Amyotrophic Lateral Sclerosis Clinical Trial
Official title:
The Study of Tamoxifen Treatment in Patients With Motor Neuron Disease
Verified date | June 2014 |
Source | Taipei Medical University Shuang Ho Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study is to survey the effect of Tamoxifen in motor neuron disease (MND) patients, amyotrophic lateral sclerosis (ALS) with regular riluzole usage. TDP-43 is related to ALS. Increased the ubiquitinated or phosphorylated TDP-43 can cause animal model of ALS, and TDP43 can be degraded either by proteasome or autophagy pathway system. Autophagy pathway can be activated by mTOR inhibition, resulting in ameliorating TDP-43 accumulation and rescue in motor function in animal model. Tamoxifen had shown ability of enhance both proteasome and autophagy pathway, therefore the investigators assume that Tamoxifen probably can ameliorate TDP-43 accumulation and inclusion body formation in ALS.
Status | Completed |
Enrollment | 20 |
Est. completion date | September 18, 2019 |
Est. primary completion date | September 17, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 80 Years |
Eligibility |
Inclusion Criteria: 1. Clinical diagnosed and confirmed ALS patients, with regular follow up and oral form riluzole at National Taiwan University or Shuang- Ho Hospital for more than 6 months. 2. Age ?20 years old Exclusion Criteria: 1. Patients who had already ventilator dependent, not regular followed up for more than 6 months or against medical advice, refuse to follow up at neurology department will be excluded in this study. 2. Patients with now or previous usage of Tamoxifen 3. Patients with any contraindications of Tamoxifen usage 4. Patients with other internal medicine illiness |
Country | Name | City | State |
---|---|---|---|
Taiwan | Po-Chih Chen | New Taipei City |
Lead Sponsor | Collaborator |
---|---|
Taipei Medical University Shuang Ho Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change from Baseline in blood TDP43 related biomarkers at 1, 3, 6,12 months | baseline, month 1, 3, 6, 12 | ||
Primary | Change from Baseline in Amyotrophic Lateral Sclerosis Functional Ration Scales (ALSFRS) at 1, 3, 6,12 months | Amyotrophic Lateral Sclerosis Functional Ration Scales (ALSFRS) measured by a neurologist | Baseline, month 1, 3, 6, 12 | |
Secondary | Change from Baseline in pulmonary function test at 1, 3, 6,12 months | Expiratory reserve volume (ERV) Forced vital capacity (FVC) Forced expiratory volume (FEV) Forced expiratory flow 25% to 75% Functional residual capacity (FRC) Maximum voluntary ventilation (MVV) Residual volume (RV) Peak expiratory flow (PEF). Slow vital capacity (SVC) Total lung capacity (TLC) |
baseline, month 1, 3, 6, 12 |
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