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

Phase:

Phase II

Study Chair(s)/Principal Investigator(s):

Nazem Atassi, MD MMSc (Massachusetts General Hospital)

Clinicaltrials.gov ID (11 digit #):

NCT01257581

Neals Affiliated?

Yes

Coordinating 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.

Study Sponsor:

ALS Therapy Alliance (ATA)

Participant Duration:

38 weeks on drug; 42 weeks total participation.

Estimated Enrollment:

60

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
  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    18

    Maximum Age:

    N/A

    Min Vital Capacity (% predicted normal):

    50

    Time since Symptom Onset:

    N/A

    Time since Diagnosis:

    <36 months

    Can participants use Riluzole?

    Yes


    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.

  • Site Contact Information

    University of Kansas Medical Center
    Department of Neurology, MSN 2012
    Kansas City, Kansas 66160
    United States

    University of Massachusetts Medical Center
    Department of Neurology / University Campus Room S5-710
    Worcester, Massachusetts 01655
    United States

    Massachusetts General Hospital
    149 13th St, Room 2266
    Charlestown, Massachusetts 02114
    United States

    Washington University at St. Louis
    660 S. Euclid Ave.
    St. Louis, Missouri 63110
    United States

    SUNY Upstate Medical University
    750 East Adams Street
    Syracuse, New York 13210
    United States

    Carolinas Medical Center
    Neuroscience and Spine Institute
    Charlotte, North Carolina 28207
    United States

    Cleveland Clinic Foundation
    9500 Euclid Ave
    Cleveland, Ohio 44195
    United States

    Pennsylvania State University, Hershey Medical Center
    Department of Neurology, EC037
    Hershey, Pennsylvania 17033
    United States

    University of Washington Medical Center
    RR638 Health Sciences Building
    Seattle, Washington 98195
    United States

    Medical College of Wisconsin
    Froedtert Memorial Lutheran Hospital
    Milwaukee, Wisconsin 53208
    United States

  • Study Results
    View trial results on clinicaltrials.gov here https://clinicalt...CT01257581&rank=1