Clinical Trial Results:
SFX-01 AFTER SUBARACHNOID HAEMORRHAGE - SAS
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Summary
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EudraCT number |
2014-003284-38 |
Trial protocol |
GB |
Global end of trial date |
06 Sep 2019
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Results information
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Results version number |
v1(current) |
This version publication date |
02 Jun 2021
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First version publication date |
02 Jun 2021
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
EVG001SAH
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02614742 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Evgen Pharma plc
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Sponsor organisation address |
Suite 24G13, Alderley Park, Alderley Edge, United Kingdom, SK10 4TG
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Public contact |
Clinical Trials Information, Evgen Pharma plc, 44 1625466591, randd@evgen.com
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Scientific contact |
Clinical Trials Information, Evgen Pharma plc, 44 1625466591, randd@evgen.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
31 Jan 2020
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
06 Sep 2019
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To evaluate the safety of up to 28 days of SFX-01 dosed at up to 600mg (92mg sulforaphane [SFN]) per day vs placebo, following spontaneous aneurysmal subarachnoid haemorrhage (SAH) and given in addition to Nimodipine as standard of care.
To determine if a minimum of 7 days treatment with SFX-01 vs placebo reduces Middle Cerebral Artery (MCA) peak flow velocity following SAH, in addition to Nimodipine as standard of care.
To determine the levels of SFN and principal metabolites in Cerebrospinal Fluid (CSF) after treatment with SFX-01 vs placebo following SAH.
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Protection of trial subjects |
All patients admitted to study sites with a diagnosis of spontaneous SAH were assessed by the hospital study team against the protocol inclusion and exclusion criteria. Identified subjects who fulfilled the criteria were subsequently approached by a member of the research team, who would seek to obtain consent from the subject, or in the case of adults lacking capacity, the Personal Legal Representative, if available or if not, a Professional Legal representative.
The Patient Information was given to the subject, Personal Legal Representative or Professional Legal representative and they were given sufficient time to review and discuss material in order to make a decision to participate in the study or not.
Patients and/or Personal Legal Representative had the right to discontinue trial medication at any time and for any reason. The Investigator also had the right to discontinue trial medication if they felt that treatment was no longer appropriate, if in their opinion the patient’s clinical condition was worsening or for safety (adverse events).
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Background therapy |
The aims of the study were to assess the safety and tolerability of SFX-01 vs placebo, and if the addition of SFX-01 to nimodipine as standard of care could improve outcomes and reduce the long-term complications of spontaneous aneurysmal SAH, such as Delayed Cerebral Ischaemia (DCI), as reflected by Trans-Cranial Doppler (TCD) readings, other neurological and quality of life rating scales. | ||
Evidence for comparator |
The only effective approved treatment to reduce morbidity from SAH is nimodipine. However, its effects are small and despite its use, poor outcomes remain a significant problem as evidenced by contemporary outcome data since its introduction. Moreover, even in survivors conventionally considered to have made a good recovery, neurocognitive deficits are common leading to extensive problems with social reintegration and functioning in the workplace. In this study, SFX-01/placebo was used in conjunction with nimodipine as per routine clinical care along with other standard supportive measures as required. The placebo arm therefore represents standard care alone. The study was randomised in order to prevent bias in the allocation of treatment and to ensure the comparability of baseline characteristics between the treatment groups. In order to prevent bias in the conduct of the clinical assessments, the study was double blind, so that neither the investigators nor the patients knew whether the patient was receiving active treatment or placebo. | ||
Actual start date of recruitment |
14 Apr 2016
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United Kingdom: 105
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Worldwide total number of subjects |
105
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EEA total number of subjects |
105
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
90
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From 65 to 84 years |
15
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85 years and over |
0
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Recruitment
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Recruitment details |
All patients admitted to study sites with a diagnosis of spontaneous SAH were assessed by the hospital study team against the protocol inclusion and exclusion criteria. Identified subjects who fulfilled the criteria were subsequently approached by a member of the research team, who would seek to obtain consent for subject to participate. | ||||||||||||||||||||||||||||||
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Pre-assignment
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Screening details |
Subjects providing consent to participate underwent a screening assessment within 48h of ictus and prior to first dosing with SFX-01/placebo. | ||||||||||||||||||||||||||||||
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Period 1
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Period 1 title |
Treatment Period (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||||||||||||||||||||
Roles blinded |
Subject, Investigator, Monitor, Data analyst, Carer, Assessor | ||||||||||||||||||||||||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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SFX-01 | ||||||||||||||||||||||||||||||
Arm description |
- | ||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||
Investigational medicinal product name |
SFX-01 300mg capsules
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Investigational medicinal product code |
SFX-01
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Other name |
Sulforadex 300mg capsules
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Pharmaceutical forms |
Capsule, hard
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Routes of administration |
Oral use
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Dosage and administration details |
SFX-01 (300 mg) or matching placebo were taken orally as capsules or as a suspension via a nasogastric tube (NG) twice-daily (morning and evening) for up to 28 days.
Patients were randomised within 48 hours of ictus to one of the IMP treatment groups by allocation of the appropriate, numbered, treatment pack. The treatment packs were pre-numbered according to a block balanced randomisation code. Patients were not discharged with the investigational medicine until 20 patients had completed dosing up to day 7 post ictus and the DSMB had issued their positive decision regarding dosing after discharge from tertiary care. After 35 patients had been treated in the study, the DSMB mandated a stratified randomisation schedule for further enrolment, with the strata defined by site and by baseline severity defined by WFNS score of 1- 3 or 4 & 5.
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Arm title
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Placebo | ||||||||||||||||||||||||||||||
Arm description |
- | ||||||||||||||||||||||||||||||
Arm type |
Placebo | ||||||||||||||||||||||||||||||
Investigational medicinal product name |
Placebo to match SFX-01 300mg capsules
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Investigational medicinal product code |
Placebo for SFX-01
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Other name |
Placebo 300mg capsules
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Pharmaceutical forms |
Capsule, hard
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Routes of administration |
Oral use
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Dosage and administration details |
SFX-01 (300 mg) or matching placebo were taken orally as capsules or as a suspension via a nasogastric tube (NG) twice-daily (morning and evening) for up to 28 days.
Patients were randomised within 48 hours of ictus to one of the IMP treatment groups by allocation of the appropriate, numbered, treatment pack. The treatment packs were pre-numbered according to a block balanced randomisation code. Patients were not discharged with the investigational medicine until 20 patients had completed dosing up to day 7 post ictus and the DSMB had issued their positive decision regarding dosing after discharge from tertiary care. After 35 patients had been treated in the study, the DSMB mandated a stratified randomisation schedule for further enrolment, with the strata defined by site and by baseline severity defined by WFNS score of 1- 3 or 4 & 5.
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Baseline characteristics reporting groups
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Reporting group title |
Treatment Period
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
Safety population
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Subject analysis set type |
Safety analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
All randomised patients who had taken at least one dose of study medication. This population was applied to all safety endpoints and pharmacokinetic data recorded in all patients.
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Subject analysis set title |
Intent-To-Treat (ITT) population
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Subject analysis set type |
Intention-to-treat | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
All randomised patients who received at least one dose of study medication. Analyses of the TCD, mRS and GOSE endpoints were performed in both the PP and ITT populations with the PP population considered as primary. Other endpoints were initially analysed in the PP population and were to be analysed in the ITT population only if there was a meaningful discrepancy in the results of endpoints analysed in both populations (which there was not).
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Subject analysis set title |
Per Protocol (PP) population
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Subject analysis set type |
Per protocol | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
The PP population consisted of all patients who received at least 10 doses of randomised treatment within the first 7 days of the first dose of study medication. However, there were 9 patients who were either known to have had (n=2), potentially had (n=3), or were associated with patients who had (n=4), a discrepancy in dispensing of randomised therapy and were therefore were excluded from the PP population. Analyses of the TCD, mRS and GOSE endpoints were performed in both the PP and ITT populations with the PP population considered as primary. Other endpoints were initially analysed in the PP population and were to be analysed in the ITT population only if there was a meaningful discrepancy in the results of endpoints analysed in both populations (which there was not).
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End points reporting groups
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Reporting group title |
SFX-01
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Reporting group description |
- | ||
Reporting group title |
Placebo
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Reporting group description |
- | ||
Subject analysis set title |
Safety population
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
All randomised patients who had taken at least one dose of study medication. This population was applied to all safety endpoints and pharmacokinetic data recorded in all patients.
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Subject analysis set title |
Intent-To-Treat (ITT) population
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Subject analysis set type |
Intention-to-treat | ||
Subject analysis set description |
All randomised patients who received at least one dose of study medication. Analyses of the TCD, mRS and GOSE endpoints were performed in both the PP and ITT populations with the PP population considered as primary. Other endpoints were initially analysed in the PP population and were to be analysed in the ITT population only if there was a meaningful discrepancy in the results of endpoints analysed in both populations (which there was not).
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Subject analysis set title |
Per Protocol (PP) population
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
The PP population consisted of all patients who received at least 10 doses of randomised treatment within the first 7 days of the first dose of study medication. However, there were 9 patients who were either known to have had (n=2), potentially had (n=3), or were associated with patients who had (n=4), a discrepancy in dispensing of randomised therapy and were therefore were excluded from the PP population. Analyses of the TCD, mRS and GOSE endpoints were performed in both the PP and ITT populations with the PP population considered as primary. Other endpoints were initially analysed in the PP population and were to be analysed in the ITT population only if there was a meaningful discrepancy in the results of endpoints analysed in both populations (which there was not).
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End point title |
Per-protocol (PP) Maximum post-dose TCD middle cerebral artery (MCA) mean flow velocity (MFV) | ||||||||||||
End point description |
Per Protocol population - primary endpoint analysis.
TCDs were performed by an experienced member of the medical physics or neuro-intensive care team, or other appropriately trained personnel who had otherwise carried out the same procedure on the same group of patients.
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End point type |
Primary
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End point timeframe |
An initial TCD reading was to be taken within 48h of ictus. TCD readings were then to be taken 3 times a week on alternate days (according to standard care procedures) until at least until Day 7 post ictus and then until no longer clinically indicated.
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Statistical analysis title |
ANOVA for the maximum post-dose TCD MCA-MFV - PP | ||||||||||||
Comparison groups |
SFX-01 v Placebo
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Number of subjects included in analysis |
90
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.5448 | ||||||||||||
Method |
ANOVA | ||||||||||||
Parameter type |
Ratio of GLS means | ||||||||||||
Point estimate |
1.0458
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
0.9032 | ||||||||||||
upper limit |
1.2108 | ||||||||||||
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End point title |
Per-protocol (PP) - Modified Rankin Scale score (mRS) - Day 90 | ||||||||||||||||||||||||||||||
End point description |
The mRS is widely used as a functional outcome measure in stroke. The purpose of the Rankin Focused Assessment (RFA) is to assign patients to mRS grades in a systematic way. The assessment consists of sections corresponding to levels of disability among stroke survivors on the mRS.
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End point type |
Secondary
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End point timeframe |
The Modified Rankin Scale (mRS) was recorded at Day 7, 28, 90 and 180 post-ictus, as well as at discharge.
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Statistical analysis title |
PP - mRS Day 90 proportional odds analysis | ||||||||||||||||||||||||||||||
Comparison groups |
Placebo v SFX-01
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Number of subjects included in analysis |
90
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||||||||||||||||
P-value |
= 0.2675 | ||||||||||||||||||||||||||||||
Method |
Regression, Logistic | ||||||||||||||||||||||||||||||
Parameter type |
Odds ratio (OR) | ||||||||||||||||||||||||||||||
Point estimate |
1.598
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Confidence interval |
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level |
95% | ||||||||||||||||||||||||||||||
sides |
2-sided
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lower limit |
0.699 | ||||||||||||||||||||||||||||||
upper limit |
3.704 | ||||||||||||||||||||||||||||||
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End point title |
Per-protocol (PP) - Glasgow Outcome Score Extended (GOSE) - Day 90 | |||||||||||||||||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
The Glasgow Outcome Scale Extended (GOSE) was recorded at Day 28, 90 and 180 post-ictus.
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Statistical analysis title |
PP - GOSE Day 90 proportional odds analysis | |||||||||||||||||||||||||||||||||
Comparison groups |
SFX-01 v Placebo
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Number of subjects included in analysis |
90
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||||||||||||||||||||||||||
P-value |
= 0.8341 | |||||||||||||||||||||||||||||||||
Method |
Regression, Logistic | |||||||||||||||||||||||||||||||||
Parameter type |
Odds ratio (OR) | |||||||||||||||||||||||||||||||||
Point estimate |
0.917
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Confidence interval |
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level |
95% | |||||||||||||||||||||||||||||||||
sides |
2-sided
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lower limit |
0.406 | |||||||||||||||||||||||||||||||||
upper limit |
2.068 | |||||||||||||||||||||||||||||||||
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End point title |
Per-protocol (PP) - Subarachnoid haemorrhage outcomes tool (SAHOT) - Day 90 | ||||||||||||||||||||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
The Subarachnoid Haemorrhage Outcomes Tool (SAHOT) was recorded at Day 28, 90 and 180 post-ictus.
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Statistical analysis title |
PP - SAHOT Day 90 proportional odds analysis | ||||||||||||||||||||||||||||||||||||
Comparison groups |
SFX-01 v Placebo
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Number of subjects included in analysis |
90
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||||||||||||||||||||||
P-value |
= 0.626 | ||||||||||||||||||||||||||||||||||||
Method |
Regression, Logistic | ||||||||||||||||||||||||||||||||||||
Parameter type |
Odds ratio (OR) | ||||||||||||||||||||||||||||||||||||
Point estimate |
0.811
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Confidence interval |
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level |
95% | ||||||||||||||||||||||||||||||||||||
sides |
2-sided
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lower limit |
0.348 | ||||||||||||||||||||||||||||||||||||
upper limit |
1.882 | ||||||||||||||||||||||||||||||||||||
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End point title |
Per-protocol (PP) - Incidence of Delayed Cerebral Ischaemia (DCI) | |||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Delayed Cerebral Ischaemia (DCI) was defined as a new focal deficit or reduction in Glasgow Coma Scale ≥2 if not explained by other causes during the study (i.e. re-bleed, hydrocephalus, seizure, meningitis, sepsis or hyponatremia).
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Statistical analysis title |
PP - incidence of DCI proportional odds analysis | |||||||||||||||
Comparison groups |
SFX-01 v Placebo
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Number of subjects included in analysis |
90
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||||||||
P-value |
= 0.3895 | |||||||||||||||
Method |
Regression, Logistic | |||||||||||||||
Parameter type |
Odds ratio (OR) | |||||||||||||||
Point estimate |
1.728
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Confidence interval |
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level |
95% | |||||||||||||||
sides |
2-sided
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lower limit |
0.5 | |||||||||||||||
upper limit |
6.463 | |||||||||||||||
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End point title |
Per-protocol (PP) - Length of acute hospital stay | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Length of acute hospital stay was the time from ictus to discharge
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Statistical analysis title |
PP-acute hospital stay proportional odds analysis | ||||||||||||
Comparison groups |
SFX-01 v Placebo
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Number of subjects included in analysis |
90
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.6448 | ||||||||||||
Method |
Regression, Cox | ||||||||||||
Parameter type |
Cox proportional hazard | ||||||||||||
Point estimate |
0.9
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
0.574 | ||||||||||||
upper limit |
1.411 | ||||||||||||
|
|||||||||||||
End point title |
Intent-to-treat (ITT) - Maximum post-dose TCD middle cerebral artery (MCA) mean flow velocity (MFV) | ||||||||||||
End point description |
Intent to treat population - primary endpoint analysis.
TCDs were performed by an experienced member of the medical physics or neuro-intensive care team, or other appropriately trained personnel who had otherwise carried out the same procedure on the same group of patients.
|
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End point type |
Other pre-specified
|
||||||||||||
End point timeframe |
An initial TCD reading was to be taken within 48 hours of ictus. Subsequent TCD readings were then taken three times a week on alternate days (according to standard care procedures). They were performed at least until Day 7 post ictus (± 1d) and then un
|
||||||||||||
|
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Statistical analysis title |
ANOVA for the maximum post-dose TCD MCA-MFV - ITT | ||||||||||||
Comparison groups |
Placebo v SFX-01
|
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Number of subjects included in analysis |
105
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.2738 | ||||||||||||
Method |
ANOVA | ||||||||||||
Parameter type |
Ratio of GLS means | ||||||||||||
Point estimate |
1.0803
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
0.9398 | ||||||||||||
upper limit |
1.2417 | ||||||||||||
|
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End point title |
Per-protocol (PP) Mean of 3 largest post-dose TCD middle cerebral artery (MCA) mean flow velocity (MFV) | ||||||||||||
End point description |
Per Protocol population - supplementary TCD endpoint analysis.
TCDs were performed by an experienced member of the medical physics or neuro-intensive care team, or other appropriately trained personnel who had otherwise carried out the same procedure on the same group of patients.
|
||||||||||||
End point type |
Other pre-specified
|
||||||||||||
End point timeframe |
An initial TCD reading was to be taken within 48h of ictus. TCD readings were then to be taken 3 times a week on alternate days (according to standard care procedures) until at least until Day 7 post ictus and then until no longer clinically indicated.
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
ANOVA mean of 3 largest post-dose TCD MCA-MFV - PP | ||||||||||||
Comparison groups |
SFX-01 v Placebo
|
||||||||||||
Number of subjects included in analysis |
90
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.7077 | ||||||||||||
Method |
ANOVA | ||||||||||||
Parameter type |
Ratio of GLS means | ||||||||||||
Point estimate |
1.0282
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
0.8874 | ||||||||||||
upper limit |
1.1915 | ||||||||||||
|
|||||||||||||
End point title |
Per protocol (PP) - Maximum post-dose TCD Lindergaard ratio | ||||||||||||
End point description |
Per Protocol population - supplementary TCD endpoint analysis.
TCDs were performed by an experienced member of the medical physics or neuro-intensive care team, or other appropriately trained personnel who had otherwise carried out the same procedure on the same group of patients.
|
||||||||||||
End point type |
Other pre-specified
|
||||||||||||
End point timeframe |
An initial TCD reading was to be taken within 48h of ictus. TCD readings were then to be taken 3 times a week on alternate days (according to standard care procedures) until at least until Day 7 post ictus and then until no longer clinically indicated.
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
ANOVA Maximum post-dose Lindergaard Ratio - PP | ||||||||||||
Comparison groups |
SFX-01 v Placebo
|
||||||||||||
Number of subjects included in analysis |
90
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.4609 | ||||||||||||
Method |
ANOVA | ||||||||||||
Parameter type |
Ratio of GLS means | ||||||||||||
Point estimate |
1.0606
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
0.9053 | ||||||||||||
upper limit |
1.2425 | ||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
AEs/SAEs were to be reported from the time a signed patient informed consent form was obtained and pre-first dose study treatment assessments performed until the end of study/early termination.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
20
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Reporting groups
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Reporting group title |
Safety population
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Reporting group description |
All randomised patients who had taken at least one dose of study medication (SFX-01 or placebo). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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|
|||
Substantial protocol amendments (globally) |
|||
| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
||
22 Mar 2016 |
Various protocol clarifications and administrative updates. |
||
23 Aug 2016 |
Temporary halt to patient recruitment was required because of a short term interruption in the SFX-01/placebo IMP supply to the study site. |
||
10 Feb 2017 |
Additional of new study site/investigator and various protocol clarifications regarding alternate day timing of TCD and other assessments post-dose, removal of requirement for fasting safety bloods (as not practical), removal of urine dipstick testing and clarification of use of routine safety test results for the study. |
||
17 Mar 2017 |
A temporary halt of trial was put in place to allow permanent corrective and preventive actions to be implemented at site before restart, following investigation into potential SFX-01/placebo dispensing errors for 9 patients, who were either known to have had (n=2), potentially had (n=3), or were associated with patients who had (n=4), a discrepancy in dispensing of randomised therapy; these patients were excluded from the PP analysis population. |
||
27 Jun 2017 |
Update to SFX-01/placebo study drug kits/bottle labelling and submission of IMPD v8. |
||
10 Aug 2017 |
Restart of study after temporary halt. |
||
25 Sep 2017 |
Submission of SFX-01 Investigator's Brochure v7. |
||
04 Jan 2018 |
Submission of study Protocol v6 and revised SFX-01/placebo study drug labels. |
||
Interruptions (globally) |
|||
| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| This summary provides an overview of the key study results. | |||
