NCT01172379

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for phase_2

Geographic Reach
6 countries

33 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2005

Completed
5.5 years until next milestone

First Submitted

Initial submission to the registry

July 26, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 29, 2010

Completed
Last Updated

August 22, 2014

Status Verified

August 1, 2014

Enrollment Period

9 months

First QC Date

July 26, 2010

Last Update Submit

August 21, 2014

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

  • Efficacy assessments: Parkinsonian symptomology will be recorded on an out-patient basis using patient diary cards (indicating "on" and "off" periods, sleep and dyskinesias).

    12 Weeks

Study Arms (4)

Experimental 1

EXPERIMENTAL
Drug: E2007

Experimental 2

EXPERIMENTAL
Drug: E2007

Experimental 3

EXPERIMENTAL
Drug: E2007

Placebo Comparator

PLACEBO COMPARATOR
Other: Placebo Comparator

Interventions

E2007DRUG

Experimental 1 Drug: E2007 0.5 mg 1 tablet per day

Experimental 1
Placebo ComparatorOTHER

Placebo 1 tablet per day

Placebo Comparator

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female patients with idiopathic PD fulfilling the Queen Square Brain Bank diagnostic criteria, with good response to levodopa.
  • 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.
  • 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.
  • Patients must have clinically relevant dyskinesias during the "on" period following each morning dose of his/her current medication.
  • Patients must rate between II-IV on the Hoehn and Yahr scale when in an "off" state.
  • Patients must be taking levodopa at least three times daily.
  • Patients must have been on a fixed dose of any treatments for PD for at least 4 weeks prior to the Baseline Visit.
  • In the Investigator's opinion patients must be able to distinguish their own motor states and the absence or presence of dyskinesias.
  • Patients must be capable of giving full written informed consent.
  • In the Investigator's opinion patients must be of capable of completing patient diary cards according to instructions.
  • In the Investigator's opinion patients who are good candidates and able to complete the study.

You may not qualify if:

  • 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 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.
  • 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.
  • 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.
  • 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.
  • Patients with significantly elevated liver enzymes (abnormal bilirubin or seum transaminase levels of more than 1.5 times the upper normal limit).
  • Patients currently receiving treatment with medication that could significantly interfere with gastric absorption.
  • 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.
  • 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.
  • Patients with previous stereotactic surgery (e.g., pallidotomy) for Parkinson's disease.
  • Patients receiving deep brain stimulation.
  • 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.
  • 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 (mild sensory or pain syndromes limited to off periods) that could interfere with the evaluation of any such symptoms caused by the study drug.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (33)

Clinic of Neurology, Faculty Hospital Olomouc

Olomouc, 775 20, Czechia

Location

Private Neurology Practise

Ostrava, 702 00, Czechia

Location

Department of Neurology, Regional Hospital Pardubice

Pardubice, 532 03, Czechia

Location

First Faculty of Medicine Charles University

Prague, 120 00, Czechia

Location

Dept. of Neurology - Second Faculty of Medicine Charles University

Prague, 84 - 150 06, Czechia

Location

Centre D'Investigation Clinique Pavillon Riser - Hopital Purpan

Toulouse, 31059, France

Location

Parkinson's Competence Network Germany Dept. of Neurology - Philipps-University Marburg

Marburg, Hesse, 35039, Germany

Location

Humboldt Universit?t Charite Neurologische Klinik

Berlin, D-13353, Germany

Location

Klinikum der Friedrich-Wilhelms- Univerit?t Bonn

Bonn, D-53105, Germany

Location

Zentralkrankenhaus Reinkenheide Neurologische Klinik

Bremerhaven, D-27574, Germany

Location

Klinikum der Heinrich-Heine- Universit?t

D?sseldorf, D-40225, Germany

Location

Praxis

Erbach im Odenwald, D-64711, Germany

Location

Klinikum der Georg-August- Universit?t

G?ttingen, D-37099, Germany

Location

Universit?tskrankenh aus Hamburg Eppendorf

Hamburg, D-20246, Germany

Location

Krankenhaus Hanau

Hanau, D-63450, Germany

Location

Medizinische Hochschule Hannover

Hanover, D-30623, Germany

Location

Universit?tsklinikum Heidelberg

Heidelberg, D-69120, Germany

Location

Universit?tsklinikum

Homburg/Saar, D-66421, Germany

Location

Paracelsus-Elena-Kli nik

Kassel, D-34126, Germany

Location

Hopital Roger Salengro

Lille, 59037, Germany

Location

Universit?tsklinikum Rostock Klinik f?r Neurologie

Rostock, D-18147, Germany

Location

Reparto di Neurologia - Ospedale Misericordia

Grosseto, 171 - 58100, Italy

Location

Universit? di Napoli Federico II

Napoli, 5 - 80131, Italy

Location

Unit? Operativa Parkinson e Disordini del Movimento

Pavia, 6 - 27100, Italy

Location

Istituto Neuromed SRL Neurologia

Pozzilli, 18 - 86077, Italy

Location

III Clinica Neurologica

Roma, 30 - 00185, Italy

Location

Militzary Medical Academy

Belgrade, 11000, Serbia

Location

Clinic of Neurology

Belgrade, Serbia

Location

Institute of Neurology

Belrade, Serbia

Location

Hospital Vall d'Hebron

Barcelona, 119 - 08035, Spain

Location

Hospital del Mar

Barcelona, 25-29 08003, Spain

Location

Hospital Clinic I Provincial de Barcelona

Barcelona, 8036, Spain

Location

Hospital Mutua de Terrassa

Terrassa, 25-27 - 08221, Spain

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

perampanel

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Jonathan Webster

    Eisai Limited

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 26, 2010

First Posted

July 29, 2010

Study Start

May 1, 2004

Primary Completion

February 1, 2005

Last Updated

August 22, 2014

Record last verified: 2014-08

Locations

SE(3)DE(15)ES(4)FR(1)CZ(5)IT(5)