Double-blind Placebo-controlled 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-UMIN000000465
- Lead Sponsor
- Center for Clinical Trials, Japan Medical Association
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 170
Not provided
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.
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 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