Status:
COMPLETED
Safety and Efficacy Study of Creatine and Tamoxifen in Volunteers With Amyotrophic Lateral Sclerosis (ALS)
Lead Sponsor:
Nazem Atassi
Collaborating Sponsors:
ALS Therapy Alliance
State University of New York - Upstate Medical University
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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).
Detailed Description
Amyotrophic lateral sclerosis (ALS) is a rare, neurodegenerative disorder that results in progressive wasting and paralysis of voluntary muscles. It is known that nerve cells called motor neurons die ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01257581
Start Date
March 1 2011
End Date
February 1 2013
Last Update
December 4 2014
Active Locations (9)
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1
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
3
University of Massachusetts Medical Center
Worcester, Massachusetts, United States, 01655
4
Washington University at St. Louis
St Louis, Missouri, United States, 63110