- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00870454
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
386
Phase
- 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
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 |
Intervention / Treatment |
---|---|
Experimental: 001
Carisbamate 800 mg/d 200 mg/d twice daily titrated up to 400 mg twice daily as tolerated by Week 3
|
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
|
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
|
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
|
Placebo capsules twice daily
|
What is the study measuring?
Primary Outcome Measures
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
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
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
May 1, 2009
Primary Completion (Actual)
December 1, 2010
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
March 25, 2009
First Submitted That Met QC Criteria
March 26, 2009
First Posted (Estimate)
March 27, 2009
Study Record Updates
Last Update Posted (Estimate)
January 24, 2013
Last Update Submitted That Met QC Criteria
January 15, 2013
Last Verified
January 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Endocrine System Diseases
- Diabetes Complications
- Diabetes Mellitus
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Diabetic Neuropathies
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Membrane Transport Modulators
- Anti-Anxiety Agents
- Anticonvulsants
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Pregabalin
Other Study ID 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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