EpilepsyPhase 3NCT00175903
Levetiracetam Versus Standard Antiepileptic Drugs (Carbamazepine and Valproate) Used as Monotherapy in Patients With Newly Diagnosed Epilepsy
A Phase 3 study testing Levetiracetam and Valproate Extended Release in people with Epilepsy, run by UCB Pharma at 229 sites in 24 countries.
Trial summary
Study N01175 was to compare overall effectiveness (efficacy and safety) of levetiracetam (LEV) versus the 2 older antiepileptic drugs (AEDs), sodium valproate extended release (VPA-ER) and carbamazepine controlled release (CBZ-CR) in the treatment of subjects with newly diagnosed epilepsy. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- Levetiracetam and Valproate Extended Release
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,701 participants
- Where
- 229 sitesin 24 countries
- Study dates
- Feb 2005to Oct 2007
- Phase
- Phase 3
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of epilepsy (all types of seizures) was made during the past year
- Subjects must have had at least two unprovoked seizures in the past 2 years with at least one during the last 6 months
- Female subjects without childbearing potential are eligible. Female subjects with childbearing potential are eligible if they use a medically accepted contraceptive method
Who cannot join
- Subjects previously allocated to a trial treatment (CBZ, VPA and LEV) used in this trial
- Participation in another clinical trial with an investigational drug or device within 12 weeks of the selection visit (V1), or at any time during this trial
- Pregnant or lactating women
- Presence of known pseudoseizures within the last year
- Uncountable seizures (clusters) or history of convulsive status epilepticus
- Any disorder or condition that may interfere with the absorption, distribution, metabolisation or excretion of drugs
Show all 9Show fewer
- History of suicide attempt, current suicidal ideation, or other serious psychiatric disorders requiring or having required hospitalization or medication within the previous five years
- Presence of progressive cerebral disease, any other progressively degenerative neurological disease, or any cerebral tumors
- Presence of a terminal illness or any medical condition that might interfere with the subject's trial participation
Trial locations and contacts
229 sites in 24 countries.
229 sites in 24 countries
Germany37 sites
Study site
Altenburg
Study site
Arnsdorf
Study site
Aschaffenburg
Study site
Bamberg
Study site
Berlin
Study site
Bernau
Study site
Bernburg
Study site
Bielefeld
Study site
Bonn
Study site
Butzbach
Study site
Celle
Study site
Dillingen
Study site
Dresden
Study site
Düsseldorf
Study site
Erbach im Odenwald
Study site
Essen
Study site
Giessen
Study site
Göttingen
Study site
Halle
Study site
Hamburg
Study site
Hohenschönhausen
Study site
Jena
Study site
Königsbrück
Study site
Leipzig
Study site
Lengerich
Study site
Liegau-Augustusbad
Study site
Mittweida
Study site
Münster
Study site
Neukirchen-Vluyn
Study site
Neumünster
Study site
Oldenburg
Study site
Potsdam
Study site
Quickborn
Study site
Regenburg
Study site
Schalmstadt-Treysa
Study site
Siegen
Study site
Wermsdorf
Italy33 sites
Study site
Ancona
Study site
Asti
Study site
Bari
Study site
Busto Arsizio
Study site
Casarano
Study site
Catania
Study site
Cremona
Study site
Eboli
Study site
Faenza
Study site
Ferrara
Study site
Florence
Study site
Foggia
Study site
Forlì
Study site
Garbagnate
Study site
Grosseto
Study site
Milan
Study site
Naples
Study site
Padova
Study site
Perugia
Study site
Pescara
Study site
Pisa
Study site
Potenza
Study site
Prato
Study site
Ragusa
Study site
Reggio Emilia
Study site
Roma
Study site
Siena
Study site
Taranto
Study site
Torino
Study site
Udine
Study site
Verona
Study site
Vimercate
Study site
Vittoria
France25 sites
Study site
Blaye
Study site
Bordeaux
Study site
Brest
Study site
Carcassonne
Study site
Cherbourg
Study site
Colmar
Study site
Creil
Study site
Dijon
Study site
Freyming-Merlebach
Study site
Grenoble
Study site
La Seyne-sur-Mer
Study site
Lille
Study site
Lyon
Study site
Marseille
Study site
Mulhouse
Study site
Nancy
Study site
Nîmes
Study site
Paris
Study site
Rennes
Study site
Roanne
Study site
Saint-Brieuc
Study site
Saint-Quentin
Study site
Toulouse
Study site
Valenciennes
Study site
Vesoul
Spain15 sites
Study site
Badalona
Study site
Barakaldo Vizcaya
Study site
Barcelona
Study site
Castellon
Study site
Elda
Study site
Girona
Study site
Leganes (Madrid)
Study site
Madrid
Study site
Móstoles
Study site
Murcia
Study site
Santa Cruz de Tenerife
Study site
Seville
Study site
Terrassa
Study site
Valencia
Study site
Vigo
United Kingdom14 sites
Study site
Ashford
Study site
Bangor
Study site
Bristol
Study site
Cardiff
Study site
Dundee
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Leeds
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Liverpool
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London
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Plymouth
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Southampton
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Stoke-on-Trent
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Sunderland
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Swindon
Study site
Truro
Australia12 sites
Study site
Adelaide
Study site
Bedford Park
Study site
Brisbane
Study site
Cairns
Study site
Camperdown
Study site
Chatswood
Study site
Clayton
Study site
Maroochydore
Study site
Parkville
Study site
Perth
Study site
Randwick
Study site
West Heidelberg
Poland11 sites
Study site
Bydgoszcz
Study site
Częstochowa
Study site
Gdansk
Study site
Kielce
Study site
Krakow
Study site
Lodz
Study site
Lublin
Study site
Olsztyn
Study site
Poznan
Study site
Warsaw
Study site
Zgierz
Belgium10 sites
Study site
Bruges
Study site
Dendermonde
Study site
Edegem
Study site
Ghent
Study site
Haine-Saint-Paul
Study site
Jette
Study site
Kortrijk
Study site
Leuven
Study site
Ostend
Study site
Ottignies
Norway10 sites
Study site
Drammen
Study site
Fredrikstad
Study site
Lillehammer
Study site
Molde
Study site
Nordbyhagen
Study site
Sandvika
Study site
Stavanger
Study site
Tønsberg
Study site
Tromsø
Study site
Trondheim
Austria6 sites
Study site
Graz
Study site
Innsbrick
Study site
Klagenfurt
Study site
Linz
Study site
Steyr
Study site
Vienna
Greece6 sites
Study site
Aklion
Study site
Alexandroupoli
Study site
Athens
Study site
Pátrai
Study site
Thessaloniki
Study site
Thessalonikis
Netherlands6 sites
Study site
Eindhoven
Study site
Heerenvegen
Study site
Leeuwarden
Study site
Maastricht
Study site
Nijmegen
Study site
Tilburg
Switzerland6 sites
Study site
Bern
Study site
Biel
Study site
Geneva
Study site
Lausanne
Study site
Sankt Gallen
Study site
Zurich
Slovakia5 sites
Study site
Bratislava
Study site
Dolný Kubín
Study site
Dubnica nad Váhom
Study site
Martin
Study site
Žilina
Sweden5 sites
Study site
Karlstad
Study site
Linköping
Study site
Motala
Study site
Stockholm
Study site
Varberg
Turkey (Türkiye)5 sites
Study site
Adana
Study site
Ankara
Study site
Bursa
Study site
Istanbul
Study site
Izmir
Denmark4 sites
Study site
Aalborg
Study site
Copenhagen
Study site
Holbæk
Study site
Holstebro
Russia3 sites
Study site
Krasnoyasrk
Study site
Moscow
Study site
Saint Petersburg
About this study
Official title: A Therapeutic Confirmatory, Open-label, Multi-center, Randomized 2 Parallel Groups, Community-based Trial Studying the Efficacy and Safety of Levetiracetam (1000 to 3000 mg/Day Oral Tablets 250-500 mg b.i.d.) Compared to Sodium Valproate (1000 to 2000 mg/Day Oral ER Tablets 300-500 mg b.i.d.) and Carbamazepine (600 to 1600 mg/Day Oral CR Tablets 200-400 mg b.i.d.) as Monotherapy in Subjects With Newly Diagnosed Epilepsy.
Study N01175 was to compare overall effectiveness (efficacy and safety) of levetiracetam (LEV) versus the 2 older antiepileptic drugs (AEDs), sodium valproate extended release (VPA-ER) and carbamazepine controlled release (CBZ-CR) in the treatment of subjects with newly diagnosed epilepsy.
- Conditions
- Epilepsy
- Being tested
- Levetiracetam, Carbamazepine Controlled Release (CBZ-CR), Valproate Extended Release
- Keywords
- Newly Diagnosed Epilepsy, Levetiracetam, Keppra, Carbamazepine, Valproate
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevetiracetamDrug
Daily dose of 1000 to 3000 mg film-coated oral tablets, 250-500 mg twice daily.
Carbamazepine Controlled Release (CBZ-CR)Drug
Daily dose of 600-1600 mg CR oral tablets, 200 mg and 400 mg twice daily.
Valproate Extended ReleaseDrug
Daily dose of 1000-2000 mg ER oral tablets, 300 mg and 500 mg twice daily.
| Study group | Role | What they receive |
|---|---|---|
| Levetiracetam | Experimental | Daily dose of 1000 to 3000 mg film-coated oral tablets, 250-500 mg twice daily. Receives: Drug: Levetiracetam |
| Older Antepileptic Drugs | Active comparator | Older AEDs consist of CBZ-CR 200 mg and 400 mg and VPA-ER 300 mg and 500 mg. Receives: Drug: Carbamazepine Controlled Release (CBZ-CR); Drug: Valproate Extended Release |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to withdrawal from study medication (starting at V1) as a measure of combined efficacy and safety
Measured: Visit 1 to End of Study (approximately 52 weeks)
Secondary outcomes (11)
The time to withdrawal comparing Levetiracetam versus the older Antiepileptic Drugs based on the subset of subjects whose best recommended treatment was Carbamazepine Controlled Release or Sodium Valproate Extended Release
Measured: Visit 1 to End of Study (approximately 52 weeks)
The retention rate after 6 months comparing Levetiracetam versus the older Antiepileptic Drugs
Measured: Visit 1 to Visit 4 (approximately 26 weeks)
The retention rate after 12 months comparing Levetiracetam versus the older Antiepileptic Drugs
Measured: Visit 1 to Visit 5 (approximately 52 weeks)
The retention rate after 6 months comparing Levetiracetam versus older Antiepileptic Drugs based on the subset of subjects whose best recommended treatment was Carbamazepine Controlled Release or Sodium Valproate Extended Release
Measured: Visit 1 to Visit 4 (approximately 26 weeks)
The retention rate after 12 months comparing Levetiracetam versus older Antiepileptic Drugs based on the subset of subjects whose best recommended treatment was Carbamazepine Controlled Release or Sodium Valproate Extended Release
Measured: Visit 1 to Visit 5 (approximately 52 weeks)
Seizure freedom at 6 months comparing Levetiracetam versus older Antiepileptic Drugs
Measured: Visit 1 to Visit 4 (approximately 26 weeks)
Seizure freedom at 12 months comparing Levetiracetam versus older Antiepileptic Drugs
Measured: Visit 1 to Visit 5 (approximately 52 weeks)
Seizure freedom at 6 months comparing Levetiracetam versus older Antiepileptic Drugs based on based on the subset of subjects whose best recommended treatment was Carbamazepine Controlled Release or Sodium Valproate Extended Release
Measured: Visit 1 to Visit 4 (approximately 26 weeks)
Seizure freedom at 12 months comparing Levetiracetam versus older Antiepileptic Drugs based on based on the subset of subjects whose best recommended treatment was Carbamazepine Controlled Release or Sodium Valproate Extended Release
Measured: Visit 1 to Visit 5 (approximately 52 weeks)
Time to first seizure comparing Levetiracetam versus older Antiepileptic Drugs
Measured: Visit 1 to End of Study (approximately 52 weeks)
Time to first seizure comparing Levetiracetam versus older Antiepileptic Drugs based on the subset of subjects whose best recommended treatment was Carbamazepine Controlled Release or Sodium Valproate Extended Release
Measured: Visit 1 to End of Study (approximately 52 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startFeb 2005
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,701 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, UCB Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00175903
- Sponsor's protocol ID
- N01175
- Other IDs
- 2004-001339-41, 2004
- Status last verified
- Mar 2015
- First submitted
- 9 Sep 2005
- Last updated
- 17 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Pohlmann-Eden B, Marson AG, Noack-Rink M, Ramirez F, Tofighy A, Werhahn KJ, Wild I, Trinka E. Comparative effectiveness of levetiracetam, valproate and carbamazepine among elderly patients with newly diagnosed epilepsy: subgroup analysis of the randomized, unblinded KOMET study. BMC Neurol. 2016 Aug 23;16(1):149. doi: 10.1186/s12883-016-0663-7.
PubMed 27552848Trinka E, Marson AG, Van Paesschen W, Kalviainen R, Marovac J, Duncan B, Buyle S, Hallstrom Y, Hon P, Muscas GC, Newton M, Meencke HJ, Smith PE, Pohlmann-Eden B; KOMET Study Group. KOMET: an unblinded, randomised, two parallel-group, stratified trial comparing the effectiveness of levetiracetam with controlled-release carbamazepine and extended-release sodium valproate as monotherapy in patients with newly diagnosed epilepsy. J Neurol Neurosurg Psychiatry. 2013 Oct;84(10):1138-47. doi: 10.1136/jnnp-2011-300376. Epub 2012 Aug 29.
PubMed 22933814
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Therapeutic Confirmatory, Open-label, Multi-center, Randomized 2 Parallel Groups, Community-based Trial Studying the Efficacy and Safety of Levetiracetam (1000 to 3000 mg/Day Oral Tablets 250-500 mg b.i.d.) Compared to Sodium Valproate (1000 to 2000 mg/Day Oral ER Tablets 300-500 mg b.i.d.) and Carbamazepine (600 to 1600 mg/Day Oral CR Tablets 200-400 mg b.i.d.) as Monotherapy in Subjects With Newly Diagnosed Epilepsy.
- ClinicalTrials.gov ID
- NCT00175903
- Acronym / sponsor ID
- N01175
- Conditions
- Epilepsy
- Keywords
- Newly Diagnosed Epilepsy, Levetiracetam, Keppra, Carbamazepine, Valproate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,701 participants (actual)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- Feb 2005
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 15 Sep 2005 (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.
Study N01175 was to compare overall effectiveness (efficacy and safety) of levetiracetam (LEV) versus the 2 older antiepileptic drugs (AEDs), sodium valproate extended release (VPA-ER) and carbamazepine controlled release (CBZ-CR) in the treatment of subjects with newly diagnosed epilepsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levetiracetam | Experimental | Drug: LevetiracetamDaily dose of 1000 to 3000 mg film-coated oral tablets, 250-500 mg twice daily. |
| Older Antepileptic Drugs | Active comparator | Drug: Carbamazepine Controlled Release (CBZ-CR), Drug: Valproate Extended ReleaseOlder AEDs consist of CBZ-CR 200 mg and 400 mg and VPA-ER 300 mg and 500 mg. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of epilepsy (all types of seizures) was made during the past year
- Subjects must have had at least two unprovoked seizures in the past 2 years with at least one during the last 6 months
- Female subjects without childbearing potential are eligible. Female subjects with childbearing potential are eligible if they use a medically accepted contraceptive method
Key exclusion criteria (9 listed)
- Subjects previously allocated to a trial treatment (CBZ, VPA and LEV) used in this trial
- Participation in another clinical trial with an investigational drug or device within 12 weeks of the selection visit (V1), or at any time during this trial
- Pregnant or lactating women
- Presence of known pseudoseizures within the last year
- Uncountable seizures (clusters) or history of convulsive status epilepticus
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 |
|---|---|---|
| LevetiracetamDaily dose of 1000 to 3000 mg film-coated oral tablets, 250-500 mg twice daily. | Drug | Levetiracetam |
| Carbamazepine Controlled Release (CBZ-CR)Daily dose of 600-1600 mg CR oral tablets, 200 mg and 400 mg twice daily. | Drug | Older Antepileptic Drugs |
| Valproate Extended ReleaseDaily dose of 1000-2000 mg ER oral tablets, 300 mg and 500 mg twice daily. | Drug | Older Antepileptic Drugs |
Primary outcome
Time to withdrawal from study medication (starting at V1) as a measure of combined efficacy and safety
Time frame: Visit 1 to End of Study (approximately 52 weeks)
11 secondary outcomes
The time to withdrawal comparing Levetiracetam versus the older Antiepileptic Drugs based on the subset of subjects whose best recommended treatment was Carbamazepine Controlled Release or Sodium Valproate Extended Release
Time frame: Visit 1 to End of Study (approximately 52 weeks)
The retention rate after 6 months comparing Levetiracetam versus the older Antiepileptic Drugs
Time frame: Visit 1 to Visit 4 (approximately 26 weeks)
The retention rate after 12 months comparing Levetiracetam versus the older Antiepileptic Drugs
Time frame: Visit 1 to Visit 5 (approximately 52 weeks)
The retention rate after 6 months comparing Levetiracetam versus older Antiepileptic Drugs based on the subset of subjects whose best recommended treatment was Carbamazepine Controlled Release or Sodium Valproate Extended Release
Time frame: Visit 1 to Visit 4 (approximately 26 weeks)
The retention rate after 12 months comparing Levetiracetam versus older Antiepileptic Drugs based on the subset of subjects whose best recommended treatment was Carbamazepine Controlled Release or Sodium Valproate Extended Release
Time frame: Visit 1 to Visit 5 (approximately 52 weeks)
Seizure freedom at 6 months comparing Levetiracetam versus older Antiepileptic Drugs
Time frame: Visit 1 to Visit 4 (approximately 26 weeks)
Seizure freedom at 12 months comparing Levetiracetam versus older Antiepileptic Drugs
Time frame: Visit 1 to Visit 5 (approximately 52 weeks)
Seizure freedom at 6 months comparing Levetiracetam versus older Antiepileptic Drugs based on based on the subset of subjects whose best recommended treatment was Carbamazepine Controlled Release or Sodium Valproate Extended Release
Time frame: Visit 1 to Visit 4 (approximately 26 weeks)
Seizure freedom at 12 months comparing Levetiracetam versus older Antiepileptic Drugs based on based on the subset of subjects whose best recommended treatment was Carbamazepine Controlled Release or Sodium Valproate Extended Release
Time frame: Visit 1 to Visit 5 (approximately 52 weeks)
Time to first seizure comparing Levetiracetam versus older Antiepileptic Drugs
Time frame: Visit 1 to End of Study (approximately 52 weeks)
Time to first seizure comparing Levetiracetam versus older Antiepileptic Drugs based on the subset of subjects whose best recommended treatment was Carbamazepine Controlled Release or Sodium Valproate Extended Release
Time frame: Visit 1 to End of Study (approximately 52 weeks)
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 17 Mar 2015.
- Derived from this study: PubMed 27552848Pohlmann-Eden B, Marson AG, Noack-Rink M, Ramirez F, Tofighy A, Werhahn KJ, Wild I, Trinka E. Comparative effectiveness of levetiracetam, valproate and carbamazepine among elderly patients with newly diagnosed epilepsy: subgroup analysis of the randomized, unblinded KOMET study. BMC Neurol. 2016 Aug 23;16(1):149. doi: 10.1186/s12883-016-0663-7.
- Derived from this study: PubMed 22933814Trinka E, Marson AG, Van Paesschen W, Kalviainen R, Marovac J, Duncan B, Buyle S, Hallstrom Y, Hon P, Muscas GC, Newton M, Meencke HJ, Smith PE, Pohlmann-Eden B; KOMET Study Group. KOMET: an unblinded, randomised, two parallel-group, stratified trial comparing the effectiveness of levetiracetam with controlled-release carbamazepine and extended-release sodium valproate as monotherapy in patients with newly diagnosed epilepsy. J Neurol Neurosurg Psychiatry. 2013 Oct;84(10):1138-47. doi: 10.1136/jnnp-2011-300376. Epub 2012 Aug 29.
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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
UCB Pharma
229 sites in 24 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Levetiracetam and Valproate Extended Release in people with Epilepsy, run by UCB Pharma at 229 sites in 24 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 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 17 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 229 sites in Germany, Italy, France, Spain, United Kingdom and 19 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Time to withdrawal from study medication (starting at V1) as a measure of combined efficacy and safety (time frame: Visit 1 to End of Study (approximately 52 weeks)). 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 NCT00175903, 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 17 Mar 2015.