A Prospective Longitudinal Study in Adult Patients With Multifocal Motor Neuropathy

JRCT ID: jRCT1030240145

Registered date:07/06/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Multifocal Motor Neuropathy (MMN)
• Date of first enrollment: 15/04/2024
• Target sample size: 6
• Countries of recruitment: Bulgaria,Japan,China,Japan,Czechia,Japan,Italy,Japan,Latvia,Japan,Poland,Japan,Serbia,Japan,Sweden,Japan,United States,Japan,Australia,Japan,Austria,Japan,Belgium,Japan,Denmark,Japan,France,Japan,Germany,Japan,Romania,Japan,Spain,Japan,United Kingdom,Japan,Canada,Japan,Netherlands,Japan
• Study type: Observational

Outcome(s)

Primary Outcome

-Demographics
-Medical history
-Prior and current therapy use
-Diagnosis parameters
-Clinical characteristics
-Initial symptoms
-Limbs affected, number of limbs affected
-Treatment parameters
-Values and change over time in MMN-RODS scale score
-Values and change over time in MMRC-10 sum score
-Values and change over time in adjusted INCAT score
-Values and change over time in the EQ-5D-5L
-Values and change over time in the RT-FSS
-Values and change over time in the CAP-PRI
-Values and change over time in the PGI-S scale
-Values and change over time in the HRPQ
-Values over time for health care resource utilization

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1.Is at least the local legal age of consent for clinical studies when signing the ICF
2.Is capable of providing signed informed consent, and complying with protocol requirements
3.Has an existing or new diagnosis of MMN made by a neuromuscular specialist or neurologist

Exclude criteria

1.Is currently participating in any clinical study with an IMP
2.Has other medical conditions that could affect the assessment of MMN

Related Information

• Primary Sponsor: Takano Mitsuru
• Secondary ID(s): NCT05988073