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

Painful Diabetic Neuropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00861042
• Other study ID #: SP0665
• Status: Completed
• Phase: Phase 2
• Start date: April 2002
• Est. completion date: March 2005

Study information

• Verified date: January 2024
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: March 2005
• Est. primary completion date: December 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Painful Diabetic Neuropathy

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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.
Primary	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.
Primary	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.
Primary	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	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
Secondary	Within-subject change in average pain score: Daily assessments throughout the trial		Daily assessment during entire trial participation including assessments at site visits
Secondary	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
Secondary	Time to exit (days) de to lack of efficacy of treatment		Daily assessment during entire trial participation including assessments at site visits
Secondary	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
Secondary	Patient's Global Impression of Change in Pain (PGIC) during specific site visit		Daily assessment during entire trial participation including assessments at site visits
Secondary	Clinical Global Impression of Change in Pain (CGIC): Assessments during specific site visit		Daily assessment during entire trial participation including assessments at site visits
Secondary	Quality of life assessments during specific site visits		Daily assessment during entire trial participation including assessments at site visits