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Trial · NCT05347147

Outcomes12

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYChange in ICP From Baseline to Week 24 Measured by Lumbar Puncture (LP), Where a Higher LP Value Indicates Greater ICPBaseline to Week 24
Data presented represents collected data from individual subjects. For subject anonymity, study-assigned subject IDs are not included here, and subject numbers used throughout the ClinicalTrials.gov results do not consistently relate to the same subjects.
cm CSFNUMBER
SECONDARYChange in Perimetric Mean Deviation (PMD), Measured by Humphrey Visual Field (HVF) Analysis (24-2 SITA-Standard), Where a Larger Negative Result Indicates Greater Visual LossBaseline to Week 24
Data presented represent collected data from individual subjects for study eyes only. Baseline PMD had to be -2 dB to -7 dB for an eye to count as a study eye. For subject anonymity, study-assigned subject IDs are not included here, and subject numbers used throughout the ClinicalTrials.gov results do not consistently relate to the same subjects.
dBNUMBER
SECONDARYPapilloedema by Change in Retinal Nerve Fibre Layer (RNFL) Thickness, With a Greater Thickness of RNFL Indicating Greater Swelling and Greater Extent of PapilloedemaBaseline to Week 24
Data presented represents collected data from individual subjects for study eyes only. Baseline PMD had to be -2 dB to -7 dB for an eye to count as a study eye. For subject anonymity, study-assigned subject IDs are not included here, and subject numbers used throughout the ClinicalTrials.gov results do not consistently relate to the same subjects. Cirrus was the imaging platform used for all subjects except Subjects 6 and 7, where Zeiss was used.
µmNUMBER
SECONDARY
Papilloedema by Percent Change in Optic Nerve Head Size, Measured by Optical Coherence Tomography (OCT), Where a Larger Optic Nerve Head Size Reflects Greater Swelling and a Greater Extent of Papilloedema
Baseline to Week 24
Data presented represents collected data from individual subjects for study eyes only. Baseline PMD had to be -2 dB to -7 dB for an eye to count as a study eye. For subject anonymity, study-assigned subject IDs are not included here, and subject numbers used throughout the ClinicalTrials.gov results do not consistently relate to the same subjects.
percentage changeNUMBER
SECONDARYThe Number of Monthly Headache Days (MHD)Baseline to Week 24
Data presented represents collected data from individual subjects. For subject anonymity, study-assigned subject IDs are not included here, and subject numbers used throughout the ClinicalTrials.gov results do not consistently relate to the same subjects.~The number of days on which data were collected for each subject during the 7-day baseline period and the last 28-day period are provided in parentheses in the row titles.~No data were collected for Subject 7 during the 7-day baseline period.
Monthly headache daysNUMBER
SECONDARYNumber of Moderate to Severe MHDBaseline to Week 24
Data presented represents collected data from individual subjects. For subject anonymity, study-assigned subject IDs are not included here, and subject numbers used throughout the ClinicalTrials.gov results do not consistently relate to the same subjects.~The number of days on which data were collected for each subject during the 7-day baseline period and the last 28-day period are provided in parentheses in the row titles.~No data were collected for Subject 7 during the 7-day baseline period.
Monthly headache daysNUMBER
SECONDARYNumber of MHD Responders (Defined as a ≥50% Reduction in MHD)Baseline to Week 24
The number of responders is provided for all subjects (including those who were considered non-responders because they dropped out of the study prior to Week 24) and for subjects who completed the study.
ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Moderate to Severe MHD Responders (Defined as a ≥50% Reduction in Moderate to Severe MHD)Baseline to Week 24
The number of responders is provided for all subjects (including those who were considered non-responders because they dropped out of the study prior to Week 24) and for subjects who completed the study.
ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYHeadache SeverityBaseline to Week 24
Data presented represents collected data from individual subjects. For anonymity, study-assigned subject IDs are not included and subject numbers used throughout ClinicalTrials.gov results do not consistently relate to the same subjects.~Number of days on which severity data were collected for each subject during the 7-day baseline and the last 28-day periods are provided in row titles.
score on a scaleMEDIAN
SECONDARYUse of Acute Headache Analgesic Medications (Acute Headache Analgesics in Days Per Month)Baseline to Week 24
Data presented represents collected data from individual subjects. For anonymity, study-assigned subject IDs are not included here, and subject numbers used throughout the ClinicalTrials.gov results do not consistently relate to the same subjects. The number of days on which analgesic use were collected for each subject during the 7-day baseline and the last 28-day periods are provided in parentheses in row titles.
Acute headache analgesics days per monthNUMBER
SECONDARYVisual AcuityBaseline to Week 24Data were not collected from subjects with qualifying study eyes for this endpoint.
SECONDARYNumber of Patients With Treatment FailureBaseline to Week 24participantsNUMBER

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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