Trial · NCT02017444
Safety and Effectiveness of 11b-Hydroxysteroid Dehydrogenase Type 1 Inhibitor (AZD4017) to Treat Idiopathic Intracranial Hypertension.
NCT02017444, Phase 2, Completed, University of Birmingham; results first posted 2021-10-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Effectiveness of 11b-Hydroxysteroid Dehydrogenase Type 1 Inhibitor (AZD4017) to Treat Idiopathic Intracranial Hypertension. Trials, record NCT02017444. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02017444
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Effectiveness of 11b-Hydroxysteroid Dehydrogenase Type 1 Inhibitor (AZD4017) to Treat Idiopathic Intracranial Hypertension.
- NCT number
- NCT02017444
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 31 participants, actual
- Lead sponsor
- University of Birmingham
- Conditions
- Idiopathic Intracranial Hypertension
- Interventions
- AZD4017, Placebo
- First posted
- 2013-12-20
- Last updated
- 2021-10-27
- Other registries' IDs
- eudract:2013-003643-31
- Results first posted
- 2021-10-27
- Limitations and caveats
A duration of 12 weeks was chosen for the evaluation of safety and tolerability, being the longest duration of dosing to date with AZD4017. This may not have been enough for meaningful evaluation of clinical outcomes.~The sample size is small, which may have reduced power and limited meaningful evaluation of clinical measures: the trial was not designed to establish significant changes in the secondary clinical outcome measures.
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Intracranial Pressure | 12 weeks | cmCSF | MEAN | |
| SECONDARY | Tinnitus | 12 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Anthropometric Measurements (BMI) | 12 weeks | kg/m^2 | MEAN | |
| SECONDARY | Visual Loss | 12 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Diplopia | 12 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Visual Obscuration | 12 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Headache | 12 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Visual Acuity | 12 weeks | LogMAR (log of the minimum angle of reso | MEAN | |
| SECONDARY | Papilloedema | 12 weeks | NB: assessment missed for one participant at baseline | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Headache-associated Disability | 12 weeks | Score on HIT-6 scale | MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group70
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Intracranial Pressure | Placebo | -0.3 | Standard Deviation 5.9 | cmCSF | |
| Intracranial Pressure | AZD4017 (11b-HSD1 Inhibitor) | -4.3 | Standard Deviation 5.7 | cmCSF | |
| Tinnitus | Placebo | Presence | 7 | Participants | |
| Tinnitus | AZD4017 (11b-HSD1 Inhibitor) | Presence | 9 | Participants | |
| Tinnitus | Placebo | Absence | 5 | Participants | |
| Tinnitus | AZD4017 (11b-HSD1 Inhibitor) | Absence | 8 | Participants | |
| Anthropometric Measurements (BMI) | Placebo | 37.4 | Standard Deviation 8.4 | kg/m^2 | |
| Anthropometric Measurements (BMI) | AZD4017 (11b-HSD1 Inhibitor) | 37.5 | Standard Deviation 6.9 | kg/m^2 | |
| Visual Loss | Placebo | Presence | 7 | Participants | |
| Visual Loss | AZD4017 (11b-HSD1 Inhibitor) | Presence | 6 | Participants |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 14 | |
| Overall Study | STARTED | AZD4017 (11b-HSD1 Inhibitor) | 17 | |
| Overall Study | COMPLETED | Placebo | 12 | |
| Overall Study | COMPLETED | AZD4017 (11b-HSD1 Inhibitor) | 17 | |
| Overall Study | NOT COMPLETED | Placebo | 2 | |
| Overall Study | NOT COMPLETED | AZD4017 (11b-HSD1 Inhibitor) | 0 |
Source ClinicalTrials.gov
Adverse events30
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Cardiovascular | Cardiac disorders | Placebo | 1 | 14 | |
| other | Cardiovascular | Cardiac disorders | AZD4017 (11b-HSD1 Inhibitor) | 1 | 17 | |
| other | Respiratory | Respiratory, thoracic and mediastinal disorders | Placebo | 3 | 14 | |
| other | Respiratory | Respiratory, thoracic and mediastinal disorders | AZD4017 (11b-HSD1 Inhibitor) | 4 | 17 | |
| other | Gastro-intestinal | Gastrointestinal disorders | Placebo | 3 | 14 | |
| other | Gastro-intestinal | Gastrointestinal disorders | AZD4017 (11b-HSD1 Inhibitor) | 8 | 17 | |
| other | Genito-urinary | General disorders | Placebo | 0 | 14 | |
| other | Genito-urinary | General disorders | AZD4017 (11b-HSD1 Inhibitor) | 6 | 17 | |
| other | Endocrine | Endocrine disorders | Placebo | 1 | 14 | |
| other | Endocrine | Endocrine disorders | AZD4017 (11b-HSD1 Inhibitor) | 1 | 17 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 14 |
| Total, all-cause mortality | AZD4017 (11b-HSD1 Inhibitor) | 0 | 17 |
| Total, other adverse events | Placebo | 11 | 14 |
| Total, other adverse events | AZD4017 (11b-HSD1 Inhibitor) | 16 | 17 |
| Total, serious adverse events | Placebo | 1 | 14 |
| Total, serious adverse events | AZD4017 (11b-HSD1 Inhibitor) | 0 | 17 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| AZD4017 (11b-HSD1 Inhibitor) vs Placebo: deaths from any cause | Trial comparisons |
| AZD4017 (11b-HSD1 Inhibitor) vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02017444
GET https://conductscience.org/api/trials/v1/NCT02017444/results?page=2