AzTrials
AzTrials

Parkinson's DiseasePhase 3NCT00286897

The Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations

A Phase 3 study testing E2007 in people with Parkinson's Disease, run by Eisai Limited at 118 sites in 17 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

Patients will be randomised to receive either placebo or the study drug for a period of 30 weeks, in addition to their standard Parkinsonian medications. During the first 8 weeks, the patient's levodopa doses may be adjusted if necessary by the investigator. Read more about this study

Who is it for?
Ages 30 years and older
Conditions the study is for
Parkinson's Disease
What is being tested?
E2007
How many people
702 participants
Where
118 sitesin 17 countries
Study dates
Feb 2006to Aug 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 30 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female patients with idiopathic PD fulfilling the (UK) Parkinson's disease Society Brain Bank diagnostic criteria, with a good response to levodopa.
  • Patients must have been diagnosed with idiopathic PD at >= 30 years of age.
  • Patients must have predictable motor fluctuations of the wearing OFF type with the presence of at least 2 hours of OFF time during the waking day (excluding the morning OFF time) as evidenced by diary cards completed at screening and confirmed by diary data collected at the baseline visit.
  • Before patients are randomised they must be able to show that they are able to accurately complete the diary cards. During the diary-training period at the initial screening visit there must be diary evidence of at least one transition of OFF to ON or from ON to OFF and patients must show 75% concordance with Investigator's completion of the diary card.
  • Patients must rate between II-IV on the Hoehn \& Yahr scale when in an OFF state.
  • Patients must be taking optimised levodopa therapy (according to investigator's opinion) at least 3 times during the waking day (not including bedtime/night time dose) up to a maximum of 8 doses daily (includes bedtime/night time dose).
Show all 9Show fewer
  • Patients who are treated with dopamine agonists, COMT inhibitors or MAOB inhibitors and other anti-PD drugs must be on optimised and stable doses for at least 4 weeks prior to initial screening visit and must remain stable throughout the study. Only levodopa dosage can be adjusted downwards in the first 8 weeks of the double-blind treatment phase.
  • In the Investigator's opinion patients must be able to distinguish their own motor states and the absence or presence of troublesome or non-troublesome dyskinesias.
  • In the Investigator's opinion patients are able to complete the study including the completion of the home diary cards and capable of giving full written informed consent.

Who cannot join

  • Pregnant or lactating women.
  • Women of child bearing potential unless infertile (including surgically sterile) or practicing effective contraception (e.g., abstinence, IUD or barrier method plus hormonal method). These patients must have a negative serum B-HCG test at the initial screening visit (Visit 1), and a negative urine pregnancy test at the Baseline visit (Visit 3). These patients must also be willing to remain on their current form of contraception for the duration of the study. Postmenopausal women may be recruited but must be amenorrhoeic for at least 1 year to be considered of non-child bearing potential as determined by the investigator.
  • Fertile men not willing to use reliable contraception and fertile men with partners not willing to use reliable contraception.
  • Patients with a past or present history of drug or alcohol abuse as per DSM IV criteria.
  • Patients with a past (within one year) or present history of psychotic symptoms requiring antipsychotic treatment. Patients may be taking anti-depressant medication, however the dose must be stable for 4 weeks prior to the baseline visit. Use of anti-psychotic medication including clozapine and quetiapine is prohibited even if the indication is for movement disorders.
  • Patients with a past (within one year) or present history of suicidal ideation or suicide attempts.
Show all 16Show fewer
  • Patients with unstable abnormalities of the hepatic, renal, cardiovascular, respiratory, gastro-intestinal, haematological, endocrine or metabolic systems which might complicate assessment of the tolerability of the study medication.
  • Patients with significantly elevated liver enzymes (abnormal bilirubin or serum transaminase levels of more than 1.5 times the upper normal limit).
  • Patients with current or prior treatment (within 4 weeks prior to the baseline visit) with medication known to induce the enzyme cytochrome P450 3A4.
  • Current or prior treatment (within 4 weeks prior to the baseline visit) with tolcapone, methyldopa, budipine, reserpine, seroquel or intermittent use of either liquid forms of levodopa or subcutaneous apomorphine.
  • Patients with previous stereotactic surgery (eg pallidotomy) for Parkinson's disease or with planned stereotactic surgery during the study period.
  • Patients receiving or with planned (next 6 months) deep brain stimulation.
  • Patients who have received an investigational product within 4 weeks prior to the screening visit or patients that have participated in a previous study with E2007.
  • Patients with clinically significant cognitive impairment (MMSE <24 and /or fulfilling DSM IV criteria for dementia due to Parkinson's disease).
  • Patients with conditions affecting the peripheral or central sensory system unless related to Parkinson's disease (such as mild sensory or pain syndromes limited to OFF periods) that could interfere with the evaluation of any such symptoms caused by the study drug.
  • Patients with any condition that would make the patient, in the opinion of the Investigator, unsuitable for the study.

Trial locations and contacts

118 sites in 17 countries.

118 sites in 17 countries

Germany16 sites

  • Kliniken Beelitz GmbH

    Beelitz-Heilstätten

  • Uni-klinikum Charite, Campus Virchow-klinikum

    Berlin, 13353

  • Study site

    Bochum

  • Universitaetsklinikum Carl Gustav Carus

    Dresden, 01307

  • Neurologische Universitatsklinik

    Göttingen

  • Universitatkrankenhaus Hamburg Eppendorf

    Hamburg, D 20246

  • Study site

    Hanau

  • Study site

    Hanover

  • Paracelsus-Elena-Klinik

    Kassel, 34128

  • Gertrudis-Klinik, Parkinson Klinik

    Leun-Biskirchen

  • Universitatsklinik Lubeck Klinik fur Neurologie Ratzeburger Allee 160 D-23538 Lubeck

    Lübeck, 23538

  • Klinik fuer Neurologie

    Marburg, 35033

  • Technische Universitaet Muenchen

    München, 81675

  • LMU Munchen, Neurologische Universitatsklinik

    München

  • Study site

    Tübingen

  • Study site

    Wiesbaden, 65191

Other trials in Germany

Poland11 sites

  • Nzoz Kendrion

    Bialystok, 15420

  • PSK Klinika Neurologii

    Bialystok

  • Klinika Neurologii Doroslych AM

    Gdansk, 80211

  • Centralny Szpital Kliniczny

    Katowice, 40752

  • WSS im. Kardynala S. Wyszynskiego

    Lublin, 20718

  • Study site

    Lublin

  • Indywidualna Specjalistyczna Praktyka Lekarska, Gabinet Neur

    Mosina k/Poznania, 62050

  • Specjalistyczna Przychodnia Lekarska

    Płock, 09402

  • Centralny Szpital Kliniczny MSwia

    Warsaw, 02507

  • Study site

    Warsaw, 02507

  • Centrum Leczenia Chorob

    Warsaw, 02777

Other trials in Poland

Hungary10 sites

  • Clinexpert SMO, Budapest

    Budapest, 1091

  • St. Imre Hospital

    Budapest, 1115

  • Semmelweis University

    Budapest, 1145

  • Uzsoki Street Hospital

    Budapest, 1145

  • Jahn Ferenc Hospital

    Budapest, 1204

  • B-A-Z County Hospital

    Budapest, 3501

  • Study site

    Budapest

  • A Petz Hospital

    Győr, 9024

  • Nyiro Gyula Hospital

    Győr

  • Jahn Ferenc Del-Pesti Hospital

    Miscolc, 3501

Other trials in Hungary

Italy10 sites

  • Ospedal Villa Margherita

    Arcugnano, 36057

  • Universita degli Studi di Genova

    Genova, 16132

  • Ospedale della Misericordia

    Grosseto, 58100

  • Policlinico Umberto I

    Grosseto, 58100

  • Ospedale Versillia

    Lido di Camaiore, 55043

  • Universita degli Studi Federico II

    Naples, 80131

  • IRCSS Fondazione Casimiro Mondino

    Pavia, 27100

  • Ospedale Civile di Pescara

    Pescara, 65124

  • Ospedale San Giovanni Battista

    Roma, 00148

  • Study site

    Roma

Other trials in Italy

South Africa10 sites

  • 407 Medi Clinic

    Bloemfontein, 9301

  • Rosepark Hospital

    Bloemfontein

  • Groote Schuur Hospital

    Cape Town, 7925

  • Christian Barnard Memorial Hospital

    Cape Town, 8001

  • 406 Claremont Hospital

    Cape Town

  • Study site

    Morningside, Johannesburg, 2196

  • Panorama Medi-Clinic

    Parow, 7550

  • Wilgers Medical Centre

    Pretoria, 0041

  • Sunninghill Hospital

    Sunninghill, Johannesburg, 2052

  • Umhlanga Hospital

    Umhlanga, 4321

Other trials in South Africa

France9 sites

  • Centre Hospitalier du Pays d'Aix

    Aix-en-Provence, 13090

  • Service Neurologie

    Bayonne, 64100

  • CHU Gabrief Montpied

    Clermont-Ferrand, 69003

  • Contis, Patrick

    Colomiers, 31770

  • Study site

    Lille

  • Centre de Pharmacologie Clinique et Evaluation Therapeutique

    Marseille, 13385

  • Study site

    Nantes

  • Hopital de la Pitie Salpetriere

    Paris, 75013

  • Centre d'Investigation Clinique, Hospital Purpan

    Toulouse, 31059

Other trials in France

Czechia8 sites

  • University Hospital

    Olomouc, 77520

  • University Hospital

    Ostrava, 70852

  • Pliklinika Modry Pavilon

    Ostrava, 71000

  • Nemocnice Pardubice

    Pardubice, 53203

  • FN Plzen

    Pilsen, 30460

  • Nemocnice Pisek

    Plsek, 39723

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, 10034

  • VFN Praha

    Prague, 12800

Other trials in Czechia

Spain8 sites

  • Hospital Clinic I Provincial

    Barcelona, 08036

  • Hospital de sant Pau

    Barcelona, 8025

  • Hospital Vall d'Hebron

    Barcelona, 8035

  • Hospital del Mar, Servei de Neurologia

    Barcelona

  • Hospital Ramon y Cajal

    Madrid, 28034

  • Hospital Puerta de Hierro

    Madrid, 28035

  • Clinica Universitaria de Navarra

    Pamplona, 31008

  • Hospital Clinico Universitario de Santiago

    Santiago de Compostela, 15706

Other trials in Spain

Belgium7 sites

  • Cliniques Universitaires St-Luc

    Brussels, 1200

  • C.H.U.de Charleroi

    Charleroi, 6000

  • U.Z. Antwerpen

    Edegem, 2650

  • U.Z. Gent

    Ghent, 9000

  • C.H.R. de la Citadelle

    Liège, 4000

  • Hopital St-Pierre

    Ottignies, 1340

  • St-Andries Ziekenhuis

    Tielt, 8700

Other trials in Belgium

United Kingdom7 sites

  • Bupa Flyde Coast Hospital

    Blackpool, FY38BP

  • North Surrey Primary Care Trust

    Chertsey, KT160QA

  • District General Hospital NHS Trust

    Clwyd, LL185UJ

  • North Manchester General Hospital

    Crumpsall, M85RB

  • Royal Free Hospital

    London, NW32QG

  • University College Hospital

    London, W1N8AA

  • Royal Hallamshire Hospital

    Sheffield, S102FJ

Other trials in United Kingdom

Israel6 sites

  • Cham Sheba Medical Center

    Haifa, 52621

  • Rabin MC

    Petah Tikva, 49372

  • Ichilov Sourasky MC

    Petah Tikva, 64239

  • Rambam Healthcare Center

    Ramat Gan, 52621

  • Carmel Medical Center

    Tel Aviv

  • Assaf Harofe Medical Center

    Zerafin, 70300

Other trials in Israel

Estonia3 sites

  • Parnu Hospital

    Pärnu, 80010

  • West Tallinn Central Hospital

    Tallinn, 10617

  • Tartu University Hospital

    Tartu, 51014

Other trials in Estonia

Lithuania3 sites

  • Kaunas Medical University Hospital

    Kaunas, LT5009

  • Vilnius University Emergency Hospital

    Vilnius, 04130

  • Vilnius University Hospital, Santariskiu Clinic

    Vilnius, 2600

Other trials in Lithuania

Portugal3 sites

  • Servico de Neurologia

    Coimbra, 3000-075

  • Hospital Santa Maria

    Lisbon, 1649-035

  • Hospital Santo Antonio

    Porto, 4099-001

Other trials in Portugal

Serbia3 sites

  • Clinic of Neurology and Psychiatry

    Belgrade, Serbia and Montenegro

  • Clinic of Neurology

    Belgrade, Serbia and Montenegro

  • Institute of Neurology

    Belgrade, Serbia and Montenegro

Other trials in Serbia

Austria2 sites

  • University Clinic Innsbruck

    Innsbruck, 6020

  • Department of Neurology

    Vienna

Other trials in Austria

Sweden2 sites

  • Praktiken Ankaret

    Karlstad, 65224

  • St Gorans Sjukhus

    Stockholm, 11281

Other trials in Sweden

About this study

Official title: A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations

Patients will be randomised to receive either placebo or the study drug for a period of 30 weeks, in addition to their standard Parkinsonian medications. During the first 8 weeks, the patient's levodopa doses may be adjusted if necessary by the investigator. For the remainder of the 22 weeks, all medications should be kept stable. Patients will be required to attend the clinic twice during the screening period and then a further 8 times during the treatment period. They will be required to complete home diaries where they will record their motor function. In addition, their doctor will assess their Parkinson's disease during the clinic visits. There will also be blood draws for safety and pharmacokinetic and pharmacogenomics evaluation. Following the treatment and assessment period, they will return to the clinic one month later for follow up.

Being tested
E2007
Medical subject headings
Parkinson Disease

What participants receive

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

  • E2007Drug

What is being measured

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

  1. Patient diaries: Change from baseline to final efficacy visit in the mean total daily OFF time (hr).

Secondary outcomes (1)

  1. Change from baseline on average OFF time over total treatment period; UPDRS Part II: OFF state; UPDRS Part III: ON state; change from baseline to final efficacy visit in mean total daily ON time w/o dyskinesias or with no troublesome dyskinesias.

Timeline

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

  1. First posted6 Feb 2006 (estimated)
  2. Study startFeb 2006
  3. Primary completionJun 2007
  4. Study completionAug 2007

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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
702 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00286897
Sponsor's protocol ID
E2007-E044-301
Other IDs
2005-004314-33, 2005
Status last verified
Nov 2015
First submitted
3 Feb 2006
Last updated
3 Nov 2015
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing E2007 in people with Parkinson's Disease, run by Eisai Limited at 118 sites in 17 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 16 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 3 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 118 sites in Germany, Poland, Hungary, Italy, South Africa and 12 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?

Patient diaries: Change from baseline to final efficacy visit in the mean total daily OFF time (hr).. 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 NCT00286897.

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 3 Nov 2015.

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