MAEPLE study

JRCT ID: jRCTs031180070

Registered date:28/12/2018

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: epilepsy
• Date of first enrollment: 27/08/2018
• Target sample size: 35
• Study type: Interventional
• Intervention(s): Administration of unapproved drug

Outcome(s)

• Primary Outcome: To examine the differences in the distributions of AMPARs among the groups divided by seizure pattern in comparison with those of healthy subjects.

Secondary Outcome

To analyse the differences in the distribution between [11C] K-2 and FDG separately on the basis of seizure patterns.
To analyse the difference in the distribution between [11C] K-2 and signal origin identified by scalpe EEG separately on the basis of seizure patterns.
To determine the brain regions showing good correlation between the densities of AMPA receptors and IQ scores calculated based on psychological test.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 60age old
• Gender: Male

Include criteria

1. Patients diagnosed with epilepsy on the basis of ILAE criteria
2. Patients who have seizures 12months prior to registration
3. Patients without neurosurgery in the past
4. Patients who are over 20 years and below 60 years
5. Patients who can consent to this study by oneself

Exclude criteria

1. Patients who have experienced the electric stimulation therapy
2. Patients who have severe renal dysfunction (Serum Cre>1.5)
3. Patients who have severe liver dysfunction (AST and ALT>150)
4. Patients who have severe cardiovascular disorder
5. Patients who have tatoo
6. Claustrophobic patients
7. Patients who can not agree with contraception during 7days after [11C]K-2 PET
8. Patients who take Perampanel or Topiramate(within 1month before this registration)
9.Patients who underwent nuclear medicine examination within
1 week before this registration
10.Patients who underwent other clinical trials using unapproved
nuclear medicine examination within 6 months before this
registration
11.Patients who underwent other clinical trial within 12 weeks before this registration
12.Patients whom study doctors consider inappropriate

Related Information

• Primary Sponsor: Miyazaki Tomoyuki
• Source(s) of Monetary Support: EISAI Co., Ltd.
• Secondary ID(s): UMIN000031624