Trial of Analgesia With Lidocaine or Extended-release Oxycodone for Neuropathic Pain Treatment in Multiple Sclerosis

June 23, 2015 updated by: Robert Dworkin, University of Rochester

Trial of Analgesia With Lidocaine or Extended-release Oxycodone for Neuropathic Pain Treatment in Multiple Sclerosis (TALENT-MS)

This study will determine whether treatment with an extended-release opioid or topical lidocaine is effective in relieving distal symmetric lower extremity burning pain associated with multiple sclerosis (MS). If treatment with topical lidocaine is efficacious, it will have important implications for understanding this chronic pain syndrome, which is widely assumed to be caused by central nervous system pathology.

Study Overview

Status

Status

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

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.

Detailed Description

This study is a single-center, double-blind, 15-week, 3-period crossover clinical trial. Subjects will complete each of the following 5-week long periods (unless they withdraw from the trial): 1) placebo pills and topical lidocaine patches, 2)extended-release oxycodone pills and placebo(vehicle) patches, and 3)placebo pills and placebo patches. Sixty subjects will be randomized to one of 6 treatment sequences. It is expected that this trial will take approximately 2 years to complete.

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.
19

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.
  • Phase 4

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
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • "Definite MS" as defined by revised McDonald criteria.
  • Bilateral distal symmetric burning pain involving both feet for at least three months.
  • Baseline weekly average pain rating equal to four or greater on 0-10 numerical scale.
  • Stable MS medication and pain-related medications for 8 weeks prior to screening.
  • Must come to Research Center for appointments

Exclusion Criteria:

  • Topical treatment with lidocaine, capsaicin, or other topical analgesics within 3 months prior to screening.
  • Any treatment with opioid analgesics or tramadol within 3 months prior to screening.
  • Hypersensitivity to Lidoderm, lidocaine, or other local anesthetics.
  • Hypersensitivity or inability to tolerate opioid analgesics.
  • Current treatment with a total of 3 or more antidepressant or anticonvulsant drugs for pain.
  • Current treatment with Class I anti-arrhythmic agents at baseline.
  • Beck Depression Inventory score > 16 or clinically significant depression or dementia.
  • History of suicide attempt or current intent or plan.
  • History of excessive alcohol use or any illicit drug use within the past 2 years.
  • Lack of adequate birth control in pre-menopausal women of childbearing age.
  • Other pain more severe than lower extremity burning pain.
  • Open skin lesions in the area where the lidocaine patch is to be applied.
  • Cancer within the previous 5 years other than skin cancer.
  • MS exacerbation or any treatment with corticosteroids within 3 months prior to screening.
  • History of peripheral neuropathy, lower limb amputation, or another neuromuscular syndrome or systemic disorder known to be associated with sensory neuropathy.
  • Does not meet criteria of baseline lab values at screening visit.
  • Nerve conduction studies consistent with peripheral neuropathy.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

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.
Active Comparator: Lidocaine 5% + placebo patch, ER and placebo pills
5% lidocaine patch used as intervention placebo patch used with extended release oxycodone or with placebo pills and placebo patches a randomized subjects given extended release oxycodone and placebo patches during this treatment placebo pills used with lidocaine 5% patch group and with placebo patch/placebo pill group period
Drug: Lidocaine patch 5%
lidocaine 5% patch; 12 hours on, 12 hours off
Other Names:
  • Lidoderm
Drug: Extended-release oxycodone
extended-release oxycodone titrating schedule
Other Names:
  • Oxycontin
Drug: Placebo extended-release oxycodone pills
placebo pills with titrating schedule
Other Names:
  • Placebo pill
Drug: Placebo lidocaine patches
used with extended release oxycodone group; used with placebo pills/placebo patches
Other Names:
  • Placebo patch

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
Mean Daily Diary Pain Ratings During Final Week of Each Treatment Period
Time Frame: Daily
subject identifies daily pain rating during final week of each treatment period using a numeric rating scale
Daily

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
Tolerability (e.g., Number of Adverse Effects, Number of Drop-outs)
Time Frame: rating of adverse events occur at each visit
subject is questioned regarding any adverse events that have occured since the last contact; also subject can document any issues on daily pain rating diaries
rating of adverse events occur at each visit
Safety (i.e., Number of Serious Adverse Events)
Time Frame: rating and review of any adverse events occurs at each visit
Subject is asked about any adverse events that may have occurred since last contact; also subject can document any adverse events on daily pain diary scales
rating and review of any adverse events occurs at each visit
Brief Pain Inventory Interference Items
Time Frame: occurs Visit 1, 3,4,5
subject completes the brief pain questionaire
occurs Visit 1, 3,4,5
Daily Diary Sleep Interference Ratings
Time Frame: daily
Subject identifies degree of sleep interference on a daily basis
daily
Beck Depression Inventory
Time Frame: occurs at Visit 1, 3, 4 and 5
Subject completes Beck questionaire
occurs at Visit 1, 3, 4 and 5
Short-form Health Survey 36 (SF-36)
Time Frame: Occurs at Visit 1, 3, 4 and 5
Subject completes short form health survey 36 questionaire
Occurs at Visit 1, 3, 4 and 5
Short-Form McGill Pain Questionnaire
Time Frame: Occurs Visit 1, 3, 4 and 5
Subject completes short form McGill Pain questionaire
Occurs Visit 1, 3, 4 and 5
Patient Global Impression of Change Scale
Time Frame: Occurs Visit 3, 4, 5
Subject completes patient global impression questionaire of change scale
Occurs Visit 3, 4, 5
Kurtzke Expanded Disability Status Scale
Time Frame: Occurs at Visit 1
Subject completes questionaire on functional status
Occurs at Visit 1

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.
University of Rochester

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Endo Pharmaceuticals

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: Robert H. Dworkin, PhD, University of Rochester

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.
January 1, 2007

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.
August 1, 2011

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.
August 1, 2011

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).
December 19, 2006

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.
December 20, 2006

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.
December 21, 2006

Study Record Updates

Last Update Posted (Estimate)

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.
July 17, 2015

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.
June 23, 2015

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.
June 1, 2015

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.
  • TALENT-MS

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.

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