Painful Diabetic NeuropathyPhase 2NCT00861042
An Open-label follow-on Trial to Assess the Long-term Safety and Efficacy of Oral SPM 927 in Subjects With Diabetic Neuropathy
A Phase 2 study testing SPM927/Lacosamide in people with Painful Diabetic Neuropathy, run by UCB Pharma.
Trial summary
The primary objective of the trial is to assess the tolerability and safety of long-term SPM 927 administration in subjects with diabetic neuropathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Painful Diabetic Neuropathy
- What is being tested?
- SPM927/Lacosamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- No sites listed yet
- Study dates
- Apr 2002to Mar 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 has successfully completed a previous trial with SPM 927 in diabetic neuropathy and, in the investigator's opinion, would benefit from long-term administration of SPM 927.
- Subject has stable, good or fair diabetic control (HbA1c ≤10% ).
Who cannot join
- Subject has other conditions that cause neuropathic pain at least as severe as the diabetic pain, i.e. peripheral arterio-vascular disease.
- Subject receives treatment for seizures.
- Subject has had an amputation related to diabetes, other than toe amputation.
- Subject has major skin ulcers.
- Subject has clinically significant ECG abnormalities.
- Subject expects to take during the study: TCAs, mexiletine hydrochloride, lidoderm patch, tramadol, AEDs, dextromethorphan, opioids, capsaicin, skeletal muscle relaxants, benzodiazepines or over-the-counter medications with centrally acting properties.
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- Subject has laboratory values which are outside the normal range and judged by the investigator to be clinically significant.
- Subject has liver function tests (AST, ALT, alkaline phosphatase, total bilirubin, or GGT) ≥ 2x ULN at Visit 1.
- At Visit 1, subject has impaired renal function, i.e., creatinine clearance (ClCr) is lower than 60 mL/min.
About this study
The primary objective of the trial is to assess the tolerability and safety of long-term SPM 927 administration in subjects with diabetic neuropathy.
- Conditions
- Painful Diabetic Neuropathy
- Being tested
- SPM927/Lacosamide
- Keywords
- Lacosamide, Vimpat®
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPM927/LacosamideDrug
Also called SPM927 / Lacosamide / Vimpat®
SPM927 (film-coated tablets, 25/50/100mg per tablet), dosage up to 400mg/day, intake in the morning and in the evening; duration of intake depending on individual trial participation SPM927 (film-coated tablets, 25/50/100mg per tablet), dosage up to 400mg/day, intake in the morning and in the evening; duration of intake depending on individual trial participation
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: SPM927/Lacosamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the tolerability and safety of long-term SPM 927 administration in subjects with diabetic neuropathy
Measured: Assessments during whole course of the trial: spontaneously by the subject and observed by the investigators during site visits
Adverse events reported spontaneously by the subject or observed by the investigator
Measured: Assessments during whole course of the trial: spontaneously by the subject and observed by the investigators during site visits.
Changes laboratory, ECG and vital signs parameters.
Measured: Assessments during whole course of the trial: spontaneously by the subject and observed by the investigators during site visits.
Changes in physical or neurological examination findings
Measured: Assessments during whole course of the trial: spontaneously by the subject and observed by the investigators during site visits.
Subject withdrawal due to adverse events
Measured: Assessments during whole course of the trial: spontaneously by the subject and observed by the investigators during site visits.
Secondary outcomes (8)
The secondary objective is to gather further information on the efficacy of SPM 927 in this indication.
Measured: Daily assessment during entire trial participation including assessments at site visits
Within-subject change in average pain score: Daily assessments throughout the trial
Measured: Daily assessment during entire trial participation including assessments at site visits
Change in subject's perception of different neuropathic pain qualities during specific site visit
Measured: Daily assessment during entire trial participation including assessments at site visits
Time to exit (days) de to lack of efficacy of treatment
Measured: Daily assessment during entire trial participation including assessments at site visits
Change in subject's perception of sleep and activity throughout the trial, daily assessments
Measured: Daily assessment during entire trial participation including assessments at site visits
Patient's Global Impression of Change in Pain (PGIC) during specific site visit
Measured: Daily assessment during entire trial participation including assessments at site visits
Clinical Global Impression of Change in Pain (CGIC): Assessments during specific site visit
Measured: Daily assessment during entire trial participation including assessments at site visits
Quality of life assessments during specific site visits
Measured: Daily assessment during entire trial participation including assessments at site visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2009 (estimated)
- Study startApr 2002
- Primary completionDec 2004
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Painful Diabetic NeuropathyStudies 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
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- UCB Clinical Trial Call Center, Study director, +1 877 822 9493 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00861042
- Sponsor's protocol ID
- SP0665
- Status last verified
- Jan 2024
- First submitted
- 12 Mar 2009
- Last updated
- 29 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18619874
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label follow-on Trial to Assess the Long-term Safety and Efficacy of Oral SPM 927 in Subjects With Diabetic Neuropathy
- ClinicalTrials.gov ID
- NCT00861042
- Acronym / sponsor ID
- SP0665
- Conditions
- Painful Diabetic Neuropathy
- Keywords
- Lacosamide, Vimpat®
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- Apr 2002
- Primary completion
- Dec 2004 (actual)
- Study completion
- Mar 2005 (actual)
- First posted
- 13 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the trial is to assess the tolerability and safety of long-term SPM 927 administration in subjects with diabetic neuropathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: SPM927/Lacosamide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject has successfully completed a previous trial with SPM 927 in diabetic neuropathy and, in the investigator's opinion, would benefit from long-term administration of SPM 927.
- Subject has stable, good or fair diabetic control (HbA1c ≤10% ).
Key exclusion criteria (9 listed)
- Subject has other conditions that cause neuropathic pain at least as severe as the diabetic pain, i.e. peripheral arterio-vascular disease.
- Subject receives treatment for seizures.
- Subject has had an amputation related to diabetes, other than toe amputation.
- Subject has major skin ulcers.
- Subject has clinically significant ECG abnormalities.
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 |
|---|---|---|
| SPM927/LacosamideAlso: SPM927 / Lacosamide / Vimpat®SPM927 (film-coated tablets, 25/50/100mg per tablet), dosage up to 400mg/day, intake in the morning and in the evening; duration of intake depending on individual trial participation SPM927 (film-coated tablets, 25/50/100mg per tablet), dosage up to 400mg/day, intake in the morning and in the evening; duration of intake depending on individual trial participation | Drug | 1 |
Primary outcome
Assess the tolerability and safety of long-term SPM 927 administration in subjects with diabetic neuropathy
Time frame: Assessments during whole course of the trial: spontaneously by the subject and observed by the investigators during site visits
Adverse events reported spontaneously by the subject or observed by the investigator
Time frame: Assessments during whole course of the trial: spontaneously by the subject and observed by the investigators during site visits.
Changes laboratory, ECG and vital signs parameters.
Time frame: Assessments during whole course of the trial: spontaneously by the subject and observed by the investigators during site visits.
Changes in physical or neurological examination findings
Time frame: Assessments during whole course of the trial: spontaneously by the subject and observed by the investigators during site visits.
Subject withdrawal due to adverse events
Time frame: Assessments during whole course of the trial: spontaneously by the subject and observed by the investigators during site visits.
8 secondary outcomes
The secondary objective is to gather further information on the efficacy of SPM 927 in this indication.
Time frame: Daily assessment during entire trial participation including assessments at site visits
Within-subject change in average pain score: Daily assessments throughout the trial
Time frame: Daily assessment during entire trial participation including assessments at site visits
Change in subject's perception of different neuropathic pain qualities during specific site visit
Time frame: Daily assessment during entire trial participation including assessments at site visits
Time to exit (days) de to lack of efficacy of treatment
Time frame: Daily assessment during entire trial participation including assessments at site visits
Change in subject's perception of sleep and activity throughout the trial, daily assessments
Time frame: Daily assessment during entire trial participation including assessments at site visits
Patient's Global Impression of Change in Pain (PGIC) during specific site visit
Time frame: Daily assessment during entire trial participation including assessments at site visits
Clinical Global Impression of Change in Pain (CGIC): Assessments during specific site visit
Time frame: Daily assessment during entire trial participation including assessments at site visits
Quality of life assessments during specific site visits
Time frame: Daily assessment during entire trial participation including assessments at site visits
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2024.
- 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.
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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)
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SPM927/Lacosamide in people with Painful Diabetic Neuropathy, run by UCB Pharma.
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 2 inclusion and 9 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 29 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assess the tolerability and safety of long-term SPM 927 administration in subjects with diabetic neuropathy (time frame: Assessments during whole course of the trial: spontaneously by the subject and observed by the investigators during site visits). The study lists 5 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 NCT00861042, which also lists 1 linked publication.
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 29 Jan 2024; AzTrials last refreshed its copy on 7 Nov 2026.