A Study of E2007 In Patients With Parkinson's Disease

NCT ID: NCT00427011

Last Updated: 2013-02-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2008-04-30

Brief Summary

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).

Conditions

Parkinson's Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

E2007

Intervention Type: DRUG

E2007 2mg tablets. Dose (2mg, 4mg, 6mg or 8mg), is taken orally at nighttime.

Interventions

E2007

E2007 2mg tablets. Dose (2mg, 4mg, 6mg or 8mg), is taken orally at nighttime.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. 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.

Exclusion Criteria

1. Pregnant or lactating women.

2. 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.

3. Patients who withdrew from Study 214 prior to the final efficacy visit for any reason, including lack of efficacy.

4. Patients with serious adverse events in Study 214 that are either ongoing or that are possibly or probably related to the study drug.

5. Patients with ongoing adverse events from Study 214 thought to be related to E2007.

6. 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).

7. Patients with a past (within 1 year) or present history of psychotic symptoms requiring antipsychotic treatment.

8. Patients with a past (within 1 year) or present history of suicidal ideation or suicide attempts.

9. 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).

10. Patients with clinically significant ECG abnormality, including prolonged QTc (defined as QTc >= 450 msec using Fridericia's correction).

11. Patients with clinically significant cardiovascular, metabolic, respiratory, renal, endocrinological, gastrointestinal diseases, psychiatric disorders, and bacterial or viral infections within the previous 30 days.

12. Patients who are currently taking medications known to induce the enzyme cytochrome P450 3A4.

13. 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.

14. Patients with previous stereotactic surgery (e.g., pallidotomy) for Parkinson's disease or with planned stereotactic surgery during the study period.

15. Patients receiving or with planned (next 6 months) deep brain stimulation.

16. 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.

17. Patients with any condition that would make the patient, in the opinion of the investigator, unsuitable for the study.

18. Patients who have received an investigational product (other than E2007) within 4 weeks before screening.

19. Patients with clinically significant cognitive impairment (mini-mental state examination [MMSE] <24 or fulfilling DSM IV criteria for dementia due to Parkinson's disease).

20. 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eisai Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Squillacote, MD

Role: STUDY_DIRECTOR

Eisai Inc.

Locations

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

Countries

United States

Other Identifiers

E2007-A001-220

Identifier Type: -

Identifier Source: org_study_id