EpilepsyPhase 3NCT00693017

Efficacy and Safety of Adjunctive Zonisamide in Myoclonic Seizures Associated With Idiopathic Generalised Epilepsy

A Phase 3 study testing Zonisamide in people with Epilepsy, run by Eisai Limited at 72 sites in 13 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

This study is intended to provide evidence that zonisamide is safe and effective in the treatment of myoclonic seizures. The total planned trial duration will be 6.5 months. After that, subjects who have completed the study will be eligible to enroll in an open-label extension study until zonisamide is marketed for… Read more about this study

Who is it for?: Ages 12 to 65 years
Conditions the study is for: Epilepsy
What is being tested?: Zonisamide
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 10 participants
Where: 72 sitesin 13 countries
Study dates: Jun 2008to Nov 2008
Phase: Phase 3
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 12 to 65 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Subject is male or female and aged 12-65 years.
Subject has at least eight days with at least one myoclonic seizure over the two months Baseline Period. Myoclonic seizures must occur in the context of IGE and may be accompanied by other primary generalized seizures, provided these are also consistent with a diagnosis of Idiopathic Generalized Epilepsy (IGE).
Subject (or parent/caregiver, for subjects below the age of consent) is willing to sign an informed consent form. Subjects below the age of consent in their country, must where appropriate be willing to give informed (written or verbal) assent. Subjects from the age specified in local regulations will be required to sign an appropriate informed consent form.
Subject is taking a stable regimen of one or two other AEDs for at least two weeks prior to Visit 1 (start of the Baseline Period).
Subject has a clinical diagnosis of any type of idiopathic generalised epilepsy (IGE) which has myoclonic seizures (and which may be accompanied by other generalised seizure types), according to the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures (1981) and the ILAE Classification of Epilepsies and Epileptic Syndromes (1989). Diagnosis should have been established by clinical history, electroencephalogram (EEG) and computed tomography/magnetic resonance imaging (CT/MRI) of the brain consistent with idiopathic generalised epilepsy. A CT/MRI scan should have been performed within five years of the screening visit or, if not available from this period, should be performed in the Baseline Period.
EEG should have been performed within one year of the screening visit or, if not available from this period, should be performed in the Baseline Period.
Female subjects are pre-menarchal, or if of childbearing potential, are not pregnant or lactating, or are post-menopausal.
Female subjects of childbearing potential ≥ 18 years must abide by one of the following medically acceptable contraceptive measures: oral contraception pill, contraceptive injections, implants or patches, intrauterine device in place for at least three months or vasectomised partner or abstinence throughout the study. Subjects <18 years and of childbearing potential must be either abstinent or willing to use one of the medically appropriate forms of contraception for the duration of the study.

Who cannot join

Subject has progressive or focal neurological disease (as determined by preexisting brain imaging such as CT or MRI performed maximally five years before the screening visit), or clinically significant organic disease.
Subject has a history of, or results of clinical investigations (including EEG data) that are suggestive of, partial seizures as defined by the ILAE, including generalised tonic clonic seizures which are suspected to be secondarily generalised.
Subjects with cryptogenic or symptomatic generalised epilepsy.
Subjects with psychogenic seizures.
Subject has a history of convulsive status epilepticus within a year of screening while complying with AEDs.
Subject has a history of renal calculi or renal insufficiency (above the upper normal limits of creatinine).

Show all 22Show fewer

Subject has a known diagnosis of human immunodeficiency virus (HIV) or hepatitis B or C.
Subject has a predisposing condition that might interfere with absorption, distribution, or excretion of zonisamide.
Subject has a history of sensitivity to sulfonamide drugs or to zonisamide or any of its excipients.
Subject has a recent history of excessive alcohol use or drug abuse.
Subject has a history of suicide attempt in the five years before the screening visit.
Subject has abnormal screening laboratory values that are clinically significant.
Subject has a history of demonstrated non-compliance with treatment, or the subject or parent/caregiver can be reasonably expected not to be compliant with study procedures or to complete the study.
Subject has participated in a study of an investigational drug or device within 30 days prior to screening.
Subject has received previous treatment with zonisamide.
Subject is treated with ketogenic diet or vagus nerve stimulator.
Subject has a history of necessary treatment with rescue benzodiazepines which is foreseen to continue during the study. Rescue benzodiazepines will not be allowed in this study (stable dosing with a benzodiazepine as (one of the) baseline anti-epileptic drug(s) is allowed).
Concomitant use of acetazolamide, carbonic anhydrase inhibitors such as topiramate and drugs with anticholinergic activity.
Current psychosis or moderate to severe depression, or use of anti-psychotic drugs, MAOIs, tricyclic antidepressants, benzodiazepine or barbiturate treatment for disorders other than epilepsy, and stimulants (amphetamine derivatives) within 28 days before the screening visit.
Concomitant use of felbamate or use of felbamate within two months prior to Visit 1.
Subject is unable to swallow capsules.
Subject is not in general good health as determined by medical history, physical exam and screening laboratory results.

Trial locations and contacts

72 sites in 13 countries.

Country

City, postcode or hospital

72 sites in 13 countries

Russia12 sites

GOU VPO Krasnoyarskaya State Medical Academy of Roszdrav
Krasnoyarsk, 660022
FGU Moscow Research Institute of Psychiatry of Roszdrav
Moscow, 107076
GOU VPO Russian State Medical University of Roszdrav
Moscow, 117997
GUZ of Moscow City Clinical Hospital #1 n.a. N.I.Pirogov
Moscow, 119049
GOU VPO Moscow State University of Medicine and Dentistry of Roszdra
Moscow, 127473
GOU VPO Novosibirsk State Medical University of Roszdrav
Novosibirsk, 630091
GU St. Petersburg Research Institute of Psychoneurology Bekhtereva of Roszdrav
Saint Petersburg, 192019
St. Petersburg State Medical Pediatric Academy
Saint Petersburg, 194100
GOU VPO St. Petersburg State Medical University
Saint Petersburg, 197022
GOU VPO Smolensk State Medical Academy of Roszdrav
Smolensk, 214018
GOU VPO Smolensk State Medical Academy of Roszdrav
Smolensk, 214019
Yaroslavskaya State Medical Academy
Yaroslavl, 150000

Other trials in Russia

Hungary9 sites

National Institute of Psychiatry and Neurology
Budapest, 1021
Heim Pal Hospital
Budapest, 1089
Szent Istvan Hospital
Budapest, 1091
Orszagos Idegsebeszeti Tudomanyos Intezet
Budapest, 1145
Bethesda Hospital for Children
Budapest, 1146
Bekes County Pandy Kalman Hospital
Gyula, 5703
Bacs-Kiskun County ONK Hospital
Kecskemét, 6000
Vas County Markusovszky Hospital
Szombathely, 9400
Veszprem County Csolnoky F. Hospital
Veszprém, 8200

Other trials in Hungary

Czechia7 sites

Neurologicke oddeleni
Kralove, 500 03
Private Neurologi Office
Kroměříž, 767 01
Fakultni nemocnice Olomouc
Olomouc, 775 20
Fakultni nemocnice s poliklinikou Ostrava
Ostrava, 708 52
Fakultni nemocnice Plzen
Pilsen, 305 99
Nemocnice Na Homolce
Prague, 150 30
Centrum neurologicke pece
Rychnov nad Kněžnou, 516 01

Other trials in Czechia

Romania7 sites

Centrul Medical Sana
Bucharest, 011025
Spitalul Clinic de Psihiatrie "Prof. Dr. Alexandru Obregia"
Bucharest, 041914
Spitalul Universitar de Urgenta Bucuresti
Bucharest, 050098
Spitalul Clinic Judetean de Urgenta Cluj
Cluj-Napoca, 400006
Spitalul Clinic Judetean de Urgenta "Sf Spiridon" Iasi
Lasi, 700111
Spitalul Clinic de Urgenta "Sfanta Treime"
Lasi, 700309
Spitalul Clinic Judetean de Urgenta Tg Mures
Tg Mures, 540136

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Ukraine7 sites

Tsentr Psihosomatychnoyi Patologiyi Dnipropetrovskoyi oblasnoyi klinichnoyi likarni imeni Mechnikova
Dnipropetrovsk, 49005
Derzhavna Ustanova Institut Nevrologiy
Kharkiv, 61068
Kyiv City Psychiatric Hospital #2, Poliklinichne Viddilenya
Kyiv, 2660
Miska Klinichna psihonevrologichna
Kyiv, 3080
Lvivskyiy oblasnyi Protyepileptuchnyy tsentr
Lviv, 7910
Odesskyy Derzhavnyy Medychnyy Universitet
Odesa, 65006
Vinnitskyy Natsionalnyy Medychnyy Universitet
Vinnitsa, 21005

Other trials in Ukraine

Poland6 sites

Niepubliczny ZOZ Kendron
Bialystok, 15-420
Wojewozki Szpital Specjalistyczny im. M. Kopernika
Gdansk, 80-803
Specjalistyczny Szpital Wieloprofilowy
Katowice, 40-635
Centrum Neurologii Klinicznej
Krakow, 31-530
Szpital im. M. Kopernika
Lodz, 93-513
Uniwersytet Medyczny
Poznan, 60-355

Other trials in Poland

Germany5 sites

Institut fur Diagnostik der Epilepsien (IDE) gGmbH Epilepsie-Zentrum Berlin- Brandenburg.
Berlin, 10365
Neurochirurgische Klinik der Universitat Freiburg
Freiburg im Breisgau, 79106
Interdisziplinares Epilepsiezentrum am Klinikum der Philipps-Universitat Marburg
Marburg, 35039
Neurologische Gemeinschaftspraxis
München, 80333
Universitatsklinikum Ulm
Ulm, 89081

Other trials in Germany

Australia4 sites

Strategic Health Evaluators Pty Ltd
Chatswood, New South Wales, 2067
Austin Health
Heidelburg, Victoria, 3084
The Royal Melbourne Hospital
Melbourne, Victoria, 3050
The Prince of Wales Hospital
Randwick, New South Wales, 2031

Other trials in Australia

Serbia4 sites

Clinical Center of Serbia
Belgrade, 11000
University Medical Center Zvezdara
Belgrade, 11000
Clinical center Kragujevac
Kragujevac, 34000
Clinical Center of NIS
Niš, 18000

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Croatia3 sites

CH Split
Split, HR, 10000
CH Sestre Milosrdnice University Hospita
Zagreb, HR, 10000
UHC Zagreb
Zagreb, HR, 10000

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Estonia3 sites

West-Tallinn Central Hospital
Tallinn, 10611
Neurodiagnostica AP OY
Tallinn, 11312
Tartu University Hospital
Tartu, 51014

Other trials in Estonia

Lithuania3 sites

Kaunas Medical University Hospital
Kaunas, 50009
Neuromeda
Kaunas, 50185
Vilnius University Hospital Santariskiu klinikos
Vilnius, 8861

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Finland2 sites

Kuopio Epilepsy Center
Kuopio, SF-70211
Oulu University Central Hospital
Oulu, 90220

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About this study

Official title: A Double-blind, Randomised, Placebo-controlled, Multi-centre Study to Assess the Efficacy and Safety of Adjunctive Zonisamide in Myoclonic Seizures Associated With Idiopathic Generalised Epilepsy

Conditions: Epilepsy
Being tested: Zonisamide, Placebo
Medical subject headings: Epilepsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ZonisamideDrug
Also called Zonegran
50-400 mg capsules once daily in the evening orally.
Maximum study duration 28 weeks comprising:
Baseline Period (Week -8 to Week 0): no treatment
Titration Period (Week 0 to Week 4): 50 mg daily titrated weekly until 300 mg was reached by Week 4
Maintenance Period (Week 4 to Week 16) 400 mg (or 350 mg in the event of dose limiting adverse events)
Down Titration Period (4 Weeks)
PlaceboDrug
50-400 mg Zonisamide Placebo capsules once daily in the evening orally.
Maximum study duration 28 weeks comprising:
Baseline Period (Week -8 to Week 0): no treatment
Titration Period (Week 0 to Week 4): 50 mg Zonisamide Placebo daily titrated weekly until 300 mg was reached by Week 4
Maintenance Period (Week 4 to Week 16) 400 mg Zonisamide Placebo (or 350 mg in the event of dose limiting adverse events)
Down Titration Period (4 Weeks)

Study groups in NCT00693017
Study group	Role	What they receive
Zonisamide	Active comparator	Not described Receives: Drug: Zonisamide
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Considered Responders as Assessed During the Maintenance Period
The number of participants who were considered responders during the 12 week Maintenance Period (Week 4 to Week 16). A responder was defined as a participant with a decrease >= 50% from baseline in the number of days with myoclonic seizures per 28 days (i.e. 28-day myoclonic seizure frequency in Period from Week 4 to the Week 16 visit compared to Week -8 to randomization at Week 0 [Screening/ Baseline Period]). Occurrence of seizures was documented in a seizure diary. The diary was dispensed at the Screening Visit and maintained by the participant (parent/caregiver) and reviewed at each following visit. The diary was completed daily. All seizures except myoclonic seizures were counted individually in the the diary. Due to early termination of the study by the Sponsor, no formal analyses were conducted.
Measured: Baseline (Week -8 to Week 0) and Maintenance Period (Week 4 to Week 16)

Secondary outcomes (1)

Percentage Change From Baseline in the Monthly Number of Days With Myoclonic Seizures
Percentage Change from Baseline in the monthly number of days with myoclonic seizures was assessed both for the Maintenance Period alone (Week 4 to Week 16) and for the entire double-blind treatment period (Week 0 to Week 16). Due to early termination of the study by the Sponsor, no formal analyses were conducted.
Measured: Baseline and up to 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2008Nov 2008

First posted6 Jun 2008 (estimated)
Study startJun 2008
Primary completionNov 2008

Why it stopped: Sponsor's decision

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 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: Double blind
Who is masked: Participant, Investigator
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00693017
Sponsor's protocol ID: E2090-E044-317
Other IDs: 2007-003556-10
Status last verified: Nov 2015
First submitted: 3 Jun 2008
Last updated: 24 Dec 2015
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Clinical Trial of SEEG for Drug-resistant Epilepsy
Drug-Resistant Epilepsy
RecruitingPhase 3
Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
Seizures, Lennox Gastaut Syndrome
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Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
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Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
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RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
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All Epilepsy trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-blind, Randomised, Placebo-controlled, Multi-centre Study to Assess the Efficacy and Safety of Adjunctive Zonisamide in Myoclonic Seizures Associated With Idiopathic Generalised Epilepsy
ClinicalTrials.gov ID: NCT00693017
Acronym / sponsor ID: E2090-E044-317
Conditions: Epilepsy
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Sponsor's decision
Enrolment: 10 participants (actual)
Lead sponsor: Eisai LimitedIndustry (pharma, biotech, devices)
Study start: Jun 2008
Primary completion: Nov 2008 (actual)
First posted: 6 Jun 2008 (estimated)
Results: Posted 12 Sep 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Zonisamide	Active comparator	Drug: Zonisamide
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 12 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (8 listed)

Subject is male or female and aged 12-65 years.
Subject has at least eight days with at least one myoclonic seizure over the two months Baseline Period. Myoclonic seizures must occur in the context of IGE and may be accompanied by other primary generalized seizures, provided these are also consistent with a diagnosis of Idiopathic Generalized Epilepsy (IGE).
Subject (or parent/caregiver, for subjects below the age of consent) is willing to sign an informed consent form. Subjects below the age of consent in their country, must where appropriate be willing to give informed (written or verbal) assent. Subjects from the age specified in local regulations will be required to sign an appropriate informed consent form.
Subject is taking a stable regimen of one or two other AEDs for at least two weeks prior to Visit 1 (start of the Baseline Period).
Subject has a clinical diagnosis of any type of idiopathic generalised epilepsy (IGE) which has myoclonic seizures (and which may be accompanied by other generalised seizure types), according to the International League Against Epilepsy (ILAE) Classification of Epileptic Seizures (1981) and the ILAE Classification of Epilepsies and Epileptic Syndromes (1989). Diagnosis should have been established by clinical history, electroencephalogram (EEG) and computed tomography/magnetic resonance imaging (CT/MRI) of the brain consistent with idiopathic generalised epilepsy. A CT/MRI scan should have been performed within five years of the screening visit or, if not available from this period, should be performed in the Baseline Period.

Key exclusion criteria (22 listed)

Subject has progressive or focal neurological disease (as determined by preexisting brain imaging such as CT or MRI performed maximally five years before the screening visit), or clinically significant organic disease.
Subject has a history of, or results of clinical investigations (including EEG data) that are suggestive of, partial seizures as defined by the ILAE, including generalised tonic clonic seizures which are suspected to be secondarily generalised.
Subjects with cryptogenic or symptomatic generalised epilepsy.
Subjects with psychogenic seizures.
Subject has a history of convulsive status epilepticus within a year of screening while complying with AEDs.

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
ZonisamideAlso: Zonegran50-400 mg capsules once daily in the evening orally. Maximum study duration 28 weeks comprising: Baseline Period (Week -8 to Week 0): no treatment Titration Period (Week 0 to Week 4): 50 mg daily titrated weekly until 300 mg was reached by Week 4 Maintenance Period (Week 4 to Week 16) 400 mg (or 350 mg in the event of dose limiting adverse events) Down Titration Period (4 Weeks)	Drug	Zonisamide
Placebo50-400 mg Zonisamide Placebo capsules once daily in the evening orally. Maximum study duration 28 weeks comprising: Baseline Period (Week -8 to Week 0): no treatment Titration Period (Week 0 to Week 4): 50 mg Zonisamide Placebo daily titrated weekly until 300 mg was reached by Week 4 Maintenance Period (Week 4 to Week 16) 400 mg Zonisamide Placebo (or 350 mg in the event of dose limiting adverse events) Down Titration Period (4 Weeks)	Drug	Placebo

Primary outcome

Number of Participants Considered Responders as Assessed During the Maintenance Period
Time frame: Baseline (Week -8 to Week 0) and Maintenance Period (Week 4 to Week 16)
The number of participants who were considered responders during the 12 week Maintenance Period (Week 4 to Week 16). A responder was defined as a participant with a decrease >= 50% from baseline in the number of days with myoclonic seizures per 28 days (i.e. 28-day myoclonic seizure frequency in Period from Week 4 to the Week 16 visit compared to Week -8 to randomization at Week 0 [Screening/ Baseline Period]). Occurrence of seizures was documented in a seizure diary. The diary was dispensed at the Screening Visit and maintained by the participant (parent/caregiver) and reviewed at each following visit. The diary was completed daily. All seizures except myoclonic seizures were counted individually in the the diary. Due to early termination of the study by the Sponsor, no formal analyses were conducted.

1 secondary outcome

Percentage Change From Baseline in the Monthly Number of Days With Myoclonic Seizures
Time frame: Baseline and up to 16 weeks

Results and safety

Results posted to the registry on 12 Sep 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Zonisamide	2	0
Placebo	2	0

Primary outcome: Number of Participants Considered Responders as Assessed During the Maintenance Period

Time frame: Baseline (Week -8 to Week 0) and Maintenance Period (Week 4 to Week 16)

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Zonisamide	0 of 2 (0%)	2 of 2 (100%)	Not reported
Placebo	1 of 2 (50%)	2 of 2 (100%)	Not reported

Limitations and caveats (from the sponsor): Due to early termination of the study by the Sponsor. No formal analyses were conducted.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Epilepsy

Not yet recruiting
Clinical Trial of SEEG for Drug-resistant Epilepsy
Drug-Resistant Epilepsy
RecruitingPhase 3
Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
Seizures, Lennox Gastaut Syndrome
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy

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.

Rob van Maanen, M.D. study director

Eisai Limited

72 sites in 13 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Zonisamide in people with Epilepsy, run by Eisai Limited at 72 sites in 13 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 8 inclusion and 22 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 24 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 72 sites in Russia, Hungary, Czechia, Romania, Ukraine and 8 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 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?

Yes. Results are posted in the registry (first posted 12 Sep 2012). 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?

Number of Participants Considered Responders as Assessed During the Maintenance Period (time frame: Baseline (Week -8 to Week 0) and Maintenance Period (Week 4 to Week 16)). 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 NCT00693017.

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 24 Dec 2015.