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Phase 2 Selection Trial of High Dosage Creatine and Two Dosages of Tamoxifen in Amyotrophic Lateral Sclerosis (ALS)

 
Study Focus:
The purpose of this study is to evaluate the safety and effectiveness of creatine and tamoxifen in volunteers with ALS.
Disease:
Amyotrophic Lateral Sclerosis (ALS), Sporadic ALS, Familial ALS
Study Category:
Drug Trial
Study Status:
Closed
Study Results:
preliminary trial results in the analysis process, expected spring 2013
Phase:
Phase II
Type:
Interventional Trial
with active agents/drugs only
Funding Source:
ALS Therapy Alliance (ATA)
Study Chair(s)/Principal Investigator(s):
Nazem Atassi, MD MMSc (Massachusetts General Hospital)
Clinicaltrials.gov ID:
NCT01257581
Study ID:
SDALS-001
NEALS Affiliated?
Yes
Study Summary:
There are a large number of potential drugs that may improve the survival or slow down the disease progression in people with ALS. The current strategy is to test one drug at a time against placebo. "Selection Design" is a different type of study design that uses multiple drugs to screen against each other and picks the winner to take to a larger study. This design can speed the search for effective drugs to treat ALS. In this study, each volunteer will take one active study drug (creatine 30mg, tamoxifen 40mg, or tamoxifen 80mg) and one placebo.

Approximately 60 eligible volunteers with ALS will be recruited from multiple centers in the US. Volunteers will be randomly assigned equally to the three treatment arms: creatine 30gm/day, tamoxifen 40mg/day and tamoxifen 80mg/day. Volunteers will take study treatment for 38 weeks. Volunteers will have 7 in-person visits and 4 telephone visits during the study.
Participant Duration:
38 weeks on drug; 42 weeks total participation.
# of Subjects:
60
Enrollment Start Date:
03/01/2011
Enrollment End Date:
12/01/-0001
Posting Last Modified Date:
03/01/2013
Date Study Added to alsconsortium.org:
10/15/2011
Eligibility Criteria
Gender:
Male & Female
Minimum Age:
18
Min Vital Capacity (% predicted normal):
50%
Time since Symptom Onset:
Not applicable
Time since Diagnosis:
Less than 36 months
Can participants use Riluzole?
Yes
Coordinating Center
Contact Information
Other Eligibility Criteria:
Inclusion Criteria:
• Familial or sporadic ALS.
• Disease duration from diagnosis no greater than 36 months at Screening Visit.
• Aged 18 years or older.
• Capable of providing informed consent and complying with trial procedures.
• Vital capacity (VC) equal to or more than 50% predicted normal value for gender, height and age at the Screening Visit.
• Not taking, or on a stable dose of riluzole (50mg bid) for at least 30 days prior to the Screening Visit.
• Women must not be able to become pregnant for the duration of the study (e.g., post menopausal for at least one year, surgically sterile, or practicing adequate birth control methods) for the duration of the study. Women of childbearing potential must have a negative serum pregnancy test at the Screening Visit and be non-lactating.

Exclusion Criteria:
• History of known sensitivity or intolerability to creatine monohydrate or tamoxifen citrate or to any other related compound.
• Prior exposure to creatine or tamoxifen within 30 days of the Screening Visit.
• Exposure to any investigational agent within 30 days of the Screening Visit.
• Use of any prohibited medication including but not limited to coumadin , rifampin, aminoglutethimide, medroxyprogesterone, letrozole, bromocriptine, Aminoglutethimide, Anastrazole, Bromocriptine, Colchicines, Conivaptan, Dabigatran etexilate, Duloxetine, Everolimus, Fluconazole, Rifamycin, Silodosin,Topotecan, or Vitamin K antagonists (warfarin).
• Presence of any of the following clinical conditions at the Screening Visit: Clinical evidence of unstable medical or psychiatric illness; Screening AST > 3 times the upper limit of normal or serum creatinine > 1.5 mg/dl (133 umol/L); Permanent assisted ventilation or mechanical ventilation; tracheostomy; or Lactating or have a positive serum pregnancy test.
• History of any of the following: blood clots including deep vein thrombosis, pulmonary embolism, and stroke, cataracts, renal problems, endometrial cancer, uterine sarcoma, or diabetes mellitus.

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