A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations.

• Register: EUCTR
• Last refreshed on: 18 April 2012
• Main ID: EUCTR2006-002339-26-GB
• Date of registration: 16/10/2006
• Prospective Registration: Yes
• Primary sponsor: Eisai Limited
• Public title: A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations.
• Scientific title: A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations.
• Date of first enrolment: 28/12/2006
• Target sample size: 1400
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-002339-26
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Austria, Czech Republic, Estonia, Germany, Hungary, Italy, Lithuania, Portugal, Spain, Sweden, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
1. Male or female patients with idiopathic PD who have fulfilled the entry criteria to either E2007-E044-301 or E2007-A001-302 and have completed that study up to and including the final efficacy visit.
2. Patients will not be eligible if they withdrew from the core study prior to the final efficacy visit for any reason including lack of efficacy.
3. Patients with SAEs which are ongoing or possibly or probably related to the study drug, will not be eligible for this study.
4. Patients with ongoing adverse events categorized as severe and thought to be related to E2007 should not be entered.
5. Patients with mild or moderate adverse events thought to be related to E2007 can be entered to the study if the investigator considers it safe.
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

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 or urine ß-HCG
test at their first study 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 as determined by the investigator.
3. Patients with a past (within the past 5 years) or present history of drug or alcohol
abuse as per DSM IV criteria.
4. Patients with a past (within one year) or present history of suicidal ideation or
suicide attempts.
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 4 weeks prior to the baseline visit.
Use of anti-psychotic medication including clozapine and quetiapine is prohibited
even if the indication is for movement disorders.
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. Medication known to induce the enzyme cytochrome P450 3A4 is prohibited
throughout the study.
9. Current or prior treatment (within 4 weeks prior to entry visit) with tolcapone,
methyldopa, budipine, reserpine, seroquel.
10. 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.
11. Patients receiving or with planned (next 12 months) deep brain stimulation.
12. Patients with any condition that would make the patient, in the opinion of the
Investigator, unsuitable for the study.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Levodopa treated Parkinson's disease patients with motor fluctuations.
MedDRA version: 8.1 Level: LLT Classification code 10061536 Term: Parkinson's disease

Intervention(s)

Product Name: MARS
Product Code: E2007
Pharmaceutical Form: Film-coated tablet
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-

Primary Outcome(s)

Secondary Objective: To evaluate the long-term efficacy of E2007 on the motor fluctuations of Parkinson’s disease including the duration of OFF time during the waking day, and ON period dyskinesias.

Main Objective: To evaluate the long-term safety and tolerability of E2007 as an adjunctive therapy in levodopa treated Parkinson’s disease (PD) patients with motor fluctuations.

Primary end point(s): -Patient diaries: Change from baseline to the efficacy visit at week 56 in the mean total daily OFF time.
-Patient Diaries: Change from baseline to the efficacy visit at week 56 on the average OFF time.
-Patient Diaries: Change from baseline to final efficacy visit in the mean total daily ON time without dyskinesias or with non troublesome dyskinesias.
-Patient Diaries: Change from baseline to final efficacy visit in the mean total daily ON time with dyskinesias.
- UPDRS Part II (ADL): OFF state
- UPDRS Part III (Motor): ON state

Secondary ID(s)

2006-002339-26-LT

E2007-G000-303