An Open-label follow-on Trial to Assess the Long-term Safety and Efficacy of Oral SPM 927 in Subjects With Diabetic Neuropathy

Phase 2

Completed

• Conditions: Painful Diabetic Neuropathy
• Interventions: Drug: SPM927/Lacosamide

• Registration Number: NCT00861042
• Lead Sponsor: UCB Pharma

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-04
• Primary Completion: 2004-12
• Study Completion: 2005-03
• Study First Submitted: 2009-03-12
• Study First Submitted QC: 2009-03-12
• Study First Posted: 2009-03-13
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-26
• Last Update Posted: 2024-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	SPM927/Lacosamide	-

Primary Outcome Measures

Name	Time	Method
Subject withdrawal due to adverse events	Assessments during whole course of the trial: spontaneously by the subject and observed by the investigators during site visits.
Assess the tolerability and safety of long-term SPM 927 administration in subjects with diabetic neuropathy	Assessments during whole course of the trial: spontaneously by the subject and observed by the investigators during site visits
Changes laboratory, ECG and vital signs parameters.	Assessments during whole course of the trial: spontaneously by the subject and observed by the investigators during site visits.
Changes in physical or neurological examination findings	Assessments during whole course of the trial: spontaneously by the subject and observed by the investigators during site visits.
Adverse events reported spontaneously by the subject or observed by the investigator	Assessments during whole course of the trial: spontaneously by the subject and observed by the investigators during site visits.

Secondary Outcome Measures

Name	Time	Method
The secondary objective is to gather further information on the efficacy of SPM 927 in this indication.	Daily assessment during entire trial participation including assessments at site visits
Within-subject change in average pain score: Daily assessments throughout the trial	Daily assessment during entire trial participation including assessments at site visits
Change in subject's perception of different neuropathic pain qualities during specific site visit	Daily assessment during entire trial participation including assessments at site visits
Time to exit (days) de to lack of efficacy of treatment	Daily assessment during entire trial participation including assessments at site visits
Change in subject's perception of sleep and activity throughout the trial, daily assessments	Daily assessment during entire trial participation including assessments at site visits
Patient's Global Impression of Change in Pain (PGIC) during specific site visit	Daily assessment during entire trial participation including assessments at site visits
Clinical Global Impression of Change in Pain (CGIC): Assessments during specific site visit	Daily assessment during entire trial participation including assessments at site visits
Quality of life assessments during specific site visits	Daily assessment during entire trial participation including assessments at site visits