Double-blind Placebo-controlled Phase III Clinical Trial of TAP-144-SR (3M) in Patients with Spinal and Bulbar Muscular Atrophy (SBMA)

UMIN ID: UMIN000000465

Registered date:05/09/2006

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: 2006/09/01
• Target sample size: 170
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

TAP-144-SR(3M) 11.25mg subcutaneous injection every 12 weeks
Placebo subcutaneous injection every 12 weeks

Outcome(s)

• Primary Outcome: Pharyngeal barium residue (%) in videofluorography
• Secondary Outcome: Frequency of anti-poly Q staining in Scrotal Skin Clinical scores (ALSFRS-R, QMG Score, 6-minute walk) QOL (ALSAQ-5) serum creatine kinase (CK) parameters in videofluorography

Key inclusion & exclusion criteria

• Age minimum: 30years-old
• Age maximum: 70years-old
• Gender: Male
• Exclude criteria: 1) Patients who have taken LH-RH agonists, testosterone drugs, 5-alpha-reductase inhibitors, anti-androgen drugs or estrogen drugs within 48 weeks prior to the informed consent. 2) Patients who have taken LH-RH agonists for more than 48 weeks prior to the informed consent. 3) Patients who have undergone operations (eg. orchiectomy), which reduce serum testosterone levels. 4) Patients who are unable to undergo skin biopsies. 5) Patients who are unable to undergo videofluorography. 6) Patients who are diagnosed being depressed by M.I.N.I. Japanese version 5.0.0 major depression episode. 7) Patients who have severe complications. 8) Patients who have suffered angina pectoris or myocardial infarction within one month prior to the informed consent. 9) Heart rate > 120 bpm, systolic BP > 180mmHg or diastolic BP > 100 mmHg. 10) Patients with past medical history of allergy to leuprorelin acetate, synthetic LH-RH or LH-RH delivatives. 11) Patients who have participated in other clinical trials within 12 weeks prior to the informed consent. 12) Patients who are not appropriate to participate to the trial.

Related Information

• Primary Sponsor: Center for Clinical Trials, Japan Medical Association
• Secondary Sponsor: Hokkaido, Tohoku, Chiba, Tokyo med & dental, Niigata, Kobe, Tottori, Nagasaki and Kumamoto univ, Jichi med college, Univ of Tokyo, NHO Sagamihara hosp, Hamamatsu med college.
• Source(s) of Monetary Support: Center for Clinical Trials, Japan Medical Association