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

NCT00237458 | Completed Phase 2 Results

• 1 other identifier: SP0647
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Number of Subjects Reporting At Least 1 Treatment-Emergent Adverse Event (TEAE) During The Treatment Period.

  From Baseline Visit to Final Week of Treatment (approximately 10 years)

• Number of Subjects Withdrawing From Study Due To A Treatment-Emergent Adverse Event (TEAE) During The Treatment Period.

  From Baseline Visit to Final Week of Treatment (approximately 10 years)

Secondary Outcomes (11)

• Within-Subject Change In Average Daily Pain Score During the Treatment Period.

  From Baseline Visit to Final Week of Treatment (approximately 9 years)

• Within-Subject Change In The Perception Of Each Of The Individual Cardinal Symptoms of Pain During The Treatment Period - Shooting.

  From Baseline Visit to Final Week of Treatment (approximately 9 years)

• Within-Subject Change In The Perception Of Each Of The Individual Cardinal Symptoms of Pain During The Treatment Period - Burning.

  From Baseline Visit to Final Week of Treatment (approximately 9 years)

• Within-Subject Change In The Perception Of Each Of The Individual Cardinal Symptoms of Pain During The Treatment Period - Paraesthesiae.

  From Baseline Visit to Final Week of Treatment (approximately 9 years)

• Within-Subject Change In The Perception Of Each Of The Individual Cardinal Symptoms of Pain During The Treatment Period - Numbness.

  From Baseline Visit to Final Week of Treatment (approximately 9 years)

Study Arms (1)

Lacosamide

EXPERIMENTAL

Open-label active treatment

Drug: Lacosamide

Interventions

Lacosamide DRUG

Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years

Also known as: SPM 927, Vimpat

Lacosamide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UCB Pharma: lead

Study Sites (1)

Unknown Facility

Monheim, Germany

Location

Related Publications (2)

• 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.

  PMID: 14625037 RESULT

• 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.

  PMID: 18619874 RESULT

Related Links

• FDA Safety Alerts and Recalls

MeSH Terms

Interventions

Lacosamide; 2-(acetylamino)-3-methoxy-N-(phenylmethyl)-, (2R)-

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids

Results Point of Contact

• Title: UCB (Study Director)
• Organization: UCB Clinical Trial Call Center

+1 887 822 9493

Study Officials

• UCB Clinical Trial Call Center

  +1 877 822 9493 (UCB)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2005
• First Posted: October 12, 2005
• Study Start: May 1, 2001
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: August 28, 2017
• Results First Posted: May 15, 2012

Record last verified: 2017-07

Locations

DE (1)