NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2061200046

Registered date:15/01/2021

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

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedinfantile episodic limb pain
Date of first enrollment18/01/2021
Target sample size30
Countries of recruitmentJapan
Study typeInterventional
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 Outcome1. 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 Outcome1. 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< 20age old
GenderBoth
Include criteria1. 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 criteria1. 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

Contact

Public contact
Name HIROTSUGU HAYASHI
Address 33-94, Enoki-cho, Suita-shi, Osaka, Japan Osaka Japan 564-0053
Telephone +81-6-6310-6036
E-mail h.hayashi@alphanavi.com
Affiliation AlphaNavi Pharma Inc.
Scientific contact
Name TSUTOMU TAKAHASHI
Address 44-2 Hasunuma Hiroomote, Akita-shi, Akita, Japan Akita Japan 010-8543
Telephone +81-18-884-6157
E-mail tomy@med.akita-u.ac.jp
Affiliation Akita University Hospital