An Open-label Continuation Trial to Assess the Continued Efficacy and Safety of Ascending Doses of SPM 927 in Subjects With Chronic Refractory Neuropathic Pain - Full Text View

Sponsor:	UCB, Inc.
Information provided by:	UCB, Inc.
ClinicalTrials.gov Identifier:	NCT00237458

Purpose

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	Intervention	Phase
Chronic Refractory Neuropathic Pain	Drug: Lacosamide	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open-label Continuation Trial to Assess the Continued Efficacy and Safety of Ascending Doses of SPM 927 in Subjects With Chronic Refractory Neuropathic Pain

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:

The primary objective of the trial is to assess the tolerability and safety of long-term lacosamide administration in subjects with neuropathic pain. Assessment of adverse events, changes in laboratory parameters, ECGs, and physical examinations. [ Time Frame: 8.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The secondary objective is to evaluate the efficacy of long-term use of lacosamide in this indication. Efficacy will be determined by pain score ratings assessed in a patient's diary and with ratings at the clinic visits. [ Time Frame: 8.5 years ] [ Designated as safety issue: No ]

Enrollment:	7
Study Start Date:	May 2001
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Lacosamide: Experimental Open-label active treatment	Drug: Lacosamide Lacosamide up to 400 mg/day; Film-coated tablets; two times per day; 8.5 years

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

chronic refractory neuropathic pain

Exclusion Criteria:

no benefit from long term administration

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00237458

Locations

Germany
Schwarz
Monheim, Germany

Sponsors and Collaborators

UCB, Inc.

Investigators

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493 (UCB)

More Information

No publications provided

Responsible Party:	UCB ( Study Director )
Study ID Numbers:	SP647
Study First Received:	October 11, 2005
Last Updated:	January 5, 2010
ClinicalTrials.gov Identifier:	NCT00237458 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

ClinicalTrials.gov processed this record on February 08, 2010