Phase 2 Selection Trial of High Dosage Creatine and Two Dosages of Tamoxifen in Amyotrophic Lateral Sclerosis (ALS)
Study Purpose: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), Familial ALS, Sporadic ALS
Study Type:Interventional Trial
Study Category:Drug Trial
Study Status:Not enrolling
Study Chair(s)/Principal Investigator(s):Nazem Atassi, MD MMSc (Massachusetts General Hospital)
Clinicaltrials.gov ID (11 digit #):NCT01257581
Coordinating Center Contact Information
Full 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.
Study Sponsor:ALS Therapy Alliance (ATA)
Participant Duration:38 weeks on drug; 42 weeks total participation.
Estimated Study Start Date:02/28/2011
Estimated Study Completion Date:11/02/2016
Posting Last Modified Date:02/28/2013
Date Study Added to alsconsortium.org:10/14/2011
Time since Symptom Onset:N/A
Time since Diagnosis:<36 months
Can participants use Riluzole?Yes
• 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.
• 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.
Site Contact Information
University of Kansas Medical Center
Department of Neurology, MSN 2012
Kansas City, Kansas 66160
University of Massachusetts Medical Center
Department of Neurology / University Campus Room S5-710
Worcester, Massachusetts 01655
Massachusetts General Hospital
149 13th St, Room 2266
Charlestown, Massachusetts 02114
Washington University at St. Louis
660 S. Euclid Ave.
St. Louis, Missouri 63110
SUNY Upstate Medical University
750 East Adams Street
Syracuse, New York 13210
Carolinas Medical Center
Neuroscience and Spine Institute
Charlotte, North Carolina 28207
Cleveland Clinic Foundation
9500 Euclid Ave
Cleveland, Ohio 44195
Pennsylvania State University, Hershey Medical Center
Department of Neurology, EC037
Hershey, Pennsylvania 17033
University of Washington Medical Center
RR638 Health Sciences Building
Seattle, Washington 98195
Medical College of Wisconsin
Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin 53208
View trial results on clinicaltrials.gov here https://clinicalt...CT01257581&rank=1