Double-blind Placebo-controlled Clinical Trial of Leuprorelin acetate in Patients with Spinal and Bulbar Muscular Atrophy (SBMA)

Double-blind Placebo-controlled Clinical Trial of Leuprorelin acetate in Patients with Spinal and Bulbar Muscular Atrophy (SBMA) - Clinical Trial of Leuprorelin acetate in Patients with SBMA

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000000474

Enrollment

Registered

2006-09-01

Start date

2003-09-01

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 (SBMA)

Interventions

Leuprorelin acetate 3.75 mg subcutaneous injection every 4 weeks Placebo subcutaneous injection every 4 weeks

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Genetically confirmed SBMA male patients in Japan who have no desire to father a child with written informed consent.

Exclusion criteria

Exclusion criteria: 1) Patients with past medical history of allergy to leuprorelin acetate 2) Patients who have severe complications and are not appropriate to participate to the trial.. 3) Patients who have taken testosterone within 8 weeks prior to the informed consent.

Design outcomes

Primary

Measure	Time frame
Motor function(ALSFRS-R)	—

Secondary

Measure	Time frame
Frequency of aspiration pneumonia, serum creatine kinase, serum testosterone, liver function test, HbA1c, NCV, immunohistological study of scrotal skin biopsy and Respiratory function test.	—

Countries

Japan

Outcome results

None listed

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