infantile episodic limb pain infantile episodic limb pain, voltage-gated sodium channel Nav1.9
Conditions
Interventions
0.5~1 mg/kg ANP-230 BID oral administration
Open-label PK phase
2 weeks
Double-blind phase
6 weeks
Open-label extension
Sponsors
TAKAHASHI TSUTOMU
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with aged 6 years or older until aged 20 years at the time of providing consent 2. Patients diagnosed with the infantile episodic limb pain 3. Patients have ability to comply with compliance rules during participation in the clinical trial, receive examinations and tests specified in the clinical trial procedures, and can report subjective symptoms (pain intensity, number of attacks, duration of attacks)
Exclusion criteria
Exclusion criteria: 1. Patients have a history of allergy to ANP-230 2. Patients have a history of epilepsy 3. Patients have had any prior exposure to ANP-230 (Previous Investigational ingredient code: DSP-2230) 4. Patients who cannot adequately assess their own pain or pain attacks using the NRS-11 indicators despite prior training
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change in pain score from baseline using NRS -11 2. Change from baseline in total duration and total number of pain attacks reported by subject themselves. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate the pharmacokinetics of ANP -230 and its metabolite M1 after repeated administration of ANP -230 to Japanese patients with infantile episodic limb pain 2. Percentage of 30% and 50% responders with change in pain score from baseline using NRS -11 3. CGI-I score 4. Changes from baseline in the amount and number of use of the rescue drug | — |
Contacts
Public ContactHIROTSUGU HAYASHI
AlphaNavi Pharma Inc.
Outcome results
None listed