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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02166944 |
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Date of registration:
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09/06/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Tamoxifen Treatment in Patients With Motor Neuron Disease
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Scientific title:
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The Study of Tamoxifen Treatment in Patients With Motor Neuron Disease |
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Date of first enrolment:
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April 2014 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02166944 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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Taiwan
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Contacts
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Name:
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Chaur-Jong Hu, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Shung Ho Hospital, Taipei Meidcal University |
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Key inclusion & exclusion criteria
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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
Age minimum:
20 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Tamoxifen
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Amyotrophic Lateral Sclerosis
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TAR-DNA-binding Protein-43
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ALS Functional Ration Scale
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mTOR
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Intervention(s)
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Drug: tamoxifen 40 mg daily for one year
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Primary Outcome(s)
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Change from Baseline in Amyotrophic Lateral Sclerosis Functional Ration Scales (ALSFRS) at 1, 3, 6,12 months
[Time Frame: Baseline, month 1, 3, 6, 12]
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Secondary Outcome(s)
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Change from Baseline in pulmonary function test at 1, 3, 6,12 months
[Time Frame: baseline, month 1, 3, 6, 12]
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Secondary ID(s)
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201307022
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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