Safety and Efficacy Study of Creatine and Tamoxifen in Volunteers With Amyotrophic Lateral Sclerosis (ALS) (SDALS-001)
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ClinicalTrials.gov Identifier: NCT01257581 |
Recruitment Status :
Completed
First Posted : December 9, 2010
Results First Posted : December 4, 2014
Last Update Posted : December 4, 2014
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Amyotrophic Lateral Sclerosis |
Interventions |
Drug: creatine Drug: tamoxifen |
Enrollment | 60 |
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Creatine 30gm | Tamoxifen 40mg | Tamoxifen 80mg |
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Creatine will be taken as a powder mixed into food or liquid twice a day. Volunteers in this arm will take a total of 30gm of creatine per day for 38 weeks. Volunteers will also take placebo capsules twice a day for 38 weeks. This is a blinded study, so neither participants nor study staff will know which treatment a volunteer is receiving. Creatine is a nutritional supplement and is not approved by the U.S. Food and Drug Administration (FDA) for treating ALS. creatine: creatine monohydrate powder |
Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 40mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks. This is a blinded study, so neither participants nor study staff will know which treatment a volunteer is receiving. Tamoxifen is approved by the U.S. Food and Drug Administration (FDA) for breast cancer treatment but is not approved for treating ALS. tamoxifen: Tamoxifen citrate capsules |
Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 80mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks. This is a blinded study, so neither participants nor study staff will know which treatment a volunteer is receiving. Tamoxifen is approved by the U.S. Food and Drug Administration (FDA) for breast cancer treatment but is not approved for treating ALS. tamoxifen: Tamoxifen citrate capsules |
Period Title: Overall Study | |||
Started | 22 | 21 | 17 |
Completed | 17 | 18 | 11 |
Not Completed | 5 | 3 | 6 |
Reason Not Completed | |||
Early Termination | 3 | 1 | 2 |
Death | 2 | 2 | 4 |
Arm/Group Title | Creatine 30gm | Tamoxifen 40mg | Tamoxifen 80mg | Total | |
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Creatine will be taken as a powder mixed into food or liquid twice a day. Volunteers in this arm will take a total of 30gm of creatine per day for 38 weeks. Volunteers will also take placebo capsules twice a day for 38 weeks. | Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 40mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks. | Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 80mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks. | Total of all reporting groups | |
Overall Number of Baseline Participants | 22 | 21 | 17 | 60 | |
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Efficacy outcomes are adjusted for baseline differences in time from symptom onset to diagnosis, site of symptom onset, and VC.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 22 participants | 21 participants | 17 participants | 60 participants | |
55.5 (11.4) | 60.3 (10.6) | 56.3 (11.3) | 57.4 (11.1) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 22 participants | 21 participants | 17 participants | 60 participants | |
Female |
6 27.3%
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4 19.0%
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9 52.9%
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19 31.7%
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Male |
16 72.7%
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17 81.0%
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8 47.1%
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41 68.3%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 22 participants | 21 participants | 17 participants | 60 participants | |
Hispanic or Latino |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Not Hispanic or Latino |
22 100.0%
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21 100.0%
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17 100.0%
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60 100.0%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 22 participants | 21 participants | 17 participants | 60 participants | |
American Indian or Alaska Native |
0 0.0%
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1 4.8%
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0 0.0%
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1 1.7%
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Asian |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Black or African American |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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White |
22 100.0%
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20 95.2%
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17 100.0%
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59 98.3%
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More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 22 participants | 21 participants | 17 participants | 60 participants |
22 | 21 | 17 | 60 | ||
Years from Symptom Onset to Screening
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 22 participants | 21 participants | 17 participants | 60 participants | |
2.8 (1.7) | 1.9 (1.4) | 2.0 (1.0) | 2.3 (1.5) | ||
Years from Diagnosis to Screening
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 22 participants | 21 participants | 17 participants | 60 participants | |
1.3 (0.8) | 0.9 (0.8) | 1.0 (0.8) | 1.1 (0.8) | ||
Years from Symptom Onset to Diagnosis
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 22 participants | 21 participants | 17 participants | 60 participants | |
1.6 (1.5) | 0.9 (0.8) | 1.0 (0.8) | 1.2 (1.1) | ||
Baseline ALS Functional Rating Scale - Revised (ALSFRS-R) Total
[1] Mean (Standard Deviation) Unit of measure: Score on a scale |
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Number Analyzed | 22 participants | 21 participants | 17 participants | 60 participants | |
35.82 (7.20) | 36.19 (6.04) | 34.76 (6.56) | 35.65 (6.54) | ||
[1]
Measure Description: The ALSFRS-R is a quickly administered (5 min) ordinal rating scale used to determine a subject's assessment of their capability and independence in 12 functional activities. There are 12 questions, graded by the subject 0-4 (4 is normal). Score of 0 (worst) to 48 (best). Reflects speech and swallowing, fine motor skills, large motor skills, and breathing.
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Baseline VC% Predicted Max
[1] Mean (Standard Deviation) Unit of measure: % of predicted max value |
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Number Analyzed | 22 participants | 21 participants | 17 participants | 60 participants | |
90.64 (20.29) | 86.90 (13.92) | 81.71 (19.93) | 86.80 (18.31) | ||
[1]
Measure Description: The vital capacity (VC) (percent of predicted normal) was determined using the slow VC method. Vital Capacity is the maximum amount of air a person can expel from the lungs after a maximum inhalation. A subject's VC depends on their age, sex and height. The value is recorded as a percent of predicted normal.
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Name/Title: | Nazem Atassi, MD |
Organization: | Massachusetts General Hospital |
Phone: | 617-643-1807 |
EMail: | natassi@partners.org |
Responsible Party: | Nazem Atassi, Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT01257581 |
Other Study ID Numbers: |
SDALS-001 |
First Submitted: | December 8, 2010 |
First Posted: | December 9, 2010 |
Results First Submitted: | March 10, 2014 |
Results First Posted: | December 4, 2014 |
Last Update Posted: | December 4, 2014 |