Research of sirolimus administration for FCD II type

JRCT ID: jRCTs031190157

Registered date:11/12/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Epileptic patients with focal cortical dysplasia type 2
• Date of first enrollment: 18/12/2019
• Target sample size: 15
• Study type: Interventional
• Intervention(s): Sirolimus 0.5-4mg (0.5-4 tablets of the study drug) is administered orally once a day in the morning.

Outcome(s)

• Primary Outcome: adverse event
• Secondary Outcome: Dose & level of sirolimus around adverse event, continuation of sirolimus, seizure frequency

Key inclusion & exclusion criteria

• Age minimum: >= 2age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1.After completion of clinical trial (FCDS-01 or Hokudai FCDS or sirolimus Shizuoka 2019-1), age >= 2 years old; bodyweight >= 10kg
2.Improvement of epileptic seizures by FCDS-01 or Hokudai FCDS or sirolimus Shizuoka 2019-1
3.No severe adverse effect by sirolimus or antiepileptic drugs in preceding clinical trial (FCDS-01 or Hokudai FCDS or sirolimus Shizuoka 2019-1)
4.Informed consent by written agreement after precise explanation

Exclude criteria

1.Patients without accurate data of compliance, adverse event, seizure frequency, duration of seizure
2.Possible attendance another clinical trial
3.Prescription of PB or VGB
4.Possible ketogenic diet therapy
5.Pregnant patient or no agreement for contraception
6.Basic disease inflammation, degenerative diseases
7.Risk of suicide
8.History of alcoholic abuse
9.Among preceding clinical trial (FCDS-01 or Hokudai FCDS or sirolimus Shizuoka 2019-1), the following laboratory data were observed
9-1 AST or ALT >= 2.5 folds of standard value in our hospital
9-2 WBC < 3000 /mm3, Ht < 30%, Platelet < 80000/mm3, neutrophils < 1000/mm3
9-3 C cr < 50ml/min, eGFR < 30mL/min/1.73m2
9-4 HBsAg (+), HBs Ab(+) after HBV infection, HBc Ab (+)
9-5 Uncontrolled hyperlipidemia
10.Association of arrythmia or cardiac failure requiring treatment.
11.Association of immunodeficiency
12.Irregular visit to hospital
13.Decision of inappropriate patient for this study by responsible doctor

Related Information

• Primary Sponsor: Kato Mitsuhiro
• Source(s) of Monetary Support: Nobelpharma Co., Ltd.