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

Last updated: November 2, 2015
Sponsor: Eisai Limited
Overall Status: Completed

Phase

3

Condition

Dyskinesias

Parkinson's Disease

Treatment

N/A

Clinical Study ID

NCT00286897
E2007-E044-301
2005-004314-33
  • Ages > 30
  • All Genders

Study 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. 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.

Eligibility Criteria

Inclusion

INCLUSION CRITERIA:

  1. Male or female patients with idiopathic PD fulfilling the (UK) Parkinson's diseaseSociety Brain Bank diagnostic criteria, with a good response to levodopa.

  2. Patients must have been diagnosed with idiopathic PD at >= 30 years of age.

  3. Patients must have predictable motor fluctuations of the wearing OFF type with thepresence of at least 2 hours of OFF time during the waking day (excluding the morningOFF time) as evidenced by diary cards completed at screening and confirmed by diarydata collected at the baseline visit.

  4. Before patients are randomised they must be able to show that they are able toaccurately complete the diary cards. During the diary-training period at the initialscreening visit there must be diary evidence of at least one transition of OFF to ONor from ON to OFF and patients must show 75% concordance with Investigator'scompletion of the diary card.

  5. Patients must rate between II-IV on the Hoehn & Yahr scale when in an OFF state.

  6. Patients must be taking optimised levodopa therapy (according to investigator'sopinion) at least 3 times during the waking day (not including bedtime/night timedose) up to a maximum of 8 doses daily (includes bedtime/night time dose).

  7. Patients who are treated with dopamine agonists, COMT inhibitors or MAOB inhibitorsand other anti-PD drugs must be on optimised and stable doses for at least 4 weeksprior to initial screening visit and must remain stable throughout the study. Onlylevodopa dosage can be adjusted downwards in the first 8 weeks of the double-blindtreatment phase.

  8. In the Investigator's opinion patients must be able to distinguish their own motorstates and the absence or presence of troublesome or non-troublesome dyskinesias.

  9. In the Investigator's opinion patients are able to complete the study including thecompletion of the home diary cards and capable of giving full written informedconsent.

Exclusion

EXCLUSION CRITERIA:

  1. Pregnant or lactating women.

  2. Women of child bearing potential unless infertile (including surgically sterile) orpracticing effective contraception (e.g., abstinence, IUD or barrier method plushormonal method). These patients must have a negative serum B-HCG test at the initialscreening 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 ofcontraception for the duration of the study. Postmenopausal women may be recruited butmust be amenorrhoeic for at least 1 year to be considered of non-child bearingpotential as determined by the investigator.

  3. Fertile men not willing to use reliable contraception and fertile men with partnersnot willing to use reliable contraception.

  4. Patients with a past or present history of drug or alcohol abuse as per DSM IVcriteria.

  5. Patients with a past (within one year) or present history of psychotic symptomsrequiring antipsychotic treatment. Patients may be taking anti-depressant medication,however the dose must be stable for 4 weeks prior to the baseline visit. Use ofanti-psychotic medication including clozapine and quetiapine is prohibited even if theindication is for movement disorders.

  6. Patients with a past (within one year) or present history of suicidal ideation orsuicide attempts.

  7. Patients with unstable abnormalities of the hepatic, renal, cardiovascular,respiratory, gastro-intestinal, haematological, endocrine or metabolic systems whichmight complicate assessment of the tolerability of the study medication.

  8. Patients with significantly elevated liver enzymes (abnormal bilirubin or serumtransaminase levels of more than 1.5 times the upper normal limit).

  9. Patients with current or prior treatment (within 4 weeks prior to the baseline visit)with medication known to induce the enzyme cytochrome P450 3A4.

  10. Current or prior treatment (within 4 weeks prior to the baseline visit) withtolcapone, methyldopa, budipine, reserpine, seroquel or intermittent use of eitherliquid forms of levodopa or subcutaneous apomorphine.

  11. Patients with previous stereotactic surgery (eg pallidotomy) for Parkinson's diseaseor with planned stereotactic surgery during the study period.

  12. Patients receiving or with planned (next 6 months) deep brain stimulation.

  13. Patients who have received an investigational product within 4 weeks prior to thescreening visit or patients that have participated in a previous study with E2007.

  14. Patients with clinically significant cognitive impairment (MMSE <24 and /or fulfillingDSM IV criteria for dementia due to Parkinson's disease).

  15. Patients with conditions affecting the peripheral or central sensory system unlessrelated to Parkinson's disease (such as mild sensory or pain syndromes limited to OFFperiods) that could interfere with the evaluation of any such symptoms caused by thestudy drug.

  16. Patients with any condition that would make the patient, in the opinion of theInvestigator, unsuitable for the study.

Study Design

Total Participants: 702
Study Start date:
February 01, 2006
Estimated Completion Date:
August 31, 2007

Connect with a study center

  • University Clinic Innsbruck

    Innsbruck, 6020
    Austria

    Site Not Available

  • Department of Neurology

    Vienna,
    Austria

    Site Not Available

  • Cliniques Universitaires St-Luc

    Brussels, 1200
    Belgium

    Site Not Available

  • C.H.U.de Charleroi

    Charleroi, 6000
    Belgium

    Site Not Available

  • U.Z. Antwerpen

    Edegem, 2650
    Belgium

    Site Not Available

  • U.Z. Gent

    Gent, 9000
    Belgium

    Site Not Available

  • C.H.R. de la Citadelle

    Liege, 4000
    Belgium

    Site Not Available

  • Hopital St-Pierre

    Ottignies, 1340
    Belgium

    Site Not Available

  • St-Andries Ziekenhuis

    Tielt, 8700
    Belgium

    Site Not Available

  • University Hospital

    Olomouc, 77520
    Czech Republic

    Site Not Available

  • University Hospital

    Ostrava, 70852
    Czech Republic

    Site Not Available

  • Pliklinika Modry Pavilon

    Ostrava 10, 71000
    Czech Republic

    Site Not Available

  • Nemocnice Pardubice

    Pardubice, 53203
    Czech Republic

    Site Not Available

  • Nemocnice Pisek

    Plsek, 39723
    Czech Republic

    Site Not Available

  • FN Plzen

    Plzen, 30460
    Czech Republic

    Site Not Available

  • Fakultni nemocnice Kralovske Vinohrady

    Praha 10, 10034
    Czech Republic

    Site Not Available

  • VFN Praha

    Praha 2, 12800
    Czech Republic

    Site Not Available

  • Parnu Hospital

    Parnu, 80010
    Estonia

    Site Not Available

  • West Tallinn Central Hospital

    Tallinn, 10617
    Estonia

    Site Not Available

  • Tartu University Hospital

    Tartu, 51014
    Estonia

    Site Not Available

  • Centre Hospitalier du Pays d'Aix

    Aix-en-Provence, 13090
    France

    Site Not Available

  • Service Neurologie

    Bayonne Cedex, 64100
    France

    Site Not Available

  • CHU Gabrief Montpied

    Clermont Ferrand, 69003
    France

    Site Not Available

  • Contis, Patrick

    Colomiers, 31770
    France

    Site Not Available

  • Lille Cedex,
    France

    Site Not Available

  • Centre de Pharmacologie Clinique et Evaluation Therapeutique

    Marseille Cedex 05, 13385
    France

    Site Not Available

  • Nantes Cedex 1,
    France

    Site Not Available

  • Hopital de la Pitie Salpetriere

    Paris Cedex 13, 75013
    France

    Site Not Available

  • Centre d'Investigation Clinique, Hospital Purpan

    Toulouse Cedex 9, 31059
    France

    Site Not Available

  • Kliniken Beelitz GmbH

    Beelitz-Heilstatten,
    Germany

    Site Not Available

  • Uni-klinikum Charite, Campus Virchow-klinikum

    Berlin, 13353
    Germany

    Site Not Available

  • Bochum,
    Germany

    Site Not Available

  • Universitaetsklinikum Carl Gustav Carus

    Dresden, 01307
    Germany

    Site Not Available

  • Neurologische Universitatsklinik

    Gottingen,
    Germany

    Site Not Available

  • Universitatkrankenhaus Hamburg Eppendorf

    Hamburg, D 20246
    Germany

    Site Not Available

  • Hanau,
    Germany

    Site Not Available

  • Hannover,
    Germany

    Site Not Available

  • Paracelsus-Elena-Klinik

    Kassel, 34128
    Germany

    Site Not Available

  • Gertrudis-Klinik, Parkinson Klinik

    Leun-Biskirchen,
    Germany

    Site Not Available

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

    Lubeck, 23538
    Germany

    Site Not Available

  • Klinik fuer Neurologie

    Marburg, 35033
    Germany

    Site Not Available

  • Technische Universitaet Muenchen

    Muenchen, 81675
    Germany

    Site Not Available

  • LMU Munchen, Neurologische Universitatsklinik

    Munchen,
    Germany

    Site Not Available

  • Tuebingen,
    Germany

    Site Not Available

  • Wiesbaden, 65191
    Germany

    Site Not Available

  • B-A-Z County Hospital

    Budapest, 3501
    Hungary

    Site Not Available

  • Clinexpert SMO, Budapest

    Budapest, 1091
    Hungary

    Site Not Available

  • Jahn Ferenc Hospital

    Budapest, 1204
    Hungary

    Site Not Available

  • Semmelweis University

    Budapest, 1145
    Hungary

    Site Not Available

  • St. Imre Hospital

    Budapest, 1115
    Hungary

    Site Not Available

  • Uzsoki Street Hospital

    Budapest, 1145
    Hungary

    Site Not Available

  • Budapest,
    Hungary

    Site Not Available

  • A Petz Hospital

    Gyor, 9024
    Hungary

    Site Not Available

  • Nyiro Gyula Hospital

    Gyor,
    Hungary

    Site Not Available

  • Jahn Ferenc Del-Pesti Hospital

    Miscolc, 3501
    Hungary

    Site Not Available

  • Cham Sheba Medical Center

    Haifa, 52621
    Israel

    Site Not Available

  • Ichilov Sourasky MC

    Petach-Tikva, 64239
    Israel

    Site Not Available

  • Rabin MC

    Petach-Tikva, 49372
    Israel

    Site Not Available

  • Rambam Healthcare Center

    Ramat-Gan, 52621
    Israel

    Site Not Available

  • Carmel Medical Center

    Tel Aviv,
    Israel

    Site Not Available

  • Assaf Harofe Medical Center

    Zerafin, 70300
    Israel

    Site Not Available

  • Ospedal Villa Margherita

    Arcugnano, 36057
    Italy

    Site Not Available

  • Universita degli Studi di Genova

    Genova, 16132
    Italy

    Site Not Available

  • Ospedale della Misericordia

    Grosseto, 58100
    Italy

    Site Not Available

  • Policlinico Umberto I

    Grosseto, 58100
    Italy

    Site Not Available

  • Ospedale Versillia

    Lido di Camaiore, 55043
    Italy

    Site Not Available

  • Universita degli Studi Federico II

    Napoli, 80131
    Italy

    Site Not Available

  • IRCSS Fondazione Casimiro Mondino

    Pavia, 27100
    Italy

    Site Not Available

  • Ospedale Civile di Pescara

    Pescara, 65124
    Italy

    Site Not Available

  • Ospedale San Giovanni Battista

    Roma, 00148
    Italy

    Site Not Available

  • Roma,
    Italy

    Site Not Available

  • Kaunas Medical University Hospital

    Kaunas, LT5009
    Lithuania

    Site Not Available

  • Vilnius University Emergency Hospital

    Vilnius, 04130
    Lithuania

    Site Not Available

  • Vilnius University Hospital, Santariskiu Clinic

    Vilnius, 2600
    Lithuania

    Site Not Available

  • Nzoz Kendrion

    Bialystok, 15420
    Poland

    Site Not Available

  • PSK Klinika Neurologii

    Bialystok,
    Poland

    Site Not Available

  • Klinika Neurologii Doroslych AM

    Gdansk, 80211
    Poland

    Site Not Available

  • Centralny Szpital Kliniczny

    Katowice, 40752
    Poland

    Site Not Available

  • WSS im. Kardynala S. Wyszynskiego

    Lublin, 20718
    Poland

    Site Not Available

  • Lublin,
    Poland

    Site Not Available

  • Indywidualna Specjalistyczna Praktyka Lekarska, Gabinet Neur

    Mosina k/Poznania, 62050
    Poland

    Site Not Available

  • Specjalistyczna Przychodnia Lekarska

    Plock, 09402
    Poland

    Site Not Available

  • Centralny Szpital Kliniczny MSwia

    Warszawa, 02507
    Poland

    Site Not Available

  • Centrum Leczenia Chorob

    Warszawa, 02777
    Poland

    Site Not Available

  • Warszawa, 02507
    Poland

    Site Not Available

  • Hospital Santa Maria

    1649-035 Lisboa,
    Portugal

    Site Not Available

  • Servico de Neurologia

    3000-075,
    Portugal

    Site Not Available

  • Hospital Santo Antonio

    4099-001 Porto,
    Portugal

    Site Not Available

  • Servico de Neurologia

    Coimbra, 3000-075
    Portugal

    Site Not Available

  • Hospital Santa Maria

    Lisboa, 1649-035
    Portugal

    Site Not Available

  • Hospital Santo Antonio

    Porto, 4099-001
    Portugal

    Site Not Available

  • Clinic of Neurology

    Belgrade, Serbia and Montenegro,
    Serbia

    Site Not Available

  • Clinic of Neurology and Psychiatry

    Belgrade, Serbia and Montenegro,
    Serbia

    Site Not Available

  • Institute of Neurology

    Belgrade, Serbia and Montenegro,
    Serbia

    Site Not Available

  • 407 Medi Clinic

    Bloemfontein, 9301
    South Africa

    Site Not Available

  • Rosepark Hospital

    Bloemfontein 9301,
    South Africa

    Site Not Available

  • 406 Claremont Hospital

    Cape Town,
    South Africa

    Site Not Available

  • Christian Barnard Memorial Hospital

    Cape Town, 8001
    South Africa

    Site Not Available

  • Groote Schuur Hospital

    Cape Town, 7925
    South Africa

    Site Not Available

  • Morningside, Johannesburg, 2196
    South Africa

    Site Not Available

  • Panorama Medi-Clinic

    Parow, 7550
    South Africa

    Site Not Available

  • Wilgers Medical Centre

    Pretoria, 0041
    South Africa

    Site Not Available

  • Sunninghill Hospital

    Sunninghill, Johannesburg, 2052
    South Africa

    Site Not Available

  • Umhlanga Hospital

    Umhlanga, 4321
    South Africa

    Site Not Available

  • Hospital Clinic I Provincial

    Barcelona, 08036
    Spain

    Site Not Available

  • Hospital Vall d'Hebron

    Barcelona, 8035
    Spain

    Site Not Available

  • Hospital de sant Pau

    Barcelona, 8025
    Spain

    Site Not Available

  • Hospital del Mar, Servei de Neurologia

    Barcelona,
    Spain

    Site Not Available

  • Hospital Puerta de Hierro

    Madrid, 28035
    Spain

    Site Not Available

  • Hospital Ramon y Cajal

    Madrid, 28034
    Spain

    Site Not Available

  • Clinica Universitaria de Navarra

    Pamplona, 31008
    Spain

    Site Not Available

  • Hospital Clinico Universitario de Santiago

    Santiago de Compostela, 15706
    Spain

    Site Not Available

  • Praktiken Ankaret

    Karlstad, 65224
    Sweden

    Site Not Available

  • St Gorans Sjukhus

    Stockholm, 11281
    Sweden

    Site Not Available

  • Bupa Flyde Coast Hospital

    Blackpool, FY38BP
    United Kingdom

    Site Not Available

  • North Surrey Primary Care Trust

    Chertsey, KT160QA
    United Kingdom

    Site Not Available

  • District General Hospital NHS Trust

    Clwyd, LL185UJ
    United Kingdom

    Site Not Available

  • North Manchester General Hospital

    Crumpsall, M85RB
    United Kingdom

    Site Not Available

  • Royal Free Hospital

    London, NW32QG
    United Kingdom

    Site Not Available

  • University College Hospital

    London, W1N8AA
    United Kingdom

    Site Not Available

  • Royal Hallamshire Hospital

    Sheffield, S102FJ
    United Kingdom

    Site Not Available

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