An Efficacy and Safety Study of Carisbamate in the Treatment of Nerve Pain in Diabetics

January 15, 2013 updated by: SK Life Science, Inc.

A Randomized, Double-Blind, Placebo- and Active-Controlled Study of Carisbamate in the Treatment of Neuropathic Pain in Diabetic Peripheral Neuropathy Followed by a Blinded Extension Phase

The purpose of this study is to evaluate the safety, tolerability, and efficacy of carisbamate (800 and 1200 mg/day) in patients with diabetic neuropathic pain.

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.

Detailed Description

This is a randomized (study medication assigned by chance), double-blind (neither the investigator or the patient knows the name of the study assigned drug), placebo- and active-controlled, parallel-group, multicenter study, with an optional extension phase, in patients with diabetic peripheral neuropathy (DPN), or nerve pain in their lower extremities resulting from diabetes. The study population includes men and women between 18 and 75 years of age who have chronic neuropathic pain associated with diabetic neuropathy. Up to 440 subjects will be enrolled and randomly assigned (like flipping a coin) in a 1:1:1:1 ratio to treatment with carisbamate 800 milligrams per day (mg/d), carisbamate 1,200 mg/d, pregabalin 300 mg/d, or placebo. The double-blind treatment will be administered orally, in a twice-daily regimen, with or without food, over a period of 15 weeks. The study will consist of a pretreatment phase, including a screening, washout, and baseline period; a double-blind treatment phase, with a titration and a fixed-dosage period; an optional blinded extension phase (with carisbamate 400 to 1,200 mg/d or pregabalin 150 to 300 mg/d); and a posttreatment phase (including a follow-up visit and telephone contact). The duration of the study (excluding the pretreatment phase) is approximately 58 weeks for patients who decide to enter the extension phase and approximately 19 weeks for the other patients. The pretreatment phase will last up to 28 days, including a screening visit up to 28 days before the planned first dose of study drug, a washout of up to 7 days for subjects who need to discontinue medications, and a baseline period of at least 7 days to determine daily average DPN scores for entry into the study. The double-blind treatment phase will include a titration period of 3 weeks to determine the dosage, and a fixed-dosage period for the next 12 weeks. All patients who complete the double-blind treatment phase will be offered the option to enter the blinded extension phase for an additional 37 weeks, in which patients previously treated with carisbamate or placebo will receive carisbamate at their individual dosage at the end of the double-blind treatment period, and patients previously treated with pregabalin will receive pregabalin at their individual dosage at the end of the double-blind treatment period. During the double-blind and extension phases, patients will have daily assessments of their pain, using the 11-point DPN pain rating scale; and how much their pain interferes with their sleep, using an 11-point Sleep Interference rating scale. In addition, specific scales will be used at visits (every week for the first 4 weeks, every 4 weeks through the end of the double-blind treatment phase, every 11 to 12 weeks in the extension phase) to assess pain, overall health quality, the effects of pain on daytime sleepiness, and the effects of pain on work, activities, and health care utilization. Patients will remain blinded to the drug assignment during the extension phase. The posttreatment phase will include a follow-up visit with 7 to 14 days after the final visit of the double-blind treatment phase (for patients who do not participate in the extension phase) or the extension phase. In addition, the investigator staff will call patients 30 to 33 days after the last dose of study drug, to ask about any adverse events. Patients will take two oral capsules each day, either carisbamate (200 or 400 mg), matching pregabalin (75 or 150 mg), or matching placebo.

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.
386

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 2

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 to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with diabetes mellitus (type 1 or 2)
  • Have had diabetes-related painful peripheral neuropathy in the lower extremities for >=6 months prior to entry
  • Have experienced lower extremity pain on a nearly daily basis for the previous 3 months
  • Have a mean daily average DPN pain score of >=4 (on an 11-point scale) during the baseline period
  • Have had a stable diabetic treatment regimen, including oral hypoglycemics, insulin, or diet, for >=3 months before screening
  • Have hemoglobin A1c levels <=11%
  • Willing to discontinue prohibited medications, including antiepileptic drugs (including gabapentin and pregabalin), opioids or opioid-containing pain medications, and antidepressants
  • Women must be postmenopausal for >=2 years, surgically sterile, abstinent, or practicing a highly effective method of birth control
  • Women of childbearing potential must have a negative pregnancy test at screening and on Day 1.

Exclusion Criteria:

  • History of poor response to >=3 classes of medications for DPN
  • Currently taking warfarin (Coumadin)
  • Prior treatment with neurolysis (destruction of nerves by application of chemicals, heat, or cold), neurosurgery, intrathecal pumps, or spinal cord stimulators for DPN
  • Use of herbal topical creams or ointments for pain relief with 48 hours, capsaicin with 6 months, or systemic (oral) corticosteroids with 3 months before the baseline period
  • Any dermatologic or vascular disease in the limbs affected by the neuralgia that may interfere with assessment, including a diabetic ulcer or to or limb amputation
  • Hospitalized within the last month for episodes of hypoglycemia or hyperglycemia
  • History of progressive or neurologic disorders (such as multiple sclerosis, amyotrophic lateral sclerosis)

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: Parallel 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: 001
Carisbamate 800 mg/d 200 mg/d twice daily titrated up to 400 mg twice daily as tolerated by Week 3
Drug: Carisbamate 800 mg/d
200 mg/d twice daily, titrated up to 400 mg twice daily, as tolerated, by Week 3
Experimental: 002
Carisbamate 1 200 mg/d 200 mg/d twice daily titrated up to 600 mg twice daily as tolerated by Week 3
Drug: Carisbamate 1,200 mg/d
200 mg/d twice daily, titrated up to 600 mg twice daily, as tolerated, by Week 3
Active Comparator: 003
Pregabalin 300 mg/d 75 mg/d twice daily for Week 1 followed by 150 mg twice daily for the remainder
Drug: Pregabalin 300 mg/d
75 mg/d twice daily for Week 1, followed by 150 mg twice daily for the remainder
Placebo Comparator: 004
Placebo Placebo capsules twice daily
Drug: Placebo
Placebo capsules twice daily

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
Time Frame
Mean of the last 7 daily average diabetic peripheral neuropathy (DPN) pain scores
Time Frame: Through 15 weeks
Through 15 weeks

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
Time Frame
Other secondary outcomes include the mean Neuropathic Pain Symptom Inventory (NPSI) subscale scores, the mean SF-36 subscale scores, and the Subject Global Impression of Change (SGIC) and Subject Global Impression of Severity (SGIS) scores.
Time Frame: Through 15 weeks
Through 15 weeks
The proportion of patients who take rescue medication for breakthrough pain, and the number of days with rescue medication per week, will also be assessed.
Time Frame: Through 15 weeks
Through 15 weeks
Responder rates (50% and 30% reduction from baseline in the mean of the last 7 daily average DPN pain scores).
Time Frame: Through 15 weeks
Through 15 weeks
The mean of the last 7 daily maximum DPN pain scores.
Time Frame: Through 15 weeks
Through 15 weeks
The mean of the last 7 Daily Sleep Interference scores.
Time Frame: Through 15 weeks
Through 15 weeks

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.
SK Life Science, Inc.

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.
May 1, 2009

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.
December 1, 2010

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.
December 1, 2010

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 25, 2009

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 26, 2009

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 27, 2009

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.
January 24, 2013

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.
January 15, 2013

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.
January 1, 2013

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.
  • CR015973
  • CARISNPP2003

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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