Chronic Refractory Neuropathic PainPhase 2NCT00237458
An Open-label Continuation Trial to Assess the Continued Efficacy and Safety of Ascending Doses of Lacosamide in Subjects With Chronic Refractory Neuropathic Pain
A Phase 2 study testing Lacosamide in people with Chronic Refractory Neuropathic Pain, run by UCB Pharma at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Refractory Neuropathic Pain
- What is being tested?
- Lacosamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteGermany
- Study dates
- May 2001to Mar 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Lacosamide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LacosamideDrug
Also called SPM 927, Vimpat
Dosage: Lacosamide up to 400 mg/day;
Dosage form: Film-coated tablets;
Dosage Frequency and Duration: Two times per day; 9.5 years
| Study group | Role | What they receive |
|---|---|---|
| Lacosamide | Experimental | Open-label active treatment Receives: Drug: Lacosamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Reporting At Least 1 Treatment-Emergent Adverse Event (TEAE) During The Treatment Period.
Measured: 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.
Measured: 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.
The Average Daily Pain Score is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst pain ever experienced).
Measured: 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.
Each individual cardinal symptom of pain is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst possible pain).
Measured: 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.
Each individual cardinal symptom of pain is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst possible pain).
Measured: 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.
Each individual cardinal symptom of pain is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst possible pain).
Measured: 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.
Each individual cardinal symptom of pain is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst possible pain).
Measured: 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.
Each individual cardinal symptom of pain is calculated using an 11-point Likert scale, ranging from 0 (no pain) to 10 (worst possible pain).
Allodynia is defined as neuropathic pain caused by normally innocuous stimuli becoming painful.
Measured: From Baseline Visit to Final Week of Treatment (approximately 9 years)
Subject's Global Impression of Change In Pain During The Treatment Period.
The Subject's Global Impression of Change is a self-evaluation by the subject of their overall change in relief of neuropathic pain since the beginning of the study rated on a 7-point scale ranging from:
- Much better
- Moderately better
- Mildly better
- No change
- Mildly worse
- Moderately worse
- Much worse
Measured: From Baseline Visit to Final Week of Treatment (approximately 9 years)
Investigator's Global Impression of Change In Pain During The Treatment Period.
The Investigator's Global Impression of Change is a physician's assessment of the patient's overall change in relief of neuropathic pain since the beginning of the study rated on a 7-point scale ranging from:
- Much better
- Moderately better
- Mildly better
- No change
- Mildly worse
- Moderately worse
- Much worse
Measured: From Baseline Visit to Final Week of Treatment (approximately 9 years)
Percentage of Days With Concomitant Pain ("Rescue") Medications Taken During Baseline Phase.
The percentage of days where rescue medication was taken is summarized by visit and by Treatment Phase (Baseline, Titration, and Titration + Treatment).
The percentage of days of rescue medication use is defined as the number of days observed within the visit/study phase with rescue medication divided by the number of days in the visit/study phase times 100 for subjects who had taken the rescue medication.
Summary statistics include mean and standard deviation.
Measured: Baseline Period (approximately 1 week)
Percentage of Days With Concomitant Pain ("Rescue") Medications Taken During Titration Phase.
The percentage of days where rescue medication was taken is summarized by visit and by Treatment Phase (Baseline, Titration, and Titration + Treatment).
The percentage of days of rescue medication use is defined as the number of days observed within the visit/study phase with rescue medication divided by the number of days in the visit/study phase times 100 for subjects who had taken the rescue medication.
Summary statistics include mean and standard deviation.
Measured: Titration Period (approximately 6 weeks)
Percentage of Days With Concomitant Pain ("Rescue") Medications Taken During Titration and Treatment Phases.
The percentage of days where rescue medication was taken is summarized by visit and by Treatment Phase (Baseline, Titration, and Titration + Treatment).
The percentage of days of rescue medication use is defined as the number of days observed within the visit/study phase with rescue medication divided by the number of days in the visit/study phase times 100 for subjects who had taken the rescue medication.
Summary statistics include mean and standard deviation.
Measured: From Titration Phase through Treatment Phase (approximately 9 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2005 (estimated)
- Study startMay 2001
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Refractory Neuropathic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Clinical Trial Call Center, Study director, +1 877 822 9493 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00237458
- Sponsor's protocol ID
- SP0647
- Status last verified
- Jul 2017
- First submitted
- 11 Oct 2005
- Last updated
- 28 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 14625037Shaibani 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.
PubMed 18619874
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT00237458
- Acronym / sponsor ID
- SP0647
- Conditions
- Chronic Refractory Neuropathic Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- May 2001
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 12 Oct 2005 (estimated)
- Results
- Posted 15 May 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lacosamide | Experimental | Drug: LacosamideOpen-label active treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LacosamideAlso: SPM 927, VimpatDosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years | Drug | Lacosamide |
Primary outcome
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)
11 secondary outcomes
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)
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 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)
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 - Numbness.
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)
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)
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)
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 Phase.
Time frame: Titration Period (approximately 6 weeks)
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 14625037McCleane 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.
- Results publication: PubMed 18619874Shaibani 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.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
UCB Clinical Trial Call Center study director
+1 877 822 9493 (UCB)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lacosamide in people with Chronic Refractory Neuropathic Pain, run by UCB Pharma at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 May 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00237458, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2017.