A Follow-On Trial to Assess the Long Term Safety and Efficacy of SPM 927 in Painful Distal Diabetic Neuropathy
Recruiting in Palo Alto (17 mi)
+83 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2 & 3
Waitlist Available
Sponsor: UCB Pharma
No Placebo Group
Prior Safety Data
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?
Phase 2/3 open-label trial to assess the safety and tolerability of long-term treatment with lacosamide (SPM 927) in subjects with painful diabetic neuropathy. The safety and tolerability of the different doses of lacosamide will be investigated.
Eligibility Criteria
Inclusion Criteria
Subjects who completed Study SP665, SP742, or SP768 and, in the investigators opinion, might benefit from long-term administration of SPM 927. Exception: subjects who prematurely discontinued Study SP742 or SP768 due to lack of efficacy or due to intolerability to trial medication may be eligible to participate in Study SP745, after consultation with the medical monitor.
Treatment Details
Interventions
- Lacosamide (Anti-epileptic drug)
Participant Groups
1Treatment groups
Experimental Treatment
Group I: 1Experimental Treatment1 Intervention
Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Lacosamide is already approved in European Union, United States for the following indications:
🇪🇺 Approved in European Union as Vimpat for:
- Partial-onset seizures
- Primary generalized tonic-clonic seizures
🇺🇸 Approved in United States as Vimpat for:
- Partial-onset seizures
- Primary generalized tonic-clonic seizures
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
NCT00235443Pinellas Park, FL
NCT00235443South Miami, FL
NCT00235443Tallahassee, FL
NCT00235443Evansville, IN
More Trial Locations
Loading ...
Who Is Running the Clinical Trial?
UCB PharmaLead Sponsor