An exploratory Phase I/II study of ANP-230 in patients with infantile episodic limb pain

JRCT ID: jRCT2061200046

Registered date:15/01/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: infantile episodic limb pain
• Date of first enrollment: 18/01/2021
• Target sample size: 30
• Study type: Interventional

Intervention(s)

0.5~1 mg/kg ANP-230 BID oral administration
Open-label PK phase; 2 weeks
Double-blind phase; 6 weeks
Open-label extension; 6 weeks

Outcome(s)

Primary Outcome

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 Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 6age old
• Age maximum: Not applicable
• Gender: Both

Include 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)

Exclude 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

Related Information

• Primary Sponsor: TAKAHASHI TSUTOMU