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Principal Investigator:
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Lakshmi Putcha, Ph.D.
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Organization:
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NASA Johnson Space Center
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Project Ended:
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2008
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Space motion sickness is commonly experienced by astronauts and often requires treatment with medications that can cause performance and cognitive function deficits. Dr. Lakshmi Putcha is testing the drug scopolamine for its effectiveness in treating space motion sickness, for the best dosage levels and for its cognitive side effects. Results of this bed-rest study are expected to provide an easily administered, rapid-acting and effective treatment for space motion sickness.
|
Principal Investigator:
|
Lakshmi Putcha, Ph.D.
|
|
Organization:
|
NASA Johnson Space Center
|
|
Project Ended:
|
2008
|
Project Aims- Establish the pharmacodynamics of intranasal scopolamine (IN SCOP) with four escalating dose levels between 0.1 and 0.4 mg;
- Examine the efficacy of two dose levels of IN SCOP for prevention and treatment of motion sickness; and
- Determine if bioavailability and pharmacodynamics of scopolamine are altered in a simulated microgravity environment.
Two Investigational New Drug Phase II clinical protocols have been compiled per Food and Drug Administration (FDA) guidelines and submitted to the FDA before implementation. Standard operating procedures for scopolamine sample analysis have been validated. Good laboratory practice operating procedures required in support of the project have been identified and established. An external audit by an experienced auditing agency found that record keeping and procedures relating to storage of samples, documentation and quality assurance were outstanding and higher than their standard of excellence, the Mayo Clinic.
The experimental procedure to address Aim 1 is completed. Of the 1,600 total samples collected in this protocol, analysis of plasma samples (600) is complete. Data reduction and analysis is partially completed.
Experimental procedures have been partially (2/3) completed to accomplish Aim 2. Experimental procedures to complete sample and data collection for Aim 3 will be initiated in the second quarter of Year 3 funding and targeted for completion by mid- to late-Year 3 period. Project progress is on schedule and will be completed by the projected period.
|
Principal Investigator:
|
Lakshmi Putcha, Ph.D.
|
|
Organization:
|
NASA Johnson Space Center
|
|
Project Ended:
|
2008
|
Intranasal scopolamine can be marketed as a motion sickness medication for military personnel and for recreational air and sea travelers, once industry partnership is established for completing Phase IV Food and Drug Administration trials.
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