Trial · NCT02017444
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Intracranial Pressure | 12 weeks | ICP measured by lumbar puncture in cmCSF as the change from week 0 and week 12 of treatment, measured at baseline and week 12 |
| Secondary | Tinnitus | 12 weeks | The temporal change in IIH symptoms (presence or absence of tinnitus), measured at baseline and week 12 |
| Secondary | Anthropometric Measurements (BMI) | 12 weeks | The temporal change in Body Mass Index (in kg/m\^2) over 12 weeks of treatment, measured at baseline and week 12 |
| Secondary | Visual Loss | 12 weeks | The temporal change in IIH symptoms (presence or absence of visual loss, measured at baseline and week 12 |
| Secondary | Diplopia | 12 weeks | The temporal change in IIH symptoms (presence or absence of diplopia, measured at baseline and week 12 |
| Secondary | Visual Obscuration | 12 weeks | The temporal change in IIH symptoms (presence or absence of visual obscuration, measured at baseline and week 12 |
| Secondary | Headache | 12 weeks | The temporal change in IIH symptoms (presence or absence of headache, measured at baseline and week 12 |
| Secondary | Visual Acuity | 12 weeks | The temporal change in IIH visual function in both eyes (measured by LogMAR (log of the minimum angle of resolution) chart to assess visual acuity, between the baseline to week 12, measured at baseline and week 12 |
| Secondary | Papilloedema | 12 weeks | The temporal change in papilloedema (evaluated at the end of trial follow up using stereoscopic fundus photographs by masked neuro-ophthalmologists to grade the images according to Frisen classification) measured at baseline and week 12. There are 6 grades, 0-5, 5 being the worst. The modified Frisén scale for grading papilledema using fundus photography is as follows: Grade 1 - C-Shaped halo with a temporal gap Grade 2 - The halo becomes circumferential Grade 3 - Loss of major vessels as they leave the disc Grade 4 - Loss of major vessels on the disc Grade 5 - Criteria of Grade IV + partial or total obscuration of all vessels on the disc For further details see e.g. Scott, C.J., et al., Diagnosis and grading of papilledema in patients with raised intracranial pressure using optical coherence tomography vs clinical expert assessment using a clinical staging scale. Arch. Ophthalmol, 2010. 128(6): p. 705-711. |
| Secondary | Headache-associated Disability | 12 weeks | The change in headache associated disability through the headache impact test-6 score (HIT 6), measured at baseline and week 12. This is scored 11-66 with higher scores indicating worse headache. |
| Secondary | Adverse Events | 16 weeks | The safety and tolerability profile of AZD4017 in female patients with IIH through adverse event reporting and safety bloods. |
| Secondary | Serious Adverse Events | 16 weeks | The safety and tolerability profile of AZD4017 in female patients with IIH through adverse event reporting and safety bloods. |
| Secondary | OCT Total Average Retinal Nerve Fibre Layer Thickness (μm) | 12 weeks | The temporal change in OCT Total average retinal nerve fibre layer thickness (μm), measured at baseline and week 12 |
| Secondary | Visual Field Mean Deviation | 12 weeks | The temporal change in IIH visual function in both eyes using automated perimetry (Humphrey 24-2 central threshold) to measure the visual field mean deviation between the baseline to week 12 |
| Secondary | Log Contrast Sensitivity | 12 weeks | The temporal change in IIH visual function in both eyes using a Pelli-Robson chart to evaluate log contrast sensitivity between the baseline to week 12 |
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.
For software
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