Clinical Trial Ceftriaxone in subjects with ALS
Status: Open to Enrollment
Start Date: Aug 05 2009
End Date: OPEN
STAGE 3is to determine whether chronic treatment with ceftriaxoneprolongs survival free of tracheotomy or permanent assisted ventilation and slows rate of decline in function as measured by the ALSFRS-R. The final dosage of 4g (2g bid) per day, for the efficacy study was selected based on the data obtained in STAGE 1 and 2. An additional 540 subjects will be enrolled in the study in STAGE 3.
1. Participants with familial or sporadic ALS diagnosed as laboratory supported probable, probable or definite according to the World Federation of Neurology El Escorial criteria
2. Age 18 years or older
3. Capable of providing informed consent and complying with trial procedures.
4. Vital capacity (VC) at least 60% predicted value for gender, height and age at screening
5. Women must not be able to become pregnant (e.g. post menopausal, surgically sterile, or using adequate birth control methods) for the duration of the study. Adequate implanted contraception, injected contraception or other hormonal (patch or contraceptive ring, for example) contraception), intrauterine device (IUD) in place for ≥ 3 months, barrier method in conjunction with spermicide, or another adequate method (as determined by steering committee member review). Women of childbearing potential must have a negative pregnancy test at screening and be nonlactating.
6. First ALS symptoms occurred no more than 3 years prior to screening visit
7. Not taking riluzole, or on a stable dosage for at least thirty days prior to the screening visit
8. Subject has a competent caregiver who can and will be responsible for administration of study drug. If there is no caregiver, another qualified individual must be available to administer the study drug.
9. Geographic accessibility to the study site
10. Subjects medically able to undergo placement of central venous catheter as determined by the investigator (to include absence of systemic infection, a medical disorder which precludes catheter placement)
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