Combination Therapy Selection Trial in Amyotrophic Lateral Sclerosis
Tracking Information | |||||
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First Received Date ICMJE | July 21, 2006 | ||||
Last Updated Date | January 31, 2011 | ||||
Start Date ICMJE | July 2006 | ||||
Primary Completion Date | |||||
Current Primary Outcome Measures ICMJE |
ALS Functional Rating Scale Revised (ALSFRS-R) completed monthly during trial. [ Time Frame: Up to 6 months from the start of treatment ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE |
ALS Functional Rating Scale Revised (ALSFRS-R) completed monthly during trial. | ||||
Change History | Complete list of historical versions of study NCT00355576 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
Forced Vital Capacity, Quality of Life, Timed Get Up and Go performed monthly. Survival and measures of safety throughout the trial. [ Time Frame: Up to 6 months from the start of treatment ] [ Designated as safety issue: Yes ] | ||||
Original Secondary Outcome Measures ICMJE |
Forced Vital Capacity, Quality of Life, Timed Get Up and Go performed monthly. Survival and measures of safety throughout the trial. | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Combination Therapy Selection Trial in Amyotrophic Lateral Sclerosis | ||||
Official Title ICMJE | Phase II Combination Therapy Selection Trial in Amyotrophic Lateral Sclerosis | ||||
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. |
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Detailed Description | Excess free radicals, energy mishandling, excitotoxicity, activation of cell death pathways and inflammation likely all contribute to neurodegeneration in ALS. Past trials may have been negative in part because they tested single agents, usually influencing only one mechanism of cell death. Combinations of agents that affect different and multiple mechanisms of neurodegeneration may be necessary to reach meaningful outcomes in trials of ALS. This trial has several unique features. First, it compares the neuroprotective potential of two combinations of agents that impact multiple mechanisms of cell death. The combinations of minocycline/creatine and celecoxib/creatine are the only agents that have had additive effects in the mouse model of ALS, reducing neurodegeneration and prolonging survival more than individual agents alone. Second, it uses an important new phase II selection trial design to determine which combination is superior. Not only does this trial test combination therapy, but there is no placebo, so everyone who enrolls in the trial will receive active treatment. Minocycline, creatine and celecoxib have been tested individually and have been shown to be safe in patients with ALS. This will be the first time human trials will be conducted with combinations of minocycline/creatine and celecoxib/creatine. We will compare combinations of drugs in a phase II trial design to determine which combination is superior. If successful, this trial will lead directly to a phase III trial of the selected combination. If the design is found useful, this trial will lead to larger phase II selection trials assessing greater numbers of agents simultaneously, thereby improving the efficiency of drug screening in ALS. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 2 | ||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Amyotrophic Lateral Sclerosis | ||||
Intervention ICMJE |
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Study Arm (s) |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 86 | ||||
Completion Date | May 2007 | ||||
Primary Completion Date | |||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 21 Years to 85 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00355576 | ||||
Other Study ID Numbers ICMJE | AAAB6334, ALSA ID#920 | ||||
Has Data Monitoring Committee | Yes | ||||
Responsible Party | Paul H. Gordon, Columbia University Medical Center | ||||
Study Sponsor ICMJE | Columbia University | ||||
Collaborators ICMJE |
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Investigators ICMJE |
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Information Provided By | Columbia University | ||||
Verification Date | January 2011 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |