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Last Updated: November 4, 2024

CLINICAL TRIALS PROFILE FOR ORVATEN


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All Clinical Trials for ORVATEN

Trial ID Title Status Sponsor Phase Start Date Summary
NCT02379156 ↗ Thermoregulation and Cognition During Cool Ambient Exposure in Tetraplegia Active, not recruiting The Craig H. Neilsen Foundation Phase 4 2015-04-01 The ability to maintain normal core body temperature (Tcore = 98.6°F) is impaired in persons with a cervical spinal cord injury (tetraplegia). Despite the known deficits in the ability of persons with spinal cord injury (SCI) to maintain Tcore, and the effects of hypothermia to impair mental function in able-bodied (AB) persons, there has been no work to date addressing these issues in persons with tetraplegia. Primary Aim: To determine if exposure of up to 2 hours to cool temperatures (64°F) causes Tcore to decrease in persons with tetraplegia, and if that decrease is associated with a decrease in cognitive function. Primary Hypotheses: Based on our pilot data: (1) 66% of persons with tetraplegia and none of the matched controls will demonstrate a decline of 1.8°F in Tcore; (2) 80% of persons with tetraplegia and 30% of controls will have a decline of at least one T-score in Stroop Interference scores (a measure of executive function). Secondary Aim: To determine the change in: (1) distal skin temperature, (2) metabolic rate, and (3) thermal sensitivity. Secondary Hypothesis: Persons with tetraplegia will have less of a percent change in average distal skin temperatures and metabolic rate, and report lower thermal sensitivity ratings compared with AB controls. Tertiary Aim: To determine if a 10 mg dose of an approved blood pressure-raising medicine (midodrine hydrochloride) will (1) reduce the decrease in Tcore and (2) prevent or delay the decline in cognitive performance in the group with tetraplegia compared to the exact same procedures performed on the day with no medicine (Visit 1) in that same group. Tertiary Hypothesis: Through administering a one-time dose of midodrine, the medicine-induced decreased blood flow to the skin will lessen the decline in Tcore and prevent or delay the associated decline in cognitive performance compared to the changes in Tcore and cognitive performance during cool temperature exposure without midodrine in the same group with tetraplegia.
NCT02379156 ↗ Thermoregulation and Cognition During Cool Ambient Exposure in Tetraplegia Active, not recruiting James J. Peters Veterans Affairs Medical Center Phase 4 2015-04-01 The ability to maintain normal core body temperature (Tcore = 98.6°F) is impaired in persons with a cervical spinal cord injury (tetraplegia). Despite the known deficits in the ability of persons with spinal cord injury (SCI) to maintain Tcore, and the effects of hypothermia to impair mental function in able-bodied (AB) persons, there has been no work to date addressing these issues in persons with tetraplegia. Primary Aim: To determine if exposure of up to 2 hours to cool temperatures (64°F) causes Tcore to decrease in persons with tetraplegia, and if that decrease is associated with a decrease in cognitive function. Primary Hypotheses: Based on our pilot data: (1) 66% of persons with tetraplegia and none of the matched controls will demonstrate a decline of 1.8°F in Tcore; (2) 80% of persons with tetraplegia and 30% of controls will have a decline of at least one T-score in Stroop Interference scores (a measure of executive function). Secondary Aim: To determine the change in: (1) distal skin temperature, (2) metabolic rate, and (3) thermal sensitivity. Secondary Hypothesis: Persons with tetraplegia will have less of a percent change in average distal skin temperatures and metabolic rate, and report lower thermal sensitivity ratings compared with AB controls. Tertiary Aim: To determine if a 10 mg dose of an approved blood pressure-raising medicine (midodrine hydrochloride) will (1) reduce the decrease in Tcore and (2) prevent or delay the decline in cognitive performance in the group with tetraplegia compared to the exact same procedures performed on the day with no medicine (Visit 1) in that same group. Tertiary Hypothesis: Through administering a one-time dose of midodrine, the medicine-induced decreased blood flow to the skin will lessen the decline in Tcore and prevent or delay the associated decline in cognitive performance compared to the changes in Tcore and cognitive performance during cool temperature exposure without midodrine in the same group with tetraplegia.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for ORVATEN

Condition Name

Condition Name for ORVATEN
Intervention Trials
Hypothermia 1
Mild Cognitive Impairment 1
Tetraplegia 1
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Condition MeSH

Condition MeSH for ORVATEN
Intervention Trials
Hypothermia 1
Cognitive Dysfunction 1
Cognition Disorders 1
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Clinical Trial Locations for ORVATEN

Trials by Country

Trials by Country for ORVATEN
Location Trials
United States 1
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Trials by US State

Trials by US State for ORVATEN
Location Trials
New York 1
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Clinical Trial Progress for ORVATEN

Clinical Trial Phase

Clinical Trial Phase for ORVATEN
Clinical Trial Phase Trials
Phase 4 1
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Clinical Trial Status

Clinical Trial Status for ORVATEN
Clinical Trial Phase Trials
Active, not recruiting 1
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Clinical Trial Sponsors for ORVATEN

Sponsor Name

Sponsor Name for ORVATEN
Sponsor Trials
The Craig H. Neilsen Foundation 1
James J. Peters Veterans Affairs Medical Center 1
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Sponsor Type

Sponsor Type for ORVATEN
Sponsor Trials
Other 1
U.S. Fed 1
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