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

NCT00505622 | Terminated Phase 3 Results

• 2 other identifiers: E2007-G000-3182007-000801-30
• Study Type: interventional
• Target: 328
• Locations: 1 country
• Sites: 1

Brief Summary

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

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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

  Baseline, Week 0, Week 2, Week 4, Week 8, Week 20, Follow-up

Study Arms (1)

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).

Drug: Perampanel

Interventions

Perampanel DRUG

E2007

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Subjects with a past (within one year) or present history of major depression, suicidal ideation, or suicide attempts.
• 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.

Sponsors & Collaborators

• Eisai Limited: lead

Study Sites (1)

Centre d'Investigation Clinique, Hospital Purpan

Toulouse, Toulouse Cedex, 31059, France

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

perampanel

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Limitations and Caveats

Due to early termination, no subjects completed this open-label extension study.

Results Point of Contact

• Title: Eisai Inc.
• Organization: Eisai Call Center

888-422-4743

Study Officials

• David Squillacote, MD

  Eisai Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2007
• First Posted: July 23, 2007
• Study Start: July 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: January 21, 2016
• Results First Posted: November 22, 2012

Record last verified: 2015-11

Locations

FR (1)