ong Term Follow-up Phase III Clinical Trial of TAP-144-SR (3M) in Patients with Spinal and Bulbar Muscular Atrophy (SBMA)
- Conditions
- Spinal and Bulbar Muscular Atrophy (SBMA)
- Registration Number
- JPRN-UMIN000001010
- Lead Sponsor
- Department of Neurology, Nagoya University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 152
Not provided
1) Patients who have met the termination criteria for the double-blind placebo-controlled phase III clinical trial. 2) Patients who have taken LH-RH agonists, testosterone drugs, 5-alpha-reductase inhibitors, anti-androgen drugs estrogen drugs or unapproved drugs after the recruitment of the double-blind placebo-controlled phase III clinical trial 3) Patients who have undergone operations (eg. orchiectomy), which reduce serum testosterone levels. 4) Patients who are unable to undergo videofluorography. 5) Patients who are diagnosed being depressed by M.I.N.I. Japanese version 5.0.0 major depression episode. 6) Patients who have severe complications. 7) Patients with past medical history of allergy to trial drugs in double-blind placebo-controlled phase III clinical trial. 8) Patients who are not appropriate to participate to the trial.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pharyngeal barium residue (%) in videofluorography
- Secondary Outcome Measures
Name Time Method Clinical scores (ALSFRS-R, QMG Score, 6-minute walk) QOL (ALSAQ-5) serum creatine kinase (CK)