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Trial · NCT03181399

Outcomes12

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYNeuropsychological Score of Sustained AttentionChange post 6 months of treatment
Although 29 patients completed the 6-month treatment phase, some patients were unable to perform the test due to cognitive or physical impairment. The analysis population comprises of participants who were present at the time of testing and were able to comprehend and perform the test.
ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYNeuropsychological Score of Sustained AttentionChange after 3 months off treatment
Although 28 patients completed the 3-month treatment phase, some patients were unable to perform the test due to cognitive or physical impairment. The analysis population comprises of participants who were present at the time of testing and were able to comprehend and perform the test.
ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYNeuropsychological Score of Working Memory Index Scale (WMI)Change post 6 months of treatment
Some patients were unable to perform the test due to cognitive, physical impairment or underdeveloped vocabulary skills. The analysis population comprises of participants who were present at the time of testing and were able to comprehend and perform the test.
ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYNeuropsychological Score of Working Memory Index Scale (WMI)Change after 3 months off-treatment
Some patients were unable to perform the test due to cognitive, physical impairment or underdeveloped vocabulary skills. The analysis population comprises of participants who were present at the time of testing and were able to comprehend and perform the test.
ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYNeuropsychological Score of Processing Speed Index (PSI)Change post 6 months of treatment
Some patients were cognitively unable to perform or comprehend the test. The analysis population comprises of participants who were present at the time of testing and were able to comprehend and perform the test.
ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYNeuropsychological Score of Processing Speed Index (PSI)Change after 3 months off-treatment
Some patients were cognitively unable to perform or comprehend the test. The analysis population comprises of participants who were present at the time of testing and were able to comprehend and perform the test.
ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYEEG Changes: Generalized Spike Wave Activity and BurstChange post 6 months of treatmentOut of 45 enrolled, 29 patients completed the 6 month treatment periodParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYEEG Changes: Generalized Spike Wave Activity and BurstChange after 3 months off-treatmentOut of 29 patients who completed the treatment period, 28 returned for the 3 month off-treatment visit.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYBrief Ataxia Rating ScaleChange post 6 months of treatment
Although 29 patients completed the study, some patients were unable to perform the test due to physical impairment and inability to comprehend the task. Here, the number of participants analyzed reflects the total number of patients that were present at the test and were able to complete it.
ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYBrief Ataxia Rating ScaleChange after 3 months off treatment
Although 28 patients completed the off-treatment phase of study, some patients were unable to perform the test due to physical impairment and inability to comprehend the task. Here, the number of participants analyzed reflects the total number of patients that were present at the test and were able to comprehend it.
ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYClinical Global Impression Severity ScaleChange post 6 months of treatmentOut of the 45 patients enrolled, 29 completed the 6 month treatment phase.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYClinical Global Impression Severity ScaleChange after 3 months off-treatmentOut of the 29 patients that completed the treatment phase, 28 completed the following 3 month off-treatment phase. The assessment was incomplete for one patient due to inability to report symptoms.ParticipantsCOUNT_OF_PARTICIPANTS

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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