Back to resultsA Trial to Investigate Safety and Efficacy of SPM927 in Painful Diabetic Neuropathy
Primary Purpose
Painful Diabetic Neuropathy
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
SPM927/Lacosamide
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Painful Diabetic Neuropathy focused on measuring Lacosamide, Vimpat®
Eligibility Criteria
Inclusion Criteria:
- Subject has clinically diagnosed pain attributed to diabetic distal sensory motor polyneuropathy for 1-5 years and a diagnosis of diabetes mellitus (Type I or Type II).
- Subjects must have at least moderate pain (mean pain intensity ≥ 4 out of 10 during the baseline week on Likert scale).
- subjects must have good or fair diabetic control (Hgb A1c < 10%)
Exclusion Criteria:
- Subject has other conditions that cause neuropathic pain at least as severe as the diabetic pain i.e. peripheral arterio-vascular disease.
- Subject receives treatment for seizures.
- Subject has had any amputations other than diabetically-related toe amputations.
- Subject has major skin ulcers.
- Subject has clinically significant ECG abnormalities.
- Subject is expected to take within 7 days prior to randomization and during the study: TCAs, mexiletine hydrochloride, lidoderm patch, tramadol, AEDs, dextromethorphan, opioids, capsaicin, nonsteroidal anti-inflammatory drugs, acetaminophen / paracetamol, skeletal muscle relaxants, benzodiazepines, alpha-2-agonists (e.g. clonidine), drugs indicated for sleep disturbance (e. g. zolpidem tartrate, zaleplon) and over-the-counter medications with centrally acting properties.
- Subject has laboratory values which are outside the normal range and judged by the investigator to be clinically significant.
- At study entry, subject has liver function tests values (AST, ALT,alkaline phosphatase, total bilirubin and GGT) 2 times upper limit of normal.
- subject has impaired renal function, i.e., creatinine clearance is lower than 60 mL/min.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
The primary objective of this trial is to evaluate the efficacy of SPM 927 in reducing pain in subjects with diabetic distal sensory polyneuropathy
Secondary Outcome Measures
Different qualities of neuropathic pain, sleep and activity (daily assessment during entire trial participation)
Quality of Life and the Profile of Mood States (assessment at site visits during entire trial participation)
Investigate the tolerability and safety of SPM927 (assessment during entire trial participation)
Examine the pharmacokinetics of SPM927 (assessment at all site visits during entire trial participation)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00861445
Brief Title
A Trial to Investigate Safety and Efficacy of SPM927 in Painful Diabetic Neuropathy
Official Title
A Randomized, Double-Blind Placebo Controlled Trial to Investigate Safety and Efficacy of SPM927 in Painful Diabetic Neuropathy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
June 2001 (undefined)
Primary Completion Date
January 2003 (Actual)
Study Completion Date
February 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
UCB Pharma
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The primary purpose is to investigate the safety and efficacy of SPM927 in patients with Painful Diabetic Neuropathy
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Painful Diabetic Neuropathy
Keywords
Lacosamide, Vimpat®
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
119 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
SPM927/Lacosamide
Intervention Description
SPM927 (film-coated tablets, 25/50/100mg per tablet), dosage 400mg/day, intake in the morning and in the evening, intake for 10 weeks
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
SPM927, Lacosamide, Vimpat®
Intervention Description
Placebo tablets two times a day for 10 weeks
Primary Outcome Measure Information:
Title
The primary objective of this trial is to evaluate the efficacy of SPM 927 in reducing pain in subjects with diabetic distal sensory polyneuropathy
Time Frame
Assessments throughout the trial, either daily and/or at clinic visits
Secondary Outcome Measure Information:
Title
Different qualities of neuropathic pain, sleep and activity (daily assessment during entire trial participation)
Time Frame
Daily assessment during entire trial participation including visits at the site
Title
Quality of Life and the Profile of Mood States (assessment at site visits during entire trial participation)
Time Frame
Daily assessment during entire trial participation including visits at the site
Title
Investigate the tolerability and safety of SPM927 (assessment during entire trial participation)
Time Frame
Daily assessment during entire trial participation including visits at the site
Title
Examine the pharmacokinetics of SPM927 (assessment at all site visits during entire trial participation)
Time Frame
Daily assessment during entire trial participation including visits at the site
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject has clinically diagnosed pain attributed to diabetic distal sensory motor polyneuropathy for 1-5 years and a diagnosis of diabetes mellitus (Type I or Type II).
Subjects must have at least moderate pain (mean pain intensity ≥ 4 out of 10 during the baseline week on Likert scale).
subjects must have good or fair diabetic control (Hgb A1c < 10%)
Exclusion Criteria:
Subject has other conditions that cause neuropathic pain at least as severe as the diabetic pain i.e. peripheral arterio-vascular disease.
Subject receives treatment for seizures.
Subject has had any amputations other than diabetically-related toe amputations.
Subject has major skin ulcers.
Subject has clinically significant ECG abnormalities.
Subject is expected to take within 7 days prior to randomization and during the study: TCAs, mexiletine hydrochloride, lidoderm patch, tramadol, AEDs, dextromethorphan, opioids, capsaicin, nonsteroidal anti-inflammatory drugs, acetaminophen / paracetamol, skeletal muscle relaxants, benzodiazepines, alpha-2-agonists (e.g. clonidine), drugs indicated for sleep disturbance (e. g. zolpidem tartrate, zaleplon) and over-the-counter medications with centrally acting properties.
Subject has laboratory values which are outside the normal range and judged by the investigator to be clinically significant.
At study entry, subject has liver function tests values (AST, ALT,alkaline phosphatase, total bilirubin and GGT) 2 times upper limit of normal.
subject has impaired renal function, i.e., creatinine clearance is lower than 60 mL/min.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
+1 877 822 9493 (UCB)
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
17237664
Citation
Rauck RL, Shaibani A, Biton V, Simpson J, Koch B. Lacosamide in painful diabetic peripheral neuropathy: a phase 2 double-blind placebo-controlled study. Clin J Pain. 2007 Feb;23(2):150-8. doi: 10.1097/01.ajp.0000210957.39621.b2.
Results Reference
result
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A Trial to Investigate Safety and Efficacy of SPM927 in Painful Diabetic Neuropathy
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