Painful PolyneuropathyPhase 4NCT00286260
Levetiracetam for Painful Polyneuropathy
A Phase 4 study testing levetiracetam in people with Painful Polyneuropathy, run by Odense University Hospital at 1 site in Denmark.
Trial summary
Polyneuropathy of different etiologies is often associated with pain. The standard treatment of this pain is anticonvulsants or antidepressants, but none of these treatment are effective or tolerable for all patients. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Painful Polyneuropathy
- What is being tested?
- levetiracetam
- Type of treatment
- Pill or oral medicine
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2006to Oct 2008
- Phase
- Phase 4
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 20 to 0 years
- painful symptoms of polyneuropathy for at least 6 months
- confirmed diagnosis of polyneuropathy
- baseline pain score of 4 or more (0 to 10 point scale)
- pain at least 4 days a week
- adequate anticonceptive treatment for women with childbearing potential
- informed consent
Who cannot join
- other cause of pain
- previous allergic reactions towards levetiracetam
- known adverse drug reactions on levetiracetam
- pregnancy
- severe disease
- inability to follow study protocol
- treatment with antidepressants, other anticonvulsants or opioids
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Neurology, Odense University Hospital
Odense C, DK-5000
About this study
Official title: Double-blind, Randomised, Placebo-controlled Trial of the Effect of Levetiracetam on Painful Polyneuropathy
Polyneuropathy of different etiologies is often associated with pain. The standard treatment of this pain is anticonvulsants or antidepressants, but none of these treatment are effective or tolerable for all patients. Levetiracetam is a newer anticonvulsant and it is the hypothesis is that it could relieve neuropathic pain in polyneuropathy. This is a randomised, double-blind, placebo-controlled, cross-over trial on the effect of levetiracetam 3.000 mg/day on pain in polyneuropathy
- Conditions
- Painful Polyneuropathy
- Being tested
- levetiracetam
- Keywords
- polyneuropathy, neuropathic pain, levetiracetam
- Medical subject headings
- Polyneuropathies, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levetiracetamDrug
Levetiracetam tablet 500 mg, daily dose titrated to 3000 mg, 6 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain relief rated on a 0 to 10 point numeric rating scale (median value for last treatment week in each period)
Measured: Daily
Secondary outcomes (8)
Pain rated on 0 to 10 point numeric rating scales
Measured: Daily
Pain subtypes rated on 0 to 10 point numeric rating scales
Measured: Daily
Bruch-evoked pain
Measured: Baseline and end of each treament period
Pin-prick evoked pain
Measured: Baseline and end of each treatment period
Cold evoked pain
Measured: Baseline and end of each treatment period
Health related quality of life(SF-36)
Measured: Baseline and end of each treatment period
Pain related sleep disturbance
Measured: Daily
Use of escape medication
Measured: Daily
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2006 (estimated)
- Study startJan 2006
- Primary completionAug 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Painful PolyneuropathyStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Søren H Sindrup, Professor, Study chair, Department of Neurology, Odense Unviersity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00286260
- Sponsor's protocol ID
- keppra2
- Status last verified
- Jan 2006
- First submitted
- 1 Feb 2006
- Last updated
- 18 Dec 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomised, Placebo-controlled Trial of the Effect of Levetiracetam on Painful Polyneuropathy
- ClinicalTrials.gov ID
- NCT00286260
- Acronym / sponsor ID
- keppra2
- Conditions
- Painful Polyneuropathy
- Keywords
- polyneuropathy, neuropathic pain, levetiracetam
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Aug 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 3 Feb 2006 (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.
Polyneuropathy of different etiologies is often associated with pain. The standard treatment of this pain is anticonvulsants or antidepressants, but none of these treatment are effective or tolerable for all patients. Levetiracetam is a newer anticonvulsant and it is the hypothesis is that it could relieve neuropathic pain in polyneuropathy. This is a randomised, double-blind, placebo-controlled, cross-over trial on the effect of levetiracetam 3.000 mg/day on pain in polyneuropathy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- age 20 to 0 years
- painful symptoms of polyneuropathy for at least 6 months
- confirmed diagnosis of polyneuropathy
- baseline pain score of 4 or more (0 to 10 point scale)
- pain at least 4 days a week
Key exclusion criteria (7 listed)
- other cause of pain
- previous allergic reactions towards levetiracetam
- known adverse drug reactions on levetiracetam
- pregnancy
- severe disease
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 |
|---|---|---|
| levetiracetamLevetiracetam tablet 500 mg, daily dose titrated to 3000 mg, 6 weeks | Drug | – |
Primary outcome
Pain relief rated on a 0 to 10 point numeric rating scale (median value for last treatment week in each period)
Time frame: Daily
8 secondary outcomes
Pain rated on 0 to 10 point numeric rating scales
Time frame: Daily
Pain subtypes rated on 0 to 10 point numeric rating scales
Time frame: Daily
Bruch-evoked pain
Time frame: Baseline and end of each treament period
Pin-prick evoked pain
Time frame: Baseline and end of each treatment period
Cold evoked pain
Time frame: Baseline and end of each treatment period
Health related quality of life(SF-36)
Time frame: Baseline and end of each treatment period
Pain related sleep disturbance
Time frame: Daily
Use of escape medication
Time frame: Daily
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 18 Dec 2009.
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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.
Søren H Sindrup, Professor study chair
Department of Neurology, Odense Unviersity Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing levetiracetam in people with Painful Polyneuropathy, run by Odense University Hospital at 1 site in Denmark.
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 7 inclusion and 7 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 18 Dec 2009. 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 Denmark. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Pain relief rated on a 0 to 10 point numeric rating scale (median value for last treatment week in each period) (time frame: Daily). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Dec 2009.