A Study of E2007 In Patients With Parkinson's Disease

Stopped early · Phase 2

Conditions studied: Parkinson's Disease

In brief

Phase IIb open-label extension study for patients with Parkinson's Disease. All patients will receive active study drug. The study will involve outpatient visits only. Patients who completed Study E2007-A001-214 (Cohorts I and II) and who meet inclusion/exclusion criteria will be enrolled and enter the 12-week Titration Phase (from "Dispense Study Drug" at Week 0 \[Visit 2\] through Week 12 \[Visit 7\]) followed by the Maintenance Phase (from Week 12 \[Visit 7\] to end of study).

Key facts

Study ID

NCT00427011

Run by

Eisai Inc.

People needed

25

Starts

2007-02-01

Expected to finish

2008-04-01

Last updated by the study team

2013-02-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female patients with idiopathic Parkinson's disease who have fulfilled the entry criteria for E2007-A001-214 and have completed that study up to and including the end of treatment (Day 70) visit and the Follow-up Visit at Day 91.

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., intrauterine device or barrier method plus hormonal method). These patients must have a negative serum beta human chorionic gonadotropin (B-HCG) test at the initial visit (Visit 1) and urine pregnancy tests throughout the study. 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 nonchildbearing potential as determined by the investigator.
• Patients who withdrew from Study 214 prior to the final efficacy visit for any reason, including lack of efficacy.
• Patients with serious adverse events in Study 214 that are either ongoing or that are possibly or probably related to the study drug.
• Patients with ongoing adverse events from Study 214 thought to be related to E2007.
• Patients with a past (within the past 5 years) or present history of drug or alcohol abuse as per the criteria in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM IV).
• Patients with a past (within 1 year) or present history of psychotic symptoms requiring antipsychotic treatment.
• Patients with a past (within 1 year) or present history of suicidal ideation or suicide attempts.
• Patients with 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).
• Patients with clinically significant ECG abnormality, including prolonged QTc (defined as QTc >= 450 msec using Fridericia's correction).
• Patients with clinically significant cardiovascular, metabolic, respiratory, renal, endocrinological, gastrointestinal diseases, psychiatric disorders, and bacterial or viral infections within the previous 30 days.
• Patients who are currently taking medications known to induce the enzyme cytochrome P450 3A4.
• Patients with current or prior treatment (within 4 weeks before entry visit) with tolcapone, methyldopa, budipine, reserpine, seroquel, or intermittent use of either liquid forms of levodopa or subcutaneous apomorphine.
• Patients with previous stereotactic surgery (e.g., pallidotomy) for Parkinson's disease or with planned stereotactic surgery during the study period.
• Patients receiving or with planned (next 6 months) deep brain stimulation.
• Patients with conditions affecting the peripheral or central sensory system, unless related to Parkinson's disease (such as mild sensory or pain syndromes limited to OFF periods), that could interfere with the evaluation of any such symptoms caused by the study drug.
• Patients with any condition that would make the patient, in the opinion of the investigator, unsuitable for the study.
• Patients who have received an investigational product (other than E2007) within 4 weeks before screening.
• Patients with clinically significant cognitive impairment (mini-mental state examination [MMSE] <24 or fulfilling DSM IV criteria for dementia due to Parkinson's disease).
• Patients with any condition that could, in the opinion of the investigator, place the patient at increased risk or is likely to prevent completion of the study.

Where it is running

• Pivotal Research Centers — Peoria, Arizona, United States
• Clinical Trials Incorporated — Little Rock, Arkansas, United States
• Pacific Neuroscience Medical Group — Oxnard, California, United States
• Parkinson's Disease and Movement Disorders Center of Boca Raton — Boca Raton, Florida, United States
• Brain Matters Research — Delray Beach, Florida, United States
• Charlotte Neurological Services — Port Charlotte, Florida, United States
• Suncoast Neuroscience Associates, Inc. — St. Petersburg, Florida, United States
• Raleigh Neurology Associates — Raleigh, North Carolina, United States
• Agape Medical Research Center, Inc. — Lubbock, Texas, United States

Full record on ClinicalTrials.gov

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