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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02166944
Other study ID # 201307022
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date April 2014
Est. completion date September 18, 2019

Study information

Verified date June 2014
Source Taipei Medical University Shuang Ho Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

The investigators will assess the ALSFR-s in ALS patients at start, 1, 3, 6 and 12 months and correlate the score to the neurological outcome of the patients with and without tamoxifen treatment at dose of 40mg daily for one year.

The study will be able to prove the investigators hypothesis: Tamoxifen, a protease and autophagy enhancer, has synergic effect with riluzole in ALS patients to slowing the progression of neurological dysfunction, and respiratory insufficiency.


Recruitment information / eligibility

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

Study Design


Intervention

Drug:
tamoxifen 40 mg daily for one year
both arms with riluzole daily

Locations

Country Name City State
Taiwan Po-Chih Chen New Taipei City

Sponsors (1)

Lead Sponsor Collaborator
Taipei Medical University Shuang Ho Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

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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