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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01257581
• Date of registration: 08/12/2010
• Prospective Registration: Yes
• Primary sponsor: Nazem Atassi
• Public title: Safety and Efficacy Study of Creatine and Tamoxifen in Volunteers With Amyotrophic Lateral Sclerosis (ALS) SDALS-001
• Scientific title: Phase 2 Selection Trial of High Dosage Creatine and Two Dosages of Tamoxifen in Amyotrophic Lateral Sclerosis (ALS)
• Date of first enrolment: March 2011
• Target sample size: 60
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01257581
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Nazem Atassi, MD, MMSc
• Affiliation: Masaschusetts General Hospital, Boston, MA

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Amyotrophic Lateral Sclerosis

Intervention(s)

Drug: creatine

Drug: tamoxifen

Primary Outcome(s)

Change in ALS Functional Rating Scale - Revised (ALSFRS-R) [Time Frame: 38 weeks of treatment followed by a telephone interview at 42 weeks.]

Secondary Outcome(s)

HHD Lower % Baseline [Time Frame: 38 weeks of treatment followed by a telephone interview at 42 weeks.]

HHD Upper % Baseline [Time Frame: 38 weeks of treatment followed by a telephone interview at 42 weeks.]

Lab Abnormal Reports by Treatment Assignment [Time Frame: 38 weeks of treatment followed by a telephone interview at 42 weeks.]

HHD Upper Z-score [Time Frame: 38 weeks of treatment followed by a telephone interview at 42 weeks.]

Tracheostomy-free Survival [Time Frame: 38 weeks of treatment followed by a telephone interview at 42 weeks.]

Accurate Test of Limb Isometric Strength (ATLIS) Lower Percentage of Predicted Normal (PPN) [Time Frame: 38 weeks of treatment followed by a telephone interview at 42 weeks.]

Dose Adjustments [Time Frame: 38 weeks of treatment followed by a telephone interview at 42 weeks.]

Vital Capacity/Pulmonary Function Testing [Time Frame: 38 weeks of treatment followed by a telephone interview at 42 weeks.]

ATLIS Upper Percentage of Predicted Normal (PPN) [Time Frame: 38 weeks of treatment followed by a telephone interview at 42 weeks.]

Hand Held Dynamometry (HHD) Lower Z-score [Time Frame: 38 weeks of treatment followed by a telephone interview at 42 weeks.]

Secondary ID(s)

SDALS-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

State University of New York - Upstate Medical University

ALS Therapy Alliance

Results

• Results available: Yes
• Date Posted: 04/12/2014
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01257581