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Trial · NCT00550459

Outcomes29

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYChange From Baseline in the Neurocognitive Composite Score of Speed Domains (NCS-SD; Sum of All Correct Speed Domain Z-Scores)baseline and Day 22Analysis based upon observed cases (OC).Z-scoreMEAN
SECONDARYChange From Baseline to Day 22 in the Individual Neurocognitive Domains Included in the Primary Endpoint: Reaction Time in Computer Testsbaseline and Day 22ITT population with OCZ-scoreMEAN
SECONDARYChange From Baseline in the Individual Neurocognitive Domains Included in the Primary Endpoint: Psychomotor Speed Via Morse Tapping Testbaseline and Day 22ITT population with OCZ-scoreMEAN
SECONDARY
Change From Baseline in the Individual Neurocognitive Domains Included in the Primary Endpoint: Processing Speed of Rapid Visual Information Processing Test, Numeric Working Memory Test, and Word Recognition Test
baseline and Day 22ITT population with OCZ-scoreMEAN
SECONDARYChange From Baseline in Overall Neurocognitive Composite Scorebaseline and Day 22ITT population with OCZ-scoreMEAN
SECONDARYChange From Baseline in Gait Test (Timed Get-Up-and-Go Test)baseline and Day 22ITT population with OCSecondsMEAN
SECONDARYChange From Baseline in Postural Stability Testbaseline and Day 22ITT population with LOCF (this group includes missing values)Z-scoreMEAN
SECONDARYChange From Baseline in Serum Sodium; ITT PopulationBaseline and Day 22ITT population with OCmEq/LMEAN
SECONDARYNumber of Patients With Vital Sign Abnormalities: Blood Pressure28 daysSafety population defined as all randomized subjects who consumed at least 1 dose of trial medicationparticipantsNUMBER
SECONDARYNumber of Patients With Vital Sign Abnormalities: Pulse Rate28 daysSafety population defined as all randomized subjects who consumed at least 1 dose of trial medicationparticipantsNUMBER
SECONDARYNumber of Patients With Vital Sign Abnormalities: Body Weight28 daysSafety population defined as all randomized subjects who consumed at least 1 dose of trial medicationparticipantsNUMBER
SECONDARYNumber of Patients With Vital Sign Abnormalities: Body Temperature28 daysSafety population defined as all randomized subjects who consumed at least 1 dose of trial medicationparticipantsNUMBER
SECONDARYNumber of Patients With Hematology Laboratory Abnormalities: Hemoglobin28 daysSafety population defined as all randomized subjects who consumed at least 1 dose of trial medicationparticipantsNUMBER
SECONDARYNumber of Patients With Hematology Laboratory Abnormalities: Activated Partial Thromboplastin Time (aPTT)28 daysSafety population defined as all randomized subjects who consumed at least 1 dose of trial medicationparticipantsNUMBER
SECONDARYNumber of Patients With Hematology Laboratory Abnormalities: Lymphocytes28 daysSafety population defined as all randomized subjects who consumed at least 1 dose of trial medicationparticipantsNUMBER
SECONDARYNumber of Patients With Hematology Laboratory Abnormalities: Neutrophils28 daysSafety population defined as all randomized subjects who consumed at least 1 dose of trial medicationparticipantsNUMBER
SECONDARYNumber of Patients With Serum Chemistry Laboratory Abnormalities: Blood Urea Nitrogen (BUN)28 daysSafety population defined as all randomized subjects who consumed at least 1 dose of trial medicationparticipantsNUMBER
SECONDARYNumber of Patients With Serum Chemistry Laboratory Abnormalities: Uric Acid28 daysSafety population defined as all randomized subjects who consumed at least 1 dose of trial medicationparticipantsNUMBER
SECONDARYNumber of Patients With Serum Chemistry Laboratory Abnormalities: Cholesterol28 daysSafety population defined as all randomized subjects who consumed at least 1 dose of trial medicationparticipantsNUMBER
SECONDARYNumber of Patients With Serum Chemistry Laboratory Abnormalities: Glucose28 daysSafety population defined as all randomized subjects who consumed at least 1 dose of trial medicationparticipantsNUMBER

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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