Trial record 1 of 1 for:    NCT00235443
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A Follow-On Trial to Assess the Long Term Safety and Efficacy of SPM 927 in Painful Distal Diabetic Neuropathy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT00235443
First received: October 6, 2005
Last updated: September 19, 2011
Last verified: September 2011
Results First Received: August 31, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Diabetic Neuropathy
Intervention: Drug: lacosamide

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Trial SP745 (NCT00235443) was conducted in 93 sites in the US and 89 of these sites screened at least 1 subject. The first subject was enrolled on 13Sep2004 and the last subject completed on 25Jul2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Lacosamide 100mg/Day Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Lacosamide 200mg/Day Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Lacosamide 300mg/Day Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Lacosamide 400mg/Day Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Lacosamide 500mg/Day Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Lacosamide 600mg/Day Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day

Participant Flow:   Overall Study
    Lacosamide 100mg/Day     Lacosamide 200mg/Day     Lacosamide 300mg/Day     Lacosamide 400mg/Day     Lacosamide 500mg/Day     Lacosamide 600mg/Day  
STARTED     11     57     85     205     39     54  
COMPLETED     3     19     23     108     9     9  
NOT COMPLETED     8     38     62     97     30     45  
Adverse Event                 4                 12                 17                 44                 10                 15  
Lack of Efficacy                 0                 1                 5                 12                 2                 9  
Withdrawal by Subject                 3                 9                 25                 24                 10                 12  
Lost to Follow-up                 0                 8                 6                 6                 4                 3  
Unsatisfactory compliance                 0                 2                 3                 4                 1                 0  
Other reasons for premature termination                 1                 6                 6                 7                 3                 6  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Lacosamide 100mg/Day Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Lacosamide 200mg/Day Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Lacosamide 300mg/Day Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Lacosamide 400mg/Day Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Lacosamide 500mg/Day Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Lacosamide 600mg/Day Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Total Total of all reporting groups

Baseline Measures
    Lacosamide 100mg/Day     Lacosamide 200mg/Day     Lacosamide 300mg/Day     Lacosamide 400mg/Day     Lacosamide 500mg/Day     Lacosamide 600mg/Day     Total  
Number of Participants  
[units: participants]
  11     57     85     205     39     54     451  
Age  
[units: participants]
             
<=18 years     0     0     0     0     0     0     0  
Between 18 and 65 years     6     38     61     160     30     44     339  
>=65 years     5     19     24     45     9     10     112  
Age  
[units: years]
Mean ± Standard Deviation
  64.0  ± 8.16     59.3  ± 10.53     60.5  ± 8.55     57.3  ± 9.43     56.9  ± 9.52     55.5  ± 10.10     58.1  ± 9.60  
Gender  
[units: participants]
             
Female     5     33     48     80     16     18     200  
Male     6     24     37     125     23     36     251  
Region of Enrollment  
[units: participants]
             
United States     11     57     85     205     39     54     451  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Subjects With Adverse Events (AEs) Reported Spontaneously by the Subject or Observed by the Investigator.   [ Time Frame: Throughout the study up to a maximum study period of 2.8 years ]

2.  Secondary:   Change From Baseline in Average Daily Pain Score Using an 11-point Likert Scale (0-10).   [ Time Frame: Baseline to end of entire treatment phase (maximum study period of 2.8 years). ]

3.  Secondary:   Change From Baseline in Average Pain Score as Measured by a 100mm Visual Analogue Scale (VAS).   [ Time Frame: Baseline to end of entire treatment phase (maximum study period of 2.8 years). ]

4.  Secondary:   Patient’s Global Impression of Change (PGIC) From Baseline in Pain.   [ Time Frame: Baseline to Termination Visit ]

5.  Secondary:   Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Intensity.   [ Time Frame: Baseline to Termination Visit ]

6.  Secondary:   Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Sharpness   [ Time Frame: Baseline to Termination Visit ]

7.  Secondary:   Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Heat   [ Time Frame: Baseline to Termination Visit ]

8.  Secondary:   Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Dullness   [ Time Frame: Baseline to Termination Visit ]

9.  Secondary:   Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Cold   [ Time Frame: Baseline to Termination Visit ]

10.  Secondary:   Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Sensitivity   [ Time Frame: Baseline to Termination Visit ]

11.  Secondary:   Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Itchiness   [ Time Frame: Baseline to Termination Visit ]

12.  Secondary:   Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Unpleasantness   [ Time Frame: Baseline to Termination Visit ]

13.  Secondary:   Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Deep Pain   [ Time Frame: Baseline to Termination Visit ]

14.  Secondary:   Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Surface Pain   [ Time Frame: Baseline to Termination Visit ]

15.  Secondary:   Change From Baseline in Average Pain Interference With Sleep (11-point Likert Scale)   [ Time Frame: Baseline to end of entire treatment phase visit ]

16.  Secondary:   Change From Baseline in Average Pain Interference With Activity (11-point Likert Scale)   [ Time Frame: Baseline to end of entire treatment phase visit ]

17.  Secondary:   Change From Baseline in Quality of Life Using the SF-36 Health Survey - Physical Component Summary (PCS)   [ Time Frame: Baseline to Termination Visit ]

18.  Secondary:   Change From Baseline in Quality of Life Using the SF-36 Health Survey – Mental Component Summary (MCS)   [ Time Frame: Baseline to Termination Visit ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: UCB Clinical Trial Call Center
Organization: UCB Pharma
phone: +1 877 822 9493


No publications provided by UCB Pharma

Publications automatically indexed to this study:

Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00235443     History of Changes
Other Study ID Numbers: SP745
Study First Received: October 6, 2005
Results First Received: August 31, 2009
Last Updated: September 19, 2011
Health Authority: United States: Food and Drug Administration