New Studies at the University of Miami Neurology Department

Contact Person: Julie Steele, RN, CCRC
Study Coordinator
(305) 243-7526

Dr. Don Koggan
Study Coordinator
(305) 243 7424

Research studies

Creatine Study
This study of the nutritional supplement "creatine" is still looking for individuals to participate. The study is 6 months in length, some participants will receive creatine 5 gms/day and some will receive placebo (like a sugar pill).

The objective of this study is to determine whether creatine slows disease progression in ALS. Creatine, an agent that improves mitochondrial function, has been shown to be neuroprotective in animal models of ALS.

Sanofi Study
This study is not enrolling participants.
The blinded phase of this study completed some time ago. The company, Sanofi-Synthelabo is submitting data to the FDA, no information regarding the status is available. The medication, xyloproden, continues to be supplied to those who participated in the blinded phase of the study. The drug is not allowed to be dispensed to anyone else until FDA approval.

Avanir Study
This study of a compound dexomethorphan/quinidine is still looking for individuals to participate. The study is 1 month in length, will determine if this compound is effective in treating a symptom, which some ALS patients have called "pseudobulbar affect". This symptom is characterized by uncontrollable outbursts of laughing or crying.

BiPAP Study
The study enrollment should start January or February 2002. A study to determine if the initiation of BiPAP (Bi-level Positive Air Pressure) is more beneficial for ALS patients if begun earlier than the standard treatment.

BiPAP is used to assist patients with their breathing when they become short of breath. BiPAP is done by placing a mask over the patient's nose and pushing air into their lungs. Currently, Medicare does not allow reimbursement for BiPAP until the patient's forced vital capacity (a measurement of breathing strength) falls to half of what it normally should be. Arrangements have been made with a local respiratory company to supply the equipment.

Celebrex
Enrollment to begin early February.
Some paperwork is pending.

Topiramate Study
No longer enrolling participants.
Here is good example of why placebo groups are an important part of research. This study was terminated when the group that was receiving the drug had more serious (life-threatening) side effects than the placebo group. This information would not have been available if a placebo group was not part of the research.

The objective of this study is to determine whether topiramate slows disease progression in ALS. The data from this study continues to be reviewed to determine the effectiveness.

Post-Mortem Study
Not seeking donors at this time.
The University of Miami is collecting brain and tissue samples from ALS patients. The tissue is used for current and future research.

Familiar ALS Study
Enrolling participants.
This genetic study is looking for possible genes that may be associated with ALS. The participants are selected when there is a known family history of ALS. The study involves collecting blood samples and consulting with a genetic counselor.