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Study Evaluating Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Distal Diabetic Neuropathy.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00546351
First received: October 16, 2007
Last updated: March 26, 2012
Last verified: March 2012
History of Changes
Results First Received: December 21, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Painful 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
The study started in May 2004 with subjects from Austria, Belgium, Bulgaria, Czech Republic, Finland, France, Germany, Hungary, Italy, Poland, Romania, Russia, Serbia, Spain, and United Kingdom. The primary completion date occurred in January 2011, with study completion in January 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participant Flow and Baseline Characteristics refer to the Safety Set (SS).

Reporting Groups
  Description
Lacosamide 50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.

Participant Flow:   Overall Study
    Lacosamide  
STARTED     621  
COMPLETED     385  
NOT COMPLETED     236  
Adverse Event                 76  
Lack of Efficacy                 15  
Withdrawal by Subject                 109  
Lost to Follow-up                 9  
Protocol Deviation                 1  
Unsatisfactory compliance                 9  
Other reasons for premature termination                 17  



  Baseline Characteristics
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Reporting Groups
  Description
Lacosamide 50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.

Baseline Measures
    Lacosamide  
Number of Participants  
[units: participants]
 		  621  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     500  
>=65 years     121  
Age  
[units: years]
Mean ± Standard Deviation 		  56.8  ± 9.51  
Gender  
[units: participants]
 		 
Female     296  
Male     325  
Region of Enrollment  
[units: participants]
 		 
Serbia     54  
Finland     1  
Spain     2  
Austria     9  
Russian Federation     30  
United Kingdom     19  
Italy     7  
France     6  
Czech Republic     57  
Hungary     76  
Belgium     19  
Poland     101  
Romania     61  
Bulgaria     62  
Germany     117  



  Outcome Measures
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1.  Primary:   Number of Participants Experiencing the Occurrence of at Least One Treatment-emergent Adverse Event (TEAE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (Approximately 6.5 Years).   [ Time Frame: From entry Visit 1 through end of treatment (approximately 6.5 years) ]
  Show Outcome Measure 1

2.  Primary:   Number of Participants Experiencing the Occurrence of at Least One Serious Adverse Event (SAE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (Approximately 6.5 Years).   [ Time Frame: From entry Visit 1 through end of treatment (approximately 6.5 years) ]
  Show Outcome Measure 2

3.  Secondary:   Average Daily Pain Score Using an 11-point Likert Scale (0-10) at Baseline Visit.   [ Time Frame: Baseline ]
  Show Outcome Measure 3

4.  Secondary:   Average Daily Pain Score Using an 11-point Likert Scale (0-10) at Last Visit.   [ Time Frame: Last Visit (approximately 2 years) ]
  Show Outcome Measure 4

5.  Secondary:   Average Pain Score as Measured by a 100 mm Visual Analog Scale (VAS) at Baseline.   [ Time Frame: Baseline ]
  Show Outcome Measure 5

6.  Secondary:   Average Pain Score as Measured by a 100 mm Visual Analogue Scale (VAS) at Last Visit.   [ Time Frame: Last Visit (approximately 2 years) ]
  Show Outcome Measure 6

7.  Secondary:   Patient’s Global Impression of Change (PGIC) at Last Visit.   [ Time Frame: Last Visit (approximately 2 years) ]
  Show Outcome Measure 7

8.  Secondary:   Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Intensity at Last Visit.   [ Time Frame: Baseline Visit; Last Visit (approximately 2 years) ]
  Show Outcome Measure 8

9.  Secondary:   Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Sharpness at Last Visit.   [ Time Frame: Baseline Visit; Last Visit (approximately 2 years) ]
  Show Outcome Measure 9

10.  Secondary:   Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Heat at Last Visit.   [ Time Frame: Baseline Visit; Last Visit (approximately 2 years) ]
  Show Outcome Measure 10

11.  Secondary:   Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Cold at Last Visit.   [ Time Frame: Baseline Visit; Last Visit (approximately 2 years) ]
  Show Outcome Measure 11

12.  Secondary:   Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Dullness at Last Visit.   [ Time Frame: Baseline Visit; Last Visit (approximately 2 years) ]
  Show Outcome Measure 12

13.  Secondary:   Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Unpleasantness at Final Visit.   [ Time Frame: Baseline Visit; Last Visit (approximately 2 years) ]
  Show Outcome Measure 13

14.  Secondary:   Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Surface Pain at Last Visit.   [ Time Frame: Baseline Visit; Last Visit (approximately 2 years) ]
  Show Outcome Measure 14

15.  Secondary:   Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Deep Pain at Last Visit.   [ Time Frame: Baseline Visit; Last Visit (approximately 2 years) ]
  Show Outcome Measure 15

16.  Secondary:   Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Itchiness at Final Visit.   [ Time Frame: Baseline Visit; Last Visit (approximately 2 years) ]
  Show Outcome Measure 16

17.  Secondary:   Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Sensitivity at Last Visit.   [ Time Frame: Baseline Visit; Last Visit (approximately 2 years) ]
  Show Outcome Measure 17

18.  Secondary:   Average Pain Interference With Sleep (11-point Likert Scale) at Baseline.   [ Time Frame: Baseline ]
  Show Outcome Measure 18

19.  Secondary:   Average Pain Interference With Sleep (11-point Likert Scale) at Last Visit.   [ Time Frame: Last Visit ]
  Show Outcome Measure 19

20.  Secondary:   Average Pain Interference With Activity (11-point Likert Scale) at Baseline.   [ Time Frame: Baseline ]
  Show Outcome Measure 20

21.  Secondary:   Average Pain Interference With Activity (11-point Likert Scale) at Last Visit.   [ Time Frame: Last Visit ]
  Show Outcome Measure 21

22.  Secondary:   Average Quality of Life Using the SF-36 Health Survey – Physical Component Summary (PCS) at Baseline.   [ Time Frame: Baseline ]
  Show Outcome Measure 22

23.  Secondary:   Average Quality of Life Using the SF-36 Health Survey – Physical Component Summary (PCS) at Last Visit.   [ Time Frame: Last Visit ]
  Show Outcome Measure 23

24.  Secondary:   Average Quality of Life Using the SF-36 Health Survey – Mental Component Summary (MCS) at Baseline.   [ Time Frame: Baseline ]
  Hide Outcome Measure 24

Measure Type Secondary
Measure Title Average Quality of Life Using the SF-36 Health Survey – Mental Component Summary (MCS) at Baseline.
Measure Description The SF-36 Health Survey measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS = physical functioning, role-physical, bodily pain, and general health; MCS = vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0 = worst score (or quality of life) and 100 = best score.
Time Frame Baseline  
Safety Issue No  

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.

Of the 621 subjects in the Safety Set (SS), 588 are included in this analysis.

Data was not available for 33 subjects at the time of this measurement.

Reporting Groups
  Description
Lacosamide 50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.

Measured Values
    Lacosamide  
Number of Participants Analyzed  
[units: participants]
 		  588  
Average Quality of Life Using the SF-36 Health Survey – Mental Component Summary (MCS) at Baseline.  
[units: units on a scale]
Mean ± Standard Deviation 		  42.8  ± 11.04  

No statistical analysis provided for Average Quality of Life Using the SF-36 Health Survey – Mental Component Summary (MCS) at Baseline.



25.  Secondary:   Average Quality of Life Using the SF-36 Health Survey – Mental Component Summary (MCS) at Last Visit.   [ Time Frame: Last Visit ]
  Show Outcome Measure 25


  Serious Adverse Events
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  Other Adverse Events
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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.


Limitations and Caveats
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
No text entered.  


Results Point of Contact:  
Name/Title: UCB (Study Director)
Organization: UCB Clinical Trial Call Center
phone: 1-887-822-9493


No publications provided


Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT00546351     History of Changes
Other Study ID Numbers: SP746, 2004-000551-42
Study First Received: October 16, 2007
Results First Received: December 21, 2011
Last Updated: March 26, 2012
Health Authority: Austria: Agency for Health and Food Safety
Belgium: Directorate general for the protection of Public health: Medicines
Bulgaria: Ministry of Health
Czech Republic: State Institute for Drug Control
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Paul-Ehrlich-Institut
Hungary: National Institute of Pharmacy
Italy: Ministry of Health
Poland: Ministry of Health
Romania: National Medicines Agency
Russia: Ministry of Health of the Russian Federation
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Spain: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency