Parkinson's DiseasePhase 3NCT00505622

Evaluation of the Long-term Safety, Tolerability, and Efficacy of Perampanel (E2007) as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects With Motor Fluctuations

A Phase 3 study testing Perampanel in people with Parkinson's Disease, run by Eisai Limited at 1 site in France.

Terminated

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

Official record

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Trial summary

Who is it for?: Ages 30 years and older
Conditions the study is for: Parkinson's Disease
What is being tested?: Perampanel
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 328 participants
Where: 1 siteFrance
Study dates: Jul 2007to Apr 2008
Phase: Phase 3
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 30 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female subjects with idiopathic PD who have fulfilled the entry criteria to studies E2007-G000-309 or E2007-E044-213.
Subjects must have completed the core efficacy study up to and including the final efficacy and follow up visits as applicable.
Subjects with mild or moderate AEs thought to be related to Perampanel (E2007) can be entered into the study if the investigator considers it safe.

Who cannot join

Show evidence of clinically significant disease (i.e., severe cardiovascular or pulmonary disease, bronchial asthma, endocrine disease, history of peptic ulcer disease, history of myocardial infarction with residual atrial nodal or ventricular arrhythmias) that, in the opinion of the investigator, could affect either the patient's safety or the conduct of the study.
Pregnant or lactating women.
Women of childbearing potential (WOCBP) unless infertile (including surgically sterile) or practicing effective contraception (e.g., intrauterine device [IUD] or barrier method plus hormonal method). These subjects must have a negative urine pregnancy test at Visit 1 or 2 as indicated by entry into the study. These subjects 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.
Subjects with a past (within the past 5 years) or present history of drug or alcohol abuse as per Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM IV) criteria.
Antipsychotics are permitted as necessary. Subjects may be taking anti-depressant medication, however the dose must be stable for 4 weeks prior to their first study visit (the visit at which the inclusion and exclusion criteria are done with the patient).
Subjects with a past (within one year) or present history of major depression, suicidal ideation, or suicide attempts.

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Subjects with unstable abnormalities of the hepatic, renal, cardiovascular, respiratory, gastrointestinal, haematological, endocrine, or metabolic systems that might complicate assessment of the tolerability of the study medication.
Subjects with significantly elevated liver enzymes (abnormal bilirubin or serum transaminase levels of more than 1.5 times the upper limit of the normal range).
Subjects with current or prior treatment (within 4 weeks prior to the Screening Visit) with medication known to induce the enzyme CYP3A4.
Clinically significant ECG abnormality, and/or prolonged QTc (defined as QTc ≥ 450 msec).
Current or prior treatment (within 4 weeks prior to entry visit) with tolcapone, methyldopa, budipine, or reserpine.
Subjects with previous stereotactic surgery (e.g., pallidotomy) for PD or with planned stereotactic surgery during the study period
Subjects receiving or with planned (next 12 months) deep brain stimulation.
Subjects with conditions affecting the peripheral or central sensory system unless related to PD (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 medication.
Subjects have received an investigational product (other than E2007 or entacapone 200 mg) within 4 weeks prior to Screening
Any condition that could, in the opinion of the investigator, place the subject at increased risk or is likely to prevent completion of the study.
Subjects with any condition that would make the subject, in the opinion of the investigator, unsuitable for the study.
Patients on pergolide or cabergoline.

Trial locations and contacts

1 site in 1 country.

France1 site

Centre d'Investigation Clinique, Hospital Purpan
Toulouse, Toulouse Cedex, 31059

Other trials in France

About this study

Official title: A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Perampanel (E2007) as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects With Motor Fluctuations

This is a multicentre, open-label extension study to evaluate the long-term safety, tolerability, and efficacy of Perampanel (E2007) as an adjunctive therapy in levodopa treated PD subjects with motor fluctuations. All subjects who have completed E2007-E044-213 or E2007-G000-309 will be candidates for entering this extension trial, provided that they meet the inclusion/exclusion criteria and have completed the core study, up to and including the final efficacy visit.

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

What participants receive

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

PerampanelDrug

Study groups in NCT00505622
Study group	Role	What they receive
E2007	Experimental	E2007 2 mg (one 2 mg tablet taken daily in the evening), or 4 mg (two 2 mg tablets daily in the evening). Receives: Drug: Perampanel

What is being measured

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

Mean Change From Baseline in Total Daily 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. All data was collected using a 3-day diary within a window of a defined visit.
Measured: Baseline, Week 0, Week 2, Week 4, Week 8, Week 20, Follow-up

Secondary outcomes (3)

Mean Change From Baseline in UPDRS Part II (ADL) Score in OFF State (Hours) During Open-label Extension Study
Unified Parkinson's Disease Rating Scale (UPDRS) is a standardized assessment of the symptoms and signs of Parkinson's Disease. 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. OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor.
Measured: Baseline, Week 0, Week 20, Week 32
Mean Change From Baseline in UPDRS Part III (Motor) Score in ON State (Hours) During Open-label Extension Study
Unified Parkinson's Disease Rating Scale (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. ON state is when medication is providing benefits to stiffness, slowness, and tremor.
Measured: Baseline, Week 0, Week 20, Week 32
Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) During Open-label Extension Study
ON state is when medication is providing benefits with regard to stiffness, slowness, and tremor. All data was collected using a 3-day diary within a window of a defined visit.
Measured: Baseline, Week 0, Week 2, Week 4, Week 8, Week 20, Follow-up

Timeline

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

Jul 2007Apr 2008

First posted23 Jul 2007 (estimated)
Study startJul 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.
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 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 328 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00505622
Sponsor's protocol ID: E2007-G000-318
Other IDs: 2007-000801-30
Status last verified: Nov 2015
First submitted: 9 Jul 2007
Last updated: 21 Jan 2016
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?

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Study at a glance

From the registry record, last updated by the sponsor on 21 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Perampanel (E2007) as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects With Motor Fluctuations
ClinicalTrials.gov ID: NCT00505622
Acronym / sponsor ID: E2007-G000-318
Conditions: Parkinson's Disease
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study stopped due to lack of efficacy.
Enrolment: 328 participants (actual)
Lead sponsor: Eisai LimitedIndustry (pharma, biotech, devices)
Study start: Jul 2007
Primary completion: Apr 2008 (actual)
Study completion: Apr 2008 (actual)
First posted: 23 Jul 2007 (estimated)
Results: Posted 22 Nov 2012

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
E2007	Experimental	Drug: PerampanelE2007 2 mg (one 2 mg tablet taken daily in the evening), or 4 mg (two 2 mg tablets daily in the evening).

Who may qualify

Ages: 30 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Male or female subjects with idiopathic PD who have fulfilled the entry criteria to studies E2007-G000-309 or E2007-E044-213.
Subjects must have completed the core efficacy study up to and including the final efficacy and follow up visits as applicable.
Subjects with mild or moderate AEs thought to be related to Perampanel (E2007) can be entered into the study if the investigator considers it safe.

Key exclusion criteria (18 listed)

Show evidence of clinically significant disease (i.e., severe cardiovascular or pulmonary disease, bronchial asthma, endocrine disease, history of peptic ulcer disease, history of myocardial infarction with residual atrial nodal or ventricular arrhythmias) that, in the opinion of the investigator, could affect either the patient's safety or the conduct of the study.
Pregnant or lactating women.
Women of childbearing potential (WOCBP) unless infertile (including surgically sterile) or practicing effective contraception (e.g., intrauterine device [IUD] or barrier method plus hormonal method). These subjects must have a negative urine pregnancy test at Visit 1 or 2 as indicated by entry into the study. These subjects 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.
Subjects with a past (within the past 5 years) or present history of drug or alcohol abuse as per Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM IV) criteria.
Antipsychotics are permitted as necessary. Subjects may be taking anti-depressant medication, however the dose must be stable for 4 weeks prior to their first study visit (the visit at which the inclusion and exclusion criteria are done with the patient).

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
Perampanel	Drug	E2007

Primary outcome

Mean Change From Baseline in Total Daily OFF Time (Hours) During Open-label Extension Study
Time frame: Baseline, Week 0, Week 2, Week 4, Week 8, Week 20, Follow-up
OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor. All data was collected using a 3-day diary within a window of a defined visit.

3 secondary outcomes

Mean Change From Baseline in UPDRS Part II (ADL) Score in OFF State (Hours) During Open-label Extension Study
Time frame: Baseline, Week 0, Week 20, Week 32
Mean Change From Baseline in UPDRS Part III (Motor) Score in ON State (Hours) During Open-label Extension Study
Time frame: Baseline, Week 0, Week 20, Week 32
Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) During Open-label Extension Study
Time frame: Baseline, Week 0, Week 2, Week 4, Week 8, Week 20, Follow-up

Results and safety

Results posted to the registry on 22 Nov 2012, 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 (Placebo During Core Study)	121	0
Perampanel (Entacapone 200mg During Core Study)	108	0
Perampanel (Perampanel 4mg During Core Study)	96	0

Primary outcome: Mean Change From Baseline in Total Daily OFF Time (Hours) During Open-label Extension Study

Time frame: Baseline, Week 0, Week 2, Week 4, Week 8, Week 20, Follow-up. Mean (Standard Deviation). Unit: Hours

Measure	Perampanel (Placebo During Core Study) n = 121	Perampanel (Entacapone 200mg During Core Study) n = 108	Perampanel (Perampanel 4mg During Core Study) n = 96
Week 0	-1.03 (2.635)	-1.07 (2.595)	-1.24 (2.643)
Week 2	-0.91 (2.323)	-1.28 (2.867)	-1.31 (2.779)
Week 4	-0.65 (2.945)	-1.15 (2.010)	-1.67 (2.438)
Week 8	-0.70 (2.983)	-1.16 (2.509)	-1.36 (2.324)
Week 20	-1.34 (2.972)	-1.14 (1.805)	-2.11 (2.163)
Follow-up	-0.77 (2.983)	-1.61 (2.435)	-0.94 (2.978)

Population analysed: Safety Population - All subjects entering the open-label extension study who took at least 1 dose of perampanel.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events (AEs) were defined as treatment emergent in this study if the start date of the event was on or after the start of study medication in this study. Adverse events that occurred 30 days after the last dose of study drug were 'post-treatment'.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Perampanel (Placebo During Core Study)	2 of 121 (1.7%)	27 of 121 (22.3%)	Not reported
Perampanel (Entacapone 200mg During Core Study)	6 of 108 (5.6%)	27 of 108 (25%)	Not reported
Perampanel (Perampanel 4mg During Core Study)	2 of 96 (2.1%)	17 of 96 (17.7%)	Not reported

Limitations and caveats (from the sponsor): Due to early termination, no subjects completed this open-label extension study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Perampanel in people with Parkinson's Disease, run by Eisai Limited at 1 site in France.

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 3 inclusion and 18 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 21 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 22 Nov 2012). 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 in Total Daily OFF Time (Hours) During Open-label Extension Study (time frame: Baseline, Week 0, Week 2, Week 4, Week 8, Week 20, Follow-up). 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 NCT00505622.

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 21 Jan 2016.