tests predict the analgesic effect of pregabalin (compared to placebo).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
26

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine/Barnes Jewish Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age >18
  2. Distal symmetric pain distribution (both feet, with or without pain in hands).
  3. The pain appeared during or up to 12 weeks after treatment with oxaliplatin, paclitaxel, docetaxel or any combination of these.
  4. Score of 4 or more on DN4 (Douleur Neuropathique 4) neuropathic pain questionnaire
  5. Pain duration > 2 months.
  6. Patient report of average daily pain intensity in the last week >3 on 0-10 Numerical Rating Scale (NRS).
  7. Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation.
  8. Able and willing to sign an IRB-approved written informed consent.

Exclusion Criteria:

  1. Hypersensitivity to pregabalin.
  2. Current treatment with pregabalin.
  3. Current treatment with a vinca alkaloid (e.g. vincristine, vinblastine), or CIPN that may be associated with previous treatment with a vinca alkaloid.
  4. History of diabetes mellitus or a neurological disorder with any previous signs of distal symmetric polyneuropathy.
  5. Moderate to severe renal failure (Creatinine clearance < 30mL/min, by Cockcroft-Gault formula).
  6. ALT (alanine aminotransferase) or AST (aspartate aminotransferase ) > 3 times the upper limit of normal.
  7. Planned surgeries or radiation treatment within 10 weeks following study inclusion.
  8. Inability to complete pain self-report.
  9. Pregnancy or lactation
  10. Patients with seizure disorders treated with anticonvulsants
  11. Current participation in a trial with another investigational agent.

  12. Concomitant medication as follows:

    • Subjects treated with gabapentin or other anticonvulsant for neuropathic pain will be required to taper the medication and discontinue for at least 2 weeks prior to study initiation.
    • Patients on antidepressant treatment for pain or depression (TCAs, SSRI, SNRIs etc. will be allowed to continue their medications provided they have been on a stable dose for at least 4 weeks before study initiation. No dose regimen changes of antidepressants will be allowed during the study period.
    • Patients on around-the clock opioid treatment (including tramadol) will be allowed to continue their medication provided they have been on a stable dose for at least 4 weeks before study initiation. The maximum allowed dose of opioid will be equivalent to 60mg oral morphine sulphate. Patients with higher doses will be required to taper down their opioid dose to maximum 60mg oral morphine equivalent, and continue on stable dose for 4 weeks before enrollment in the study. Short-acting opioids for painful CIPN treatment will not be allowed.
    • Treatment with non-steroidal anti-inflammatory drugs (NSAIDs) will be discontinued at least 2 weeks before study initiation. However, low-dose aspirin (≤325mg/day) will be allowed.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Pregabalin
Pregabalin administered for 4 weeks, titrated to highest tolerated dose up to 600 mg/day.
Drug: Pregabalin
Anticonvulsant
Other Names:
  • Lyrica
Drug: Placebo
Identical, matching inactive substance
Placebo Comparator: Placebo
Identical, matching inactive substance administered for 4 weeks following the same dosing regimen.
Drug: Pregabalin
Anticonvulsant
Other Names:
  • Lyrica
Drug: Placebo
Identical, matching inactive substance

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Spontaneous Pain Intensity as a Function of Baseline MPT
Time Frame: Baseline to week 4
Correlation between Mechanical Pain Threshold (MPT in mN) at baseline and reduction in spontaneous pain intensity (% reduction on 0-10 NRS) at the end of 4-week treatment. The slopes (Pearson coefficients) of the correlation obtained from pregabalin vs. placebo will be compared.
Baseline to week 4

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Absolute Change in Pain Intensity, Measured on 0-10 Numerical Rating Scale (NRS)
Time Frame: Baseline to week 4
Absolute change in pain intensity on 0-10 numerical rating scale (NRS) from baseline to 4 weeks with pregabalin vs. placebo NRS: 0= no pain, 10= worst pain
Baseline to week 4
Change in NPSI Outcomes
Time Frame: Baseline to week 4
Change from baseline to week 4 in total NPSI (Neuropathic Pain Symptom Inventory) score The total NPSI score is comprised by adding 5 sub-scores (Burning pain, Pressing pain, Paroxysmal pain, Evoked pain, and Paresthesia/Dysesthesia) and is expressed on a 0-100 scale; 0-minimum (least), and 100 maximum (worst) score
Baseline to week 4
Change in BPI Outcomes (SEVERITY)
Time Frame: Baseline to week 4
Change from baseline to week 4 in BPI (Brief Pain Inventory) pain severity severity score BPI severity score is expressed on 0-10 scale, with 0 being the minimum (least), and 10 being the maximum (worst) pain severity
Baseline to week 4
Change in Sleep Problem Index (SPI) Outcomes
Time Frame: Baseline to week 4
Change from baseline to week 4 in SPI (Sleep Problem Index) score, on 0-100 scale, where 0= best (least) score, and 100= maximum (worst) score
Baseline to week 4
Change in BPI Outcomes (INTERFERENCE)
Time Frame: baseline to week 4
Change from baseline to week 4 in BPI (Brief Pain Inventory) pain interference score BPI interference score is expressed on 0-10 scale, with 0 being the minimum (least), and 10 being the maximum (worst) pain interference
baseline to week 4
Number of Patients With Significant Pain Reduction
Time Frame: Baseline to week 4
Number of patients who experienced 50% or more reduction in average daily pain (on 0-10 NRS, Numerical Rating Scale, where 0=least pain, 10=worst pain)
Baseline to week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Washington University School of Medicine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Simon Haroutounian, PhD, Washington University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 2, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 2, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 4, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 20, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 14, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 201501067

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings