EpilepsyPhase 3NCT00692003
Adjunctive Zonisamide in Primary Generalised Tonic Clonic Seizures
A Phase 3 study testing Zonisamide in people with Epilepsy, run by Eisai Limited at 73 sites in 13 countries.
Trial summary
Zonisamide is already marketed for the treatment of partial seizures in epilepsy. This study is intended to provide evidence that zonisamide is safe and effective in the treatment of primary generalised tonic-clonic seizures. The total trial duration will be 5.5-6.5 months. Read more about this study
- Who is it for?
- Ages 6 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
- 21 participants
- Where
- 73 sitesin 13 countries
- Study dates
- 1 Aug 2008to 9 Jan 2009
- 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 6 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 6-65 years.
- Subject has ≥ 3 PGTCS over the two months before screening and during the eight weeks Baseline Period with at least one seizure in each one month period. PGTCS must occur in the context of Idiopathic Generalized Epilepsy (IGE) and may be accompanied by other primary generalized seizures, provided these are also consistent with a diagnosis of IGE.
- Subject (or parent/caregiver, for subjects below the age of consent) is willing to sign an informed consent form. For subjects below the age of consent in their country, where appropriate they must 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 Antiepileptic Drugs (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 generalized epilepsy which has PGTCS (and which may be accompanied by other generalized 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 generalized epilepsy. 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.
Show all 9Show fewer
- Female subjects are pre-menarchal, or if of childbearing potential, are not pregnant or lactating or are post-menopausal.
- Female subjects of childbearing potential must abide by the 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.
- Subject has a body weight ≥ 20 kg.
Who cannot join
- Subject has progressive or focal neurological disease (as determined by pre-existing 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 generalized tonic clonic seizures which are suspected to be secondarily generalized.
- Subjects with cryptogenic or symptomatic generalized epilepsy.
- Subjects with psychogenic seizures.
- Subject has a history of status epilepticus within a year of screening while complying with AEDs.
- Subject has seizures that only occur in clustered patterns.
Show all 23Show fewer
- Subject has a history of renal calculi or renal insufficiency (above the upper normal limits of creatinine).
- Subject has a known diagnosis of human immunodeficiency virus (HIV) or hepatitis B or C.
- Subject had a predisposing condition that might interfere with absorption, distribution, or excretion of zonisamide.
- Subject has a history of sensitivity to sulfonamide drugs or zonisamide and 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 were 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).
- 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 acetazolamide, carbonic anhydrase inhibitors such as topiramate and drugs with anticholinergic activity.
- Concomitant use of felbamate or use of felbamate within two months prior to Visit 1.
- Subject is not able 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
73 sites in 13 countries.
73 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, 117997/119034
GOU VPO Smolensk State Medical Academy of Roszdrav
Moscow, 119049
GOU VPO Moscow State University of Medicine and Dentistry of Roszdrav
Moscow, 127473 / 107006
GOU VPO Novosibirsk State Medical University of Roszdrav
Novosibirsk, 630091
GU St. Petersburg Research Institute of Psychoneurology
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
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
Veszpem County Csolnoky F. Hospital
Veszpem, 8200
Czechia7 sites
Neurologicke oddeleni
Hradec Králové, 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
Romania7 sites
Spitalul Clinic de Psihiatrie
Bucharest, 041914
Spitalul Universitar de Urgenta Bucuresti
Bucharest, 050098
Centrul Medical Sana
Bucharest, 11025
Spitalul Clinic Judetean de Urgenta Cluj
Cluj-Napoca, 400006
Spitalul Clinic Judetean de Urgenta Sf Spiridon Iasi
Iași, 700111
Spitalul Clinic de Urgenta Sfanta Treime
Iași, 700309
Spitalul Clinic Judetean de Urgenta Tg Mures
Tg Mures, 540136
Ukraine7 sites
Tsentr Psihosomatychnoyi Patologiyi Dnipropetrovskoyi oblasnoyi klinichnoyi likarni imeni Mechnikova
Dniepropetrovsk, 49005
Derzhavna Ustanova Institut Nevrologiy
Kharkiv, 61068
Kyiv City Psychiatric Hospital #2, Poliklinichne Viddilenya
Kyiv, 2660
Miska Klinichna psihonevrologichna Tsentr Epilepsiyi
Kyiv, 3080
Lvivskyiy oblasnyi Protyepileptuchnyy tsentr
Lviv, 7910
Odesskyy Derzhavnyy Medychnyy Universitet
Odesa, 65006
Vinnitskyy Natsionalnyy Medychnyy Universitet
Vinnitsa, 21005
Poland6 sites
Niepubliczny ZOZ KENDRON
Bialystok, 15-420
Wojewodzki 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
Australia5 sites
Strategic Health Evaluators Pty Ltd
Chatswood, New South Wales, 2067
Austin Health
Heidelburg, Victoria, 3084
The Royal Melbourne Hospital
Melbourne, Victoria, 3050
St. Vincents Hospital
Melbourne
The Prince of Wales Hospital
Randwick, New South Wales, 2031
Germany5 sites
Institut fur Diagnostik der Epilepsien
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
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
Croatia3 sites
CH Split
Split, HR, 10000
CH Sestre Milosrdnice University Hospital
Zagreb, HR, 10000
UHC Zagreb
Zagreb, HR, 10000
Estonia3 sites
West-Tallinn Central Hospital
Tallinn, 10611
Neurodiagnostica AP OY
Tallinn, 11312
Tartu University Hospital
Tartu, 51014
Lithuania3 sites
Kaunas Medical University Hospital
Kaunas, 50009
Neuromeda
Kaunas, 50185
Vilnius University Hospital Santariskiu klinikos
Vilnius, 8661
Finland2 sites
Kuopio Epilepsy Center
Kuopio, SF, 70211
Oulu University Central Hospital
Oulu, 90220
About this study
Official title: A Double-blind, Randomised, Placebo-controlled Multi-centre Study to Assess the Efficacy and Safety of Adjunctive Zonisamide in Primary Generalised Tonic Clonic Seizures
Zonisamide is already marketed for the treatment of partial seizures in epilepsy. This study is intended to provide evidence that zonisamide is safe and effective in the treatment of primary generalised tonic-clonic seizures. The total trial duration will be 5.5-6.5 months. After that subjects who have completed the study will be eligible to enrol in an open-label extension study until zonisamide is marketed for this indication or further development in this indication stops. This extension study will be described in a separate protocol (E2090-E044-316).
- 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
25-400 mg capsules orally once daily in the evening.
Maximum study duration of 28 weeks comprising:
Baseline Period (Week-8/-4 to Week 0) no treatment
Titration Period (Week 0 to Week 4) <12 years old: 1 mg/kg; >= 12 years old: 50 mg daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4
Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained (4 mg/kg or 200 mg in the event of dose limiting adverse events)
Down Titration Period (4 weeks)
PlaceboDrug
25-400 mg Zonisamide Placebo capsules orally once daily in the evening.
Maximum study duration of 28 weeks comprising:
Baseline Period (Week-8/-4 to Week 0) no treatment
Titration Period (Week 0 to Week 4) <12 years old: 1 mg/kg Zonisamide Placebo; >= 12 years old: 50 mg Zonisamide Placebo capsules daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4
Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained (4 mg/kg or 200 mg in the event of dose limiting adverse events)
Down Titration Period (4 weeks)
| 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 from baseline in Primary Generalised Tonic-Clonic Seizures (PGTCS) frequency of >= 50% (i.e. 28-day PGTC seizure frequency in the period from Week 4 to the Week 16 visit compared to Week -8/-4 to randomization at Week 0). Each participant's response to treatment was assessed on the basis of their seizure diaries. The diary was dispensed at the Screening Visit and maintained by the participant (parent/caregiver) through out the titration and maintenance treatment periods until the Early termination Visit at Week 16. Due to early termination of the study by the Sponsor, no formal analyses were conducted.
Measured: Baseline (Week -8/-4 to Week 0) and Maintenance Phase (Week 4 to Week 16)
Secondary outcomes (1)
Absolute Change From Baseline in 28-day PGTC Seizure Frequency
Absolute Change from Baseline in 28-day PGTC Seizure Frequency 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.
- First posted6 Jun 2008 (estimated)
- Study start1 Aug 2008
- Primary completionNov 2008
- Study completion9 Jan 2009
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
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rob Van Maanen, Study director, Eisai Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00692003
- Sponsor's protocol ID
- E2090-E044-315
- Other IDs
- Eudra ID #2007-003557-91.
- Status last verified
- Feb 2017
- First submitted
- 3 Jun 2008
- Last updated
- 14 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2017. 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 Primary Generalised Tonic Clonic Seizures
- ClinicalTrials.gov ID
- NCT00692003
- Acronym / sponsor ID
- E2090-E044-315
- Conditions
- Epilepsy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor's decision
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Eisai LimitedIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2008 (actual)
- Primary completion
- Nov 2008 (actual)
- Study completion
- 9 Jan 2009 (actual)
- First posted
- 6 Jun 2008 (estimated)
- Results
- Posted 12 Oct 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Zonisamide is already marketed for the treatment of partial seizures in epilepsy. This study is intended to provide evidence that zonisamide is safe and effective in the treatment of primary generalised tonic-clonic seizures. The total trial duration will be 5.5-6.5 months. After that subjects who have completed the study will be eligible to enrol in an open-label extension study until zonisamide is marketed for this indication or further development in this indication stops. This extension study will be described in a separate protocol (E2090-E044-316).
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
- 6 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Subject is male or female and aged 6-65 years.
- Subject has ≥ 3 PGTCS over the two months before screening and during the eight weeks Baseline Period with at least one seizure in each one month period. PGTCS must occur in the context of Idiopathic Generalized Epilepsy (IGE) and may be accompanied by other primary generalized seizures, provided these are also consistent with a diagnosis of IGE.
- Subject (or parent/caregiver, for subjects below the age of consent) is willing to sign an informed consent form. For subjects below the age of consent in their country, where appropriate they must 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 Antiepileptic Drugs (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 generalized epilepsy which has PGTCS (and which may be accompanied by other generalized 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 generalized epilepsy. 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 (23 listed)
- Subject has progressive or focal neurological disease (as determined by pre-existing 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 generalized tonic clonic seizures which are suspected to be secondarily generalized.
- Subjects with cryptogenic or symptomatic generalized epilepsy.
- Subjects with psychogenic seizures.
- Subject has a history of 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: Zonegran25-400 mg capsules orally once daily in the evening. Maximum study duration of 28 weeks comprising: Baseline Period (Week-8/-4 to Week 0) no treatment Titration Period (Week 0 to Week 4) <12 years old: 1 mg/kg; >= 12 years old: 50 mg daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4 Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained (4 mg/kg or 200 mg in the event of dose limiting adverse events) Down Titration Period (4 weeks) | Drug | Zonisamide |
| Placebo25-400 mg Zonisamide Placebo capsules orally once daily in the evening. Maximum study duration of 28 weeks comprising: Baseline Period (Week-8/-4 to Week 0) no treatment Titration Period (Week 0 to Week 4) <12 years old: 1 mg/kg Zonisamide Placebo; >= 12 years old: 50 mg Zonisamide Placebo capsules daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4 Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained (4 mg/kg or 200 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/-4 to Week 0) and Maintenance Phase (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 from baseline in Primary Generalised Tonic-Clonic Seizures (PGTCS) frequency of >= 50% (i.e. 28-day PGTC seizure frequency in the period from Week 4 to the Week 16 visit compared to Week -8/-4 to randomization at Week 0). Each participant's response to treatment was assessed on the basis of their seizure diaries. The diary was dispensed at the Screening Visit and maintained by the participant (parent/caregiver) through out the titration and maintenance treatment periods until the Early termination Visit at Week 16. Due to early termination of the study by the Sponsor, no formal analyses were conducted.
1 secondary outcome
Absolute Change From Baseline in 28-day PGTC Seizure Frequency
Time frame: Baseline and up to 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Rob Van Maanen study director
Eisai Limited
73 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 73 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 9 inclusion and 23 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 14 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 73 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 Oct 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/-4 to Week 0) and Maintenance Phase (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?
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 14 Mar 2017.