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An Open-label Continuation Trial to Assess the Continued Efficacy and Safety of Ascending Doses of Lacosamide in Subjects With Chronic Refractory Neuropathic Pain

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ClinicalTrials.gov Identifier: NCT00237458
Recruitment Status : Completed
First Posted : October 12, 2005
Results First Posted : May 15, 2012
Last Update Posted : August 28, 2017
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Chronic Refractory Neuropathic Pain
Intervention: Drug: Lacosamide

  Participant Flow

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 2001 with subjects from Germany. The primary completion date and study completion date occurred in March 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One subject was discontinued on the study due to the Adverse Event of Vertigo. However, the Termination page of the Case Report Form reflected that the subject withdrew consent. Therefore, the Participant Flow will reflect 3 subjects did not complete the study, while the subjects withdrawing from Adverse Events will reflect 2.

Reporting Groups
  Description
Lacosamide Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years

Participant Flow:   Overall Study
    Lacosamide
STARTED   7 
COMPLETED   4 
NOT COMPLETED   3 
Lack of Efficacy                1 
Adverse Event                1 
Withdrawal by Subject                1 



  Baseline Characteristics

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 Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years

Baseline Measures
   Lacosamide 
Overall Participants Analyzed 
[Units: Participants]
 		 7 
Age 
[Units: Participants]
Count of Participants 		 
<=18 years      0   0.0% 
Between 18 and 65 years      7 100.0% 
>=65 years      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation) 		 47.4  (10.18) 
Sex: Female, Male 
[Units: Participants]
Count of Participants 		 
Female      4  57.1% 
Male      3  42.9% 
Region of Enrollment 
[Units: Participants]
 		 
Germany   7 


  Outcome Measures

1.  Primary:   Number of Subjects Reporting At Least 1 Treatment-Emergent Adverse Event (TEAE) During The Treatment Period.   [ Time Frame: From Baseline Visit to Final Week of Treatment (approximately 10 years) ]
  Show Outcome Measure 1

2.  Primary:   Number of Subjects Withdrawing From Study Due To A Treatment-Emergent Adverse Event (TEAE) During The Treatment Period.   [ Time Frame: From Baseline Visit to Final Week of Treatment (approximately 10 years) ]
  Show Outcome Measure 2

3.  Secondary:   Within-Subject Change In Average Daily Pain Score During the Treatment Period.   [ Time Frame: From Baseline Visit to Final Week of Treatment (approximately 9 years) ]
  Show Outcome Measure 3

4.  Secondary:   Within-Subject Change In The Perception Of Each Of The Individual Cardinal Symptoms of Pain During The Treatment Period - Shooting.   [ Time Frame: From Baseline Visit to Final Week of Treatment (approximately 9 years) ]
  Show Outcome Measure 4

5.  Secondary:   Within-Subject Change In The Perception Of Each Of The Individual Cardinal Symptoms of Pain During The Treatment Period - Burning.   [ Time Frame: From Baseline Visit to Final Week of Treatment (approximately 9 years) ]
  Show Outcome Measure 5

6.  Secondary:   Within-Subject Change In The Perception Of Each Of The Individual Cardinal Symptoms of Pain During The Treatment Period - Paraesthesiae.   [ Time Frame: From Baseline Visit to Final Week of Treatment (approximately 9 years) ]
  Show Outcome Measure 6

7.  Secondary:   Within-Subject Change In The Perception Of Each Of The Individual Cardinal Symptoms of Pain During The Treatment Period - Numbness.   [ Time Frame: From Baseline Visit to Final Week of Treatment (approximately 9 years) ]
  Show Outcome Measure 7

8.  Secondary:   Within-Subject Change In The Perception Of Each Of The Individual Cardinal Symptoms of Pain During The Treatment Period - Allodynia.   [ Time Frame: From Baseline Visit to Final Week of Treatment (approximately 9 years) ]
  Show Outcome Measure 8

9.  Secondary:   Subject's Global Impression of Change In Pain During The Treatment Period.   [ Time Frame: From Baseline Visit to Final Week of Treatment (approximately 9 years) ]
  Show Outcome Measure 9

10.  Secondary:   Investigator's Global Impression of Change In Pain During The Treatment Period.   [ Time Frame: From Baseline Visit to Final Week of Treatment (approximately 9 years) ]
  Show Outcome Measure 10

11.  Secondary:   Percentage of Days With Concomitant Pain (“Rescue”) Medications Taken During Baseline Phase.   [ Time Frame: Baseline Period (approximately 1 week) ]
  Show Outcome Measure 11

12.  Secondary:   Percentage of Days With Concomitant Pain (“Rescue”) Medications Taken During Titration Phase.   [ Time Frame: Titration Period (approximately 6 weeks) ]
  Show Outcome Measure 12

13.  Secondary:   Percentage of Days With Concomitant Pain ("Rescue") Medications Taken During Titration and Treatment Phases.   [ Time Frame: From Titration Phase through Treatment Phase (approximately 9 years) ]
  Show Outcome Measure 13


  Serious Adverse Events


  Other Adverse Events


  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.


  More Information

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 (Study Director)
Organization: UCB Clinical Trial Call Center
phone: +1 887 822 9493


Publications of Results:


Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00237458     History of Changes
Other Study ID Numbers: SP0647
First Submitted: October 11, 2005
First Posted: October 12, 2005
Results First Submitted: March 7, 2012
Results First Posted: May 15, 2012
Last Update Posted: August 28, 2017