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 ALSStudy Type:
Interventional TrialStudy Category:
Drug TrialStudy Status:
Not enrollingPhase:
Phase IIStudy Chair(s)/Principal Investigator(s):
Nazem Atassi, MD MMSc (Massachusetts General Hospital)Clinicaltrials.gov ID (11 digit #):
NCT01257581Neals Affiliated?
YesCoordinating Center Contact Information
.(JavaScript must be enabled to view this email address)
.(JavaScript must be enabled to view this email address) United States
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.