A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of the Safety, Tolerability and Efficacy of E2007 in Parkinson's Disease Patients With "Wearing Off" Motor Fluctuations and "On" Period Dyskinesias

This study has been completed.
Sponsor:
Information provided by:
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT01172379
First received: July 26, 2010
Last updated: August 21, 2014
Last verified: August 2014
  Purpose

The purpose of this study is to investigate the safety, tolerability and efficacy of E2007 in Parkinson's Disease patients who have "wearing off" motor fluctuations and "on" period dyskenisias.


Condition Intervention Phase
Parkinson's Disease
Drug: E2007
Other: Placebo Comparator
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of the Safety, Tolerability and Efficacy of E2007 in Parkinson's Disease Patients With "Wearing Off" Motor Fluctuations and "On" Period Dyskinesias

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Efficacy assessments: Parkinsonian symptomology will be recorded on an out-patient basis using patient diary cards (indicating "on" and "off" periods, sleep and dyskinesias). [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 2
Study Start Date: May 2004
Primary Completion Date: February 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental 1 Drug: E2007

Experimental 1 Drug: E2007

0.5 mg 1 tablet per day

Experimental: Experimental 2 Drug: E2007

Experimental 2 Drug: E2007

1.0 mg 1 tablet per day

Experimental: Experimental 3 Drug: E2007

Drug: E2007

2.0 mg 1 tablet per day

Placebo Comparator: Placebo Comparator Other: Placebo Comparator
Placebo 1 tablet per day

Detailed Description:

This is a randomised, double-blind, placebo-controlled, dose-ranging multicentre study with parallel groups. Patients will be equally randomized to receive 0.5 mg, 1 mg or 2 mg of E2007 or matching placebo for 12 weeks (84 days) in addition to their stable antiparkinsonian treatment. The study will involve two overnight in-patient stays. The first of these will be for 2 nights and 3 days and the second will be for 1 night and 2 days. The remainder of the study will be conducted on an outpatient basis.

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female patients with idiopathic PD fulfilling the Queen Square Brain Bank diagnostic criteria, with good response to levodopa.
  2. Patients must be aged 30-75 inclusive. Patients aged between 76-80 (inclusive) may be enrolled with the prior agreement of the Study Medical Monitor.
  3. Patients must have motor fluctuations of the wearing "off" type with the presence of at least two and half hours of "off" time during the waking day and at least 90 minutes of "off" time during the eight hour period following the morning dose of levodopa each per day as evidenced by history at Screening and confirmed by diary data collected between Screening and Baseline.
  4. Patients must have clinically relevant dyskinesias during the "on" period following each morning dose of his/her current medication.
  5. Patients must rate between II-IV on the Hoehn and Yahr scale when in an "off" state.
  6. Patients must be taking levodopa at least three times daily.
  7. Patients must have been on a fixed dose of any treatments for PD for at least 4 weeks prior to the Baseline Visit.
  8. In the Investigator's opinion patients must be able to distinguish their own motor states and the absence or presence of dyskinesias.
  9. Patients must be capable of giving full written informed consent.
  10. In the Investigator's opinion patients must be of capable of completing patient diary cards according to instructions.
  11. In the Investigator's opinion patients who are good candidates and able to complete the study.

Exclusion Criteria:

  1. Pregnant or lactating women.
  2. 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 and a negative urine pregnancy test at the Baseline Visit. 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.
  3. Fertile men not willing to use reliable contraception and fertile men with partners not willing to use reliable contraception.
  4. Patients with a past or present history of drug or alcohol abuse.
  5. 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 8 weeks prior to the Baseline Visit.
  6. Patients with unstable abnormalities of the hepatic, renal, cardiovascular, respiratory, gastrointestinal, haematological, endocrine or metabolic systems which might complicate assessment of the tolerability of the study medication.
  7. Patients with significantly elevated liver enzymes (abnormal bilirubin or seum transaminase levels of more than 1.5 times the upper normal limit).
  8. Patients currently receiving treatment with medication that could significantly interfere with gastric absorption.
  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 including but not limited to: carbamazepine; dexamethasone; ethosuximide; phenobarbital; phenytoin; primidone; rifabutin; rifampacin; and St. John's Wort.
  10. Current or prior treatment (within 4 weeks prior to Baseline Visit) with methyldopa, budipine, reserpine or intermittent use of liquid forms of levodopa or apomorphine.
  11. Patients with previous stereotactic surgery (e.g., pallidotomy) for Parkinson's disease.
  12. Patients receiving deep brain stimulation.
  13. Patients who have received an investigational product within 12 weeks prior to Baseline Visit or patients that have participated in a previous study with E2007.
  14. Patients with clinically significant cognitive impairment (MMSE ; 24 and/or fulfilling DSM IV criteria for dementia due to Parkinson's disease).
  15. Patients with conditions affecting the peripheral or central sensory system unless related to Parkinson's disease (mild sensory or pain syndromes limited to off periods) that could interfere with the evaluation of any such symptoms caused by the study drug.
  16. Patients with any condition that would make the patient, in the opinion of the Investigator, unsuitable for the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01172379

Locations
Czech Republic
Clinic of Neurology, Faculty Hospital Olomouc
Olomouc, Czech Republic, 775 20
Private Neurology Practise
Ostrava, Czech Republic, 702 00
Department of Neurology, Regional Hospital Pardubice
Pardubice, Czech Republic, 532 03
Dept. of Neurology - Second Faculty of Medicine Charles University
Prague, Czech Republic, 84 - 150 06
First Faculty of Medicine Charles University
Prague, Czech Republic, 120 00
France
Centre D'Investigation Clinique Pavillon Riser - Hopital Purpan
Toulouse, France, 31059
Germany
Parkinson's Competence Network Germany Dept. of Neurology - Philipps-University Marburg
Marburg, Hesse, Germany, 35039
Humboldt Universit?t Charite Neurologische Klinik
Berlin, Germany, D-13353
Klinikum der Friedrich-Wilhelms- Univerit?t Bonn
Bonn, Germany, D-53105
Zentralkrankenhaus Reinkenheide Neurologische Klinik
Bremerhaven, Germany, D-27574
Klinikum der Heinrich-Heine- Universit?t
D?sseldorf, Germany, D-40225
Praxis
Erbach, Germany, D-64711
Klinikum der Georg-August- Universit?t
G?ttingen, Germany, D-37099
Universit?tskrankenh aus Hamburg Eppendorf
Hamburg, Germany, D-20246
Krankenhaus Hanau
Hanau, Germany, D-63450
Medizinische Hochschule Hannover
Hannover, Germany, D-30623
Universit?tsklinikum Heidelberg
Heidelberg, Germany, D-69120
Universit?tsklinikum
Homburg/Saar, Germany, D-66421
Paracelsus-Elena-Kli nik
Kassel, Germany, D-34126
Hopital Roger Salengro
Lille, Germany, 59037
Universit?tsklinikum Rostock Klinik f?r Neurologie
Rostock, Germany, D-18147
Italy
Reparto di Neurologia - Ospedale Misericordia
Grosseto, Italy, 171 - 58100
Universit? di Napoli Federico II
Napoli, Italy, 5 - 80131
Unit? Operativa Parkinson e Disordini del Movimento
Pavia, Italy, 6 - 27100
Istituto Neuromed SRL Neurologia
Pozzilli, Italy, 18 - 86077
III Clinica Neurologica
Roma, Italy, 30 - 00185
Serbia
Clinic of Neurology
Belgrade, Serbia
Militzary Medical Academy
Belgrade, Serbia, 11000
Institute of Neurology
Belrade, Serbia
Spain
Hospital Vall d'Hebron
Barcelona, Spain, 119 - 08035
Hospital Clinic I Provincial de Barcelona
Barcelona, Spain, 8036
Hospital del Mar
Barcelona, Spain, 25-29 08003
Hospital Mutua de Terrassa
Terrassa, Spain, 25-27 - 08221
Sponsors and Collaborators
Eisai Limited
Investigators
Study Director: Jonathan Webster Eisai Limited
  More Information

No publications provided

Responsible Party: Eisai Medical Services, Eisai Inc
ClinicalTrials.gov Identifier: NCT01172379     History of Changes
Other Study ID Numbers: E2007-E044-204
Study First Received: July 26, 2010
Last Updated: August 21, 2014
Health Authority: Europe: European Agency for the Evaluation of Medicinal Products

Additional relevant MeSH terms:
Dyskinesias
Parkinson Disease
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on August 21, 2014