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

NCT ID: NCT00861042

Last Updated: 2024-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-04-30
• Study Completion Date: 2005-03-31

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.

Conditions

Painful Diabetic Neuropathy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

SPM927/Lacosamide

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

SPM927 / Lacosamide / Vimpat®

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UCB Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

UCB

Principal Investigators

UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

+1 877 822 9493 (UCB)

References

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.

Reference Type: RESULT

PMID: 18619874 (View on PubMed)

Other Identifiers

SP0665

Identifier Type: -

Identifier Source: org_study_id