Spinal and Bulbar Muscular Atrophy (SBMA)
Conditions
Interventions
TAP-144-SR(3M) 11.25mg subcutaneous injection every 12 weeks
Sponsors
Department of Neurology, Nagoya University School of Medicine
Hokkaido, Tohoku Univ, Jichi Med College, Chiba Univ, Univ of Tokyo, Tokyo Medical and Dental Univ, NHO Sagamitara HP, Niigata Univ, Hamamatsu Med college, Kobe, Tottori, Nagasaki, Kumamoto Univ.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Patients who finished double-blind placebo-controlled phase III clinical trial of TAP-144-SR (3M) in patients with spinal and bulbar muscular atrophy (SBMA). 2) Patients who have no desire to father a child. 3) Patients with written informed consent. 4) Patients who are capable of ambulatory hospital visits.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharyngeal barium residue (%) in videofluorography | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical scores (ALSFRS-R, QMG Score, 6-minute walk) QOL (ALSAQ-5) serum creatine kinase (CK) | — |
Countries
Japan
Outcome results
None listed