Combination Therapy Selection Trial in Amyotrophic Lateral Sclerosis
Phase II Combination Therapy Selection Trial in Amyotrophic Lateral Sclerosis
2 other identifiers
interventional
86
1 country
19
Brief Summary
The objective of this study is to compare two combinations of drugs, minocycline and creatine or celecoxib and creatine, in a phase II trial designed to determine which combination is more effective for ALS.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2006
Shorter than P25 for phase_2
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 21, 2006
CompletedFirst Posted
Study publicly available on registry
July 24, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedFebruary 1, 2011
January 1, 2011
July 21, 2006
January 31, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
ALS Functional Rating Scale Revised (ALSFRS-R) completed monthly during trial.
Up to 6 months from the start of treatment
Secondary Outcomes (1)
Forced Vital Capacity, Quality of Life, Timed Get Up and Go performed monthly. Survival and measures of safety throughout the trial.
Up to 6 months from the start of treatment
Study Arms (2)
Minocycline + Creatine
EXPERIMENTALMinocycline 100 mg BID and Creatine 10 g BID
Celecoxib + Creatine
EXPERIMENTALCelecoxib 400 mg BID and Creatine 10 g BID
Interventions
Celecoxib 400 mg BID with creatine 10 g BID if randomized to the Celecoxib + Creatine study arm.
Minocycline 100 mg BID with creatine 10 g BID if randomized to the Minocycline + Creatine study arm
Eligibility Criteria
You may qualify if:
- A clinical diagnosis of possible, laboratory-supported probable, probable or definite ALS, according to modified EL Escorial criteria
- FVC greater or equal to 60% at the screening visit
- Symptom onset within 5 years
- to 85 years of age
- If patients are taking riluzole, they must be on a stable dose for at least the past thirty days
- A woman of childbearing age, must be nonlactating and surgically sterile or using an effective method of birth control (barrier method) and have a negative pregnancy test
- Able to maintain adequate hydration levels defined as 6-8 cups (8ounces/cup) of water or a non-caffeinated beverage per day
- Willing and able to give signed informed consent that has been approved by an Institutional Review Board (IRB)
You may not qualify if:
- Tracheotomy and mechanical ventilation
- Diagnosis of other neurodegenerative diseases (Parkinson's disease, Alzheimer's disease, etc)
- Unstable medical illness (coronary artery disease, advanced cancer, active esophageal or gastroduodenal ulcers, etc) in the last one year
- Systemic Lupus Erythematosis
- FVC \< 60%
- Pregnancy or lactation
- Allergy to minocycline, tetracyclines, celecoxib, sulfonamides, NSAIDS, or creatine
- History of congestive heart failure
- Renal disease \[baseline Cr \> 1.5 (men) or 1.2 (women)\]
- History of significant hepatic disease (baseline AST/ALT or bilirubin \> 1.5x normal)
- Use of an investigational agent within thirty days of enrollment
- First degree relative with ALS or gene identified familial ALS
- Inability or unwillingness to maintain adequate daily hydration (defined above)
- Limited mental capacity such that the patient cannot provide written informed consent or comply with evaluation procedures.
- History of recent alcohol or drug abuse or noncompliance with treatment or other experimental protocols.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Columbia Universitylead
- ALS Associationcollaborator
- Pfizercollaborator
Study Sites (19)
Phoenix Neurological Associates
Phoenix, Arizona, 85006, United States
UCLA
Los Angeles, California, 90095, United States
University of California Irvine
Orange, California, 92868, United States
California Pacific Medical Center
San Francisco, California, 94115, United States
Mayo Clinic Florida
Jacksonville, Florida, 32224, United States
Medical College of Georgia
Augusta, Georgia, 30912, United States
University of Illinois
Chicago, Illinois, 60637, United States
University of Kansas
Kansas City, Kansas, 66160, United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
Washington University
St Louis, Missouri, 63110, United States
UMDNJ
New Brunswick, New Jersey, 08901, United States
University of New Mexico
Albuquerque, New Mexico, 87131, United States
Beth Israel
New York, New York, 10003, United States
Columbia University
New York, New York, 10032, United States
Duke University
Durham, North Carolina, 27705, United States
Oregon Health and Science University
Portland, Oregon, 97201, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19107, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
University of Vermont
Burlington, Vermont, 05405, United States
Related Publications (3)
Klivenyi P, Kiaei M, Gardian G, Calingasan NY, Beal MF. Additive neuroprotective effects of creatine and cyclooxygenase 2 inhibitors in a transgenic mouse model of amyotrophic lateral sclerosis. J Neurochem. 2004 Feb;88(3):576-82. doi: 10.1046/j.1471-4159.2003.02160.x.
PMID: 14720207BACKGROUNDZhang W, Narayanan M, Friedlander RM. Additive neuroprotective effects of minocycline with creatine in a mouse model of ALS. Ann Neurol. 2003 Feb;53(2):267-70. doi: 10.1002/ana.10476.
PMID: 12557297BACKGROUNDCheung YK, Gordon PH, Levin B. Selecting promising ALS therapies in clinical trials. Neurology. 2006 Nov 28;67(10):1748-51. doi: 10.1212/01.wnl.0000244464.73221.13.
PMID: 17130405BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paul H Gordon, MD
Columbia University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 21, 2006
First Posted
July 24, 2006
Study Start
July 1, 2006
Study Completion
May 1, 2007
Last Updated
February 1, 2011
Record last verified: 2011-01