Clinical trial

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

Name

SP0665

Description

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

Trial arms

Trial start

2002-04-01

Estimated PCD

2004-12-01

Trial end

2005-03-01

Status

Completed

Phase

Early phase I

Treatment

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

Arms:

Other names:

SPM927 / Lacosamide / Vimpat®

Size

Primary endpoint

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.

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 69, 'type': 'ACTUAL'}}

Updated at

2024-01-29

1 organization

1 product

1 indication

Organization

UCB Pharma

Product

SPM927/Lacosamide

Indication

Painful Diabetic Neuropathy