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, Inc.

ClinicalTrials.gov Identifier:

NCT00235443

First received: October 6, 2005

Last updated: September 19, 2011

Last verified: September 2011

History of Changes

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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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

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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 ]

Show Outcome Measure 1

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). ]

Show Outcome Measure 2

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). ]

Show Outcome Measure 3

4. Secondary:

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

Show Outcome Measure 4

5. Secondary:

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

Show Outcome Measure 5

6. Secondary:

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

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7. Secondary:

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

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Measure Type	Secondary
Measure Title	Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Heat
Measure Description	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").
Time Frame	Baseline to Termination Visit
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.
Safety population are subjects who took at least one dose of lacosamide (LCM).

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	All modal dose groups combined

Measured Values

	Lacosamide 100mg/Day	Lacosamide 200mg/Day	Lacosamide 300mg/Day	Lacosamide 400mg/Day	Lacosamide 500mg/Day	Lacosamide 600mg/Day	Total
Number of Participants Analyzed [units: participants]	10	45	62	181	30	42	370
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Heat [units: Units on a scale] Mean ± Standard Deviation	-5.3 ± 3.74	-3.0 ± 3.65	-3.1 ± 3.44	-2.6 ± 3.14	-2.8 ± 2.58	-1.2 ± 2.86	-2.7 ± 3.26

No statistical analysis provided for Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Heat

8. Secondary:

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

Show Outcome Measure 8

9. Secondary:

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

Show Outcome Measure 9

10. Secondary:

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

Show Outcome Measure 10

11. Secondary:

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

Show Outcome Measure 11

12. Secondary:

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

Show Outcome Measure 12

13. Secondary:

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

Show Outcome Measure 13

14. Secondary:

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

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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 ]

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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 ]

Show Outcome Measure 16

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 ]

Show Outcome Measure 17

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 ]

Show Outcome Measure 18

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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: UCB has > 60 days but <= 180 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.

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
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Results Point of Contact:

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

No publications provided by UCB, Inc.

Publications automatically indexed to this study:

Shaibani A, Biton V, Rauck R, Koch B, Simpson J. Long-term oral lacosamide in painful diabetic neuropathy: a two-year open-label extension trial. Eur J Pain. 2009 May;13(5):458-63. Epub 2008 Jul 10.

Responsible Party:	UCB, Inc.
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

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