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

NCT00165789 | Completed Phase 2 Results

• 1 other identifier: E2007-A001-214
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 10

Brief Summary

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).

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Any TEAE

  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

Secondary Outcomes (10)

• Change From Baseline to Day 70 in "on" State of UPDRS Scores

  Baseline and Day 70

• Change From Baseline to Day 70 in Absolute "Off" Time

  Baseline and Day 70

• Change From Baseline to Day 70 in Absolute "on" Time With Non-troublesome Dyskinesias

  Baseline and Day 70

• Change From Baseline to Day 70 in Absolute "on" Time With Troublesome Dyskinesias

  Baseline and Day 70

• Change From Baseline to Day 70 in Goetz/Rush Score

  Baseline and Day 70

Interventions

E2007 DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (10)

Clinical Trials Incorporated

Little Rock, Arkansas, 72205, United States

Location

UMDNJ - Robert Wood Johnson Medical School

Oxnard, California, 93030, United States

Location

Parkinson's Disease and Movement Disorders Center of Boca Raton

New Haven, Connecticut, 06510, United States

Location

Inc.

Boca Raton, Florida, 33486, United States

Location

Brain Matters Research

Delray Beach, Florida, 33445, United States

Location

Suncoast Neuroscience Associates

St. Petersburg, Florida, 33701, United States

Location

Raleigh Neurology Associates

Southfield, Michigan, 48034, United States

Location

Agape Medical Research Center

Piscataway, New Jersey, 08854, United States

Location

Inc.

Raleigh, North Carolina, 27607, United States

Location

The Clinical Neuroscience Center

Lubbock, Texas, 79410, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

perampanel

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Eisai Inc.
• Organization: Eisai Call Center

888-422-4743

Study Officials

• Santiago Arroyo, M.D., Ph.D

  Eisai Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 14, 2005
• Study Start: September 1, 2005
• Primary Completion: February 1, 2006
• Study Completion: September 1, 2006
• Last Updated: June 2, 2015
• Results First Posted: June 2, 2015

Record last verified: 2015-04

Locations

US (10)