Long-Term Safety, Tolerability and Efficacy in Perampanel Treated Parkinson's Disease Patients With Motor Fluctuations

A Phase 2 study testing Perampanel in people with Parkinson's Disease, run by Eisai Inc..

Terminated

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

Trial summary

A 48-month open label multi-centered extension study to evaluate the long-term safety, tolerability and efficacy of E2007 in patients with Parkinson's Disease with "wearing off" motor fluctuations and "on" period Dyskinesias. Read more about this study

Who is it for?: Any age
Conditions the study is for: Parkinson's Disease
What is being tested?: Perampanel
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 185 participants
Where: No sites listed yet
Study dates: Nov 2004to Jun 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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Patients enrolled in Study E2007-E044-204 and who either completed 12 weeks of study drug treatment or who withdrew from the study due to lack of efficacy.

Who cannot join

Pregnant or lactating women.
Women of child bearing potential unless infertile (including surgically sterile) or practicing effective contraception (e.g. abstinence, IUD-intrauterine device, or barrier method plus hormonal method). 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.
Fertile men not willing to use reliable contraception and fertile men with partners not willing to use reliable contraception. These patients and their partners must also be willing to remain using reliable contraception for the duration of the study.
Patients with a past or present history of drug or alcohol abuse.
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 have been kept stable for at least 8 weeks prior to baseline visit.
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.

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Patients with significantly elevated liver enzymes (abnormal bilirubin or serum transaminase levels of more than 1.5 times the upper normal limit).
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; rifampicin; and St John's Wort.
Current or prior treatment (within 4 weeks prior to baseline visit) with methyldopa, budipine, reserpine or intermittent use of liquid forms of levodopa or as needed (prn) apo-morphine.
Patients with previous stereotactic surgery (e.g. pallidotomy) for Parkinson's disease or who are likely to undergo surgery for Parkinson's disease while participating in this study.
Patients receiving deep brain stimulation (DBS) or who are likely to undergo DBS for Parkinson's disease while participating in the extension study.
Patients with clinically significant cognitive impairment (mini-mental state examination (MMSE) <24 and /or fulfilling diagnostic and statistical manual of mental disorders (DSM IV) criteria for dementia due to Parkinson's disease).
Patients with conditions affecting the peripheral or central sensory system.

About this study

Official title: A 48-month Open Label Multi-centered Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 in Patients With Parkinson's Disease With "Wearing Off" Motor Fluctuations and "on" Period Dyskinesias

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
Also called E2007
1mg once daily for two weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.

Study groups in NCT01634360
Study group	Role	What they receive
Perampanel (1-4 mg)	Experimental	Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204), and dosed placebo or perampanel. Subjects started this open-label extension study on perampanel 1 mg once daily for two weeks, followed by 2 mg once daily for two weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner. 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. This outcome measure was based on data collected through use of a patient diary.
Measured: Baseline, Week 0, Week 12, Week 24, Week 36, Week 52, Week 78, Week 104, Week 130, Week 156

Secondary outcomes (2)

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. This outcome measure was based on data collected through use of a patient diary.
Measured: Baseline, Week 0, Week 12, Week 24, Week 36, Week 52, Week 78, Week 104, Week 130, Week 156
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. 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 0, Week 12, Week 24, Week 36, Week 52, Week 78, Week 104, Week 130, Week 156

Timeline

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

Nov 2004Jun 2008

First posted6 Jul 2012 (estimated)
Study startNov 2004
Primary completionJun 2008
Study completionJun 2008

Why it stopped: Due to termination of clinical program for Parkinson's Disease

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 185 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01634360
Sponsor's protocol ID: E2007-E044-205
Other IDs: 2004-000361-35, 2004
Status last verified: Jan 2013
First submitted: 3 Jul 2012
Last updated: 9 Jul 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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?

Official record

Enrolling by invitationObservational study
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All Parkinson's Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 48-month Open Label Multi-centered Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 in Patients With Parkinson's Disease With "Wearing Off" Motor Fluctuations and "on" Period Dyskinesias
ClinicalTrials.gov ID: NCT01634360
Acronym / sponsor ID: E2007-E044-205
Conditions: Parkinson's Disease
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Due to termination of clinical program for Parkinson's Disease
Enrolment: 185 participants (actual)
Lead sponsor: Eisai Inc.Industry (pharma, biotech, devices)
Study start: Nov 2004
Primary completion: Jun 2008 (actual)
Study completion: Jun 2008 (actual)
First posted: 6 Jul 2012 (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: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Perampanel (1-4 mg)	Experimental	Drug: PerampanelSubjects entered this open-label extension study from the double-blind core study (E2007-E044-204), and dosed placebo or perampanel. Subjects started this open-label extension study on perampanel 1 mg once daily for two weeks, followed by 2 mg once daily for two weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

Patients enrolled in Study E2007-E044-204 and who either completed 12 weeks of study drug treatment or who withdrew from the study due to lack of efficacy.

Key exclusion criteria (13 listed)

Pregnant or lactating women.
Women of child bearing potential unless infertile (including surgically sterile) or practicing effective contraception (e.g. abstinence, IUD-intrauterine device, or barrier method plus hormonal method). 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.
Fertile men not willing to use reliable contraception and fertile men with partners not willing to use reliable contraception. These patients and their partners must also be willing to remain using reliable contraception for the duration of the study.
Patients with a past or present history of drug or alcohol abuse.
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 have been kept stable for at least 8 weeks prior to baseline visit.

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
PerampanelAlso: E20071mg once daily for two weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.	Drug	Perampanel (1-4 mg)

Primary outcome

Mean Change From Baseline in Total Daily OFF Time (Hours) During Open-label Extension Study
Time frame: Baseline, Week 0, Week 12, Week 24, Week 36, Week 52, Week 78, Week 104, Week 130, Week 156
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.

2 secondary outcomes

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 12, Week 24, Week 36, Week 52, Week 78, Week 104, Week 130, Week 156
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 12, Week 24, Week 36, Week 52, Week 78, Week 104, Week 130, Week 156

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 (Placebo During Core Study)	49	0
Perampanel (Perampanel 0.5, 1, or 2 mg During Core Study)	136	0

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

Time frame: Baseline, Week 0, Week 12, Week 24, Week 36, Week 52, Week 78, Week 104, Week 130, Week 156. Mean (Standard Deviation). Unit: Hours

Measure	Perampanel (Placebo During Core Study) n = 45	Perampanel (Perampanel 0.5, 1, or 2 mg During Core Study) n = 125
Week 0	-0.51 (2.811)	-0.68 (2.479)
Week 12	-0.91 (2.913)	-1.08 (2.907)
Week 24	-1.05 (2.760)	-1.15 (2.754)
Week 36	-0.76 (2.638)	-1.16 (2.959)
Week 52	-0.47 (3.443)	-1.34 (2.881)
Week 78	-1.31 (2.547)	-1.54 (3.106)
Week 104	-1.14 (3.121)	-1.81 (3.149)
Week 130	-0.65 (3.710)	-1.62 (2.953)

Population analysed: Efficacy Population- All subjects who were in the Safety Population and for whom at least 1 postbaseline (post Week 0) efficacy assessment was made.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Treatment emergent adverse events (TEAE) are those that start on or after the first day of dosing with study medication in the open label extension study, and no later than 30 days after the last day of dosing with study medication.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Perampanel (Placebo During Core Study)	13 of 48 (27.1%)	3 of 48 (6.3%)	Not reported
Perampanel (Perampanel 0.5, 1, or 2 mg During Core Study)	39 of 134 (29.1%)	0 of 134 (0%)	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 9 Jul 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Parkinson's Disease

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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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Perampanel in people with Parkinson's Disease, run by Eisai Inc..

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 13 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 9 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

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 in Total Daily OFF Time (Hours) During Open-label Extension Study (time frame: Baseline, Week 0, Week 12, Week 24, Week 36, Week 52, Week 78, Week 104, Week 130, Week 156). 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 NCT01634360.

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 9 Jul 2014.