At a glance
ClinicalIndex Comparison Record- ✓Completed the SP611 trial with SPM927 (lacosamide)
- ✓Met all inclusion criteria from the original SP611 trial at time of enrollment
- ✓Willing and able to comply with all trial requirements including questionnaires
- ✕Prior participation in this continuation trial
- ✕Participation in another investigational drug trial within last 3 months (except SP611) or concurrent participation
- ✕Recent NSAID or anti-epileptic drug use within 28 days
- ✕Significant cardiovascular disease within 12 months
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-label Continuation Trial to Assess the Continued Efficacy and Safety of Ascending Doses of Lacosamide in Subjects With Chronic Refractory Neuropathic Pain
In Brief
A Phase 2 clinical trial evaluating Lacosamide for Chronic Refractory Neuropathic Pain. Completed, enrolled 7 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years