Safety and Efficacy Study of Creatine and Tamoxifen in Volunteers With Amyotrophic Lateral Sclerosis (ALS)

• Status: Completed
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to evaluate the safety and efficacy of high dose creatine and two dosages of tamoxifen treatment in amyotrophic lateral sclerosis (ALS).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nazem Atassi
• Collaborators: ALS Therapy Alliance; State University of New York - Upstate Medical University
• Treatments: Tamoxifen

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 coumarin anticoagulants (warfarin sodium), rifampin, aminoglutethimide, medroxyprogesterone, letrozole, or bromocriptine.

• Presence of any of the following clinical conditions: Clinical evidence of unstable medical or psychiatric illness at the Screening Visit; Screening aspartate aminotransferase (AST) > 3 times the upper limit of normal or serum creatinine > 1.5 mg/dl (133 umol/L); Permanent assisted ventilation or mechanical ventilation; or Lactating or have a positive serum pregnancy test at the Screening Visit.

• 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.