Neuropathic PainPhase 4NCT00414453
Trial of Analgesia With Lidocaine or Extended-release Oxycodone for Neuropathic Pain Treatment in Multiple Sclerosis
A Phase 4 study testing Lidocaine patch 5% and Extended-release oxycodone in people with Neuropathic Pain and Chronic Pain, run by University of Rochester at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuropathic Pain, Chronic Pain, Multiple Sclerosis
- What is being tested?
- Lidocaine patch 5% and Extended-release oxycodone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Aug 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- "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
Who cannot join
- 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.
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: 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.
Read the 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.
- Conditions
- Neuropathic Pain, Chronic Pain, Multiple Sclerosis
- Being tested
- Lidocaine patch 5%, Extended-release oxycodone, Placebo extended-release oxycodone pills, Placebo lidocaine patches
- Keywords
- Neuropathic pain, Chronic pain, Multiple sclerosis, Central neuropathic pain, Peripheral neuropathic pain, Opioid analgesic, Lidocaine
- Medical subject headings
- Neuralgia, Chronic Pain, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine patch 5%Drug
Also called Lidoderm
lidocaine 5% patch; 12 hours on, 12 hours off
Extended-release oxycodoneDrug
Also called Oxycontin
extended-release oxycodone titrating schedule
Placebo extended-release oxycodone pillsDrug
Also called Placebo pill
placebo pills with titrating schedule
Placebo lidocaine patchesDrug
Also called Placebo patch
used with extended release oxycodone group; used with placebo pills/placebo patches
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine 5% + placebo patch, ER and placebo pills | Active comparator | 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 Receives: Drug: Lidocaine patch 5%; Drug: Extended-release oxycodone; Drug: Placebo extended-release oxycodone pills; Drug: Placebo lidocaine patches |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Daily Diary Pain Ratings During Final Week of Each Treatment Period
subject identifies daily pain rating during final week of each treatment period using a numeric rating scale
Measured: Daily
Secondary outcomes (9)
Tolerability (e.g., Number of Adverse Effects, Number of Drop-outs)
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
Measured: rating of adverse events occur at each visit
Safety (i.e., Number of Serious Adverse Events)
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
Measured: rating and review of any adverse events occurs at each visit
Brief Pain Inventory Interference Items
subject completes the brief pain questionaire
Measured: occurs Visit 1, 3,4,5
Daily Diary Sleep Interference Ratings
Subject identifies degree of sleep interference on a daily basis
Measured: daily
Beck Depression Inventory
Subject completes Beck questionaire
Measured: occurs at Visit 1, 3, 4 and 5
Short-form Health Survey 36 (SF-36)
Subject completes short form health survey 36 questionaire
Measured: Occurs at Visit 1, 3, 4 and 5
Short-Form McGill Pain Questionnaire
Subject completes short form McGill Pain questionaire
Measured: Occurs Visit 1, 3, 4 and 5
Patient Global Impression of Change Scale
Subject completes patient global impression questionaire of change scale
Measured: Occurs Visit 3, 4, 5
Kurtzke Expanded Disability Status Scale
Subject completes questionaire on functional status
Measured: Occurs at Visit 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2006 (estimated)
- Study startJan 2007
- Primary completionAug 2011
- Study completionAug 2011
Why it stopped: Did not reach enrollment goals
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Endo USA Inc., a Keenova Therapeutics Company
- Responsible party
- Principal investigator, Robert Dworkin, University of Rochester
- Investigators
- Robert H. Dworkin, PhD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00414453
- Sponsor's protocol ID
- TALENT-MS
- Status last verified
- Jun 2015
- First submitted
- 19 Dec 2006
- Last updated
- 17 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Analgesia With Lidocaine or Extended-release Oxycodone for Neuropathic Pain Treatment in Multiple Sclerosis (TALENT-MS)
- ClinicalTrials.gov ID
- NCT00414453
- Acronym / sponsor ID
- TALENT-MS
- Conditions
- Neuropathic Pain, Chronic Pain, Multiple Sclerosis
- Keywords
- Neuropathic pain, Chronic pain, Multiple sclerosis, Central neuropathic pain, Peripheral neuropathic pain, Opioid analgesic, Lidocaine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Did not reach enrollment goals
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Endo USA Inc., a Keenova Therapeutics Company
- Study start
- Jan 2007
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 21 Dec 2006 (estimated)
- Results
- Posted 17 Jul 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lidocaine 5% + placebo patch, ER and placebo pills | Active comparator | Drug: Lidocaine patch 5%, Drug: Extended-release oxycodone, Drug: Placebo extended-release oxycodone pills, Drug: Placebo lidocaine patches5% 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- "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
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine patch 5%Also: Lidodermlidocaine 5% patch; 12 hours on, 12 hours off | Drug | Lidocaine 5% + placebo patch, ER and placebo pills |
| Extended-release oxycodoneAlso: Oxycontinextended-release oxycodone titrating schedule | Drug | Lidocaine 5% + placebo patch, ER and placebo pills |
| Placebo extended-release oxycodone pillsAlso: Placebo pillplacebo pills with titrating schedule | Drug | Lidocaine 5% + placebo patch, ER and placebo pills |
| Placebo lidocaine patchesAlso: Placebo patchused with extended release oxycodone group; used with placebo pills/placebo patches | Drug | Lidocaine 5% + placebo patch, ER and placebo pills |
Primary outcome
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
9 secondary outcomes
Tolerability (e.g., Number of Adverse Effects, Number of Drop-outs)
Time frame: 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
Brief Pain Inventory Interference Items
Time frame: occurs Visit 1, 3,4,5
Daily Diary Sleep Interference Ratings
Time frame: daily
Beck Depression Inventory
Time frame: 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
Short-Form McGill Pain Questionnaire
Time frame: Occurs Visit 1, 3, 4 and 5
Patient Global Impression of Change Scale
Time frame: Occurs Visit 3, 4, 5
Kurtzke Expanded Disability Status Scale
Time frame: Occurs at Visit 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert H. Dworkin, PhD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lidocaine patch 5% and Extended-release oxycodone in people with Neuropathic Pain and Chronic Pain, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Daily Diary Pain Ratings During Final Week of Each Treatment Period (time frame: Daily). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2015.