A Study of E2007 In Patients With Parkinson's Disease

NCT00427011 | Terminated Phase 2 Results

• 1 other identifier: E2007-A001-220
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 9

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

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline by Visit in Absolute OFF Time (Hours) During Open-label Extension Study

  OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor. This outcome measure was based on data collected through use of a patient diary.

  Baseline, Week 12, Week 20, Week 32, Week 44, Week 56

Secondary Outcomes (3)

• Mean Change From Baseline by Visit in Absolute ON Time (Without Dyskinesias or With Nontroublesome Dyskinesias) (Hours) During Open-label Extension Study

  Baseline, Week 12, Week 20, Week 32, Week 44, Week 56

• Mean Change From Baseline by Visit in UPDRS Part II (ADL) in OFF State (Hours) During Open-label Extension Study

  Baseline, Week 12, Week 20, Week 32, Week 44, Week 56

• Mean Change From Baseline by Visit in UPDRS Part III (Motor) Score in ON State (Hours) During Open- Label Extension Study

  Baseline, Week 12, Week 20, Week 32, Week 44, Week 56

Study Arms (1)

1

EXPERIMENTAL

Drug: E2007

Interventions

E2007 DRUG

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

1

Eligibility Criteria

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

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.

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (9)

Pivotal Research Centers

Peoria, Arizona, 85381, United States

Location

Clinical Trials Incorporated

Little Rock, Arkansas, 72205, United States

Location

Pacific Neuroscience Medical Group

Oxnard, California, 93030, United States

Location

Parkinson's Disease and Movement Disorders Center of Boca Raton

Boca Raton, Florida, 33486, United States

Location

Brain Matters Research

Delray Beach, Florida, 33445, United States

Location

Charlotte Neurological Services

Port Charlotte, Florida, 33952, United States

Location

Suncoast Neuroscience Associates, Inc.

St. Petersburg, Florida, 33701, United States

Location

Raleigh Neurology Associates

Raleigh, North Carolina, 27607, United States

Location

Agape Medical Research Center, Inc.

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

Limitations and Caveats

Due to early termination, a limited number of subjects (n=26) were screened for inclusion in the study and only 25 subjects were analyzed. The majority of subjects did not reach the scheduled Week 56 assessment.

Results Point of Contact

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

888-422-4743

Study Officials

• David Squillacote, MD

  Eisai Inc.

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2007
• First Posted: January 26, 2007
• Study Start: February 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: February 11, 2013
• Results First Posted: February 5, 2013

Record last verified: 2013-02

Locations

US (9)