Idiopathic Intracranial Hypertension
Conditions
Keywords
Presendin
Brief summary
Idiopathic intracranial hypertension (IIH) has significant associated morbidity and reduced quality of life. There is a significant risk of visual loss and patients also typically suffer with chronic disabling headaches. This trial has been designed to evaluate the efficacy and safety of a new formulation of exenatide (Presendin) in the reduction of intracranial pressure (ICP) in patients with IIH.
Detailed description
Patients will be provided with training on the self-administration of the trial medication from the site trial co-ordinator. A 1-week screening period will be followed by a 24-week randomised double-blind treatment period in which patients will be randomised (1:1) to receive a subcutaneous (SC) dose of either Presendin (containing 2 mg of exenatide \[active group\]) or matching placebo (placebo group), self-administered once weekly. At the end of the randomised treatment period (Week 24), all patients will have an end-of-treatment clinic visit. Five weeks after the end-of-treatment visit, an end-of-trial safety follow-up telephone visit will be performed.
Interventions
DRUGPresendin
Presendin is supplied as 2 parts, one vial consisting of a drug part (white or greyish white powder in a clear vial) and one pre-filled syringe containing the diluent part (colourless liquid). The drug part is suspended in the diluent part solution and administered SC as a suspension.
DRUGPlacebo
Placebo is supplied as 2 parts (visually identical to the Presendin vial and pre-filled diluent syringe). The drug part will exclude the active pharmaceutical ingredient (exenatide acetate) and the diluent part will be the same as the active treatment diluent. The drug part is suspended in the diluent part solution and administered SC as a suspension.
Sponsors
Premier Research
University Hospital Birmingham
University of Iowa
Invex Therapeutics Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Investigators and other site personnel, patients, contract research organisation and Sponsor personnel will be blinded regarding the treatment during the randomised period.
Intervention model description
This will be a placebo-controlled, double-blind, multi-centre clinical trial in approximately 240 randomised patients with IIH.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years at the time of consent. 2. Diagnosis of new IIH by consensus criteria, including normal structural brain imaging (excluding features of raised ICP and incidentalomas), including either magnetic resonance venography or computed tomographic venography to exclude thrombosis and no evidence of a secondary causes of raised ICP. 3. Newly diagnosed patients with screening commenced no more than 4 weeks after the diagnostic LP. 4. Lumbar puncture opening pressure ≥25 cm cerebrospinal fluid (CSF) at diagnosis. 5. Presence of bilateral papilloedema (Frisén grade ≥1). Verification of papilloedema by the OCT Reading Centre. Where there is uncertainty fundus photography and/or ultrasound scan (B scan) of the optic nerves should be conducted for evaluation by the Independent Adjudication Committee (IAC). 6. Perimetric Mean Deviation defined as between -2 to -7 decibels (dB) in at least one eye. Eyes meeting this criterion will defined as 'study eyes'. 7. Reproducible visual loss present on automated perimetry including no more than 15% false positive responses (reliability confirmed by the Visual Field Reading Centre) in study eyes. 8. Two or more headache days over the 7-day period prior to screening and also the patient must meet this criterion during the 7-day screening period. 9. Females of childbearing potential must have a negative pregnancy test and must agree to use a highly effective birth control method (failure rate less than 1% per year when used consistently and correctly) during the whole trial duration including the last follow-up visit (12 weeks after ceasing drug). Female patients who are lactating must agree to stop breast-feeding OR Female patients of non-childbearing potential (defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or post-menopausal females defined as 12 months of amenorrhoea \[in questionable cases a blood sample with simultaneous follicle stimulation hormone 25-140 IE/L and oestradiol \<200 pmol/L is confirmatory\]). 10. Male patients with a female partner of childbearing potential must commit to practice methods of contraception (e.g., condom, vasectomy) and abstain from sperm donation during the trial including the last follow-up visit (12 weeks after ceasing drug). Their partners, if they are women of childbearing potential, must agree to practice contraception and to use a highly effective method of contraception during the trial, including the last follow-up visit (12 weeks after ceasing drug). 11. Able to provide written informed consent.
Exclusion criteria
IIH-related
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 | — |
| 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 |
| 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 |
| 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. |
| 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 | — |
| 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 |
| 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 |
| Visual Acuity | Baseline to Week 24 | Corrected visual acuity will be recorded using a Logarithm of the Minimum Angle of Resolution (LogMAR) scoring chart, with a range of -0.3 to 1.00, where a lower score indicates better visual acuity. |
| Number of Patients With Treatment Failure | Baseline to Week 24 | Treatment failure is defined as the initiation of either medical therapy or a surgical intervention to lower ICP during the study. |
| 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. |
Countries
Australia, Germany, Israel, New Zealand, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Presendin 2.0 mg
Presendin: Presendin is supplied as 2 parts, one vial consisting of a drug part (white or greyish white powder in a clear vial) and one pre-filled syringe containing the diluent part (colourless liquid). The drug part is suspended in the diluent part solution and administered SC as a suspension. | 8 |
| Placebo Placebo: Placebo is supplied as 2 parts (visually identical to the Presendin vial and pre-filled diluent syringe). The drug part will exclude the active pharmaceutical ingredient (exenatide acetate) and the diluent part will be the same as the active treatment diluent. The drug part is suspended in the diluent part solution and administered SC as a suspension. | 6 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Sponsor request | 3 | 3 |
| Overall Study | Study termination | 2 | 1 |
Baseline characteristics
| Characteristic | Presendin | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 28.0 Years STANDARD_DEVIATION 8.5 | 28.2 Years STANDARD_DEVIATION 7.06 | 28.5 Years STANDARD_DEVIATION 5.32 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 13 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized More than 1 Race | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 7 Participants | 10 Participants | 3 Participants |
| Region of Enrollment Australia | 4 Participants | 8 Participants | 4 Participants |
| Region of Enrollment New Zealand | 3 Participants | 4 Participants | 1 Participants |
| Region of Enrollment United Kingdom | 0 Participants | 1 Participants | 1 Participants |
| Region of Enrollment United States | 1 Participants | 1 Participants | 0 Participants |
| Sex: Female, Male Female | 7 Participants | 13 Participants | 6 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 6 | 0 / 14 |
| other Total, other adverse events | 8 / 8 | 6 / 6 | 2 / 14 |
| serious Total, serious adverse events | 0 / 8 | 0 / 6 | 0 / 14 |
Outcome results
Primary
Change in ICP From Baseline to Week 24 Measured by Lumbar Puncture (LP), Where a Higher LP Value Indicates Greater ICP
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.
Time frame: Baseline to Week 24
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Presendin | Change in ICP From Baseline to Week 24 Measured by Lumbar Puncture (LP), Where a Higher LP Value Indicates Greater ICP | Subject 1 Baseline ICP | 25 cm CSF |
| Presendin | Change in ICP From Baseline to Week 24 Measured by Lumbar Puncture (LP), Where a Higher LP Value Indicates Greater ICP | Subject 1 Week 24 ICP | 28 cm CSF |
| Presendin | Change in ICP From Baseline to Week 24 Measured by Lumbar Puncture (LP), Where a Higher LP Value Indicates Greater ICP | Subject 2 Baseline ICP | 28 cm CSF |
| Presendin | Change in ICP From Baseline to Week 24 Measured by Lumbar Puncture (LP), Where a Higher LP Value Indicates Greater ICP | Subject 2 Week 24 ICP | 29 cm CSF |
| Placebo | Change in ICP From Baseline to Week 24 Measured by Lumbar Puncture (LP), Where a Higher LP Value Indicates Greater ICP | Subject 3 Baseline ICP | 40 cm CSF |
| Placebo | Change in ICP From Baseline to Week 24 Measured by Lumbar Puncture (LP), Where a Higher LP Value Indicates Greater ICP | Subject 3 Week 24 ICP | 30 cm CSF |
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
Time frame: Baseline to Week 24
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Presendin | 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 | Subject 1: right eye, Baseline PMD | -5.89 dB |
| Presendin | 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 | Subject 1: right eye, Week 24 PMD | 0.74 dB |
| Presendin | 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 | Subject 2: right eye, Baseline PMD | -3.60 dB |
| Presendin | 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 | Subject 2: right eye, Week 24 PMD | -1.09 dB |
| Presendin | 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 | Subject 6: right eye, Baseline PMD | -3.64 dB |
| Presendin | 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 | Subject 6: right eye, Week 24 PMD | -0.88 dB |
| Presendin | 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 | Subject 6: left eye, Baseline PMD | -2.55 dB |
| Presendin | 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 | Subject 6: left eye, Week 24 PMD | 0.15 dB |
| Presendin | 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 | Subject 9: right eye, Baseline PMD | -2.37 dB |
| Presendin | 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 | Subject 9: right eye, Week 24 PMD | -2.59 dB |
| Presendin | 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 | Subject 9: left eye, Baseline PMD | -3.81 dB |
| Presendin | 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 | Subject 9: left eye, Week 24 PMD | -2.04 dB |
| Placebo | 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 | Subject 5: right eye, Baseline PMD | -2.24 dB |
| Placebo | 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 | Subject 5: right eye, Week 24 PMD | -2.69 dB |
| Placebo | 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 | Subject 5: left eye, Baseline PMD | -3.66 dB |
| Placebo | 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 | Subject 5: left eye, Week 24 PMD | -2.98 dB |
| Placebo | 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 | Subject 7: left eye, Baseline PMD | -3.15 dB |
| Placebo | 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 | Subject 7: left eye, Week 24 PMD | -0.26 dB |
| Placebo | 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 | Subject 8: left eye, Baseline PMD | -2.6 dB |
| Placebo | 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 | Subject 8: left eye, Week 24 PMD | -1.5 dB |
| Placebo | 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 | Subject 7: right eye, Baseline PMD | -2.54 dB |
| Placebo | 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 | Subject 7: right eye, Week 24 PMD | -0.49 dB |
| Placebo | 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 | Subject 3: right eye, Baseline PMD | -2.79 dB |
| Placebo | 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 | Subject 3: right eye, Week 24 PMD | -1.50 dB |
| Placebo | 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 | Subject 3: left eye, Baseline PMD | -4.78 dB |
| Placebo | 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 | Subject 3: left eye, Week 24 PMD | -2.33 dB |
| Placebo | 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 | Subject 4: right eye, Baseline PMD | -3.16 dB |
| Placebo | 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 | Subject 4: right eye, Week 24 PMD | -2.20 dB |
| Placebo | 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 | Subject 4: left eye, Baseline PMD | -2.36 dB |
| Placebo | 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 | Subject 4: left eye, Week 24 PMD | -1.60 dB |
Secondary
Headache Severity
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
Time frame: Baseline to Week 24
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Presendin | Headache Severity | Subject 1 baseline (5 days) | 6 score on a scale |
| Presendin | Headache Severity | Subject 1 28-day period 6 (14 days) | 4 score on a scale |
| Presendin | Headache Severity | Subject 2 Baseline (5 days) | 3 score on a scale |
| Presendin | Headache Severity | Subject 2 28-day period 6 (3 days) | 4 score on a scale |
| Presendin | Headache Severity | Subject 4 Baseline (5 days) | 5 score on a scale |
| Presendin | Headache Severity | Subject 4 28-day period 4 (11 days) | 7 score on a scale |
| Presendin | Headache Severity | Subject 5 Baseline (1 day) | NA score on a scale |
| Presendin | Headache Severity | Subject 5 28-day period 4 (2 days) | 3 score on a scale |
| Presendin | Headache Severity | Subject 9 Baseline (5 days) | 4 score on a scale |
| Presendin | Headache Severity | Subject 9 28-day period 6 (11 days) | 1 score on a scale |
| Presendin | Headache Severity | Subject 10 Baseline (5 days) | 7 score on a scale |
| Presendin | Headache Severity | Subject 10 28-day period 4 (8 days) | 6 score on a scale |
| Presendin | Headache Severity | Subject 12 Baseline (4 days) | NA score on a scale |
| Presendin | Headache Severity | Subject 12 28-day period 1 (25 days) | 6 score on a scale |
| Presendin | Headache Severity | Subject 14 28-day period 3 (1 day) | 3 score on a scale |
| Placebo | Headache Severity | Subject 3 Baseline (7 days) | 4 score on a scale |
| Placebo | Headache Severity | Subject 3 28-day period 6 (9 days) | 8 score on a scale |
| Placebo | Headache Severity | Subject 11 Baseline (5 days) | 5 score on a scale |
| Placebo | Headache Severity | Subject 11 28-day period 4 (3 days) | 4 score on a scale |
| Placebo | Headache Severity | Subject 13 Baseline (6 days) | 4.5 score on a scale |
| Placebo | Headache Severity | Subject 13 28-day period 4 (2 days) | 4 score on a scale |
| Placebo | Headache Severity | Subject 6 Baseline (3 days) | NA score on a scale |
| Placebo | Headache Severity | Subject 6 28-day period 2 (5 days) | 2 score on a scale |
| Placebo | Headache Severity | Subject 7 28-day period 4 (4 days) | 2 score on a scale |
| Placebo | Headache Severity | Subject 8 Baseline (6 days) | 4.5 score on a scale |
| Placebo | Headache Severity | Subject 8 28-day period 2 (8 days) | 7 score on a scale |
Secondary
Number of MHD Responders (Defined as a ≥50% Reduction in MHD)
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.
Time frame: Baseline to Week 24
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Presendin | Number of MHD Responders (Defined as a ≥50% Reduction in MHD) | Number of responders (subjects who completed the study) | 1 Participants |
| Presendin | Number of MHD Responders (Defined as a ≥50% Reduction in MHD) | Number of responders (all subjects) | 1 Participants |
| Placebo | Number of MHD Responders (Defined as a ≥50% Reduction in MHD) | Number of responders (subjects who completed the study) | 0 Participants |
| Placebo | Number of MHD Responders (Defined as a ≥50% Reduction in MHD) | Number of responders (all subjects) | 0 Participants |
Secondary
Number of Moderate to Severe MHD
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
Time frame: Baseline to Week 24
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Presendin | Number of Moderate to Severe MHD | Subject 12 28-day period 1 (27 days) | 18.667 Monthly headache days |
| Presendin | Number of Moderate to Severe MHD | Subject 4 Baseline (5 days) | 16.8 Monthly headache days |
| Presendin | Number of Moderate to Severe MHD | Subject 4 28-day period 4 (11 days) | 28 Monthly headache days |
| Presendin | Number of Moderate to Severe MHD | Subject 5 Baseline (2 days) | NA Monthly headache days |
| Presendin | Number of Moderate to Severe MHD | Subject 5 28-day period 4 (10 days) | 0 Monthly headache days |
| Presendin | Number of Moderate to Severe MHD | Subject 9 Baseline (6 days) | 14 Monthly headache days |
| Presendin | Number of Moderate to Severe MHD | Subject 9 28-day period 6 (18 days) | 0 Monthly headache days |
| Presendin | Number of Moderate to Severe MHD | Subject 10 Baseline (7 days) | 20 Monthly headache days |
| Presendin | Number of Moderate to Severe MHD | Subject 10 28-day period 4 (12 days) | 14 Monthly headache days |
| Presendin | Number of Moderate to Severe MHD | Subject 12 Baseline (4 days) | NA Monthly headache days |
| Presendin | Number of Moderate to Severe MHD | Subject 14 Baseline (3 days) | NA Monthly headache days |
| Presendin | Number of Moderate to Severe MHD | Subject 14 28-day period 3 (10 days) | 0 Monthly headache days |
| Presendin | Number of Moderate to Severe MHD | Subject 1 Baseline (5 days) | 5.6 Monthly headache days |
| Presendin | Number of Moderate to Severe MHD | Subject 1 28-day period 6 (14 days) | 10 Monthly headache days |
| Presendin | Number of Moderate to Severe MHD | Subject 2 Baseline (7 days) | 12 Monthly headache days |
| Presendin | Number of Moderate to Severe MHD | Subject 2 28-day period 6 (24 days) | 1.167 Monthly headache days |
| Placebo | Number of Moderate to Severe MHD | Subject 13 Baseline (7 days) | 8 Monthly headache days |
| Placebo | Number of Moderate to Severe MHD | Subject 6 Baseline (4 days) | NA Monthly headache days |
| Placebo | Number of Moderate to Severe MHD | Subject 6 28-day period 2 (10 days) | 5.6 Monthly headache days |
| Placebo | Number of Moderate to Severe MHD | Subject 7 28-day period 4 (7 days) | 0 Monthly headache days |
| Placebo | Number of Moderate to Severe MHD | Subject 8 Baseline (6 days) | 9.333 Monthly headache days |
| Placebo | Number of Moderate to Severe MHD | Subject 3 Baseline (7 days) | 8 Monthly headache days |
| Placebo | Number of Moderate to Severe MHD | Subject 3 28-day period 6 (9 days) | 24.889 Monthly headache days |
| Placebo | Number of Moderate to Severe MHD | Subject 8 28-day period 2 (8 days) | 28 Monthly headache days |
| Placebo | Number of Moderate to Severe MHD | Subject 13 28-day period 4 (21 days) | 1.333 Monthly headache days |
| Placebo | Number of Moderate to Severe MHD | Subject 11 Baseline (7 days) | 4 Monthly headache days |
| Placebo | Number of Moderate to Severe MHD | Subject 11 28-day period 4 (15 days) | 0 Monthly headache days |
Secondary
Number of Moderate to Severe MHD Responders (Defined as a ≥50% Reduction in Moderate to Severe MHD)
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.
Time frame: Baseline to Week 24
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Presendin | Number of Moderate to Severe MHD Responders (Defined as a ≥50% Reduction in Moderate to Severe MHD) | Number of responders (subjects who completed the study) | 2 Participants |
| Presendin | Number of Moderate to Severe MHD Responders (Defined as a ≥50% Reduction in Moderate to Severe MHD) | Number of responders (all subjects) | 2 Participants |
| Placebo | Number of Moderate to Severe MHD Responders (Defined as a ≥50% Reduction in Moderate to Severe MHD) | Number of responders (subjects who completed the study) | 0 Participants |
| Placebo | Number of Moderate to Severe MHD Responders (Defined as a ≥50% Reduction in Moderate to Severe MHD) | Number of responders (all subjects) | 0 Participants |
Secondary
Number of Patients With Treatment Failure
Treatment failure is defined as the initiation of either medical therapy or a surgical intervention to lower ICP during the study.
Time frame: Baseline to Week 24
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Presendin | Number of Patients With Treatment Failure | Treatment failure suspected | 0 participants |
| Presendin | Number of Patients With Treatment Failure | Treatment failure confirmed | 0 participants |
| Placebo | Number of Patients With Treatment Failure | Treatment failure suspected | 1 participants |
| Placebo | Number of Patients With Treatment Failure | Treatment failure confirmed | 0 participants |
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
Time frame: Baseline to Week 24
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Presendin | Papilloedema by Change in Retinal Nerve Fibre Layer (RNFL) Thickness, With a Greater Thickness of RNFL Indicating Greater Swelling and Greater Extent of Papilloedema | Subject 1: right eye, Baseline RNFL | 115 µm |
| Presendin | Papilloedema by Change in Retinal Nerve Fibre Layer (RNFL) Thickness, With a Greater Thickness of RNFL Indicating Greater Swelling and Greater Extent of Papilloedema | Subject 1: right eye, Week 24 RNFL | 105 µm |
| Presendin | Papilloedema by Change in Retinal Nerve Fibre Layer (RNFL) Thickness, With a Greater Thickness of RNFL Indicating Greater Swelling and Greater Extent of Papilloedema | Subject 2: right eye, Baseline RNFL | 199 µm |
| Presendin | Papilloedema by Change in Retinal Nerve Fibre Layer (RNFL) Thickness, With a Greater Thickness of RNFL Indicating Greater Swelling and Greater Extent of Papilloedema | Subject 2: right eye, Week 24 RNFL | 173 µm |
| Presendin | Papilloedema by Change in Retinal Nerve Fibre Layer (RNFL) Thickness, With a Greater Thickness of RNFL Indicating Greater Swelling and Greater Extent of Papilloedema | Subject 6: right eye, Baseline RNFL | 111 µm |
| Presendin | Papilloedema by Change in Retinal Nerve Fibre Layer (RNFL) Thickness, With a Greater Thickness of RNFL Indicating Greater Swelling and Greater Extent of Papilloedema | Subject 6: right eye, Week 24 RNFL | 101 µm |
| Presendin | Papilloedema by Change in Retinal Nerve Fibre Layer (RNFL) Thickness, With a Greater Thickness of RNFL Indicating Greater Swelling and Greater Extent of Papilloedema | Subject 6: left eye, Baseline RNFL | 111 µm |
| Presendin | Papilloedema by Change in Retinal Nerve Fibre Layer (RNFL) Thickness, With a Greater Thickness of RNFL Indicating Greater Swelling and Greater Extent of Papilloedema | Subject 6: left eye, Week 24 RNFL | 105 µm |
| Presendin | Papilloedema by Change in Retinal Nerve Fibre Layer (RNFL) Thickness, With a Greater Thickness of RNFL Indicating Greater Swelling and Greater Extent of Papilloedema | Subject 8: right eye, Baseline RNFL | 81 µm |
| Presendin | Papilloedema by Change in Retinal Nerve Fibre Layer (RNFL) Thickness, With a Greater Thickness of RNFL Indicating Greater Swelling and Greater Extent of Papilloedema | Subject 8: right eye, Week 24 RNFL | 74 µm |
| Presendin | Papilloedema by Change in Retinal Nerve Fibre Layer (RNFL) Thickness, With a Greater Thickness of RNFL Indicating Greater Swelling and Greater Extent of Papilloedema | Subject 8: left eye, Baseline RNFL | 132 µm |
| Presendin | Papilloedema by Change in Retinal Nerve Fibre Layer (RNFL) Thickness, With a Greater Thickness of RNFL Indicating Greater Swelling and Greater Extent of Papilloedema | Subject 8: left eye, Week 24 RNFL | 92 µm |
| Placebo | Papilloedema by Change in Retinal Nerve Fibre Layer (RNFL) Thickness, With a Greater Thickness of RNFL Indicating Greater Swelling and Greater Extent of Papilloedema | Subject 5: right eye, Baseline RNFL | 127 µm |
| Placebo | Papilloedema by Change in Retinal Nerve Fibre Layer (RNFL) Thickness, With a Greater Thickness of RNFL Indicating Greater Swelling and Greater Extent of Papilloedema | Subject 5: right eye, Week 24 RNFL | 119 µm |
| Placebo | Papilloedema by Change in Retinal Nerve Fibre Layer (RNFL) Thickness, With a Greater Thickness of RNFL Indicating Greater Swelling and Greater Extent of Papilloedema | Subject 5: left eye, Baseline RNFL | 121 µm |
| Placebo | Papilloedema by Change in Retinal Nerve Fibre Layer (RNFL) Thickness, With a Greater Thickness of RNFL Indicating Greater Swelling and Greater Extent of Papilloedema | Subject 5: left eye, Week 24 RNFL | 126 µm |
| Placebo | Papilloedema by Change in Retinal Nerve Fibre Layer (RNFL) Thickness, With a Greater Thickness of RNFL Indicating Greater Swelling and Greater Extent of Papilloedema | Subject 7: right eye, Baseline RNFL | 114 µm |
| Placebo | Papilloedema by Change in Retinal Nerve Fibre Layer (RNFL) Thickness, With a Greater Thickness of RNFL Indicating Greater Swelling and Greater Extent of Papilloedema | Subject 7: right eye, Week 24 RNFL | 107 µm |
| Placebo | Papilloedema by Change in Retinal Nerve Fibre Layer (RNFL) Thickness, With a Greater Thickness of RNFL Indicating Greater Swelling and Greater Extent of Papilloedema | Subject 7: left eye, Baseline RNFL | 119 µm |
| Placebo | Papilloedema by Change in Retinal Nerve Fibre Layer (RNFL) Thickness, With a Greater Thickness of RNFL Indicating Greater Swelling and Greater Extent of Papilloedema | Subject 7: left eye, Week 24 RNFL | 111 µm |
| Placebo | Papilloedema by Change in Retinal Nerve Fibre Layer (RNFL) Thickness, With a Greater Thickness of RNFL Indicating Greater Swelling and Greater Extent of Papilloedema | Subject 3: right eye, Baseline RNFL | 140 µm |
| Placebo | Papilloedema by Change in Retinal Nerve Fibre Layer (RNFL) Thickness, With a Greater Thickness of RNFL Indicating Greater Swelling and Greater Extent of Papilloedema | Subject 3: right eye, Week 24 RNFL | 155 µm |
| Placebo | Papilloedema by Change in Retinal Nerve Fibre Layer (RNFL) Thickness, With a Greater Thickness of RNFL Indicating Greater Swelling and Greater Extent of Papilloedema | Subject 3: left eye, Baseline RNFL | 114 µm |
| Placebo | Papilloedema by Change in Retinal Nerve Fibre Layer (RNFL) Thickness, With a Greater Thickness of RNFL Indicating Greater Swelling and Greater Extent of Papilloedema | Subject 3: left eye, Week 24 RNFL | 122 µm |
| Placebo | Papilloedema by Change in Retinal Nerve Fibre Layer (RNFL) Thickness, With a Greater Thickness of RNFL Indicating Greater Swelling and Greater Extent of Papilloedema | Subject 4: right eye, Baseline RNFL | 432 µm |
| Placebo | Papilloedema by Change in Retinal Nerve Fibre Layer (RNFL) Thickness, With a Greater Thickness of RNFL Indicating Greater Swelling and Greater Extent of Papilloedema | Subject 4: right eye, Week 24 RNFL | 372 µm |
| Placebo | Papilloedema by Change in Retinal Nerve Fibre Layer (RNFL) Thickness, With a Greater Thickness of RNFL Indicating Greater Swelling and Greater Extent of Papilloedema | Subject 4: left eye, Baseline RNFL | 358 µm |
| Placebo | Papilloedema by Change in Retinal Nerve Fibre Layer (RNFL) Thickness, With a Greater Thickness of RNFL Indicating Greater Swelling and Greater Extent of Papilloedema | Subject 4: left eye, Week 24 RNFL | 317 µm |
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
Time frame: Baseline to Week 24
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Presendin | 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 | Subject 1, right eye | -6.67 percentage change |
| Presendin | 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 | Subject 6, left eye | -8.10 percentage change |
| Presendin | 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 | Subject 2, right eye | 18.64 percentage change |
| Presendin | 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 | Subject 6, right eye | -11.87 percentage change |
| Placebo | 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 | Subject 4, left eye | 2.35 percentage change |
| Placebo | 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 | Subject 5, right eye | -1.53 percentage change |
| Placebo | 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 | Subject 7, right eye | -2.82 percentage change |
| Placebo | 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 | Subject 5, left eye | 11.41 percentage change |
| Placebo | 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 | Subject 7, left eye | -6.46 percentage change |
| Placebo | 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 | Subject 3, right eye | 8.61 percentage change |
| Placebo | 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 | Subject 3, left eye | 2.61 percentage change |
| Placebo | 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 | Subject 4, right eye | 0.77 percentage change |
Secondary
The Number of Monthly Headache Days (MHD)
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
Time frame: Baseline to Week 24
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Presendin | The Number of Monthly Headache Days (MHD) | Subject 1 Baseline (5 days) | 28 Monthly headache days |
| Presendin | The Number of Monthly Headache Days (MHD) | Subject 1 28-day period 6 (14 days) | 28 Monthly headache days |
| Presendin | The Number of Monthly Headache Days (MHD) | Subject 2 Baseline (7 days) | 20 Monthly headache days |
| Presendin | The Number of Monthly Headache Days (MHD) | Subject 2 28-day period 6 (24 days) | 3.5 Monthly headache days |
| Presendin | The Number of Monthly Headache Days (MHD) | Subject 4 28-day period 4 (11 days) | 28 Monthly headache days |
| Presendin | The Number of Monthly Headache Days (MHD) | Subject 5 Baseline (2 days) | NA Monthly headache days |
| Presendin | The Number of Monthly Headache Days (MHD) | Subject 5 28-day period 4 (10 days) | 5.6 Monthly headache days |
| Presendin | The Number of Monthly Headache Days (MHD) | Subject 9 Baseline (6 days) | 14 Monthly headache days |
| Presendin | The Number of Monthly Headache Days (MHD) | Subject 9 28-day period 6 (18 days) | 9.33 Monthly headache days |
| Presendin | The Number of Monthly Headache Days (MHD) | Subject 10 Baseline (7 days) | 20 Monthly headache days |
| Presendin | The Number of Monthly Headache Days (MHD) | Subject 10 28-day period 4 (12 days) | 18.67 Monthly headache days |
| Presendin | The Number of Monthly Headache Days (MHD) | Subject 12 Baseline (4 days) | NA Monthly headache days |
| Presendin | The Number of Monthly Headache Days (MHD) | Subject 12 28-day period 1(27 days) | 23.85 Monthly headache days |
| Presendin | The Number of Monthly Headache Days (MHD) | Subject 14 Baseline (3 days) | NA Monthly headache days |
| Presendin | The Number of Monthly Headache Days (MHD) | Subject 14 28-day period 3 (10 days) | 0 Monthly headache days |
| Presendin | The Number of Monthly Headache Days (MHD) | Subject 4 Baseline (5 days) | 28 Monthly headache days |
| Placebo | The Number of Monthly Headache Days (MHD) | Subject 3 Baseline (7 days) | 28 Monthly headache days |
| Placebo | The Number of Monthly Headache Days (MHD) | Subject 3 28-day period 6 (9 days) | 28 Monthly headache days |
| Placebo | The Number of Monthly Headache Days (MHD) | Subject 11 Baseline (7 days) | 20 Monthly headache days |
| Placebo | The Number of Monthly Headache Days (MHD) | Subject 11 28-day period 4 (15 days) | 5.6 Monthly headache days |
| Placebo | The Number of Monthly Headache Days (MHD) | Subject 13 Baseline (7 days) | 20 Monthly headache days |
| Placebo | The Number of Monthly Headache Days (MHD) | Subject 13 28-day period 4 (21 days) | 1.3 Monthly headache days |
| Placebo | The Number of Monthly Headache Days (MHD) | Subject 6 Baseline (4 days) | NA Monthly headache days |
| Placebo | The Number of Monthly Headache Days (MHD) | Subject 6 28-day period 2 (10 days) | 11.2 Monthly headache days |
| Placebo | The Number of Monthly Headache Days (MHD) | Subject 7 28-day period 4 (7 days) | 16 Monthly headache days |
| Placebo | The Number of Monthly Headache Days (MHD) | Subject 8 Baseline (6 days) | 23.33 Monthly headache days |
| Placebo | The Number of Monthly Headache Days (MHD) | Subject 8 28-day period 2 (8 days) | 28 Monthly headache days |
Secondary
Use of Acute Headache Analgesic Medications (Acute Headache Analgesics in Days Per Month)
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
Time frame: Baseline to Week 24
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Presendin | Use of Acute Headache Analgesic Medications (Acute Headache Analgesics in Days Per Month) | Subject 1 Baseline (5 days) | 0 Acute headache analgesics days per month |
| Presendin | Use of Acute Headache Analgesic Medications (Acute Headache Analgesics in Days Per Month) | Subject 1 28-day period 6 (14 days) | 6 Acute headache analgesics days per month |
| Presendin | Use of Acute Headache Analgesic Medications (Acute Headache Analgesics in Days Per Month) | Subject 2 Baseline (5 days) | 16.8 Acute headache analgesics days per month |
| Presendin | Use of Acute Headache Analgesic Medications (Acute Headache Analgesics in Days Per Month) | Subject 2 28-day period 6 (3 days) | 0 Acute headache analgesics days per month |
| Presendin | Use of Acute Headache Analgesic Medications (Acute Headache Analgesics in Days Per Month) | Subject 4 Baseline (5 days) | 0 Acute headache analgesics days per month |
| Presendin | Use of Acute Headache Analgesic Medications (Acute Headache Analgesics in Days Per Month) | Subject 4 28-day period 4 (11 days) | 0 Acute headache analgesics days per month |
| Presendin | Use of Acute Headache Analgesic Medications (Acute Headache Analgesics in Days Per Month) | Subject 5 Baseline (1 day) | NA Acute headache analgesics days per month |
| Presendin | Use of Acute Headache Analgesic Medications (Acute Headache Analgesics in Days Per Month) | Subject 5 28-day period 4 (2 days) | 0 Acute headache analgesics days per month |
| Presendin | Use of Acute Headache Analgesic Medications (Acute Headache Analgesics in Days Per Month) | Subject 9 Baseline (5 days) | 16.8 Acute headache analgesics days per month |
| Presendin | Use of Acute Headache Analgesic Medications (Acute Headache Analgesics in Days Per Month) | Subject 9 28-day period 6 (11 days) | 0 Acute headache analgesics days per month |
| Presendin | Use of Acute Headache Analgesic Medications (Acute Headache Analgesics in Days Per Month) | Subject 10 Baseline (5 days) | 11.2 Acute headache analgesics days per month |
| Presendin | Use of Acute Headache Analgesic Medications (Acute Headache Analgesics in Days Per Month) | Subject 10 28-day period 4 (8 days) | 14 Acute headache analgesics days per month |
| Presendin | Use of Acute Headache Analgesic Medications (Acute Headache Analgesics in Days Per Month) | Subject 12 Baseline (4 days) | NA Acute headache analgesics days per month |
| Presendin | Use of Acute Headache Analgesic Medications (Acute Headache Analgesics in Days Per Month) | Subject 12 28-day period 1 (25 days) | 13.44 Acute headache analgesics days per month |
| Presendin | Use of Acute Headache Analgesic Medications (Acute Headache Analgesics in Days Per Month) | Subject 14 28-day period 3 (1 day) | 0 Acute headache analgesics days per month |
| Placebo | Use of Acute Headache Analgesic Medications (Acute Headache Analgesics in Days Per Month) | Subject 3 Baseline (7 days) | 4 Acute headache analgesics days per month |
| Placebo | Use of Acute Headache Analgesic Medications (Acute Headache Analgesics in Days Per Month) | Subject 3 28-day period 6 (9 days) | 24.89 Acute headache analgesics days per month |
| Placebo | Use of Acute Headache Analgesic Medications (Acute Headache Analgesics in Days Per Month) | Subject 11 Baseline (5 days) | 5.6 Acute headache analgesics days per month |
| Placebo | Use of Acute Headache Analgesic Medications (Acute Headache Analgesics in Days Per Month) | Subject 11 28-day period 4 (3 days) | 0 Acute headache analgesics days per month |
| Placebo | Use of Acute Headache Analgesic Medications (Acute Headache Analgesics in Days Per Month) | Subject 13 Baseline (6 days) | 9.333 Acute headache analgesics days per month |
| Placebo | Use of Acute Headache Analgesic Medications (Acute Headache Analgesics in Days Per Month) | Subject 13 28-day period 4 (2 days) | 14 Acute headache analgesics days per month |
| Placebo | Use of Acute Headache Analgesic Medications (Acute Headache Analgesics in Days Per Month) | Subject 6 Baseline (3 days) | NA Acute headache analgesics days per month |
| Placebo | Use of Acute Headache Analgesic Medications (Acute Headache Analgesics in Days Per Month) | Subject 6 28-day period 2 (5 days) | 11.2 Acute headache analgesics days per month |
| Placebo | Use of Acute Headache Analgesic Medications (Acute Headache Analgesics in Days Per Month) | Subject 7 28-day period 4 (4 days) | 0 Acute headache analgesics days per month |
| Placebo | Use of Acute Headache Analgesic Medications (Acute Headache Analgesics in Days Per Month) | Subject 8 Baseline (6 days) | 0 Acute headache analgesics days per month |
| Placebo | Use of Acute Headache Analgesic Medications (Acute Headache Analgesics in Days Per Month) | Subject 8 28-day period 2 (8 days) | 10.5 Acute headache analgesics days per month |
Secondary
Visual Acuity
Corrected visual acuity will be recorded using a Logarithm of the Minimum Angle of Resolution (LogMAR) scoring chart, with a range of -0.3 to 1.00, where a lower score indicates better visual acuity.
Time frame: Baseline to Week 24
Population: Data were not collected from subjects with qualifying study eyes for this endpoint.