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A Study to Explore the Safety And Tolerability of Doses of E2007 Up to a Maximum of 8 mg In Patients With Parkinson's Disease Who Experience End-of-Dose Wearing Off Motor Fluctuations

28. maj 2015 opdateret af: Eisai Inc.

A Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Explore the Safety And Tolerability of Doses of E2007 Up to a Maximum of 8 mg In Patients With Parkinson's Disease Who Experience End-of-Dose Wearing Off Motor Fluctuations

This is a randomized, double-blind, two treatment, two group, parallel group study. Subjects will be randomized to one of two treatment groups (E2007 or Placebo) in a 3 to 1 ratio and receive treatment for a total of ten weeks (Days 1 to 70).

Studieoversigt

Status

Afsluttet

Betingelser

Parkinsons sygdom

Intervention / Behandling

Medicin: E2007

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

Fase

Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Forenede Stater
- Arkansas
  - Little Rock, Arkansas, Forenede Stater, 72205
    - Clinical Trials Incorporated
- California
  - Oxnard, California, Forenede Stater, 93030
    - UMDNJ - Robert Wood Johnson Medical School
- Connecticut
  - New Haven, Connecticut, Forenede Stater, 06510
    - Parkinson's Disease and Movement Disorders Center of Boca Raton
- Florida
  - Boca Raton, Florida, Forenede Stater, 33486
    - Inc.
  - Delray Beach, Florida, Forenede Stater, 33445
    - Brain Matters Research
  - St. Petersburg, Florida, Forenede Stater, 33701
    - Suncoast Neuroscience Associates
- Michigan
  - Southfield, Michigan, Forenede Stater, 48034
    - Raleigh Neurology Associates
- New Jersey
  - Piscataway, New Jersey, Forenede Stater, 08854
    - Agape Medical Research Center
- North Carolina
  - Raleigh, North Carolina, Forenede Stater, 27607
    - Inc.
- Texas
  - Lubbock, Texas, Forenede Stater, 79410
    - The Clinical Neuroscience Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

Subjects of any race greater than or equal to 30 years of age
Have a diagnosis of idiopathic Parkinson's disease. Subjects should fulfill the UK Parkinson's Disease Society Brain Bank Clinical Diagnostic criteria (Queen Square criteria) and have a rating of 2 - 4 on the Hoehn and Yahr scale when in an 'off' state.
Receiving an optimized regimen of anti-Parkinsonian treatments that has been stable for at least four weeks before baseline. The regimen is not considered to be stable if "as required" or "on demand" dosing is routinely used or there is regular use of apomorphine or liquid forms of levodopa.
Taking levodopa or levodopa-containing medications (e.g. co-beneldopa, cocareldopa) at least three times daily with a good response to each levodopa dose as evidenced from patient diaries or medical notes.
Consistently experience end-of-dose "wearing-off" motor fluctuations. Subjects should:
score greater than or equal to 1 on Question 39 (What proportion of the waking day is the patient "off" on average?) of the full UPDRS at screening.
have at least 2.5 hours of "off" time on average per day recorded in the patient diary at baseline.
Willing and able to provide written informed consent and adhere to the protocol requirements, including completion of a patient diary.

Exclusion Criteria:

Receiving treatment with medication known to induce CYP3A4 activity
Previous stereotactic surgery (e.g. pallidotomy, subthalamic nucleus deep brain stimulation) for Parkinson's disease
Received an investigational product within four weeks prior to screening or having participated in a previous study with E2007.
Clinically significant cognitive impairment [mini-mental state examination (MMSE) less than 24 or fulfilling DSM IV criteria for dementia due to Parkinson's disease].
Active hepatic disease, significantly reduced hepatic function or significantly elevated liver enzymes (abnormal bilirubin or serum transaminase levels of more than 1.5 times the upper limit of the normal range).
Clinically significant ECG abnormality, including prolonged QTc (defined as QTc greater than or equal to 450 msec for males and greater than or equal to 470 msec for females using Fridericia's correction).
Clinically significant, cardiovascular, metabolic, respiratory, renal, endocrinological, gastrointestinal diseases, psychiatric disorders, and bacterial or viral infections within the previous 30 days.
History of drug or alcohol abuse.
Women who are pregnant or lactating.
Any condition that could, in the opinion of the investigator, place the subject at increased risk or is likely to prevent completion of the study

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Tildeling: Randomiseret
Interventionel model: Parallel tildeling
Maskning: Dobbelt

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Number of Participants With Any TEAE Tidsramme: Through end of study	Treatment-emergent Adverse Events (TEAEs) were defined as those adverse events (AEs) that started on or after the first dose of study medication until the end of the study. Information on any AEs were recorded throughout the study after informed consent had been signed and included abnormal clinical laboratory tests, vital sign measurements and physical examinations. Note: Safety/tolerability info captured in Adverse Event section.	Through end of study

Sekundære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Change From Baseline to Day 70 in "on" State of UPDRS Scores Tidsramme: Baseline and Day 70	The Unified Parkinson's Disease Rating Scale (UPDRS) consisted of 4 subsections used to assess symptoms and signs of Parkinson's disease, with an overall scale range of 0-147. Individual subsections included: I. Mentation, behavior, and mood (0-16); II. Activities of daily living assessed in both the "on" and "off" state (0-52); III. Motor examination (0-56); and IV. Complications of therapy assessed in the "on" fluctuations and dyskinesias (0-23). Each subsection included subscales that ranged from 0 (best possible outcome) to 1 or 4 (worst possible outcome), with the total score of subsection equaling the sum of the scores of the subscales and the overall UPDRS score equaling the sum of the scores of the 4 subsections (higher score indicating more severe Parkinson's Disease).	Baseline and Day 70
Change From Baseline to Day 70 in Absolute "Off" Time Tidsramme: Baseline and Day 70	Subjects and/or caregiver completed a diary recording their motor state and dyskinesia symptoms over the course of the day before and at the end of study drug dosing on 3 consecutive days leading up to Baseline and Day 70. An entry was made every 30 minutes whether they were in the "on" state experiencing troubling dyskinesias or "off" state. The "on" state reflected recovery of control of a particular Parkinsonian feature that readily responded to each dose of levodopa, while the "off" state reflected the re-emergence of that feature. Troublesome dyskinesias were unintentional movements that occurred while in the "on" state and which interfered with activities or caused discomfort to any extent.	Baseline and Day 70
Change From Baseline to Day 70 in Absolute "on" Time With Non-troublesome Dyskinesias Tidsramme: Baseline and Day 70	Subjects and/or caregiver completed a diary recording their motor state and dyskinesia symptoms over the course of the day before and at the end of study drug dosing on 3 consecutive days leading up to Baseline and Day 70. An entry was made every 30 minutes whether they were in the "on" state experiencing troubling dyskinesias or "off" state. The "on" state reflected recovery of control of a particular Parkinsonian feature that readily responded to each dose of levodopa, while the "off" state reflected the re-emergence of that feature. Troublesome dyskinesias were unintentional movements that occurred while in the "on" state and which interfered with activities or caused discomfort to any extent.	Baseline and Day 70
Change From Baseline to Day 70 in Absolute "on" Time With Troublesome Dyskinesias Tidsramme: Baseline and Day 70	Subjects and/or caregiver completed a diary recording their motor state and dyskinesia symptoms over the course of the day before and at the end of study drug dosing on 3 consecutive days leading up to Baseline and Day 70. An entry was made every 30 minutes whether they were in the "on" state experiencing troubling dyskinesias or "off" state. The "on" state reflected recovery of control of a particular Parkinsonian feature that readily responded to each dose of levodopa, while the "off" state reflected the re-emergence of that feature. Troublesome dyskinesias were unintentional movements that occurred while in the "on" state and which interfered with activities or caused discomfort to any extent.	Baseline and Day 70
Change From Baseline to Day 70 in Goetz/Rush Score Tidsramme: Baseline and Day 70	The Goetz/Rush scale was used to rate severity during performance of tasks intended to elicit dyskinesias, and provided an objective rating of dyskinesias during activities of daily living.The tasks included a sitting exercise, mental calculations, drinking, dressing, and walking. A 5-point scale was used: 0=absent; 1=minimal severity, no interference with voluntary motor acts; 2=dyskinesias, may impair voluntary movements but the subject was capable of efficiently completing the motor task; 3=intense dyskinesias, interference with movement control and completion of the motor task was greatly limited; 4= violent dyskinesias, incompatible with the completion of the motor task. A lower score indicated less difficulty performing the tasks.	Baseline and Day 70
Change From Baseline to Day 70 in Percent "Off" Time Tidsramme: Baseline and Day 70	Subjects and/or caregiver completed a diary recording their motor state and dyskinesia symptoms over the course of the day before and at the end of study drug dosing on 3 consecutive days leading up to Baseline and Day 70. An entry was made every 30 minutes whether they were in the "on" state experiencing troubling dyskinesias or "off" state. The "on" state reflected recovery of control of a particular Parkinsonian feature that readily responded to each dose of levodopa, while the "off" state reflected the re-emergence of that feature. Troublesome dyskinesias were unintentional movements that occurred while in the "on" state and which interfered with activities or caused discomfort to any extent.	Baseline and Day 70
Change From Baseline to Day 70 in Percent "on" Time Tidsramme: Baseline and Day 70	Subjects and/or caregiver completed a diary recording their motor state and dyskinesia symptoms over the course of the day before and at the end of study drug dosing on 3 consecutive days leading up to Baseline and Day 70. An entry was made every 30 minutes whether they were in the "on" state experiencing troubling dyskinesias or "off" state. The "on" state reflected recovery of control of a particular Parkinsonian feature that readily responded to each dose of levodopa, while the "off" state reflected the re-emergence of that feature. Troublesome dyskinesias were unintentional movements that occurred while in the "on" state and which interfered with activities or caused discomfort to any extent.	Baseline and Day 70
Change From Baseline to Day 70 in Percent "on" Time With Non-troublesome Dyskinesias Tidsramme: Baseline and Day 70	Subjects and/or caregiver completed a diary recording their motor state and dyskinesia symptoms over the course of the day before and at the end of study drug dosing on 3 consecutive days leading up to Baseline and Day 70. An entry was made every 30 minutes whether they were in the "on" state experiencing troubling dyskinesias or "off" state. The "on" state reflected recovery of control of a particular Parkinsonian feature that readily responded to each dose of levodopa, while the "off" state reflected the re-emergence of that feature. Troublesome dyskinesias were unintentional movements that occurred while in the "on" state and which interfered with activities or caused discomfort to any extent.	Baseline and Day 70
Disability of Dyskinesia From UPDRS at Baseline and Day 70 Tidsramme: Baseline and Day 70	The disability of dyskinesia was determined from question 33 (part 4) of the UPDRS assessment. It asks how disabling are the dyskinesias, and uses a 5-part scale: 0=Not disabling, 1=MIldly disabling, 2=Moderately disabling, 3=Severely disabling, 4=Completely disabling. Lower scores represented more normal functioning.	Baseline and Day 70
Duration of Dyskinesia From UPDRS at Baseline and Day 70 Tidsramme: Baseline and Day 70	The duration of dyskinesia was determined from question 32 (part 4) of the UPDRS assessment. It asks what proportion of the waking day are dyskinesias present, and uses a 5-part scale: 0 = None, 1 = 1-25% of day, 2 = 26-50% of day, 3 = 51-75% of day, 4 = 76-100% of day. Lower scores represented more normal functioning.	Baseline and Day 70

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Eisai Inc.

Efterforskere

Studieleder: Santiago Arroyo, M.D., Ph.D, Eisai Inc.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2005

Primær færdiggørelse (Faktiske)

1. februar 2006

Studieafslutning (Faktiske)

1. september 2006

Datoer for studieregistrering

Først indsendt

12. september 2005

Først indsendt, der opfyldte QC-kriterier