Back to resultsAn Open-label follow-on Trial to Assess the Long-term Safety and Efficacy of Oral SPM 927 in Subjects With Diabetic Neuropathy
Primary Purpose
Painful Diabetic Neuropathy
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
SPM927/Lacosamide
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 successfully completed a previous trial with SPM 927 in diabetic neuropathy and, in the investigator's opinion, would benefit from long-term administration of SPM 927.
- Subject has stable, good or fair diabetic control (HbA1c ≤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 an amputation related to diabetes, other than toe amputation.
- Subject has major skin ulcers.
- Subject has clinically significant ECG abnormalities.
- Subject expects to take during the study: TCAs, mexiletine hydrochloride, lidoderm patch, tramadol, AEDs, dextromethorphan, opioids, capsaicin, skeletal muscle relaxants, benzodiazepines or 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.
- Subject has liver function tests (AST, ALT, alkaline phosphatase, total bilirubin, or GGT) ≥ 2x ULN at Visit 1.
- At Visit 1, subject has impaired renal function, i.e., creatinine clearance (ClCr) is lower than 60 mL/min.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Assess the tolerability and safety of long-term SPM 927 administration in subjects with diabetic neuropathy
Adverse events reported spontaneously by the subject or observed by the investigator
Changes laboratory, ECG and vital signs parameters.
Changes in physical or neurological examination findings
Subject withdrawal due to adverse events
Secondary Outcome Measures
The secondary objective is to gather further information on the efficacy of SPM 927 in this indication.
Within-subject change in average pain score: Daily assessments throughout the trial
Change in subject's perception of different neuropathic pain qualities during specific site visit
Time to exit (days) de to lack of efficacy of treatment
Change in subject's perception of sleep and activity throughout the trial, daily assessments
Patient's Global Impression of Change in Pain (PGIC) during specific site visit
Clinical Global Impression of Change in Pain (CGIC): Assessments during specific site visit
Quality of life assessments during specific site visits
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00861042
Brief Title
An Open-label follow-on Trial to Assess the Long-term Safety and Efficacy of Oral SPM 927 in Subjects With Diabetic Neuropathy
Official Title
An Open-label follow-on Trial to Assess the Long-term Safety and Efficacy of Oral SPM 927 in Subjects With Diabetic Neuropathy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
December 2004 (Actual)
Study Completion Date
March 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
UCB Pharma
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary objective of the trial is to assess the tolerability and safety of long-term SPM 927 administration in subjects with 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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
69 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
SPM927/Lacosamide
Other Intervention Name(s)
SPM927 / Lacosamide / Vimpat®
Intervention Description
SPM927 (film-coated tablets, 25/50/100mg per tablet), dosage up to 400mg/day, intake in the morning and in the evening; duration of intake depending on individual trial participation SPM927 (film-coated tablets, 25/50/100mg per tablet), dosage up to 400mg/day, intake in the morning and in the evening; duration of intake depending on individual trial participation
Primary Outcome Measure Information:
Title
Assess the tolerability and safety of long-term SPM 927 administration in subjects with diabetic neuropathy
Time Frame
Assessments during whole course of the trial: spontaneously by the subject and observed by the investigators during site visits
Title
Adverse events reported spontaneously by the subject or observed by the investigator
Time Frame
Assessments during whole course of the trial: spontaneously by the subject and observed by the investigators during site visits.
Title
Changes laboratory, ECG and vital signs parameters.
Time Frame
Assessments during whole course of the trial: spontaneously by the subject and observed by the investigators during site visits.
Title
Changes in physical or neurological examination findings
Time Frame
Assessments during whole course of the trial: spontaneously by the subject and observed by the investigators during site visits.
Title
Subject withdrawal due to adverse events
Time Frame
Assessments during whole course of the trial: spontaneously by the subject and observed by the investigators during site visits.
Secondary Outcome Measure Information:
Title
The secondary objective is to gather further information on the efficacy of SPM 927 in this indication.
Time Frame
Daily assessment during entire trial participation including assessments at site visits
Title
Within-subject change in average pain score: Daily assessments throughout the trial
Time Frame
Daily assessment during entire trial participation including assessments at site visits
Title
Change in subject's perception of different neuropathic pain qualities during specific site visit
Time Frame
Daily assessment during entire trial participation including assessments at site visits
Title
Time to exit (days) de to lack of efficacy of treatment
Time Frame
Daily assessment during entire trial participation including assessments at site visits
Title
Change in subject's perception of sleep and activity throughout the trial, daily assessments
Time Frame
Daily assessment during entire trial participation including assessments at site visits
Title
Patient's Global Impression of Change in Pain (PGIC) during specific site visit
Time Frame
Daily assessment during entire trial participation including assessments at site visits
Title
Clinical Global Impression of Change in Pain (CGIC): Assessments during specific site visit
Time Frame
Daily assessment during entire trial participation including assessments at site visits
Title
Quality of life assessments during specific site visits
Time Frame
Daily assessment during entire trial participation including assessments at site visits
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject has successfully completed a previous trial with SPM 927 in diabetic neuropathy and, in the investigator's opinion, would benefit from long-term administration of SPM 927.
Subject has stable, good or fair diabetic control (HbA1c ≤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 an amputation related to diabetes, other than toe amputation.
Subject has major skin ulcers.
Subject has clinically significant ECG abnormalities.
Subject expects to take during the study: TCAs, mexiletine hydrochloride, lidoderm patch, tramadol, AEDs, dextromethorphan, opioids, capsaicin, skeletal muscle relaxants, benzodiazepines or 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.
Subject has liver function tests (AST, ALT, alkaline phosphatase, total bilirubin, or GGT) ≥ 2x ULN at Visit 1.
At Visit 1, subject has impaired renal function, i.e., creatinine clearance (ClCr) 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
18619874
Citation
Shaibani A, Biton V, Rauck R, Koch B, Simpson J. Long-term oral lacosamide in painful diabetic neuropathy: a two-year open-label extension trial. Eur J Pain. 2009 May;13(5):458-63. doi: 10.1016/j.ejpain.2008.05.016. Epub 2008 Jul 10.
Results Reference
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An Open-label follow-on Trial to Assess the Long-term Safety and Efficacy of Oral SPM 927 in Subjects With Diabetic Neuropathy
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