A Study of E2007 In Patients With Parkinson's Disease

This study has been terminated.
(Study stopped due to lack of efficacy.)
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00427011
First received: January 24, 2007
Last updated: February 5, 2013
Last verified: February 2013
  Purpose

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).


Condition Intervention Phase
Parkinson's Disease
Drug: E2007
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of E2007 In Patients With Parkinson's Disease Who Experience End-of-Dose "Wearing-Off" Motor Fluctuations

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Mean Change From Baseline by Visit in Absolute OFF Time (Hours) During Open-label Extension Study [ Time Frame: Baseline, Week 12, Week 20, Week 32, Week 44, Week 56 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Mean Change From Baseline by Visit in Absolute ON Time (Without Dyskinesias or With Nontroublesome Dyskinesias) (Hours) During Open-label Extension Study [ Time Frame: Baseline, Week 12, Week 20, Week 32, Week 44, Week 56 ] [ Designated as safety issue: No ]
    ON state is when medication is providing benefits with regard to stiffness, slowness, and tremor. This outcome measure was based on data collected through use of a patient diary.

  • Mean Change From Baseline by Visit in UPDRS Part II (ADL) in OFF State (Hours) During Open-label Extension Study [ Time Frame: Baseline, Week 12, Week 20, Week 32, Week 44, Week 56 ] [ Designated as safety issue: No ]
    Unified Parkinson's Disease (PD) Rating Scale (UPDRS) is a standardized assessment of the symptoms and signs of PD. Part II assesses Activities of Daily Living (ADL) based on 13 items, such as speech, hygiene, and falling. Participants receive a score of 0-4 points per item, with a higher score indicating more severe symptoms. Range of possible total scores, 0 to 52. ON state is when medication is providing benefits to mobility, slowness, and stiffness. OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor.

  • Mean Change From Baseline by Visit in UPDRS Part III (Motor) Score in ON State (Hours) During Open- Label Extension Study [ Time Frame: Baseline, Week 12, Week 20, Week 32, Week 44, Week 56 ] [ Designated as safety issue: No ]
    The UPDRS is a standardized assessment of the symptoms and signs of Parkinson's Disease. Part III assesses motor activity, based on 14 items, such as gait, facial expression, and rigidity. Participants receive a score of 0-4 points per item, with a higher score indicating more severe symptoms. Range of possible total scores, 0 to 56. ON state is when medication is providing benefits with regard to stiffness, slowness, and tremor.


Enrollment: 25
Study Start Date: February 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: E2007
E2007 2mg tablets. Dose (2mg, 4mg, 6mg or 8mg), is taken orally at nighttime.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00427011

Locations
United States, Arizona
Pivotal Research Centers
Peoria, Arizona, United States, 85381
United States, Arkansas
Clinical Trials Incorporated
Little Rock, Arkansas, United States, 72205
United States, California
Pacific Neuroscience Medical Group
Oxnard, California, United States, 93030
United States, Florida
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, United States, 33486
Brain Matters Research
Delray Beach, Florida, United States, 33445
Charlotte Neurological Services
Port Charlotte, Florida, United States, 33952
Suncoast Neuroscience Associates, Inc.
St. Petersburg, Florida, United States, 33701
United States, North Carolina
Raleigh Neurology Associates
Raleigh, North Carolina, United States, 27607
United States, Texas
Agape Medical Research Center, Inc.
Lubbock, Texas, United States, 79410
Sponsors and Collaborators
Eisai Inc.
Investigators
Study Director: David Squillacote, MD Eisai Inc.
  More Information

No publications provided

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT00427011     History of Changes
Other Study ID Numbers: E2007-A001-220
Study First Received: January 24, 2007
Results First Received: November 20, 2012
Last Updated: February 5, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on August 28, 2014