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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00355576 |
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Date of registration:
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21/07/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Combination Therapy Selection Trial in Amyotrophic Lateral Sclerosis
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Scientific title:
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Phase II Combination Therapy Selection Trial in Amyotrophic Lateral Sclerosis |
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Date of first enrolment:
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July 2006 |
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Target sample size:
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86 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00355576 |
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Study type:
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Interventional |
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Study design:
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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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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Paul H Gordon, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Columbia University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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
- 21 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)
Exclusion Criteria:
- 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.
Age minimum:
21 Years
Age maximum:
85 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Amyotrophic Lateral Sclerosis
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Intervention(s)
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Drug: Minocycline
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Drug: Creatine
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Drug: Celecoxib
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Primary Outcome(s)
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ALS Functional Rating Scale Revised (ALSFRS-R) completed monthly during trial.
[Time Frame: Up to 6 months from the start of treatment]
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Secondary Outcome(s)
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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]
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Secondary ID(s)
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AAAB6334
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ALSA ID#920
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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