Tamoxifen Treatment in Patients With Motor Neuron Disease
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ClinicalTrials.gov Identifier: NCT02166944 |
Recruitment Status :
Completed
First Posted : June 18, 2014
Last Update Posted : September 19, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Amyotrophic Lateral Sclerosis ALS Functional Ration Scale TAR-DNA-binding Protein-43 Tamoxifen mTOR | Drug: tamoxifen 40 mg daily for one year | Phase 1 Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | The Study of Tamoxifen Treatment in Patients With Motor Neuron Disease |
Actual Study Start Date : | April 2014 |
Actual Primary Completion Date : | September 17, 2019 |
Actual Study Completion Date : | September 18, 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: tamoxifen
tamoxifen 40 mg daily for one year
|
Drug: tamoxifen 40 mg daily for one year
both arms with riluzole daily
Other Name: Nolvadex |
Placebo Comparator: placebo
placebo drugs
|
Drug: tamoxifen 40 mg daily for one year
both arms with riluzole daily
Other Name: Nolvadex |
- 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 ]Amyotrophic Lateral Sclerosis Functional Ration Scales (ALSFRS) measured by a neurologist
- Change from Baseline in pulmonary function test at 1, 3, 6,12 months [ Time Frame: baseline, month 1, 3, 6, 12 ]
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)
- Change from Baseline in blood TDP43 related biomarkers at 1, 3, 6,12 months [ Time Frame: baseline, month 1, 3, 6, 12 ]

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Ages Eligible for Study: | 20 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
- Age ≧20 years old
Exclusion Criteria:
- 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.
- Patients with now or previous usage of Tamoxifen
- Patients with any contraindications of Tamoxifen usage
- Patients with other internal medicine illiness

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02166944
Taiwan | |
Po-Chih Chen | |
New Taipei City, Taiwan |
Principal Investigator: | Chaur-Jong Hu, M.D. | Shung Ho Hospital, Taipei Meidcal University |
Responsible Party: | Taipei Medical University Shuang Ho Hospital |
ClinicalTrials.gov Identifier: | NCT02166944 |
Other Study ID Numbers: |
201307022 |
First Posted: | June 18, 2014 Key Record Dates |
Last Update Posted: | September 19, 2019 |
Last Verified: | June 2014 |
amyotrophic lateral sclerosis ALS functional ration scale TAR-DNA-binding protein-43 tamoxifen mTOR |
Motor Neuron Disease Amyotrophic Lateral Sclerosis Sclerosis Pathologic Processes Neurodegenerative Diseases Nervous System Diseases Neuromuscular Diseases Spinal Cord Diseases Central Nervous System Diseases TDP-43 Proteinopathies Proteostasis Deficiencies |
Metabolic Diseases Tamoxifen Estrogen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents Selective Estrogen Receptor Modulators Estrogen Receptor Modulators Bone Density Conservation Agents |