Long-term, multicenter trial of SPP-004 in mitochondrial diseases.

Long-term, multicenter trial of SPP-004 in mitochondrial diseases. - MRCD Long- term Study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2091220214

Enrollment

Registered

2015-05-26

Start date

2015-06-02

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mitochondrial disease, mainly to cranial nerve symptoms

Interventions

Intervention type:DRUG Name of intervention:SPP-004 Dose form / Japanese Medical Device Nomenclature:CAPSULE Route of administration / Site of application:ORAL Dose per administration: 5-ALA HCl 25-75

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Japanese patients who meet all of the following criteria are included in this clinical trial. 1)Patients participated in, and completed, an exploratory study of SPP-004 in mitochondrial diseases (study protocol no.: SPED-ALA-001) 2)Patients with written informed consent from their legal representatives (persons in parental authority or guardians)

Exclusion criteria

Exclusion criteria: Patients who meet any of the following criteria are excluded from this trial. 1)Patients with mitochondrial cardiomyopathy 2)Patients with severe cardiac function or renal function disorders 3)Patients complicated by sepsis 4)Patients with a history of drug allergy 5)Patients with a history of hypersensitivity to any ingredients of the investigational drugs 6)Patients participated in another clinical study within 12 weeks prior to the informed consent, except those who participated in the exploratory study of SPP-004 in mitochondrial diseases (study protocol no.SPED-ALA-001) 7)Patients whom the investigator and sub-investigator considered inappropriate to participating this trial

Design outcomes

Primary

Measure	Time frame
The Newcastle Paediatric Mitochondrial Disease Scale (NPMDS) Section I~III	—

Secondary

Measure	Time frame
Life prognosis NPMDS Section I~IV FGF21 Weight Height Head circumference Respiratory chain complexes enzyme activity in dermal fibroblast (if informed consent is obtained)	—

Countries

Japan

Contacts

Public ContactAkira Otake

Saitama Medical University Hospital

akira_oh@saitama-med.ac.jp+81-49-276-1111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026