Clinical trial NCT00237458: An Open-label Continuation Trial to Assess the Continued Efficacy and Safety of Ascending Doses of Lacosamide in Subjects With Chronic Refractory Neuropathic Pain
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Refractory Neuropathic Pain
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2005-10-12
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Number of Subjects Reporting At Least 1 Treatment-Emergent Adverse Event (TEAE) During The Treatment Period.
timeFrame: From Baseline Visit to Final Week of Treatment (approximately 10 years)
measure: Number of Subjects Withdrawing From Study Due To A Treatment-Emergent Adverse Event (TEAE) During The Treatment Period.
timeFrame: From Baseline Visit to Final Week of Treatment (approximately 10 years)
Secondary outcomes:
measure: Within-Subject Change In Average Daily Pain Score During the Treatment Period.
timeFrame: From Baseline Visit to Final Week of Treatment (approximately 9 years)
measure: Within-Subject Change In The Perception Of Each Of The Individual Cardinal Symptoms of Pain During The Treatment Period - Shooting.
timeFrame: From Baseline Visit to Final Week of Treatment (approximately 9 years)
measure: Within-Subject Change In The Perception Of Each Of The Individual Cardinal Symptoms of Pain During The Treatment Period - Burning.
timeFrame: From Baseline Visit to Final Week of Treatment (approximately 9 years)
measure: Within-Subject Change In The Perception Of Each Of The Individual Cardinal Symptoms of Pain During The Treatment Period - Paraesthesiae.
timeFrame: From Baseline Visit to Final Week of Treatment (approximately 9 years)
measure: Within-Subject Change In The Perception Of Each Of The Individual Cardinal Symptoms of Pain During The Treatment Period - Numbness.
timeFrame: From Baseline Visit to Final Week of Treatment (approximately 9 years)
measure: Within-Subject Change In The Perception Of Each Of The Individual Cardinal Symptoms of Pain During The Treatment Period - Allodynia.
timeFrame: From Baseline Visit to Final Week of Treatment (approximately 9 years)
measure: Subject's Global Impression of Change In Pain During The Treatment Period.
timeFrame: From Baseline Visit to Final Week of Treatment (approximately 9 years)
measure: Investigator's Global Impression of Change In Pain During The Treatment Period.
timeFrame: From Baseline Visit to Final Week of Treatment (approximately 9 years)
measure: Percentage of Days With Concomitant Pain ("Rescue") Medications Taken During Baseline Phase.
timeFrame: Baseline Period (approximately 1 week)
measure: Percentage of Days With Concomitant Pain ("Rescue") Medications Taken During Titration Phase.
timeFrame: Titration Period (approximately 6 weeks)
measure: Percentage of Days With Concomitant Pain ("Rescue") Medications Taken During Titration and Treatment Phases.
timeFrame: From Titration Phase through Treatment Phase (approximately 9 years)
Other outcomes:
Locations:
city: Monheim
country: Germany
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.