niacinamide has been researched along with Pseudotumor Cerebri in 1 studies
nicotinamide : A pyridinecarboxamide that is pyridine in which the hydrogen at position 3 is replaced by a carboxamide group.
Pseudotumor Cerebri: A condition marked by raised intracranial pressure and characterized clinically by HEADACHES; NAUSEA; PAPILLEDEMA, peripheral constriction of the visual fields, transient visual obscurations, and pulsatile TINNITUS. OBESITY is frequently associated with this condition, which primarily affects women between 20 and 44 years of age. Chronic PAPILLEDEMA may lead to optic nerve injury (see OPTIC NERVE DISEASES) and visual loss (see BLINDNESS).
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 0 (0.00) | 18.7374 |
| 1990's | 0 (0.00) | 18.2507 |
| 2000's | 0 (0.00) | 29.6817 |
| 2010's | 0 (0.00) | 24.3611 |
| 2020's | 1 (100.00) | 2.80 |
| Authors | Studies |
|---|---|
| Hardy, RS | 1 |
| Botfield, H | 1 |
| Markey, K | 1 |
| Mitchell, JL | 1 |
| Alimajstorovic, Z | 1 |
| Westgate, CSJ | 1 |
| Sagmeister, M | 1 |
| Fairclough, RJ | 1 |
| Ottridge, RS | 1 |
| Yiangou, A | 1 |
| Storbeck, KH | 1 |
| Taylor, AE | 1 |
| Gilligan, LC | 1 |
| Arlt, W | 1 |
| Stewart, PM | 1 |
| Tomlinson, JW | 1 |
| Mollan, SP | 1 |
| Lavery, GG | 1 |
| Sinclair, AJ | 1 |
| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| Lowering Intracranial Pressure in Idiopathic Intracranial Hypertension: Assessing the Therapeutic Efficacy and Safety of an 11β-hydroxysteroid Dehydrogenase Type 1 Inhibitor (AZD4017). Phase II Study.[NCT02017444] | Phase 2 | 31 participants (Actual) | Interventional | 2014-04-25 | Completed | ||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
The safety and tolerability profile of AZD4017 in female patients with IIH through adverse event reporting and safety bloods. (NCT02017444)
Timeframe: 16 weeks
| Intervention | AEs related to intervention (Number) |
|---|---|
| Placebo | 0 |
| AZD4017 (11b-HSD1 Inhibitor) | 9 |
The temporal change in Body Mass Index (in kg/m^2) over 12 weeks of treatment, measured at baseline and week 12 (NCT02017444)
Timeframe: 12 weeks
| Intervention | kg/m^2 (Mean) |
|---|---|
| Placebo | 37.4 |
| AZD4017 (11b-HSD1 Inhibitor) | 37.5 |
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. (NCT02017444)
Timeframe: 12 weeks
| Intervention | Score on HIT-6 scale (Mean) |
|---|---|
| Placebo | 59.8 |
| AZD4017 (11b-HSD1 Inhibitor) | 60.1 |
ICP measured by lumbar puncture in cmCSF as the change from week 0 and week 12 of treatment, measured at baseline and week 12 (NCT02017444)
Timeframe: 12 weeks
| Intervention | cmCSF (Mean) |
|---|---|
| Placebo | -0.3 |
| AZD4017 (11b-HSD1 Inhibitor) | -4.3 |
The safety and tolerability profile of AZD4017 in female patients with IIH through adverse event reporting and safety bloods. (NCT02017444)
Timeframe: 16 weeks
| Intervention | Serious adverse events (Number) |
|---|---|
| Placebo | 1 |
| AZD4017 (11b-HSD1 Inhibitor) | 0 |
The temporal change in IIH symptoms (presence or absence of diplopia, measured at baseline and week 12 (NCT02017444)
Timeframe: 12 weeks
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| Presence | Absence | |
| AZD4017 (11b-HSD1 Inhibitor) | 2 | 15 |
| Placebo | 1 | 11 |
The temporal change in IIH symptoms (presence or absence of headache, measured at baseline and week 12 (NCT02017444)
Timeframe: 12 weeks
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| Presence | Absence | |
| AZD4017 (11b-HSD1 Inhibitor) | 13 | 4 |
| Placebo | 10 | 2 |
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 (NCT02017444)
Timeframe: 12 weeks
| Intervention | Log contrast senstivity (Mean) | |
|---|---|---|
| Baseline LCS worst eye | Week 12 LCS worst eye | |
| AZD4017 (11b-HSD1 Inhibitor) | 1.63 | 1.65 |
| Placebo | 1.63 | 1.66 |
The temporal change in OCT Total average retinal nerve fibre layer thickness (μm), measured at baseline and week 12 (NCT02017444)
Timeframe: 12 weeks
| Intervention | μm (Mean) | |
|---|---|---|
| Total average retinal nerve fibre layer baseline worst ete | Total average retinal nerve fibre layer week 12 worst eye | |
| AZD4017 (11b-HSD1 Inhibitor) | 152 | 139.7 |
| Placebo | 158.4 | 143.2 |
"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." (NCT02017444)
Timeframe: 12 weeks
| Intervention | Participants (Count of Participants) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Frisen grade 0 baseline | Frisen grade 0 week 12 | Frisen grade 1 baseline | Frisen grade 1 week 12 | Frisen grade 2 baseline | Frisen grade 2 week 12 | Frisen grade 3 baseline | Frisen grade 3 week 12 | Frisen grade 4 baseline | Frisen grade 4 week 12 | Frisen grade 5 baseline | Frisen grade 5 week 12 | |
| AZD4017 (11b-HSD1 Inhibitor) | 0 | 2 | 4 | 5 | 9 | 8 | 0 | 0 | 2 | 1 | 1 | 0 |
| Placebo | 0 | 0 | 2 | 2 | 5 | 6 | 3 | 3 | 1 | 1 | 0 | 0 |
The temporal change in IIH symptoms (presence or absence of tinnitus), measured at baseline and week 12 (NCT02017444)
Timeframe: 12 weeks
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| Presence | Absence | |
| AZD4017 (11b-HSD1 Inhibitor) | 9 | 8 |
| Placebo | 7 | 5 |
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 (NCT02017444)
Timeframe: 12 weeks
| Intervention | LogMAR (log of the minimum angle of reso (Mean) | |
|---|---|---|
| Baseline LVA worst eye | Week 12 LVA worst eye | |
| AZD4017 (11b-HSD1 Inhibitor) | 0.08 | 0.06 |
| Placebo | 0.13 | 0.09 |
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 (NCT02017444)
Timeframe: 12 weeks
| Intervention | Visual field mean deviation (Mean) | |
|---|---|---|
| Baseline MD worst eye | Week 12 MD worst eye | |
| AZD4017 (11b-HSD1 Inhibitor) | -6.1 | -3.4 |
| Placebo | -3.4 | -2.2 |
The temporal change in IIH symptoms (presence or absence of visual loss, measured at baseline and week 12 (NCT02017444)
Timeframe: 12 weeks
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| Presence | Absence | |
| AZD4017 (11b-HSD1 Inhibitor) | 6 | 11 |
| Placebo | 7 | 4 |
The temporal change in IIH symptoms (presence or absence of visual obscuration, measured at baseline and week 12 (NCT02017444)
Timeframe: 12 weeks
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| Presence | Absence | |
| AZD4017 (11b-HSD1 Inhibitor) | 2 | 15 |
| Placebo | 2 | 9 |
1 trial available for niacinamide and Pseudotumor Cerebri
| Article | Year |
|---|---|
11βHSD1 Inhibition with AZD4017 Improves Lipid Profiles and Lean Muscle Mass in Idiopathic Intracranial Hypertension.
Topics: 11-beta-Hydroxysteroid Dehydrogenase Type 1; Adolescent; Adult; Body Composition; Double-Blind Metho | 2021 |