A Study of E2007 In Patients With Parkinson's Disease

A Phase 2 study testing E2007 in people with Parkinson's Disease, run by Eisai Inc. at 9 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Parkinson's Disease
What is being tested?: E2007
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 9 sitesUnited States
Study dates: Feb 2007to Apr 2008
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

Pregnant or lactating women.
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.
Patients who withdrew from Study 214 prior to the final efficacy visit for any reason, including lack of efficacy.
Patients with serious adverse events in Study 214 that are either ongoing or that are possibly or probably related to the study drug.
Patients with ongoing adverse events from Study 214 thought to be related to E2007.
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).

Show all 20Show fewer

Patients with a past (within 1 year) or present history of psychotic symptoms requiring antipsychotic treatment.
Patients with a past (within 1 year) or present history of suicidal ideation or suicide attempts.
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).
Patients with clinically significant ECG abnormality, including prolonged QTc (defined as QTc >= 450 msec using Fridericia's correction).
Patients with clinically significant cardiovascular, metabolic, respiratory, renal, endocrinological, gastrointestinal diseases, psychiatric disorders, and bacterial or viral infections within the previous 30 days.
Patients who are currently taking medications known to induce the enzyme cytochrome P450 3A4.
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.
Patients with previous stereotactic surgery (e.g., pallidotomy) for Parkinson's disease or with planned stereotactic surgery during the study period.
Patients receiving or with planned (next 6 months) deep brain stimulation.
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.
Patients with any condition that would make the patient, in the opinion of the investigator, unsuitable for the study.
Patients who have received an investigational product (other than E2007) within 4 weeks before screening.
Patients with clinically significant cognitive impairment (mini-mental state examination [MMSE] <24 or fulfilling DSM IV criteria for dementia due to Parkinson's disease).
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.

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, 33486
Brain Matters Research
Delray Beach, Florida, 33445
Clinical Trials Incorporated
Little Rock, Arkansas, 72205
Agape Medical Research Center, Inc.
Lubbock, Texas, 79410
Pacific Neuroscience Medical Group
Oxnard, California, 93030
Pivotal Research Centers
Peoria, Arizona, 85381
Charlotte Neurological Services
Port Charlotte, Florida, 33952
Raleigh Neurology Associates
Raleigh, North Carolina, 27607
Suncoast Neuroscience Associates, Inc.
St. Petersburg, Florida, 33701

Other trials in United States

About this study

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

Conditions: Parkinson's Disease
Being tested: E2007
Medical subject headings: Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

E2007Drug
E2007 2mg tablets. Dose (2mg, 4mg, 6mg or 8mg), is taken orally at nighttime.

Study groups in NCT00427011
Study group	Role	What they receive
1	Experimental	Not described Receives: Drug: E2007

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Change From Baseline by Visit in Absolute OFF Time (Hours) During Open-label Extension Study
OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor. This outcome measure was based on data collected through use of a patient diary.
Measured: Baseline, Week 12, Week 20, Week 32, Week 44, Week 56

Secondary outcomes (3)

Mean Change From Baseline by Visit in Absolute ON Time (Without Dyskinesias or With Nontroublesome Dyskinesias) (Hours) During Open-label Extension Study
ON state is when medication is providing benefits with regard to stiffness, slowness, and tremor. This outcome measure was based on data collected through use of a patient diary.
Measured: Baseline, Week 12, Week 20, Week 32, Week 44, Week 56
Mean Change From Baseline by Visit in UPDRS Part II (ADL) in OFF State (Hours) During Open-label Extension Study
Unified Parkinson's Disease (PD) Rating Scale (UPDRS) is a standardized assessment of the symptoms and signs of PD. Part II assesses Activities of Daily Living (ADL) based on 13 items, such as speech, hygiene, and falling. Participants receive a score of 0-4 points per item, with a higher score indicating more severe symptoms. Range of possible total scores, 0 to 52. ON state is when medication is providing benefits to mobility, slowness, and stiffness. OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor.
Measured: Baseline, Week 12, Week 20, Week 32, Week 44, Week 56
Mean Change From Baseline by Visit in UPDRS Part III (Motor) Score in ON State (Hours) During Open- Label Extension Study
The UPDRS is a standardized assessment of the symptoms and signs of Parkinson's Disease. Part III assesses motor activity, based on 14 items, such as gait, facial expression, and rigidity. Participants receive a score of 0-4 points per item, with a higher score indicating more severe symptoms. Range of possible total scores, 0 to 56. ON state is when medication is providing benefits with regard to stiffness, slowness, and tremor.
Measured: Baseline, Week 12, Week 20, Week 32, Week 44, Week 56

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2007Apr 2008

First posted26 Jan 2007 (estimated)
Study startFeb 2007
Primary completionApr 2008
Study completionApr 2008

Why it stopped: Study stopped due to lack of efficacy.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
More trials run by Eisai Inc.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00427011
Sponsor's protocol ID: E2007-A001-220
Status last verified: Feb 2013
First submitted: 24 Jan 2007
Last updated: 11 Feb 2013
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
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All Parkinson's Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00427011
Acronym / sponsor ID: E2007-A001-220
Conditions: Parkinson's Disease
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study stopped due to lack of efficacy.
Enrolment: 25 participants (actual)
Lead sponsor: Eisai Inc.Industry (pharma, biotech, devices)
Study start: Feb 2007
Primary completion: Apr 2008 (actual)
Study completion: Apr 2008 (actual)
First posted: 26 Jan 2007 (estimated)
Results: Posted 5 Feb 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
1	Experimental	Drug: E2007

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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.

Key exclusion criteria (20 listed)

Pregnant or lactating women.
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.
Patients who withdrew from Study 214 prior to the final efficacy visit for any reason, including lack of efficacy.
Patients with serious adverse events in Study 214 that are either ongoing or that are possibly or probably related to the study drug.
Patients with ongoing adverse events from Study 214 thought to be related to E2007.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
E2007E2007 2mg tablets. Dose (2mg, 4mg, 6mg or 8mg), is taken orally at nighttime.	Drug	1

Primary outcome

Mean Change From Baseline by Visit in Absolute OFF Time (Hours) During Open-label Extension Study
Time frame: Baseline, Week 12, Week 20, Week 32, Week 44, Week 56
OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor. This outcome measure was based on data collected through use of a patient diary.

3 secondary outcomes

Mean Change From Baseline by Visit in Absolute ON Time (Without Dyskinesias or With Nontroublesome Dyskinesias) (Hours) During Open-label Extension Study
Time frame: Baseline, Week 12, Week 20, Week 32, Week 44, Week 56
Mean Change From Baseline by Visit in UPDRS Part II (ADL) in OFF State (Hours) During Open-label Extension Study
Time frame: Baseline, Week 12, Week 20, Week 32, Week 44, Week 56
Mean Change From Baseline by Visit in UPDRS Part III (Motor) Score in ON State (Hours) During Open- Label Extension Study
Time frame: Baseline, Week 12, Week 20, Week 32, Week 44, Week 56

Results and safety

Results posted to the registry on 5 Feb 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Perampanel	25	0

Primary outcome: Mean Change From Baseline by Visit in Absolute OFF Time (Hours) During Open-label Extension Study

Time frame: Baseline, Week 12, Week 20, Week 32, Week 44, Week 56. Mean (Standard Deviation). Unit: hours

Measure	Perampanel (Placebo During Core Study) n = 9	Perampanel (Perampanel During Core Study) n = 16
Week 12 (n=2,10)	-2.17 (4.714)	-1.18 (3.400)
Week 20 (n=2,8)	-0.50 (4.714)	-0.29 (3.261)
Week 32 (n=2,10)	-0.25 (6.718)	-0.97 (2.765)
Week 44 (n=0,7)	NA (NA)	-0.81 (2.678)
Week 56 (n=0,0)	NA (NA)	NA (NA)

Population analysed: Safety population.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Perampanel	2 of 25 (8%)	24 of 25 (96%)	Not reported

Limitations and caveats (from the sponsor): Due to early termination, a limited number of subjects (n=26) were screened for inclusion in the study and only 25 subjects were analyzed. The majority of subjects did not reach the scheduled Week 56 assessment.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Parkinson's Disease

Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

David Squillacote, MD study director

Eisai Inc.

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing E2007 in people with Parkinson's Disease, run by Eisai Inc. at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 11 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Feb 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change From Baseline by Visit in Absolute OFF Time (Hours) During Open-label Extension Study (time frame: Baseline, Week 12, Week 20, Week 32, Week 44, Week 56). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00427011.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2013.