UMIN ID: UMIN000001010
Registered date:01/02/2008
Long Term Follow-up Phase III Clinical Trial of TAP-144-SR (3M) in Patients with Spinal and Bulbar Muscular Atrophy (SBMA)
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Spinal and Bulbar Muscular Atrophy (SBMA) |
| Date of first enrollment | 2007/07/01 |
| Target sample size | 152 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | TAP-144-SR(3M) 11.25mg subcutaneous injection every 12 weeks |
Outcome(s)
| Primary Outcome | Pharyngeal barium residue (%) in videofluorography |
|---|---|
| Secondary Outcome | Clinical scores (ALSFRS-R, QMG Score, 6-minute walk) QOL (ALSAQ-5) serum creatine kinase (CK) |
Key inclusion & exclusion criteria
| Age minimum | 30years-old |
|---|---|
| Age maximum | 71years-old |
| Gender | Male |
| Include criteria | |
| Exclude 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. |
Related Information
| Primary Sponsor | Department of Neurology, Nagoya University School of Medicine |
|---|---|
| Secondary Sponsor | 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. |
| Source(s) of Monetary Support | Center for Clinical Trials, Japan Medical Association |
| Secondary ID(s) |
Contact
| public contact | |
| Name | |
| Address | Tsurumai 65, Showa-ku, Nagoya, Aichi Japan |
| Telephone | 052-744-2390 |
| sbma@med.nagoya-u.ac.jp | |
| Affiliation | JASMITT Clinical Trial Office Department of Neurology, Nagoya University, School of Medicine |
| scientific contact | |
| Name | Gen Sobue |
| Address | 65 Tsurumai, Showa-ku, Nagoya, Aichi Japan |
| Telephone | 052-744-2390 |
| Affiliation | Nagoya University, Graduate School of Medicine JASMITT Clinical Trial Office |