Spinal and Bulbar Muscular Atrophy
Conditions
Interventions
Creatine monohydrate 10 g, daily for 8 weeks
Creatine monohydrate 15 g, daily for 8 weeks
placebo for 8 weeks
Sponsors
Department of Neurology, Nagoya University Graduate School of Medicine
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Patients (males) whose number of the CAG repeat in the androgen receptor gene is more than 38 2. Patients with muscle weakness 3. Patients are between 20 and 80 years old at the time of the agreement acquisition 4. Patients who are capable of ambulatory hospital visits 5. Patients whose renal functions meet the following criteria: Serum creatinine: <1.5 * Upper Limit of Institutional Reference Value 6. Patients with written informed consent
Exclusion criteria
Exclusion criteria: 1.Patients who have taken LH-RH agonists, an LH-RH antagonists, teststerone drugs, anti-androgen drugs, estrogen drugs or unapproved drug within 48 weeks before agreement acquisition and patients who have taken 5-alpha-reductase inhibitors within 24 weeks before agreement acquisition. 2. Patients whose serum testosterone level is below the lower limit of normal. 3. Patients who have taken creatine supplementation within 8 weeks before agreement acquisition 4. Patients who have severe complications 5. Patients who are not appropriate to participate in the trial
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| (1) Muscle strength measured by quantitative muscle testing (2) Motor function: tongue pressure, Timed walk test, Rise from bed test, and modified QMG Score (3) Respiratory function test: vital capacity, forced vital capacity, forced expiratory volume one second percent, peak expiratory flow and V50/V25 (4) Activities of daily living(ADL) assessed by ALSFRS-R and SBMAFRS questionnaires (5) Swallowing Disturbance Questionnaire (6) Quality of life questionnaires: SWAL-QOL and ALSAQ-5 (7) Multidimensional Fatigue Inventory (8) Muscle mass measured by dual-energy X-ray absorptiometry (9) urinary 8-OHdG | — |
Primary
| Measure | Time frame |
|---|---|
| Grip power | — |
Countries
Japan
Contacts
Public ContactYasuhiro Hijikata
Nagoya University Graduate School of Medicine Department of Neurology
Outcome results
None listed