Clinical trial NCT00427011: A Study of E2007 In Patients With Parkinson's Disease
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Parkinson's Disease
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2007-01-26
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Mean Change From Baseline by Visit in Absolute OFF Time (Hours) During Open-label Extension Study
timeFrame: Baseline, Week 12, Week 20, Week 32, Week 44, Week 56
Secondary outcomes:
measure: Mean Change From Baseline by Visit in Absolute ON Time (Without Dyskinesias or With Nontroublesome Dyskinesias) (Hours) During Open-label Extension Study
timeFrame: Baseline, Week 12, Week 20, Week 32, Week 44, Week 56
measure: Mean Change From Baseline by Visit in UPDRS Part II (ADL) in OFF State (Hours) During Open-label Extension Study
timeFrame: Baseline, Week 12, Week 20, Week 32, Week 44, Week 56
measure: Mean Change From Baseline by Visit in UPDRS Part III (Motor) Score in ON State (Hours) During Open- Label Extension Study
timeFrame: Baseline, Week 12, Week 20, Week 32, Week 44, Week 56
Other outcomes:
Locations:
city: Peoria
country: United States
facility: Pivotal Research Centers
state: Arizona
city: Little Rock
country: United States
facility: Clinical Trials Incorporated
state: Arkansas
city: Oxnard
country: United States
facility: Pacific Neuroscience Medical Group
state: California
city: Boca Raton
country: United States
facility: Parkinson's Disease and Movement Disorders Center of Boca Raton
state: Florida
city: Delray Beach
country: United States
facility: Brain Matters Research
state: Florida
city: Port Charlotte
country: United States
facility: Charlotte Neurological Services
state: Florida
city: St. Petersburg
country: United States
facility: Suncoast Neuroscience Associates, Inc.
state: Florida
city: Raleigh
country: United States
facility: Raleigh Neurology Associates
state: North Carolina
city: Lubbock
country: United States
facility: Agape Medical Research Center, Inc.
state: Texas
Study officials:
affiliation: Eisai Inc.
name: David Squillacote, MD
role: STUDY_DIRECTOR
References: