A Follow-On Trial to Assess the Long Term Safety and Efficacy of SPM 927 in Painful Distal Diabetic Neuropathy

Diabetic Neuropathy Clinical Trial

Official title:

A Multi-Center, Open-Label, Follow-On Trial to Assess the Long Term Safety and Efficacy of SPM 927 in Subjects With Painful Distal Diabetic Neuropathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00235443
• Other study ID #: SP0745
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: September 2004
• Est. completion date: July 2008

Study information

• Verified date: July 2017
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Phase 2/3 open-label trial to assess the safety and tolerability of long-term treatment with lacosamide (SPM 927) in subjects with painful diabetic neuropathy. The safety and tolerability of the different doses of lacosamide will be investigated.

Description:

This phase 2/3 open-label trial is being conducted at approximately 100 sites in the US to assess the safety and tolerability of long-term treatment with lacosamide (SPM 927) in subjects with painful diabetic neuropathy. Approximately 525 subjects will be enrolled. To qualify for this trial, subjects with symptoms of painful distal diabetic neuropathy ranging in duration from 6 months to 5 years must have completed trials SP665, SP742, or SP768 and, in the investigator's opinion, may benefit from long-term administration of lacosamide. Subjects will be titrated to their optimal dose of lacosamide (up to 600mg/day). The safety and tolerability of the different doses of lacosamide will be investigated throughout the trial. In addition, to determine what effect lacosamide has on diabetic neuropathic pain, subjects will use a diary to record their daily pain intensity and pain interference with sleep and activity. Subjects' quality of life will also be investigated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 451
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 32 Years to 81 Years

Eligibility

Inclusion Criteria:

• Subjects who completed Study SP665, SP742, or SP768 and, in the investigators opinion, might benefit from long-term administration of SPM 927. Exception: subjects who prematurely discontinued Study SP742 or SP768 due to lack of efficacy or due to intolerability to trial medication may be eligible to participate in Study SP745, after consultation with the medical monitor.

Exclusion Criteria:

• Subject has clinically relevant electrocardiogram (ECG) abnormalities, or QT-corrected (QTc) interval >=500 milliseconds (ms), and/or a QTc interval increase of >=60ms from the mean pre-dose QTc value at Visit 2 of Studies SP665, SP742 or SP768.

• Subject has aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >=3 times the upper limit of the normal range (ULN) with total bilirubin >=2 times ULN or transaminases (AST and/or ALT) >=5 times ULN.

• Subject has a clinically relevant medical condition that, in the opinion of the investigator, jeopardizes or compromises the subject's ability to participate in this trial.

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Neuropathy
• Peripheral Nervous System Diseases

Intervention

Drug:
• lacosamide
Open-label treatment (two times per day) with film-coated tablets include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, and 600mg/day throughout individual study period.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects With Adverse Events (AEs) Reported Spontaneously by the Subject or Observed by the Investigator.	Number of subjects with adverse events (AEs) reported spontaneously by the subject or observed by the investigator (serious and non-serious).	Throughout the study up to a maximum study period of 2.8 years
Secondary	Change From Baseline in Average Daily Pain Score Using an 11-point Likert Scale (0-10).	Change from Baseline in average daily pain score using an 11-point Likert scale (0-10). On Likert scale, 0=no pain and 10=worst possible pain.	Baseline to end of entire treatment phase (maximum study period of 2.8 years).
Secondary	Change From Baseline in Average Pain Score as Measured by a 100mm Visual Analogue Scale (VAS).	Change from Baseline in average pain score as measured by a 100mm Visual Analogue Scale (VAS). On VAS 0mm=no pain and 100mm=worst possible pain.	Baseline to end of entire treatment phase (maximum study period of 2.8 years).
Secondary	Patient's Global Impression of Change (PGIC) From Baseline in Pain.	Patient's Global Impression of Change (PGIC) from Baseline in Pain. Original categorical responses are much worse, moderately worse, mildly worst, no change, mildly better, moderately better, and much better. Reported results are presented as Better (sum of mildly, moderately, or much better), No Change, or Worse (sum of mildly, moderately, or much worse).	Baseline to Termination Visit
Secondary	Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Intensity.	Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) for intensity of pain where 0=no pain and 10=most intense pain sensation imaginable.	Baseline to Termination Visit
Secondary	Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Sharpness	Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) for sharpness of pain where 0=not sharp and 10=most sharp sensation imaginable ("like a knife").	Baseline to Termination Visit
Secondary	Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Heat	Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with heat sensation where 0=not hot and 10=the most hot sensation imaginable ("on fire").	Baseline to Termination Visit
Secondary	Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Dullness	Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with dullness of pain where 0=not dull and 10=most dull sensation imaginable.	Baseline to Termination Visit
Secondary	Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Cold	Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with cold sensation where 0=not cold and 10=most cold sensation imaginable ("freezing").	Baseline to Termination Visit
Secondary	Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Sensitivity	Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with sensitivity of pain where 0=not sensitive and 10=most sensitive sensation imaginable ("raw skin").	Baseline to Termination Visit
Secondary	Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Itchiness	Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with itchiness where 0=not itchy and 10=most itchy sensation imaginable ("like poison oak").	Baseline to Termination Visit
Secondary	Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Unpleasantness	Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with unpleasantness where 0=not pleasant and 10=most unpleasant sensation imaginable ("intolerable").	Baseline to Termination Visit
Secondary	Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Deep Pain	Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with deep pain where 0=no deep pain and 10=most intense deep pain sensation imaginable.	Baseline to Termination Visit
Secondary	Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Surface Pain	Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with surface pain where 0=no surface pain and 10=most intense surface pain imaginable.	Baseline to Termination Visit
Secondary	Change From Baseline in Average Pain Interference With Sleep (11-point Likert Scale)	Change from Baseline in average pain interference with sleep (11-point Likert scale) where 0=no interference with sleep and 10=worst possible interference with sleep.	Baseline to end of entire treatment phase visit
Secondary	Change From Baseline in Average Pain Interference With Activity (11-point Likert Scale)	Change from Baseline in average pain interference with activity (11-point Likert scale) where 0=no interfence with activity and 10=worst possible interference with activity.	Baseline to end of entire treatment phase visit
Secondary	Change From Baseline in Quality of Life Using the SF-36 Health Survey - Physical Component Summary (PCS)	Change from Baseline in quality of life using the SF-36 Health Survey - Physical Component Summary (PCS). Values range from 0 to 100 with high values indicating a good condition. Positive change in baseline values indicate improvement in quality of life.	Baseline to Termination Visit
Secondary	Change From Baseline in Quality of Life Using the SF-36 Health Survey - Mental Component Summary (MCS)	Change from Baseline in quality of life using the SF-36 Health Survey - Mental Component Summary (MCS). Values range from 0 to 100 with high values indicating a good condition. Positive change in baseline values indicate improvement in quality of life.	Baseline to Termination Visit

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