Painful Diabetic NeuropathyPhase 2NCT00861445
A Trial to Investigate Safety and Efficacy of SPM927 in Painful Diabetic Neuropathy
A Phase 2 study testing SPM927/Lacosamide in people with Painful Diabetic Neuropathy, run by UCB Pharma.
Trial summary
The primary purpose is to investigate the safety and efficacy of SPM927 in patients with Painful Diabetic Neuropathy Read more about this study
- Who is it for?
- Ages 18 to 65 years
- 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?
- Yes, some participants may receive a placebo
- How many people
- 119 participants
- Where
- No sites listed yet
- Study dates
- Jun 2001to Feb 2003
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has clinically diagnosed pain attributed to diabetic distal sensory motor polyneuropathy for 1-5 years and a diagnosis of diabetes mellitus (Type I or Type II).
- Subjects must have at least moderate pain (mean pain intensity ≥ 4 out of 10 during the baseline week on Likert scale).
- subjects must have good or fair diabetic control (Hgb A1c < 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 any amputations other than diabetically-related toe amputations.
- Subject has major skin ulcers.
- Subject has clinically significant ECG abnormalities.
- Subject is expected to take within 7 days prior to randomization and during the study: TCAs, mexiletine hydrochloride, lidoderm patch, tramadol, AEDs, dextromethorphan, opioids, capsaicin, nonsteroidal anti-inflammatory drugs, acetaminophen / paracetamol, skeletal muscle relaxants, benzodiazepines, alpha-2-agonists (e.g. clonidine), drugs indicated for sleep disturbance (e. g. zolpidem tartrate, zaleplon) and over-the-counter medications with centrally acting properties.
Show all 9Show fewer
- Subject has laboratory values which are outside the normal range and judged by the investigator to be clinically significant.
- At study entry, subject has liver function tests values (AST, ALT,alkaline phosphatase, total bilirubin and GGT) 2 times upper limit of normal.
- subject has impaired renal function, i.e., creatinine clearance is lower than 60 mL/min.
About this study
Official title: A Randomized, Double-Blind Placebo Controlled Trial to Investigate Safety and Efficacy of SPM927 in Painful Diabetic Neuropathy
The primary purpose is to investigate the safety and efficacy of SPM927 in patients with Painful Diabetic Neuropathy
- Conditions
- Painful Diabetic Neuropathy
- Being tested
- SPM927/Lacosamide, Placebo
- 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
SPM927 (film-coated tablets, 25/50/100mg per tablet), dosage 400mg/day, intake in the morning and in the evening, intake for 10 weeks
PlaceboOther
Also called SPM927, Lacosamide, Vimpat®
Placebo tablets two times a day for 10 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: SPM927/Lacosamide |
| 2 | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this trial is to evaluate the efficacy of SPM 927 in reducing pain in subjects with diabetic distal sensory polyneuropathy
Measured: Assessments throughout the trial, either daily and/or at clinic visits
Secondary outcomes (4)
Different qualities of neuropathic pain, sleep and activity (daily assessment during entire trial participation)
Measured: Daily assessment during entire trial participation including visits at the site
Quality of Life and the Profile of Mood States (assessment at site visits during entire trial participation)
Measured: Daily assessment during entire trial participation including visits at the site
Investigate the tolerability and safety of SPM927 (assessment during entire trial participation)
Measured: Daily assessment during entire trial participation including visits at the site
Examine the pharmacokinetics of SPM927 (assessment at all site visits during entire trial participation)
Measured: Daily assessment during entire trial participation including visits at the site
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 startJun 2001
- Primary completionJan 2003
- Study completionFeb 2003
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 119 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
- NCT00861445
- Sponsor's protocol ID
- SP0614
- Status last verified
- Jul 2010
- First submitted
- 12 Mar 2009
- Last updated
- 20 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rauck RL, Shaibani A, Biton V, Simpson J, Koch B. Lacosamide in painful diabetic peripheral neuropathy: a phase 2 double-blind placebo-controlled study. Clin J Pain. 2007 Feb;23(2):150-8. doi: 10.1097/01.ajp.0000210957.39621.b2.
PubMed 17237664
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind Placebo Controlled Trial to Investigate Safety and Efficacy of SPM927 in Painful Diabetic Neuropathy
- ClinicalTrials.gov ID
- NCT00861445
- Acronym / sponsor ID
- SP0614
- Conditions
- Painful Diabetic Neuropathy
- Keywords
- Lacosamide, Vimpat®
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- Jun 2001
- Primary completion
- Jan 2003 (actual)
- Study completion
- Feb 2003 (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 purpose is to investigate the safety and efficacy of SPM927 in patients with Painful Diabetic Neuropathy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: SPM927/Lacosamide |
| 2 | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject has clinically diagnosed pain attributed to diabetic distal sensory motor polyneuropathy for 1-5 years and a diagnosis of diabetes mellitus (Type I or Type II).
- Subjects must have at least moderate pain (mean pain intensity ≥ 4 out of 10 during the baseline week on Likert scale).
- subjects must have good or fair diabetic control (Hgb A1c < 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 any amputations other than diabetically-related toe amputations.
- 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/LacosamideSPM927 (film-coated tablets, 25/50/100mg per tablet), dosage 400mg/day, intake in the morning and in the evening, intake for 10 weeks | Drug | 1 |
| PlaceboAlso: SPM927, Lacosamide, Vimpat®Placebo tablets two times a day for 10 weeks | Other | 2 |
Primary outcome
The primary objective of this trial is to evaluate the efficacy of SPM 927 in reducing pain in subjects with diabetic distal sensory polyneuropathy
Time frame: Assessments throughout the trial, either daily and/or at clinic visits
4 secondary outcomes
Different qualities of neuropathic pain, sleep and activity (daily assessment during entire trial participation)
Time frame: Daily assessment during entire trial participation including visits at the site
Quality of Life and the Profile of Mood States (assessment at site visits during entire trial participation)
Time frame: Daily assessment during entire trial participation including visits at the site
Investigate the tolerability and safety of SPM927 (assessment during entire trial participation)
Time frame: Daily assessment during entire trial participation including visits at the site
Examine the pharmacokinetics of SPM927 (assessment at all site visits during entire trial participation)
Time frame: Daily assessment during entire trial participation including visits at the site
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 20 Oct 2014.
- Results publication: PubMed 17237664Rauck RL, Shaibani A, Biton V, Simpson J, Koch B. Lacosamide in painful diabetic peripheral neuropathy: a phase 2 double-blind placebo-controlled study. Clin J Pain. 2007 Feb;23(2):150-8. doi: 10.1097/01.ajp.0000210957.39621.b2.
Related trials for Painful Diabetic Neuropathy
Recruiting
Effect of 4-7-8 Breathing Technique on Pain and Anxiety During Electromyography in Diabetic Neuropathy
Diabetic Neuropathies, Diabetes Mellitus (Type 2)
Active, not recruiting
Comparative Effects of tDCS and tACS on Pain, Dexterity, and Strength in Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy (DPN)
RecruitingObservational study
Safety and Effect of Peripheral Nerve Decompression Combined With Peripheral Nerve Stimulation for Painful Diabetic Peripheral Neuropathy
Painful Diabetic Peripheral Neuropathy, Diabetes Complication
Active, not recruitingPhase 3
Evaluation of the Long-term Safety and Effectiveness of Suzetrigine (SUZ) in Participants With Painful Diabetic Peripheral Neuropathy (DPN)
Diabetic Peripheral Neuropathic Pain
Not yet recruitingPhase 4
Modality Choice Before and After Failure for the Treatment of Painful Diabetic Neuropathy
Painful Diabetic Neuropathy (PDN), Diabetic Nephropathies
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 3 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 20 Oct 2014. 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. Some participants in this study may receive a placebo. 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?
The primary objective of this trial is to evaluate the efficacy of SPM 927 in reducing pain in subjects with diabetic distal sensory polyneuropathy (time frame: Assessments throughout the trial, either daily and/or at clinic visits). 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 NCT00861445, 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 20 Oct 2014.