A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of the Safety, Tolerability and Efficacy of E2007 in Parkinson's Disease Patients With "Wearing Off" Motor Fluctuations and "On" Period Dyskinesias

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01172379
• Date of registration: 26/07/2010
• Prospective Registration: No
• Primary sponsor: Eisai Limited
• Public title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of the Safety, Tolerability and Efficacy of E2007 in Parkinson's Disease Patients With "Wearing Off" Motor Fluctuations and "On" Period Dyskinesias
• Scientific title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of the Safety, Tolerability and Efficacy of E2007 in Parkinson's Disease Patients With "Wearing Off" Motor Fluctuations and "On" Period Dyskinesias
• Date of first enrolment: May 2004
• Target sample size: 2
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01172379
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Czech Republic, France, Germany, Italy, Serbia, Spain

Contacts

• Name: Jonathan Webster
• Affiliation: Eisai Limited

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Male or female patients with idiopathic PD fulfilling the Queen Square Brain Bank
diagnostic criteria, with good response to levodopa.

2. Patients must be aged 30-75 inclusive. Patients aged between 76-80 (inclusive) may
be enrolled with the prior agreement of the Study Medical Monitor.

3. Patients must have motor fluctuations of the wearing "off" type with the presence of
at least two and half hours of "off" time during the waking day and at least 90
minutes of "off" time during the eight hour period following the morning dose of
levodopa each per day as evidenced by history at Screening and confirmed by diary
data collected between Screening and Baseline.

4. Patients must have clinically relevant dyskinesias during the "on" period following
each morning dose of his/her current medication.

5. Patients must rate between II-IV on the Hoehn and Yahr scale when in an "off" state.

6. Patients must be taking levodopa at least three times daily.

7. Patients must have been on a fixed dose of any treatments for PD for at least 4 weeks
prior to the Baseline Visit.

8. In the Investigator's opinion patients must be able to distinguish their own motor
states and the absence or presence of dyskinesias.

9. Patients must be capable of giving full written informed consent.

10. In the Investigator's opinion patients must be of capable of completing patient diary
cards according to instructions.

11. In the Investigator's opinion patients who are good candidates and able to complete
the study.

Exclusion Criteria:

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 have a negative serum B-HCG test at the
Initial Screening Visit and a negative urine pregnancy test at the Baseline Visit.
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.

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 be stable for 8 weeks prior to the Baseline Visit.

6. Patients with unstable abnormalities of the hepatic, renal, cardiovascular,
respiratory, gastrointestinal, 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 seum
transaminase levels of more than 1.5 times the upper normal limit).

8. Patients currently receiving treatment with medication that could significantly
interfere with gastric absorption.

9. 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.

10. Current or prior treatment (within 4 weeks prior to Baseline Visit) with methyldopa,
budipine, reserpine or intermittent use of liquid forms of levodopa or apomorphine.

11. Patients with previous stereotactic surgery (e.g., pallidotomy) for Parkinson's
disease.

12. Patients receiving deep brain stimulation.

13. Patients who have received an investigational product within 12 weeks prior to
Baseline Visit or patients that have participated in a previous study with E2007.

14. Patients with clinically significant cognitive impairment (MMSE ; 24 and/or
fulfilling DSM IV criteria for dementia due to Parkinson's disease).

15. 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.

16. Patients with any condition that would make the patient, in the opinion of the
Investigator, unsuitable for the study.



Age minimum: 30 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Intervention(s)

Drug: E2007

Other: Placebo Comparator

Primary Outcome(s)

Efficacy assessments: Parkinsonian symptomology will be recorded on an out-patient basis using patient diary cards (indicating "on" and "off" periods, sleep and dyskinesias). [Time Frame: 12 Weeks]

Secondary ID(s)

E2007-E044-204

Source(s) of Monetary Support

Please refer to primary and secondary sponsors