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

NCT00861042 | Completed Phase 2

• 1 other identifier: SP0665
• Study Type: interventional
• Target: 69
• Locations: 0 countries
• Sites: N/A

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

Keywords

Lacosamide, Vimpat®

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (8)

• 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

Study Arms (1)

1

EXPERIMENTAL

Drug: SPM927/Lacosamide

Interventions

SPM927/Lacosamide 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

Also known as: SPM927 / Lacosamide / Vimpat®

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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% ).

You may not qualify if:

• 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.

Sponsors & Collaborators

• UCB Pharma: lead

Related Publications (1)

• 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.

  PMID: 18619874 RESULT

MeSH Terms

Conditions

Diabetic Neuropathies

Interventions

2-(acetylamino)-3-methoxy-N-(phenylmethyl)-, (2R)-; Lacosamide

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids

Study Officials

• UCB Clinical Trial Call Center

  +1 877 822 9493 (UCB)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 12, 2009
• First Posted: March 13, 2009
• Study Start: April 1, 2002
• Primary Completion: December 1, 2004
• Study Completion: March 1, 2005
• Last Updated: January 29, 2024

Record last verified: 2024-01