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

The primary objective of the trial is to assess the tolerability and safety of long-term SPM 927 administration in subjects with diabetic neuropathy.

Study Overview

• Status: Completed
• Conditions: Painful Diabetic Neuropathy
• Intervention / Treatment: Drug: SPM927/Lacosamide

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 1

Drug: SPM927/Lacosamide; 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; Other Names: SPM927 / Lacosamide / Vimpat®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
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.
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.
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.

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: UCB Pharma
• Investigators: Study Director: UCB Clinical Trial Call Center, +1 877 822 9493 (UCB)

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2002
• Primary Completion (Actual): December 1, 2004
• Study Completion (Actual): March 1, 2005

Study Registration Dates

• First Submitted: March 12, 2009
• First Submitted That Met QC Criteria: March 12, 2009
• First Posted (Estimated): March 13, 2009

Study Record Updates

• Last Update Posted (Estimated): January 29, 2024
• Last Update Submitted That Met QC Criteria: January 26, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Lacosamide, Vimpat®
• Additional Relevant MeSH Terms: Nervous System Diseases; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Neuromuscular Diseases; Peripheral Nervous System Diseases; Diabetic Neuropathies; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Anticonvulsants; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lacosamide
• Other Study ID Numbers: SP0665