A 48-MONTH OPEN LABEL MULTI-CENTERED EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY AND EFFICACY OF E2007 IN PATIENTS WITH PARKINSON’S DISEASE WITH WEARING OFF” MOTOR FLUCTUATIONS AND ON” PERIOD DYSKINESIAS.
- Conditions
- Parkinson's Disease
- Registration Number
- EUCTR2004-000361-35-CZ
- Lead Sponsor
- Eisai Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 225
1. Patients enrolled in Study 204 and who either completed 12 weeks of study drug treatment or who withdrew from the study due to lack of efficacy.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1.Pregnant or lactating women.
2.Women of child bearing potential unless infertile (including surgically sterile) or practicing effective contraception (e.g. abstinence, IUD or barrier method plus hormonal method. 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 non-child bearing potential.
3.Fertile men not willing to use reliable contraception and fertile men with partners not willing to use reliable contraception. These patients and their partners must also be willing to remain using reliable contraception for the duration of the study.
4.Patients with a past or present history of drug or alcohol abuse.
5.Patients with a past (within one year) or present history of psychotic symptoms requiring antipsychotic treatment. Patients may be taking anti-depressant medication, however the dose must have been kept stable for at least 8 weeks prior to baseline visit.
6.Patients with unstable abnormalities of the hepatic, renal, cardiovascular, respiratory, gastro-intestinal, haematological, endocrine or metabolic systems which might complicate assessment of the tolerability of the study medication.
7.Patients with significantly elevated liver enzymes (abnormal bilirubin or serum transaminase levels of more than 1.5 times the upper normal limit).
8.Patients with current or prior treatment (within 4 weeks prior to the Baseline visit) with medication known to induce the enzyme cytochrome P450 3A4 including but not limited to; carbamazepine; dexamethasone; ethosuximide; phenobarbital; phenytoin; primidone; rifabutin; rifampacin; and St John’s Wort.
9.Current or prior treatment (within 4 weeks prior to Baseline Visit) with methyldopa, budipine, reserpine or intermittent use of liquid forms of levodopa or prn apo-morphine.
10.Patients with previous stereotactic surgery (eg pallidotomy) for Parkinson’s disease or who are likely to undergo surgery for Parkinson’s disease while participating in the extension study.
11.Patients receiving deep brain stimulation (DBS) or who are likely to undergo DBS for Parkinson’s disease while participating in the extension study.
12.Patients with clinically significant cognitive impairment (MMSE <24 and /or fulfilling DSM IV criteria for dementia due to Parkinson’s disease).
13.Patients with conditions affecting the peripheral or central sensory system unless related to Parkinson’s disease (mild sensory or pain syndromes limited to off”-periods) that could interfere with the evaluation of any such symptoms caused by the study drug.
14.Patients with any condition that would make the patient, in the opinion of the Investigator, unsuitable for the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 1. To evaluate the long-term safety and tolerability of E2007, in patients with Parkinson’s disease with wearing-off” motor fluctuations and on-period dyskinesias;Secondary Objective: 1. To explore the long-term efficacy of E2007 on the symptoms of Parkinson’s disease including the duration of off” time during the waking day and on peak-dose L-dopa induced dyskinesias<br>2. To determine both total daily L-dopa dose requirement and L-dopa dose frequency;Primary end point(s): Primary safety end point:<br>1. Incidence of adverse events<br><br>Primary efficacy endpoints:<br>1. Uunited Parkinson's Disease Rating Scale<br>2. AIMS/Goetz dyskinesia rating<br>3. Clinicial Global Impression of Change<br>4. Clinical Global Impression of Tolerability<br>5. Total duration of on and off time, determined by completed patient diary cards (3 days every 3 months) measuring on” and off” time and on period dyskinesias<br>
- Secondary Outcome Measures
Name Time Method