Trial · NCT05347147
A Trial to Determine the Efficacy and Safety of Presendin in IIH
NCT05347147, Phase 3, Terminated, Invex Therapeutics Ltd.; results first posted 2024-04-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Trial to Determine the Efficacy and Safety of Presendin in IIH. Trials, record NCT05347147. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05347147
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Trial to Determine the Efficacy and Safety of Presendin in IIH
- NCT number
- NCT05347147
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 14 participants, actual
- Lead sponsor
- Invex Therapeutics Ltd.
- Conditions
- Idiopathic Intracranial Hypertension
- Interventions
- Presendin, Placebo
- First posted
- 2022-04-26
- Last updated
- 2024-04-24
- Results first posted
- 2024-04-24
- Limitations and caveats
Due to the early termination of the study, planned analyses were not fully conducted but were restricted to the most relevant safety endpoints as per the abbreviated SAP v1. Outcome measure (efficacy) data are raw data from individual subjects, with minimal analysis; e.g., where an outcome measure specified change from baseline to Week 24, baseline and Week 24 values are presented. Efficacy data were not subject to the same verification as safety data and no efficacy conclusions should be drawn.
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in ICP From Baseline to Week 24 Measured by Lumbar Puncture (LP), Where a Higher LP Value Indicates Greater ICP | Baseline to Week 24 | ICP was measured by LP (opening pressure) using an LP manometer; Baseline and Week 24 ICP values (measured in cm CSF) are presented for each subject. A standard operating procedure was followed by all study sites for all study-related ICP measurements by LP. |
| Secondary | Change in Perimetric Mean Deviation (PMD), Measured by Humphrey Visual Field (HVF) Analysis (24-2 SITA-Standard), Where a Larger Negative Result Indicates Greater Visual Loss | Baseline to Week 24 | |
| Secondary | Papilloedema by Change in Retinal Nerve Fibre Layer (RNFL) Thickness, With a Greater Thickness of RNFL Indicating Greater Swelling and Greater Extent of Papilloedema | Baseline to Week 24 | |
| 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 | |
| Secondary | The Number of Monthly Headache Days (MHD) | Baseline to Week 24 | Monthly headache days (according to daily headache diary) = number of days recorded in a 28-day window where data were collected on \>7 days and where ≥1 headache on a day met the following criteria: * Onset, continuation, or recurrence of headache * Any severity or phenotype of headache * Lasts at least 30 minutes Baseline headache frequency was calculated over the 7 days prior to the randomization visit; ≥5 days of headache data were needed to obtain a valid baseline value. The number of headache days recorded for a period were linearly scaled by the total number of days of data collected in the period for each subject to give the MHD during the baseline period (linearly scaled to a maximum of 28 days) and the last 28-day period during which data were collected on \>7 days for each subject prior to study completion or discontinuation. Period 1 = Weeks 1-4 Period 2 = Weeks 5-8 Period 3 = Weeks 9-12 Period 4 = Weeks 13-16 Period 5 = Weeks 17-20 Period 6 = Weeks 21-24 |
| Secondary | Number of Moderate to Severe MHD | Baseline to Week 24 | Moderate to severe (m-s) MHD (according to daily headache diary) = number of days recorded in a 28-day window where data were collected on \>7 days and where ≥1 headache on a day met the following criteria: * Severity was of moderate or severe pain and lasted at least 4 hours or, * Required acute headache analgesics Baseline m-s headache frequency was calculated over the 7 days prior to the randomization visit; ≥5 days of headache data were needed to obtain a valid baseline value. The number of m-s headache days recorded for a period were linearly scaled by the total number of days of data collected in the period for each subject to give the m-s MHD during the baseline period (linearly scaled to a max 28 days) and the last 28-day period during which data were collected on \>7 days for each subject prior to study completion or discontinuation. Period 1 = Weeks 1-4 Period 2 = Weeks 5-8 Period 3 = Weeks 9-12 Period 4 = Weeks 13-16 Period 5 = Weeks 17-20 Period 6 = Weeks 21-24 |
| Secondary | Number of MHD Responders (Defined as a ≥50% Reduction in MHD) | Baseline to Week 24 | A subject was considered a responder if they had at least a 50% reduction in MHD from baseline to Week 24. Subjects who dropped out prior to Week 24 were considered non-responders. |
| Secondary | Number of Moderate to Severe MHD Responders (Defined as a ≥50% Reduction in Moderate to Severe MHD) | Baseline to Week 24 | A subject was considered a responder if they had at least a 50% reduction in moderate to severe MHD from baseline to Week 24. Subjects who dropped out prior to Week 24 were considered non-responders. |
| Secondary | Headache Severity | Baseline to Week 24 | Headache severity was assessed by a 10-point Numeric Rating Scale (NRS), 0-10 where 0 = no pain and 10 = most severe pain. Severity of headaches was assessed on days where a headache occurred. Headache free days were not counted. Baseline headache severity was calculated over the 7 days prior to the randomization visit; at least 5 of 7 days of headache severity data had to be recorded by the subject to obtain a valid baseline value. * 28-day period 1 = Weeks 1-4 * 28-day period 2 = Weeks 5-8 * 28-day period 3 = Weeks 9-12 * 28-day period 4 = Weeks 13-16 * 28-day period 5 = Weeks 17-20 * 28-day period 6 = Weeks 21-24 |
| Secondary | Use of Acute Headache Analgesic Medications (Acute Headache Analgesics in Days Per Month) | Baseline to Week 24 | Number of days recorded in a 28-day window, where at least one dose of an acute headache analgesic was recorded. The baseline acute headache analgesic use was calculated over the 7 days prior to the randomization visit; at least 5 of 7 days had to be recorded by the subject to obtain a valid baseline value. The number of acute headache analgesic use days was linearly scaled for each subject to give the number of acute headache analgesic use days during the baseline period and the last 28-day period during which headache data were collected on more than 7 days for each subject prior to study completion or discontinuation. * 28-day period 1 = Weeks 1-4 * 28-day period 2 = Weeks 5-8 * 28-day period 3 = Weeks 9-12 * 28-day period 4 = Weeks 13-16 * 28-day period 5 = Weeks 17-20 * 28-day period 6 = Weeks 21-24 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in ICP From Baseline to Week 24 Measured by Lumbar Puncture (LP), Where a Higher LP Value Indicates Greater ICP | 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. | cm CSF | NUMBER |
| SECONDARY | Change in Perimetric Mean Deviation (PMD), Measured by Humphrey Visual Field (HVF) Analysis (24-2 SITA-Standard), Where a Larger Negative Result Indicates Greater Visual Loss | Baseline 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. | dB | NUMBER |
| SECONDARY | Papilloedema by Change in Retinal Nerve Fibre Layer (RNFL) Thickness, With a Greater Thickness of RNFL Indicating Greater Swelling and 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. Cirrus was the imaging platform used for all subjects except Subjects 6 and 7, where Zeiss was used. | µm | NUMBER |
| 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 change | NUMBER |
| SECONDARY | The 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 days | NUMBER |
| SECONDARY | Number of Moderate to Severe 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 days | NUMBER |
| SECONDARY | Number 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Headache Severity | Baseline 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 scale | MEDIAN |
| SECONDARY | Use 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 month | NUMBER |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group194
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in ICP From Baseline to Week 24 Measured by Lumbar Puncture (LP), Where a Higher LP Value Indicates Greater ICP | Presendin | Subject 1 Baseline ICP | 25 | cm CSF | |
| Change in ICP From Baseline to Week 24 Measured by Lumbar Puncture (LP), Where a Higher LP Value Indicates Greater ICP | Presendin | Subject 1 Week 24 ICP | 28 | cm CSF | |
| Change in ICP From Baseline to Week 24 Measured by Lumbar Puncture (LP), Where a Higher LP Value Indicates Greater ICP | Presendin | Subject 2 Baseline ICP | 28 | cm CSF | |
| Change in ICP From Baseline to Week 24 Measured by Lumbar Puncture (LP), Where a Higher LP Value Indicates Greater ICP | Presendin | Subject 2 Week 24 ICP | 29 | cm CSF | |
| Change in ICP From Baseline to Week 24 Measured by Lumbar Puncture (LP), Where a Higher LP Value Indicates Greater ICP | Placebo | Subject 3 Baseline ICP | 40 | cm CSF | |
| Change in ICP From Baseline to Week 24 Measured by Lumbar Puncture (LP), Where a Higher LP Value Indicates Greater ICP | Placebo | Subject 3 Week 24 ICP | 30 | cm CSF | |
| Change in Perimetric Mean Deviation (PMD), Measured by Humphrey Visual Field (HVF) Analysis (24-2 SITA-Standard), Where a Larger Negative Result Indicates Greater Visual Loss | Presendin | Subject 1: right eye, Baseline PMD | -5.89 | dB | |
| Change in Perimetric Mean Deviation (PMD), Measured by Humphrey Visual Field (HVF) Analysis (24-2 SITA-Standard), Where a Larger Negative Result Indicates Greater Visual Loss | Presendin | Subject 1: right eye, Week 24 PMD | 0.74 | dB | |
| Change in Perimetric Mean Deviation (PMD), Measured by Humphrey Visual Field (HVF) Analysis (24-2 SITA-Standard), Where a Larger Negative Result Indicates Greater Visual Loss | Presendin | Subject 2: right eye, Baseline PMD | -3.60 | dB | |
| Change in Perimetric Mean Deviation (PMD), Measured by Humphrey Visual Field (HVF) Analysis (24-2 SITA-Standard), Where a Larger Negative Result Indicates Greater Visual Loss | Presendin | Subject 2: right eye, Week 24 PMD | -1.09 | dB |
1 to 10 of 194Source ClinicalTrials.gov
See all 194 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Presendin | 8 | |
| Overall Study | STARTED | Placebo | 6 | |
| Overall Study | COMPLETED | Presendin | 3 | |
| Overall Study | COMPLETED | Placebo | 1 | |
| Overall Study | NOT COMPLETED | Presendin | 5 | |
| Overall Study | NOT COMPLETED | Placebo | 5 |
Source ClinicalTrials.gov
Adverse events117
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 | Injection site mass | General disorders | Presendin | 2 | 8 | 2 |
| other | Injection site mass | General disorders | Placebo | 1 | 6 | 1 |
| other | Injection site mass | General disorders | All Subjects Pre-treatment | 0 | 14 | 0 |
| other | Catheter site pain | General disorders | Presendin | 0 | 8 | 0 |
| other | Catheter site pain | General disorders | Placebo | 1 | 6 | 1 |
| other | Catheter site pain | General disorders | All Subjects Pre-treatment | 0 | 14 | 0 |
| other | Fatigue | General disorders | Presendin | 0 | 8 | 0 |
| other | Fatigue | General disorders | Placebo | 1 | 6 | 1 |
| other | Fatigue | General disorders | All Subjects Pre-treatment | 0 | 14 | 0 |
| other | Injection site bruising | General disorders | Presendin | 1 | 8 | 1 |
1 to 10 of 117Source ClinicalTrials.gov
See all 117 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Presendin | 0 | 8 |
| Total, all-cause mortality | Placebo | 0 | 6 |
| Total, all-cause mortality | All Subjects Pre-treatment | 0 | 14 |
| Total, other adverse events | Presendin | 8 | 8 |
| Total, other adverse events | Placebo | 6 | 6 |
| Total, other adverse events | All Subjects Pre-treatment | 2 | 14 |
| Total, serious adverse events | Presendin | 0 | 8 |
| Total, serious adverse events | Placebo | 0 | 6 |
| Total, serious adverse events | All Subjects Pre-treatment | 0 | 14 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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
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