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

• 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: UCB Pharma
• Information provided by (Responsible Party): UCB Pharma

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Chronic Refractory Neuropathic Pain	Drug: Lacosamide	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 7 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-label Continuation Trial to Assess the Continued Efficacy and Safety of Ascending Doses of Lacosamide in Subjects With Chronic Refractory Neuropathic Pain
• Study Start Date: May 2001
• Actual Primary Completion Date: March 2011
• Actual Study Completion Date: March 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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. 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) ]

Secondary Outcome Measures :

1. 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) ]
   The Average Daily Pain Score is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst pain ever experienced).
2. 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) ]
   Each individual cardinal symptom of pain is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst possible pain).
3. 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) ]
   Each individual cardinal symptom of pain is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst possible pain).
4. 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) ]
   Each individual cardinal symptom of pain is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst possible pain).
5. 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) ]
   Each individual cardinal symptom of pain is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst possible pain).
6. 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) ]

   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.

7. 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) ]

   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:

   1. Much better
   2. Moderately better
   3. Mildly better
   4. No change
   5. Mildly worse
   6. Moderately worse
   7. Much worse
8. 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) ]

   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:

   1. Much better
   2. Moderately better
   3. Mildly better
   4. No change
   5. Mildly worse
   6. Moderately worse
   7. Much worse
9. Percentage of Days With Concomitant Pain ("Rescue") Medications Taken During Baseline Phase. [ Time Frame: Baseline Period (approximately 1 week) ]

   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.

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

    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.

11. 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) ]

    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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Germany

Monheim, Germany

Sponsors and Collaborators

UCB Pharma

Investigators

• Study Director: UCB Clinical Trial Call Center; +1 877 822 9493 (UCB)

More Information

Additional Information:

Product Information 

FDA Safety Alerts and Recalls 

Publications of Results:

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.

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.

• Responsible Party: UCB Pharma
• ClinicalTrials.gov Identifier: NCT00237458
• Other Study ID Numbers: SP0647
• First Posted: October 12, 2005
• Results First Posted: May 15, 2012
• Last Update Posted: August 28, 2017
• Last Verified: July 2017

Additional relevant MeSH terms:

Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Lacosamide; Anticonvulsants; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action