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

This trial is the follow-on trial to a preceeding open-label trial which included patients with chronic refractory neuropathic pain. It is conducted at one site in the United Kingdom and the patient enrollment is completed. The patients had successfully completed the above mentioned trial and, in the investigator's opinion, would benefit from long-term administration of Lacosamide. After a 1-week run-in phase the patients were uptitrated to their optimal dose and then continued into the maintenance phase. Different pain qualities are assessed by a patient's diary.

Study Overview

• Status: Completed
• Conditions: Chronic Refractory Neuropathic Pain
• Intervention / Treatment: Drug: Lacosamide

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Monheim, Germany

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subject is informed and given ample time and opportunity to think about her/his participation in this extension trial and has given her/his written informed consent
• Subject met all inclusion criteria defined in the SP611 trial with SPM927 at the time of enrollment into trial SP611
• Subject has successfully completed trial SP611 and, in the investigator's opinion, would benefit from long-term administration of SPM927
• Subject is willing and able to comply with all trial requirements, including the ability to complete trial questionnaires

Exclusion Criteria:

• Subject previously participated in this trial
• Subject has participated in another trial of an investigational drug within the last 3 months (excluding trial SP611) or is currently participating in another trial of an investigational drug
• Subject has had prior therapy with a Nonsteroidal Anti-inflammatory Drug (NSAID) or Anti-epileptic Drug (AED) within 28 days prior to the Eligibility Visit
• Subject has evidence or history of significant Cardiovascular Disease within 12 months prior to the Eligibility Visit
• Subject has laboratory values, which are outside the normal range and judged by the Investigator to be clinically significant
• Subject has abnormal Renal or Hepatic function
• Subject has a history of Malignancies with the exception of subjects with a documented disease-free interval of 5 years or more
• Subject has a history of chronic alcohol or drug abuse within the last 12 months
• Subject has any medical or psychiatric condition which, in the opinion of the Investigator, could jeopardize or compromise the subject's ability to participate in this continuation trial
• Subject with a known history of severe Anaphylactic Reaction and/or serious or life threatening Blood Dyscrasias

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Lacosamide; Open-label active treatment	Drug: Lacosamide; Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years; Other Names: SPM 927; Vimpat

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Subjects Reporting At Least 1 Treatment-Emergent Adverse Event (TEAE) During The Treatment Period.	From Baseline Visit to Final Week of Treatment (approximately 10 years)
Number of Subjects Withdrawing From Study Due To A Treatment-Emergent Adverse Event (TEAE) During The Treatment Period.	From Baseline Visit to Final Week of Treatment (approximately 10 years)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Within-Subject Change In Average Daily Pain Score During the Treatment Period.	The Average Daily Pain Score is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst pain ever experienced).	From Baseline Visit to Final Week of Treatment (approximately 9 years)
Within-Subject Change In The Perception Of Each Of The Individual Cardinal Symptoms of Pain During The Treatment Period - Shooting.	Each individual cardinal symptom of pain is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst possible pain).	From Baseline Visit to Final Week of Treatment (approximately 9 years)
Within-Subject Change In The Perception Of Each Of The Individual Cardinal Symptoms of Pain During The Treatment Period - Burning.	Each individual cardinal symptom of pain is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst possible pain).	From Baseline Visit to Final Week of Treatment (approximately 9 years)
Within-Subject Change In The Perception Of Each Of The Individual Cardinal Symptoms of Pain During The Treatment Period - Paraesthesiae.	Each individual cardinal symptom of pain is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst possible pain).	From Baseline Visit to Final Week of Treatment (approximately 9 years)
Within-Subject Change In The Perception Of Each Of The Individual Cardinal Symptoms of Pain During The Treatment Period - Numbness.	Each individual cardinal symptom of pain is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst possible pain).	From Baseline Visit to Final Week of Treatment (approximately 9 years)
Within-Subject Change In The Perception Of Each Of The Individual Cardinal Symptoms of Pain During The Treatment Period - Allodynia.	Each individual cardinal symptom of pain is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst possible pain). Allodynia is defined as neuropathic pain caused by normally innocuous stimuli becoming painful.	From Baseline Visit to Final Week of Treatment (approximately 9 years)
Subject's Global Impression of Change In Pain During The Treatment Period.	The Subject's Global Impression of Change is a self-evaluation by the subject of their overall change in relief of neuropathic pain since the beginning of the study rated on a 7-point scale ranging from: Much better; Moderately better; Mildly better; No change; Mildly worse; Moderately worse; Much worse	From Baseline Visit to Final Week of Treatment (approximately 9 years)
Investigator's Global Impression of Change In Pain During The Treatment Period.	The Investigator's Global Impression of Change is a physician's assessment of the patient's overall change in relief of neuropathic pain since the beginning of the study rated on a 7-point scale ranging from: Much better; Moderately better; Mildly better; No change; Mildly worse; Moderately worse; Much worse	From Baseline Visit to Final Week of Treatment (approximately 9 years)
Percentage of Days With Concomitant Pain ("Rescue") Medications Taken During Baseline Phase.	The percentage of days where rescue medication was taken is summarized by visit and by Treatment Phase (Baseline, Titration, and Titration + Treatment). The percentage of days of rescue medication use is defined as the number of days observed within the visit/study phase with rescue medication divided by the number of days in the visit/study phase times 100 for subjects who had taken the rescue medication. Summary statistics include mean and standard deviation.	Baseline Period (approximately 1 week)
Percentage of Days With Concomitant Pain ("Rescue") Medications Taken During Titration Phase.	The percentage of days where rescue medication was taken is summarized by visit and by Treatment Phase (Baseline, Titration, and Titration + Treatment). The percentage of days of rescue medication use is defined as the number of days observed within the visit/study phase with rescue medication divided by the number of days in the visit/study phase times 100 for subjects who had taken the rescue medication. Summary statistics include mean and standard deviation.	Titration Period (approximately 6 weeks)
Percentage of Days With Concomitant Pain ("Rescue") Medications Taken During Titration and Treatment Phases.	The percentage of days where rescue medication was taken is summarized by visit and by Treatment Phase (Baseline, Titration, and Titration + Treatment). The percentage of days of rescue medication use is defined as the number of days observed within the visit/study phase with rescue medication divided by the number of days in the visit/study phase times 100 for subjects who had taken the rescue medication. Summary statistics include mean and standard deviation.	From Titration Phase through Treatment Phase (approximately 9 years)

Collaborators and Investigators

• Sponsor: UCB Pharma

Publications and helpful links

General Publications

• McCleane G, Koch B, Rauschkolb C. Does SPM 927 have an analgesic effect in human neuropathic pain? An open label study. Neurosci Lett. 2003 Dec 4;352(2):117-20. doi: 10.1016/j.neulet.2003.08.036.
• 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. doi: 10.1016/j.ejpain.2008.05.016. Epub 2008 Jul 10.

Helpful Links

• FDA Safety Alerts and Recalls
• Product Information

Study record dates

Study Major Dates

• Study Start: May 1, 2001
• Primary Completion (ACTUAL): March 1, 2011
• Study Completion (ACTUAL): March 1, 2011

Study Registration Dates

• First Submitted: October 11, 2005
• First Submitted That Met QC Criteria: October 11, 2005
• First Posted (ESTIMATE): October 12, 2005

Study Record Updates

• Last Update Posted (ACTUAL): August 28, 2017
• Last Update Submitted That Met QC Criteria: July 28, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Anticonvulsants; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lacosamide
• Other Study ID Numbers: SP0647