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

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

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.
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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

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) ]

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) ]

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) ]

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) ]

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) ]

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) ]

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) ]

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) ]

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) ]

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) ]

11.  Secondary:

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

12.  Secondary:

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

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) ]

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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