The Effect Of E2007 On Pharmacodynamic Responses To Levodopa Among Patients With Parkinson's Disease Who Experience Dyskinesia And Motor Fluctuations
NCT ID: NCT00451633
Last Updated: 2013-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
PHASE2
INTERVENTIONAL
2007-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Patients will be randomized to one of two treatment groups ('E2007' or 'Placebo') in a 1:1 ratio and receive investigational drug treatment concomitant with their standard individualized anti-Parkinsonian therapy for a total of six weeks. Investigational drug treatment for patients in the E2007 treatment group will be started 2 mg E2007 o.d. but will be escalated to 4 mg E2007 o.d. after three weeks.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
E2007
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. A diagnosis of idiopathic Parkinson's disease. Patients should fulfill the UK Parkinson's Disease Society Brain Bank clinical diagnostic criteria (Queen Square criteria) and have a rating of 2.4 on the Hoehn \&Yahr scale when in an "off" state.
3. Receiving a regimen of anti-Parkinsonian treatments that has been optimized (according to the Investigator's opinion) and has been stable for at least four weeks before baseline. The regimen is not considered to be stable if 'as required' or 'on demand' dosing is routinely used or there is regular use of apomorphine or liquid forms of levodopa.
4. Taking levodopa at least three times during the waking day (not including bedtime or nighttime doses) and with a demonstrable response to each levodopa dose.
5. Consistently experiencing clinically-relevant, peak-effect levodopa-induced dyskinesias during the 'on' period following the morning dose of levodopa. Patients should:
1. score .2 on Questions 32 and 33 of the full UPDRS at screening.
2. have at least 3 h of 'on' time with dyskinesias on average per day recorded in the patient diary at baseline, of which 1 h is within the 4 h following the first morning dose of levodopa.
6. Consistently experiencing end-of-dose motor fluctuations. Patients should:
1. score .1 on Question 39 of the full UPDRS at screening.
2. have at least 1.5 h of 'off' time on average per day recorded in the patient diary at baseline.
7. Capable of adhering to the protocol requirements and providing written informed consent.
Exclusion Criteria
2. A history of suicide attempt or suicidal ideation within the past year.
3. Receiving antipsychotic treatment or a history of psychotic symptoms requiring antipsychotic treatment within the past year. Patients taking anti-depressant medications can enter the study providing the regimen is stable.
4. Receiving treatment with monoamine oxidase (MAO)-B inhibitors (e.g., selegiline, rasagiline).
5. Receiving treatment with medication known to induce CYP3A4 activity.
6. Receiving treatment with medications believed to have an effect on levodopa-induced dyskinesias (e.g., amantadine, dextromethorphan, clozapine, olanzapine, quetiapine).
7. Receiving treatment with medications known to exacerbate dyskinesias (eg, sodium valproate, CNS stimulants).
8. Failing to respond to the specified levodopa challenge, or where the levodopa challenge is not medically appropriate.
9. Experiencing dyskinesias unrelated to peak levodopa effect (e.g., "D-I-D" pattern).
10. Previous stereotactic surgery (e.g., pallidotomy, subthalamic nucleus deep brain stimulation) for Parkinson's disease.
11. Having received an investigational product within the four weeks leading up to Screening or having participated in a previous study with E2007.
12. Clinically significant cognitive impairment (mini-mental state examination \[MMSE\] \<26 or fulfilling DSM IV criteria for dementia due to Parkinson's disease).
13. 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).
14. Clinically significant ECG abnormalities, including prolonged QT interval (defined as QTc .450 msec).
15. Narrow-angle glaucoma.
16. Conditions affecting the peripheral or central sensory system that could interfere with pharmacodynamic evaluations of the effects of levodopa.
17. Women who are pregnant or lactating, or who are intending to become pregnant within two months of completion of the study.
18. Women of child-bearing potential who do not agree to use adequate non-hormonal contraception (e.g., intrauterine device, condoms with spermicide) throughout the study.
19. A history of drug hypersensitivity, especially hypersensitivity to any component of the investigational products or medication used for levodopa challenges.
20. A history of melanoma or suspicious, undiagnosed skin lesions.
21. 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.
30 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Eisai Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Alessia Nicotra, M.D., Ph.D.
Role: STUDY_DIRECTOR
Eisai Limited
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
St. Josef Hospital
Bochum, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Neurologische Universitatsklinik Marburg
Marburg, , Germany
CESI - Centro Ricerche Cliniche - Fondazione Universita degli Studi
Chieti, , Italy
U.O. Riabilitazione Neuromotoria, IRCCS San Raffaele Pisana
Roma, , Italy
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
E2007-E044-213
Identifier Type: -
Identifier Source: org_study_id