Open clinical trial of Leuprorelin Acetate (SR) in patients with Kennedy-Alter-Sung syndrome (KAS)

UMIN ID: UMIN000001455

Registered date:23/10/2008

Basic Information

• Health condition(s) or Problem(s) studied: Kennedy-Alter-Sung syndrome (KAS)
• Date of first enrollment: 2008/10/01
• Target sample size: 10
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Leuprorelin acetate (SR) 11.25mg subcutaneous infection per 12 weeks

Outcome(s)

• Primary Outcome: Pharyngeal barium residue in videofluorography
• Secondary Outcome: serum CK, parameters in videofluorography, frequency of 1C2 antibody staining in scrotal skin, clinical scores, clinical scores, QOL scores, parameters in electrophysiological testings

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male
• Exclude criteria: "1) Patients who have taken any drugs which effect serum teststerone level within 48 weeks prior to the informed consent. 2) Patients who have taken any drugs which rduce serum teststerone level for more than 48 weaks prior to the informed concent. 3) Patients who have undergone surgical castration. 4) Patients with major depression. 5) Patients who have severe complications including sereve hypertention. 6) Patients who cannot undergo the clinical tests included in this trial. 7) Patients with allergy to leuprorelin acetate.

Related Information

• Primary Sponsor: Department of Neurology Chiba University Graduate School of Medicine
• Source(s) of Monetary Support: None