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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00237458
• Date of registration: 11/10/2005
• Prospective Registration: No
• Primary sponsor: UCB Pharma
• Public title: An Open-label Continuation Trial to Assess the Continued Efficacy and Safety of Ascending Doses of Lacosamide in Subjects With Chronic Refractory Neuropathic Pain
• Scientific title: An Open-label Continuation Trial to Assess the Continued Efficacy and Safety of Ascending Doses of Lacosamide in Subjects With Chronic Refractory Neuropathic Pain
• Date of first enrolment: May 2001
• Target sample size: 7
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00237458
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Germany

Contacts

• Name: UCB Clinical Trial Call Center
• Affiliation: [phone] (UCB)

Key inclusion & exclusion 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 met all inclusion criteria defined in the SP611 trial with SPM927 at the time
of enrollment into trial SP611

- 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Chronic Refractory Neuropathic Pain

Intervention(s)

Drug: Lacosamide

Primary Outcome(s)

Number of Subjects Reporting At Least 1 Treatment-Emergent Adverse Event (TEAE) During The Treatment Period. [Time Frame: 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. [Time Frame: From Baseline Visit to Final Week of Treatment (approximately 10 years)]

Secondary Outcome(s)

Within-Subject Change In The Perception Of Each Of The Individual Cardinal Symptoms of Pain During The Treatment Period - Shooting. [Time Frame: From Baseline Visit to Final Week of Treatment (approximately 9 years)]

Within-Subject Change In Average Daily Pain Score During the Treatment Period. [Time Frame: From Baseline Visit to Final Week of Treatment (approximately 9 years)]

Investigator's Global Impression of Change In Pain During The Treatment Period. [Time Frame: 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 - Allodynia. [Time Frame: 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. [Time Frame: 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. [Time Frame: From Baseline Visit to Final Week of Treatment (approximately 9 years)]

Percentage of Days With Concomitant Pain ("Rescue") Medications Taken During Titration Phase. [Time Frame: Titration Period (approximately 6 weeks)]

Within-Subject Change In The Perception Of Each Of The Individual Cardinal Symptoms of Pain During The Treatment Period - Numbness. [Time Frame: From Baseline Visit to Final Week of Treatment (approximately 9 years)]

Subject's Global Impression of Change In Pain During The Treatment Period. [Time Frame: From Baseline Visit to Final Week of Treatment (approximately 9 years)]

Percentage of Days With Concomitant Pain ("Rescue") Medications Taken During Baseline Phase. [Time Frame: Baseline Period (approximately 1 week)]

Percentage of Days With Concomitant Pain ("Rescue") Medications Taken During Titration and Treatment Phases. [Time Frame: From Titration Phase through Treatment Phase (approximately 9 years)]

Secondary ID(s)

SP0647

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 15/05/2012
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00237458