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

NCT00870454 | Completed Phase 2

• 2 other identifiers: CR015973CARISNPP2003
• Study Type: interventional
• Target: 386
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Diabetic Neuropathies

Keywords

Diabetic neuropathies; Diabetic neuropathy, painful; Carisbamate; Neurotherapeutic agents

Outcome Measures

Primary Outcomes (1)

• Mean of the last 7 daily average diabetic peripheral neuropathy (DPN) pain scores

  Through 15 weeks

Secondary Outcomes (5)

• 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.

  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.

  Through 15 weeks

• Responder rates (50% and 30% reduction from baseline in the mean of the last 7 daily average DPN pain scores).

  Through 15 weeks

• The mean of the last 7 daily maximum DPN pain scores.

  Through 15 weeks

• The mean of the last 7 Daily Sleep Interference scores.

  Through 15 weeks

Study Arms (4)

001

EXPERIMENTAL

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

002

EXPERIMENTAL

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

003

ACTIVE COMPARATOR

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

004

PLACEBO COMPARATOR

Placebo Placebo capsules twice daily

Drug: Placebo

Interventions

Pregabalin 300 mg/d DRUG

75 mg/d twice daily for Week 1, followed by 150 mg twice daily for the remainder

003

Carisbamate 800 mg/d DRUG

200 mg/d twice daily, titrated up to 400 mg twice daily, as tolerated, by Week 3

001

Carisbamate 1,200 mg/d DRUG

200 mg/d twice daily, titrated up to 600 mg twice daily, as tolerated, by Week 3

002

Placebo DRUG

Placebo capsules twice daily

004

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• SK Life Science, Inc.: lead

MeSH Terms

Conditions

Diabetic Neuropathies

Interventions

Pregabalin; S-2-O-carbamoyl-1-o-chlorophenyl-ethanol

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2009
• First Posted: March 27, 2009
• Study Start: May 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: January 24, 2013

Record last verified: 2013-01