OsteoarthritisPhase 2NCT00485472
Trial to Assess Efficacy and Safety of Lacosamide in Subjects With Osteoarthritis of the Knee
A Phase 2 study testing lacosamide in people with Osteoarthritis, run by UCB Pharma at 26 sites in 7 countries.
Trial summary
The purpose of this trial is to evaluate the effectiveness, safety and tolerability of lacosamide (LCM) 400mg/day in treating the signs and symptoms of osteoarthritis of the knee. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- lacosamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 194 participants
- Where
- 26 sitesin 7 countries
- Study dates
- Mar 2007to Jan 2008
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has symptomatic osteoarthritis of the knee diagnosed using clinical and radiographic evidence as well as ACR criteria with symptom duration of at least 6 months.
- Subject requires therapeutic dose of an NSAID, COX-2 NSAID, and/or paracetamol/acetaminophen for osteoarthritis pain of the index knee and has taken that medication at least 5 days per week for the last 4 weeks prior to the screening visit (Visit 1).
Who cannot join
- Subject is not able to withdraw NSAIDs, COX-2 NSAIDs and/or paracetamol
- Subject is taking analgesic other than NSAIDs COX-2 NSAIDs and/or paracetamol
- Subject is planning to begin or stop treatment with glucosamine and/or chondroitin during the trial
Trial locations and contacts
26 sites in 7 countries.
26 sites in 7 countries
Hungary6 sites
Study site
Debrecen
Study site
Esztegom
Study site
Győr
Study site
Gyula
Study site
Verseghy
Study site
Veszprém
Germany5 sites
Study site
Bad Hersfeld
Study site
Berlin
Study site
Hamburg
Study site
Leipzig
Study site
München
Poland4 sites
Study site
Bialystok
Study site
Krakow
Study site
Torun
Study site
Warsaw
Romania4 sites
Study site
Brăila
Study site
Lasi
Study site
Targoviste
Study site
Timișoara
United Kingdom4 sites
Study site
Morriston
Study site
Newcastle
Study site
Oxford
Study site
Stanmore
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of 400mg/Day Lacosamide in Subjects With Osteoarthritis of the Knee
The purpose of this trial is to evaluate the effectiveness, safety and tolerability of lacosamide (LCM) 400mg/day in treating the signs and symptoms of osteoarthritis of the knee.
Read the detailed description
LCM is an investigational drug that is being studied as a treatment in male and female patients who are diagnosed with osteoarthritis of the knee and require therapeutic doses of NSAIDs, COX-2 NSAIDs and/or paracetamol. This trial will be conducted exclusively in Europe.
The study has an adaptive 3-stage group sequential design.
The trial will last a total of 17 weeks. There will be a 2 week period to wean off current medication, followed by a 4 week period where the patient will receive placebo (inactive drug) or gradually increasing doses of LCM up to the target dose of 400mg/day. The target dose or placebo will be maintained for 8 weeks followed by a 1 week reduction period then a 2 week safety follow up period.
The last subject is expected to be enrolled in December 2007.
The study was terminated based on the outcome of the planned first interim analysis, which was performed as defined in the protocol in a subset of patients. It was decided not to continue the trial. No safety concerns were identified.
- Conditions
- Osteoarthritis
- Being tested
- lacosamide, Placebo
- Keywords
- Osteoarthritis, lacosamide, VIMPAT
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lacosamideDrug
Also called VIMPAT
50 or 100mg tablet, 400mg daily, for 12 weeks
PlaceboOther
50 or 100mg tablet, 400mg daily, for 12 weeks, matched to Lacosamide
| Study group | Role | What they receive |
|---|---|---|
| Lacosamide | Experimental | lacosamide (LCM) Receives: Drug: lacosamide |
| Placebo | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the Western Ontario and McMaster Universities (WOMAC) Pain Subscale Score (Visual Analogue Scale Version) From Baseline to the End of the 8 Week Maintenance Period
The Visual Analogue Scale (VAS) version of the WOMAC pain subscale ranges from 0 to 100, high values describe high grade of pain.
Measured: Baseline, end of 8 week Maintenance Period
Secondary outcomes (8)
Change From Baseline to End of 8 Week Maintenance Period in WOMAC Physical Function Subscale Score.
The WOMAC physical function subscale score (Visual Analogue Scale version) ranges from 0 to 100, high values describe high grade of difficulty in performing daily activities.
Measured: Baseline, end of 8 week Maintenance Period
Change From Baseline to End of 8 Week Maintenance Period in WOMAC Stiffness Subscale Score.
The WOMAC stiffness subscale score (Visual Analogue Scale version) ranges from 0 to 100, high values describe high grade of stiffness.
Measured: Baseline, end of 8 week Maintenance Period
Change From Baseline to End of 8 Week Maintenance Period in Total WOMAC Score.
The WOMAC total score is the sum of the normalized subscale scores for pain, stiffness, and physical function and ranges from 0 to 300, high values describe high grade of impact.
Measured: Baseline, end of 8 week Maintenance Period
Patient's Global Impression of Change From Baseline at the End of 8 Week Maintenance Period.
Patient's global impression of change from baseline is a score that ranges from 'very much worse' to 'very much improved'.
Measured: at the end of 8 week Maintenance Period
Response at the End of 8 Week Maintenance Period Versus Baseline Based on the (Slightly Modified)Criteria of the Osteoarthritis Research Society International (OARSI) and the Outcome Measures in Rheumatology Initiative (OMERACT).
Improvement = reduction of >= 20% and >= 10 mm in both WOMAC pain and physical function subscale. Those who met the criteria in either of the subscales had improved if response to Patient's Global Impression of change from baseline was at least 'mildly improved'. High improvement = reduction of >= 50% and >= 20 mm in either of the subscales. Response = either high improvement or improvement.
Measured: Baseline, end of 8 week Maintenance Period
Amount of Rescue Medication Use During 8 Week Maintenance Period.
Use of rescue medication is expressed in number of tablets equivalent to 500 mg Paracetamol per day.
Measured: during 8 week Maintenance Period
Change From Baseline to End of 8 Week Maintenance Period in Perception of Pain Interference With Subject's Sleep.
Pain interference with sleep refers to patient's last evening prior to the visit and was assessed using a 100mm visual analog scale (VAS). The VAS ranges from 0 (did not interfere) to 100 (completely interfered).
Measured: Baseline, end of 8 week Maintenance Period
Change From Baseline to End of 8 Week Maintenance Period in Profile of Mood States (Total Mood Disturbance Score).
Total Mood Disturbance score sums up over the domain scores regarding Tension-anxiety, Depression-ejection, Anger-hostility, Vigor-activity (was subtracted), Fatigue-inertia, Confusion-bewilderment. Domain scores were derived as sum of the respective items and range from 0 to 20. With exception of Vigor-activity high values describe bad mood.
Measured: Baseline, end of 8 week Maintenance Period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2007 (estimated)
- Study startMar 2007
- Primary completionNov 2007
- Study completionJan 2008
Why it stopped: Based on the outcome of the planned first interim analysis, it was decided not to continue the trial. No safety concerns were identified.
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.
- Other trials for OsteoarthritisStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 194 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
- NCT00485472
- Sponsor's protocol ID
- SP0905
- Other IDs
- 2006-005048-97
- Status last verified
- Jul 2017
- First submitted
- 12 Jun 2007
- Last updated
- 28 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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
- A Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of 400mg/Day Lacosamide in Subjects With Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT00485472
- Acronym / sponsor ID
- SP0905
- Conditions
- Osteoarthritis
- Keywords
- Osteoarthritis, lacosamide, VIMPAT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Based on the outcome of the planned first interim analysis, it was decided not to continue the trial. No safety concerns were identified.
- Enrolment
- 194 participants (actual)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Nov 2007 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 13 Jun 2007 (estimated)
- Results
- Posted 22 Sep 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this trial is to evaluate the effectiveness, safety and tolerability of lacosamide (LCM) 400mg/day in treating the signs and symptoms of osteoarthritis of the knee.
Detailed description
LCM is an investigational drug that is being studied as a treatment in male and female patients who are diagnosed with osteoarthritis of the knee and require therapeutic doses of NSAIDs, COX-2 NSAIDs and/or paracetamol. This trial will be conducted exclusively in Europe.
The study has an adaptive 3-stage group sequential design.
The trial will last a total of 17 weeks. There will be a 2 week period to wean off current medication, followed by a 4 week period where the patient will receive placebo (inactive drug) or gradually increasing doses of LCM up to the target dose of 400mg/day. The target dose or placebo will be maintained for 8 weeks followed by a 1 week reduction period then a 2 week safety follow up period.
The last subject is expected to be enrolled in December 2007.
The study was terminated based on the outcome of the planned first interim analysis, which was performed as defined in the protocol in a subset of patients. It was decided not to continue the trial. No safety concerns were identified.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lacosamide | Experimental | Drug: lacosamidelacosamide (LCM) |
| Placebo | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject has symptomatic osteoarthritis of the knee diagnosed using clinical and radiographic evidence as well as ACR criteria with symptom duration of at least 6 months.
- Subject requires therapeutic dose of an NSAID, COX-2 NSAID, and/or paracetamol/acetaminophen for osteoarthritis pain of the index knee and has taken that medication at least 5 days per week for the last 4 weeks prior to the screening visit (Visit 1).
Key exclusion criteria (3 listed)
- Subject is not able to withdraw NSAIDs, COX-2 NSAIDs and/or paracetamol
- Subject is taking analgesic other than NSAIDs COX-2 NSAIDs and/or paracetamol
- Subject is planning to begin or stop treatment with glucosamine and/or chondroitin during the trial
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: VIMPAT50 or 100mg tablet, 400mg daily, for 12 weeks | Drug | Lacosamide |
| Placebo50 or 100mg tablet, 400mg daily, for 12 weeks, matched to Lacosamide | Other | Placebo |
Primary outcome
Change of the Western Ontario and McMaster Universities (WOMAC) Pain Subscale Score (Visual Analogue Scale Version) From Baseline to the End of the 8 Week Maintenance Period
Time frame: Baseline, end of 8 week Maintenance Period
The Visual Analogue Scale (VAS) version of the WOMAC pain subscale ranges from 0 to 100, high values describe high grade of pain.
8 secondary outcomes
Change From Baseline to End of 8 Week Maintenance Period in WOMAC Physical Function Subscale Score.
Time frame: Baseline, end of 8 week Maintenance Period
Change From Baseline to End of 8 Week Maintenance Period in WOMAC Stiffness Subscale Score.
Time frame: Baseline, end of 8 week Maintenance Period
Change From Baseline to End of 8 Week Maintenance Period in Total WOMAC Score.
Time frame: Baseline, end of 8 week Maintenance Period
Patient's Global Impression of Change From Baseline at the End of 8 Week Maintenance Period.
Time frame: at the end of 8 week Maintenance Period
Response at the End of 8 Week Maintenance Period Versus Baseline Based on the (Slightly Modified)Criteria of the Osteoarthritis Research Society International (OARSI) and the Outcome Measures in Rheumatology Initiative (OMERACT).
Time frame: Baseline, end of 8 week Maintenance Period
Amount of Rescue Medication Use During 8 Week Maintenance Period.
Time frame: during 8 week Maintenance Period
Change From Baseline to End of 8 Week Maintenance Period in Perception of Pain Interference With Subject's Sleep.
Time frame: Baseline, end of 8 week Maintenance Period
Change From Baseline to End of 8 Week Maintenance Period in Profile of Mood States (Total Mood Disturbance Score).
Time frame: Baseline, end of 8 week Maintenance Period
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.
- 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)
26 sites in 7 countries: 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 Osteoarthritis, run by UCB Pharma at 26 sites in 7 countries.
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 3 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: stopped early, 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 26 sites in Hungary, Germany, Poland, Romania, United Kingdom and 2 more countries. 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. 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?
Yes. Results are posted in the registry (first posted 22 Sep 2009). 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?
Change of the Western Ontario and McMaster Universities (WOMAC) Pain Subscale Score (Visual Analogue Scale Version) From Baseline to the End of the 8 Week Maintenance Period (time frame: Baseline, end of 8 week Maintenance Period). 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 28 Aug 2017.