Prospective observational study in patients with spinal and bulbar muscular atrophy (SBMA) who completed the phase 3 clinical trial of TAP-144-SR (3M) .

Prospective observational study in patients with spinal and bulbar muscular atrophy (SBMA) who completed the phase 3 clinical trial of TAP-144-SR (3M) . - Prospective observational study in patients with SBMA who completed the phase 3 clinical trial of TAP-144-SR (3M).

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000003444

Enrollment

Registered

2010-04-02

Start date

2009-12-01

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

Spinal and Bulbar Muscular Atrophy

Interventions

None listed

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: (1)Patients who completed the phase 3 clinical trial of TAP-144-SR (3M) at the University of Tokyo Hospital (2)Patients with written informed consent.

Exclusion criteria

Exclusion criteria: Patients judged as inappropriate to this study by investigators.

Design outcomes

Primary

Measure	Time frame
Motor functions and QOL (videofluorographic and manometric examination of swallowing, 6-minute walk, ALSFRS-R, QMG Score, ALSAQ-5)	—

Secondary

Measure	Time frame
Blood Pressure, Body Weight, Bone Mineral Density, Serum Creatine Kinase, Testosterone, Blood Glucose, HbA1c	—

Countries

Japan

Outcome results