AzTrials
AzTrials

EpilepsyPhase 3NCT00735397

Evaluation of the Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures

A Phase 3 study testing perampanel in people with Epilepsy, run by Eisai Inc. at 239 sites in 39 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study was to evaluate the safety and tolerability of perampanel (up to 12 mg/day) given as adjunctive treatment in subjects with refractory partial seizures and to evaluate the maintenance of effect of perampanel for the control of refractory partial seizures. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Epilepsy
What is being tested?
perampanel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,218 participants
Where
239 sitesin 39 countries
Study dates
Oct 2008to Sep 2014
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 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Each participant who met the following criteria were enrolled in this study:
  • Who completed Visit 8 of study E2007-G000-304, E2007-G000-305, or E2007-G000-306 and complied with the inclusion and exclusion criteria for that study (excluding criteria that are related to seizure occurrences).
  • Provided written informed consent signed by participant or legal guardian prior to entering the study or undergoing any study procedures (If the written informed consent was provided by the legal guardian because the participant was unable to do so, a written or verbal assent from the participant was obtained).
  • Who was considered reliable and willing to be available for the study period and record seizures and report adverse events them self or have a caregiver who can record and report the events for them.
  • Females who were either of non-childbearing potential (defined as having undergone surgical sterilization, or postmenopausal [>age 50 and amenorrheic for 12 months]) or of childbearing potential. Females of childbearing potential were enrolled only if they agreed to be abstinent or continue using at least 1 medically acceptable method of contraception (eg, a double-barrier method [eg, condom + spermicide, condom + diaphragm with spermicide], IUD, or have a vasectomised partner) throughout the study period and for 2 months after the last dose of study drug. Women using hormonal contraceptives were required to use an additional approved method of contraception (as described previously) continuously throughout the entire study period and for 2 months after the last dose of study drug. (It was not required for male subjects to use contraceptive measures based on preclinical toxicology data).
  • Continued to be treated with a stable dose of 1 or a maximum of 3 approved anti-epileptic drugs.

Who cannot join

  • Participants who met the following criteria were excluded from the study:
  • 1. Those who, for any reason, discontinued early from the preceding double-blind study.

Trial locations and contacts

239 sites in 39 countries.

239 sites in 39 countries

United States57 sites

  • Study site

    Akron, Ohio, 44308

  • Study site

    Albany, New York, 12208

  • Study site

    Ames, Iowa, 50010

  • Study site

    Asheville, North Carolina, 28806

  • Study site

    Atlanta, Georgia, 30342

  • Study site

    Baltimore, Maryland, 21287-7247

  • Study site

    Bethesda, Maryland, 20817

  • Study site

    Birmingham, Alabama, 35294

  • Study site

    Boise, Idaho, 83702

  • Study site

    Buffalo, New York, 14222

  • Study site

    Charleston, South Carolina, 29425

  • Study site

    Chesterfield, Missouri, 63017

  • Study site

    Cincinnati, Ohio, 45219

  • Study site

    Columbus, Ohio, 43221

  • Study site

    Dallas, Texas, 75230

  • Study site

    Dallas, Texas, 75235

  • Study site

    Dallas, Texas, 75251

  • Study site

    Denver, Colorado, 80218

  • Study site

    El Paso, Texas, 79905

  • Study site

    Fort Collins, Colorado, 80525

  • Study site

    Fresno, California, 93710

  • Study site

    Great Neck, New York, 11021

  • Study site

    Gulf Breeze, Florida, 32561

  • Study site

    Hattiesburg, Mississippi, 39401

  • Study site

    Houma, Louisiana, 70363

  • Study site

    Houston, Texas, 77030

  • Study site

    Indianapolis, Indiana, 46256

  • Study site

    Jacksonville, Florida, 32209

  • Study site

    Jacksonville, Florida, 32224

  • Study site

    Kansas City, Missouri, 64111

  • Study site

    Lawrence, New York, 11559

  • Study site

    Lexington, Kentucky, 40536

  • Study site

    Little Rock, Arkansas, 72205

  • Study site

    Madison, Wisconsin, 53715

  • Study site

    Memphis, Tennessee, 38105

  • Study site

    New York, New York, 10016

  • Study site

    Orlando, Florida, 32819

  • Study site

    Philadelphia, Pennsylvania, 19104

  • Study site

    Philadelphia, Pennsylvania, 19107

  • Study site

    Phoenix, Arizona, 85004

  • Study site

    Phoenix, Arizona, 85013

  • Study site

    Portland, Oregon, 97210

  • Study site

    Richmond, Virginia, 23298

  • Study site

    Rochester, New York, 14642

  • Study site

    Salt Lake City, Utah, 84108

  • Study site

    San Francisco, California, 94115

  • Study site

    Seattle, Washington, 98104

  • Study site

    St Louis, Missouri, 63110

  • Study site

    Suwanee, Georgia, 30024

  • Study site

    Syracuse, New York, 13210

  • Study site

    Tallahassee, Florida, 32308

  • Study site

    Tampa, Florida, 33609

  • Study site

    Toledo, Ohio, 43614

  • Study site

    Tucson, Arizona, 85724

  • Study site

    Tulsa, Oklahoma, 74137

  • Study site

    Ventura, California, 93003

  • Study site

    Washington D.C., District of Columbia, 20010

Other trials in United States

Argentina15 sites

  • Study site

    Buenos Aires, C1117ABE

  • Study site

    Buenos Aires, C1122AAK

  • Study site

    Buenos Aires, C1182ACD

  • Study site

    Buenos Aires, C1221ADC

  • Study site

    Buenos Aires, C1280AEB

  • Study site

    Buenos Aires, C1406FWY

  • Study site

    Capital Federal, 1428

  • Study site

    Córdoba, X5000JJS

  • Study site

    Córdoba, X5010AOC

  • Study site

    La Plata, Buenos Aires, B1902AHD

  • Study site

    Lanus Oeste, Buenos Aires, B1824CWE

  • Study site

    Rosario, S2000DSV

  • Study site

    Salta, A4402AYT

  • Study site

    San Miguel de Tucumán, T4000DVD

  • Study site

    Villa Nueva, M5519FNF

Other trials in Argentina

Germany13 sites

  • Study site

    Berlin, 10117

  • Study site

    Bernau, 16321

  • Study site

    Bielefeld, 33617

  • Study site

    Bonn, 53127

  • Study site

    Düsseldorf, 40212

  • Study site

    Erlangen, 91054

  • Study site

    Göttingen, 37075

  • Study site

    Kehl-Kork, 77694

  • Study site

    Mainz, 55131

  • Study site

    Marburg, 35039

  • Study site

    München, 81377

  • Study site

    Ulm, 89081

  • Study site

    Westerstede, 26655

Other trials in Germany

Russia12 sites

  • Study site

    Kazan', 420097

  • Study site

    Moscow, 107066

  • Study site

    Moscow, 107076

  • Study site

    Moscow, 119992

  • Study site

    Moscow, 125412

  • Study site

    Nizhny Novgorod, 603005

  • Study site

    Omsk, 644001

  • Study site

    Samara, 443095

  • Study site

    Smolensk, 214018

  • Study site

    Tyumen, 625039

  • Study site

    Yaroslavl, 150030

  • Study site

    Yekaterinburg, 620149

Other trials in Russia

India11 sites

  • Study site

    Hyderabad, 500001

  • Study site

    Hyderabad, 500082

  • Study site

    Jaipur, 302004

  • Study site

    Mangalore, 575002

  • Study site

    Mumbai, 400026

  • Study site

    Nagpur, 440010

  • Study site

    Nashik, 422004

  • Study site

    New Delhi, 110060

  • Study site

    Pune, 411011

  • Study site

    Pune, 411030

  • Study site

    Visakhapatnam, 530002

Other trials in India

Spain8 sites

  • Study site

    Alcorcón, Madrid, Communidad de, 28922

  • Study site

    Badalona, Catalonia, 8916

  • Study site

    Barakaldo, Basque Country, 48903

  • Study site

    Barcelona, Catalonia, 8003

  • Study site

    Barcelona, Catalonia, 8025

  • Study site

    Granada, Andalusia, 18012

  • Study site

    Madrid, Madrid, Communidad de, 28040

  • Study site

    Valencia, Valencia, 46009

Other trials in Spain

Ukraine8 sites

  • Study site

    Donetsk, 83052

  • Study site

    Donetsk, 83114

  • Study site

    Kharkiv, 61018

  • Study site

    Kharkiv, 61068

  • Study site

    Kyiv, 4080

  • Study site

    Kyiv, 4209

  • Study site

    Lviv, 79010

  • Study site

    Uzhhorod, 88000

Other trials in Ukraine

South Korea7 sites

  • Study site

    Busan, 614735

  • Study site

    Daegu, 700712

  • Study site

    Pusan, 602715

  • Study site

    Seoul, 110744

  • Study site

    Seoul, 120752

  • Study site

    Seoul, 135710

  • Study site

    Seoul, 138736

Other trials in South Korea

Israel6 sites

  • Study site

    Ashkelon, 78278

  • Study site

    Haifa, 31096

  • Study site

    Holon, 58100

  • Study site

    Kfar Saba, 44281

  • Study site

    Petah Tikva, 49202

  • Study site

    Ramat Gan, 52621

Other trials in Israel

Poland6 sites

  • Study site

    Bialystok, 15-276

  • Study site

    Gdansk, 80-803

  • Study site

    Gdansk, 80-952

  • Study site

    Katowice, 40-635

  • Study site

    Lublin, 20-718

  • Study site

    Warsaw, 02-957

Other trials in Poland

France5 sites

  • Study site

    Béthune, 62408

  • Study site

    Bron, 69677

  • Study site

    Montpellier, 34295

  • Study site

    Rennes, 35033

  • Study site

    Toulouse, 31059

Other trials in France

Hungary5 sites

  • Study site

    Budapest, 1097

  • Study site

    Budapest, 1136

  • Study site

    Budapest, 1145

  • Study site

    Budapest, H-1143

  • Study site

    Kecskemét, 6000

Other trials in Hungary

Italy5 sites

  • Study site

    Florence, 50134

  • Study site

    Genova, 16147

  • Study site

    Milan, 20121

  • Study site

    Milan, 20133

  • Study site

    Naples, 80131

Other trials in Italy

Thailand5 sites

  • Study site

    Bangkok, 10330

  • Study site

    Bangkok, 10400

  • Study site

    Bangkok, 10700

  • Study site

    Chiang Mai, 50200

  • Study site

    Muang, 40002

Other trials in Thailand

Australia4 sites

  • Study site

    Fitzroy, Victoria, 3065

  • Study site

    Heidelberg, Victoria, 3084

  • Study site

    Parkville, Victoria, 3050

  • Study site

    Woodville, South Australia, 5011

Other trials in Australia

Bulgaria4 sites

  • Study site

    Pleven, 5800

  • Study site

    Plovdiv, 4002

  • Study site

    Sofia, 1113

  • Study site

    Sofia, 1606

Other trials in Bulgaria

Canada4 sites

  • Study site

    Calgary, Alberta, T2N 2T9

  • Study site

    Greenfield Park, Quebec, J4V 2J2

  • Study site

    London, Ontario, N6A 5A5

  • Study site

    Toronto, Ontario, M5B 1T9

Other trials in Canada

Chile4 sites

  • Study site

    Santiago, 3459

  • Study site

    Santiago, 8260094

  • Study site

    Santiago, 8900085

  • Study site

    Valdivia, 5090145

Other trials in Chile

China4 sites

  • Study site

    Beijing, 100730

  • Study site

    Chengdu, 610041

  • Study site

    Chongqing, 400016

  • Study site

    Shanghai, 200040

Other trials in China

Hong Kong4 sites

  • Study site

    Hong Kong

  • Study site

    Kowloon

  • Study site

    Pokfulam, 852

  • Study site

    Shatin

Other trials in Hong Kong

Mexico4 sites

  • Study site

    Aguascalientes, 20127

  • Study site

    Mexico City, Distrito Federal, 14050

  • Study site

    Monterrey, Nuevo Leon, 64000

  • Study site

    San Luis Potosí City, 78240

Other trials in Mexico

Taiwan4 sites

  • Study site

    Kaohsiung City, 833

  • Study site

    Taichung, 40705

  • Study site

    Tainan, 70403

  • Study site

    Taoyuan, 333

Other trials in Taiwan

United Kingdom4 sites

  • Study site

    Liverpool, L9 7LJ

  • Study site

    London, SW17 0QT

  • Study site

    Middlesbrough, TS4 3BW

  • Study site

    Stoke-on-Trent, ST4 7LN

Other trials in United Kingdom

Austria3 sites

  • Study site

    Graz, 8036

  • Study site

    Innsbruck, 6020

  • Study site

    Linz, A-4021

Other trials in Austria

Belgium3 sites

  • Study site

    Brussels, 1070

  • Study site

    Leuven, 3000

  • Study site

    Ottignies, 1340

Other trials in Belgium

Czechia3 sites

  • Study site

    Olomouc, 775 20

  • Study site

    Prague, 140 59

  • Study site

    Prague, 150 06

Other trials in Czechia

Latvia3 sites

  • Study site

    Riga, LV-1004

  • Study site

    Riga, LV-1038

  • Study site

    Valmiera, LV-4201

Other trials in Latvia

Lithuania3 sites

  • Study site

    Kaunas, LT-50009

  • Study site

    Klaipėda, LT-92288

  • Study site

    Vilnius, LT-08661

Other trials in Lithuania

Portugal3 sites

  • Study site

    Coimbra, 3000-075

  • Study site

    Lisbon, 1649-035

  • Study site

    Porto, 4200-319

Other trials in Portugal

Serbia3 sites

  • Study site

    Belgrade, 11000

  • Study site

    Niš, 18000

  • Study site

    Novi Sad, 21000

Other trials in Serbia

South Africa3 sites

  • Study site

    Cape Town, Western Cape, 7925

  • Study site

    Cape Town, 7500

  • Study site

    Johannesburg, Gauteng, 2196

Other trials in South Africa

Estonia2 sites

  • Study site

    Tallinn, EE-13419

  • Study site

    Tartu, EE-51014

Other trials in Estonia

Finland2 sites

  • Study site

    Kuopio, FI-70210

  • Study site

    Tampere, FI-33520

Other trials in Finland

Greece2 sites

  • Study site

    Thessaloniki, 546 36

  • Study site

    Thessaloniki, 57010

Other trials in Greece

Malaysia2 sites

  • Study site

    Kuala Lumpur, 59100

  • Study site

    Kuala Terengganu, 20400

Other trials in Malaysia

Netherlands2 sites

  • Study site

    Heeze, 5591 VE

  • Study site

    Zwolle, 8025 BV

Other trials in Netherlands

Philippines2 sites

  • Study site

    Ermita, 1000

  • Study site

    Makati City, 1229

Other trials in Philippines

Romania2 sites

  • Study site

    Bucharest, 20125

  • Study site

    Bucharest

Other trials in Romania

Sweden2 sites

  • Study site

    Gothenburg

  • Study site

    Linköping

Other trials in Sweden

About this study

Official title: An Open-Label Extension Phase of the Double-Blind, Placebo-Controlled, Dose-Escalation, Parallel-Group Studies to Evaluate the Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures

The purpose of this study was to evaluate the safety and tolerability of perampanel (up to 12 mg/day) given as adjunctive treatment in subjects with refractory partial seizures and to evaluate the maintenance of effect of perampanel for the control of refractory partial seizures.

Read the detailed description

This was an open-label extension (OLE) study for subjects who completed one of the following double-blind, placebo-controlled, Phase 3 studies: E2007-G000-304 (NCT00699972), E2007-G000-305 (NCT00699582), and E2007-G000-306 (NCT00700310). This OLE study consisted of 2 phases: an Open-label Treatment Phase (comprised of a 16-week blinded Conversion Period and a 256-week Maintenance Period) and a Follow-up Phase (4 weeks). During the Conversion Period, subjects and investigators remained blinded to the treatment received in the previous DB study. To achieve this, all subjects continued to take 6 tablets of study medication (2 mg perampanel or matching placebo) or fewer as they were instructed during the core Double-Blind (DB) study. During the open-label Maintenance Period, subjects were treated with the perampanel dose that provided the best combination of individual efficacy and tolerability.

Conditions
Epilepsy
Being tested
perampanel
Keywords
Partial onset seizures
Medical subject headings
Epilepsy

What participants receive

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

  • perampanelDrug

    Perampanel 2 mg to 12 mg, once daily in the Open-Label Extension (OLE) study up to approximately 5 years

Study groups in NCT00735397
Study groupRoleWhat they receive
PerampanelExperimentalParticipants previously receiving perampanel/placebo in the double blind-study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the Open-Label Extension (OLE) study up to approximately 5 years.
Receives: Drug: perampanel

What is being measured

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

  1. Number of Participants With Treatment-emergent Non-Serious Adverse Events (AEs) and Treatment-emergent Serious Adverse Events (SAEs)

    An AE was defined as any untoward medical occurrence in a clinical investigation participant administered with an investigational product. A SAE was defined as any untoward medical occurrence that at any dose; resulted in death, was life-threatening (ie, the participant was at immediate risk of death from the AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was as a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug). In this study, treatment emergent AEs (defined as an AE (serious or non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.

    Measured: From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years.

Secondary outcomes (2)

  1. Median Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline.

    Seizure frequency was derived from information (seizure count and type) recorded in participant diary. The seizure frequency per 28 days was calculated as the number of seizures divided by the number of days in the interval and multiplied by 28. The percent change in 28-day seizure frequency from pre-perampanel baseline was assessed for all partial-onset seizure types. The pre-perampanel baseline was defined as: (1) for participants who had been assigned to placebo treatment in the core DB study, the pre-perampanel baseline was computed from all data during the core DB study, and (2) for participants who had been assigned to perampanel in the core DB study, the pre-perampanel baseline was computed from the pre-randomization phase of the core DB study.

    Measured: Pre-perampanel Baseline and Weeks (1-13, 14-26, 27-39, 40-52, 53-65, 66-78, 79-91, 92-104, 105-117, 118-130, 131-143, 144-156, 157-169, 170-182, 183-195, 196-208, 209-221, 222-234, 235-247, and 248-260)

  2. Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-Perampanel Baseline.

    Seizure frequency was derived from information (seizure count and type) recorded in participant diary. The percentage of participants who experienced a 50% or greater reduction in seizure frequency per 28 days relative to the pre-perampanel Baseline(responders) was assessed. The pre-perampanel baseline was defined as: (1) for participants who had been assigned to placebo treatment in the core DB study, the Pre-perampanel baseline was computed from all data during the core Double-Blind (DB) study, and (2) for participants who had been assigned to perampanel in the core DB study, the pre-perampanel baseline was computed from the pre-randomization phase of the core DB study. The data is presented as percent responders.

    Measured: Pre-perampanel Baseline and Weeks (1-13, 14-26, 27-39, 40-52, 53-65, 66-78, 79-91, 92-104, 105-117, 118-130, 131-143, 144-156, 157-169, 170-182, 183-195, 196-208, 209-221, 222-234, 235-247, 248-260)

Timeline

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

  1. First posted14 Aug 2008 (estimated)
  2. Study startOct 2008
  3. Primary completionSep 2014
  4. Study completionSep 2014

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1,218 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00735397
Sponsor's protocol ID
E2007-G000-307
Status last verified
Feb 2016
First submitted
13 Aug 2008
Last updated
14 Mar 2016
Data monitoring committee
Yes

Publications

  • Maguire M. Response to "Perampanel and pregnancy: Could experience be a gloomy lantern that does not even illuminate its bearer?". Epilepsy Behav. 2022 Apr;129:108654. doi: 10.1016/j.yebeh.2022.108654. Epub 2022 Mar 16. No abstract available.

    PubMed 35305920

  • Krauss GL, Perucca E, Kwan P, Ben-Menachem E, Wang XF, Shih JJ, Patten A, Yang H, Williams B, Laurenza A. Final safety, tolerability, and seizure outcomes in patients with focal epilepsy treated with adjunctive perampanel for up to 4 years in an open-label extension of phase III randomized trials: Study 307. Epilepsia. 2018 Apr;59(4):866-876. doi: 10.1111/epi.14044. Epub 2018 Mar 25.

    PubMed 29574701

  • Rosenfeld W, Conry J, Lagae L, Rozentals G, Yang H, Fain R, Williams B, Kumar D, Zhu J, Laurenza A. Efficacy and safety of perampanel in adolescent patients with drug-resistant partial seizures in three double-blind, placebo-controlled, phase III randomized clinical studies and a combined extension study. Eur J Paediatr Neurol. 2015 Jul;19(4):435-45. doi: 10.1016/j.ejpn.2015.02.008. Epub 2015 Mar 5.

    PubMed 25823975

  • Krauss GL, Perucca E, Ben-Menachem E, Kwan P, Shih JJ, Clement JF, Wang X, Bagul M, Gee M, Zhu J, Squillacote D. Long-term safety of perampanel and seizure outcomes in refractory partial-onset seizures and secondarily generalized seizures: results from phase III extension study 307. Epilepsia. 2014 Jul;55(7):1058-68. doi: 10.1111/epi.12643. Epub 2014 May 27.

    PubMed 24867391

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing perampanel in people with Epilepsy, run by Eisai Inc. at 239 sites in 39 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 6 inclusion and 2 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 14 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 239 sites in United States, Argentina, Germany, Russia, India and 34 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?

Yes. Results are posted in the registry (first posted 26 Jan 2016). 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 With Treatment-emergent Non-Serious Adverse Events (AEs) and Treatment-emergent Serious Adverse Events (SAEs) (time frame: From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 5 years.). 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 NCT00735397, which also lists 4 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 14 Mar 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in