The clinical trial to evaluate the efficacy of [11C]K-2 in epilepsy patients

JRCT ID: jRCTs031180191

Registered date:06/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: refractory epilepsy patients
• Date of first enrollment: 27/03/2017
• Target sample size: 8
• Study type: Interventional
• Intervention(s): Administration of unapproved drug

Outcome(s)

• Primary Outcome: The correlation of the AMPA receptors densities examined by biochemical study and [11C]K-2 PET study

Secondary Outcome

Efficacy
1)Engel classification and ILAE classification in evaluation of postoperative epileptic seizures
2)The density of AMPA receptors obtained from preoperative [11C]K-2 PET imaging, and FDG-PET values
3)The quantitative changes in cognitive function scores {intelligence quotient (IQ), memorial quotient (MQ)} around surgery
4)The quantitative changes in prescribed anti-epileptic drugs (the number of types, and the dose per day) after surgery
Safety
The adverse events occurred in patients during 7 days after PET scan

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1.refractory epilepsy patients(mesial temporal lobe epilepsy)
2.patinets for anterior temporal lobectomy(ATL)
3.patients who are without cerebral surgery on the same side of ATL
4.patients who are 20 years or older
5.patients who can consent to this study by oneself

Exclude criteria

1.patients who have significant abnormalities insides the brains
2.patients who have experienced the electric stimulation therapy
3.patients who undergo artificial dialysis
4.patients who have severe liver dysfunction
5.patients who have tatoo
6.claustrophobic patients
7.breast-feeding mothers, expecting mothers, females who desire to be a mother
8.patients who desire to bear a child within this study period
9.patients who take Fycompa
10.patients who underwent nuclear medicine examination within one-week before this registarion
11.patients who underwent other clinical trials using unapproved nuclear medicine examination within six month before this registarion
12.patients who underwent other clinical trials within 12 weeks before this registarion
13.patients whom study doctors consider unappropriate

Related Information

• Primary Sponsor: Miyazaki Tomoyuki
• Secondary Sponsor: Takahashi Takuya
• Source(s) of Monetary Support: Translational Research Network Program
• Secondary ID(s): UMIN000025090