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

UCB

Status and phase

Completed

Phase 2

Conditions

Painful Diabetic Neuropathy

Treatments

Drug: SPM927/Lacosamide

Study type

Interventional

Funder types

Industry

Identifiers

SP0665

Details and patient eligibility

About

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

Enrollment

69 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.