Clinical trial NCT00861042: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Painful Diabetic Neuropathy
Keywords: Lacosamide, Vimpat®
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2009-03-13
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Assess the tolerability and safety of long-term SPM 927 administration in subjects with diabetic neuropathy
timeFrame: Assessments during whole course of the trial: spontaneously by the subject and observed by the investigators during site visits
measure: Adverse events reported spontaneously by the subject or observed by the investigator
timeFrame: Assessments during whole course of the trial: spontaneously by the subject and observed by the investigators during site visits.
measure: Changes laboratory, ECG and vital signs parameters.
timeFrame: Assessments during whole course of the trial: spontaneously by the subject and observed by the investigators during site visits.
measure: Changes in physical or neurological examination findings
timeFrame: Assessments during whole course of the trial: spontaneously by the subject and observed by the investigators during site visits.
measure: Subject withdrawal due to adverse events
timeFrame: Assessments during whole course of the trial: spontaneously by the subject and observed by the investigators during site visits.
Secondary outcomes:
measure: The secondary objective is to gather further information on the efficacy of SPM 927 in this indication.
timeFrame: Daily assessment during entire trial participation including assessments at site visits
measure: Within-subject change in average pain score: Daily assessments throughout the trial
timeFrame: Daily assessment during entire trial participation including assessments at site visits
measure: Change in subject's perception of different neuropathic pain qualities during specific site visit
timeFrame: Daily assessment during entire trial participation including assessments at site visits
measure: Time to exit (days) de to lack of efficacy of treatment
timeFrame: Daily assessment during entire trial participation including assessments at site visits
measure: Change in subject's perception of sleep and activity throughout the trial, daily assessments
timeFrame: Daily assessment during entire trial participation including assessments at site visits
measure: Patient's Global Impression of Change in Pain (PGIC) during specific site visit
timeFrame: Daily assessment during entire trial participation including assessments at site visits
measure: Clinical Global Impression of Change in Pain (CGIC): Assessments during specific site visit
timeFrame: Daily assessment during entire trial participation including assessments at site visits
measure: Quality of life assessments during specific site visits
timeFrame: Daily assessment during entire trial participation including assessments at site visits
Other outcomes:
Locations:
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
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.