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Tamoxifen Treatment in Patients With Motor Neuron Disease

Information source: Taipei Medical University Shuang Ho Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Amyotrophic Lateral Sclerosis; ALS Functional Ration Scale; TAR-DNA-binding Protein-43; Tamoxifen; mTOR

Intervention: tamoxifen 40 mg daily for one year (Drug)

Phase: Phase 1/Phase 2

Status: Recruiting

Sponsored by: Taipei Medical University Shuang Ho Hospital

Official(s) and/or principal investigator(s):
Chaur-Jong Hu, M.D., Principal Investigator, Affiliation: Shung Ho Hospital, Taipei Meidcal University

Overall contact:
Po-Chih Chen, M.D., Phone: 886-2-22490088, Ext: 8112, Email: euphemus2003@msn.com

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.

Clinical Details

Official title: The Study of Tamoxifen Treatment in Patients With Motor Neuron Disease

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change from Baseline in Amyotrophic Lateral Sclerosis Functional Ration Scales (ALSFRS) at 1, 3, 6,12 months

Secondary outcome: Change from Baseline in pulmonary function test at 1, 3, 6,12 months

Detailed 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.

Eligibility

Minimum age: 20 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Po-Chih Chen, M.D., Phone: 886-2-22490088, Ext: 8112, Email: euphemus2003@msn.com

Po-Chih Chen, New Taipei City, Taiwan; Recruiting
Po-Chih Chen, M.D., Phone: 886-2-22490088, Ext: 8112, Email: euphemus2003@msn.com
Chaur-Jong Hu, M.D., Phone: 886-2-22490088, Ext: 8112, Email: chaurjongh@tmu.edu.tw
Chaur-Jong Hu, M.D., Principal Investigator
Additional Information

Starting date: April 2014
Last updated: June 16, 2014

Page last updated: August 23, 2015

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