Assessment of Perampanel (E2007) on Synaptic Dopamine in Mild-moderate PD Patients: A Pilot Study With [^123I]-IBZM SPECT

NCT00566462 | Terminated Phase 2 Results

• 1 other identifier: E2007-A001-226
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 3

Brief Summary

This is a two-arm, double-blind, placebo-controlled study.

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• Change in Striatal [^123I]-Iodobenzamine (IBZM_ Binding Following a Single Dose Carbidopa/Levodopa Challenge for 15-hours at Baseline and Week 4

  Baseline and Week 4

Secondary Outcomes (1)

• Change in Caudate and Putamen [^123I]-IBZM Binding Following a Single Dose Carbidopa/Levodopa Challenge for 15-hours at Baseline and Week 4

  Baseline and Week 4

Study Arms (2)

perampanel

EXPERIMENTAL

Drug: perampanel

1

PLACEBO COMPARATOR

Drug: placebo

Interventions

perampanel DRUG

2 mg/d for 14 days followed by 4 mg/d for 14 days

perampanel

placebo DRUG

Matching placebo for for 14 days followed by 4 mg/d for 14 days

1

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 patients with idiopathic PD fulfilling the United Kingdom Parkinson's Disease Society Brain Bank (UKPDSBB) diagnostic criteria, with a good response to levodopa. The requirement in the UKPDSBB Step 2 for prior brain imaging is at the discretion of the investigator.
• Clinical diagnosis of idiopathic Parkinson's disease (patients must have at least two of the three cardinal symptoms: resting tremor, rigidity, bradykinesia)
• Hoehn and Yahr Stage II to IV.
• Treatment with monotherapy of levodopa plus an aromatic acid decarboxylase inhibitor (carbidopa). The carbidopa/levodopa medication should be taken at least two times daily (excluding the bedtime/night time dose) up to a maximum of eight doses daily (including the bedtime/night time dose).
• Intermittent use of either liquid forms of levodopa or subcutaneous apomorphine is permitted.
• Age \>30 years of age
• Women who are incapable of bearing children (e.g., clinically assessed as infertile, including surgically sterile) or who are practicing effective contraception (e.g., abstinence, intrauterine device or barrier method plus hormonal method).
• Postmenopausal women may be recruited but must be amenorrheic for at least 1 year to be considered. Women must have a negative serum beta-human chorionic gondotrophin (β-HCG) test at the Screening Visit and a negative urine pregnancy test prior to radiotracer administration on the day of each SPECT scanning session. Women must also be willing to remain on their current form of contraception for the duration of the study.
• In the investigator's opinion, patients are able to complete the study and are capable of giving full written informed consent.

You may not qualify if:

• Patients with any one of the following will be excluded:
• Inability or unwillingness to undergo SPECT or other study procedures
• Pregnant or lactating women
• Atypical or drug-induced PD
• Current treatment with dopamine agonists, MAO or COMT inhibitors, anticholinergics
• Patients with a past (within 1 year) or present history of psychotic symptoms requiring antipsychotic treatment. Patients may be taking antidepressant medication, however, the dose must be stable for 4 weeks prior to the Baseline Visit. Use of antipsychotic medication including clozapine and quetiapine is prohibited, even if the indication is for movement disorders.
• Current or prior treatment (within 4 weeks prior to Baseline Visit) with pergolide, tolcapone, methyldopa, budipine, reserpine, seroquel, or the herbal dopamine agonist, Mucuna Pruriens
• Patients with current or prior treatment (within 4 weeks prior to the Baseline Visit) with medication known to induce the enzyme cytochrome P450 3A4
• Use of an investigational product within 4 weeks prior to randomization or patients who have participated in a previous study with perampanel
• Patients with a past or present history of drug or alcohol abuse as per Diagnostic and Statistical Manual - 4th edition (DSM IV) criteria
• Dementia (as defined by a MMSE score of ≤ 24) and/or fulfilling the criteria for dementia due to PD (as defined by the Diagnostic and Statistical Manual of the American Psychiatric Association - 4th Edition)
• Clinically significant unstable medical or psychiatric illness
• Presence of physical, mental, or social condition that precludes informed consent or interferes with careful follow-up
• Past (within 1 year) or present history of suicidal ideation or suicide attempts
• Elevations of liver enzymes, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ≥ 1.5 times the upper limit of normal (ULN)

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (3)

Kenneth Marek

New Haven, Connecticut, 06510, United States

Location

Molecular NeuroImaging, LLC

New Haven, Connecticut, 06510, United States

Location

inVentiv

The Woodlands, Texas, 77380, United States

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

This study was terminated at the sponsor request after only 1 subject was enrolled and completed the study and therefore the data is limited. Similiar research in this area have required a minimum of 5-6 completers to develop a valid analysis.

Results Point of Contact

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

888-422-4743

Study Officials

• Patricia Cole, PhD, MD

  Eisai Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2007
• First Posted: December 3, 2007
• Study Start: October 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: September 6, 2018
• Results First Posted: December 24, 2012

Record last verified: 2018-01

Locations

US (3)