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

NCT ID: NCT00237458

Last Updated: 2017-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-05-31
• Study Completion Date: 2011-03-31

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.

Conditions

Chronic Refractory Neuropathic Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lacosamide

Open-label active treatment

Group Type: EXPERIMENTAL

Lacosamide

Intervention Type: DRUG

Dosage: Lacosamide up to 400 mg/day;

Dosage form: Film-coated tablets;

Dosage Frequency and Duration: Two times per day; 9.5 years

Interventions

Lacosamide

Dosage: Lacosamide up to 400 mg/day;

Dosage form: Film-coated tablets;

Dosage Frequency and Duration: Two times per day; 9.5 years

Intervention Type: DRUG

Other Intervention Names

SPM 927; Vimpat

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 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UCB Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

+1 877 822 9493 (UCB)

Locations

Monheim, , Germany

Countries

Germany

References

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.

Reference Type: RESULT

PMID: 14625037 (View on PubMed)

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.

Reference Type: RESULT

PMID: 18619874 (View on PubMed)

Related Links

http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

FDA Safety Alerts and Recalls

Other Identifiers

SP0647

Identifier Type: -

Identifier Source: org_study_id