Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43881   clinical trials with a EudraCT protocol, of which   7295   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A Double-Blind, Placebo-Controlled 16-Week Study of the Cognitive Effects of the Oral P38 Alpha Kinase Inhibitor Neflamapimod in Dementia with Lewy Bodies (DLB)

    Summary
    EudraCT number
    		 2019-001566-15
    Trial protocol
    		 NL  
    Global end of trial date
    14 Jul 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Jul 2021
    First version publication date
    16 Jul 2021
    Other versions
    Summary report(s)
    		 EIP19-NFD-501 CSR Synopsis

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    EIP19-NFD-501
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04001517
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Worldwide Clinical Trials Limited
    Sponsor organisation address
    Technology Drive, Beeston, Nottingham, United Kingdom, NG9 1LA
    Public contact
    Project Management, Worldwide Clinical Trials Limited, +44 1159567711,
    Scientific contact
    Project Management, Worldwide Clinical Trials Limited, +44 1159567711,
    Sponsor organisation name
    EIP Pharma
    Sponsor organisation address
    120 St. James Avenue, Suite 6017, Boston, United States, 02116
    Public contact
    Dr. John Alam, EIP Pharma, 1 617-669-8426, johnjalam@gmail.com
    Scientific contact
    Dr. John Alam, EIP Pharma, 1 617-669-8426, johnjalam@gmail.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    30 Jun 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Jun 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Jul 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to evaluate the effect of neflamapimod on cognitive function as assessed in a study-specific Neuropsychological Test Battery (NTB) comprised of: •Cogstate Detection test (DET) •Cogstate Identification test (IDN) •Cogstate One Card Learning test (OCL) •Cogstate One Back test (ONB) •Letter Fluency Test •Category Fluency Test (CFT)
    Protection of trial subjects
    No trial-related activities were performed until the subject had been consented and given an opportunity to ask questions and discuss the study with family/caregiver.
    Background therapy
    		 All subjects were required to be receiving cholinesterase inhibitor therapy for at least 3 months and have been on a stable dose for at least 6 weeks at the time of randomization.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 Jul 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 13
    Country: Number of subjects enrolled
    United States: 78
    Worldwide total number of subjects
    91
    EEA total number of subjects
    13
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    11
    From 65 to 84 years
    77
    85 years and over
    3

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Active recruitment and screening began 12Jul2019. The first subject was screened on 29Aug2019 and the first subject was enrolled on 30Sep2019. The last subject was screened 14Feb2020 and the last subject was enrolled 06Mar2020. Participating countries were the United States and Netherlands.

    Pre-assignment
    Screening details
    		 125 subjects were screened. 33 were determined ineligible for the study therefore deemed screen failures: 12 due to not meeting MMSE inclusion criteria, 7 due to negative DaTscan, 4 withdrew consent, and 10 due to other exclusionary reasons.

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    All subjects, caregivers, investigators and site staff, CRO staff, and sponsor staff were blinded to treatment assignment until after database lock.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Neflamapimod TID
    Arm description
    		 40 mg capsules administered orally TID with food for 16 weeks; subjects followed the TID regimen if Screening weight was ≥80 kg
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Neflamapimod
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received 3 neflamapimod 40 mg capsules per day (TID), given orally within 30 minutes following a meal or snack (i.e., morning, mid-day and evening meals). Doses were given at least 3 hours apart at approximately the same time each day for 16 weeks.

    Arm title
    		 Neflamapimod BID
    Arm description
    		 40 mg capsules administered orally BID with food for 16 weeks; subjects followed the BID regimen if Screening weight was <80 kg
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Neflamapimod
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received 2 neflamapimod 40 mg capsules per day (BID), given orally within 30 minutes following a meal or snack (i.e., morning and evening meals). Doses were given at least 3 hours apart at approximately the same time each day for 16 weeks.

    Arm title
    		 Placebo
    Arm description
    		 40 mg matching placebo capsules administered orally TID or BID with food for 16 weeks; subjects followed the TID regimen if Screening weight was ≥80 kg and the BID regimen if Screening weight was <80 kg
    Arm type
    		 Placebo

    Investigational medicinal product name
    Matching Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    For TID, subjects received 3 neflamapimod matching placebo capsules per day (TID), given orally within 30 minutes following a meal or snack (i.e., morning, mid-day and evening meals). For BID, subjects received 2 neflamapimod matching placebo capsules per day (BID), given orally within 30 minutes following a meal or snack (i.e., morning and evening meals). Doses were given at least 3 hours apart at approximately the same time each day for 16 weeks.

    Number of subjects in period 1
    		Neflamapimod TID Neflamapimod BID Placebo
    Started
    20
    26
    45
    Completed
    20
    20
    41
    Not completed
    0
    6
    4
         Adverse event, serious fatal
    -
    -
    1
         Consent withdrawn by subject
    -
    3
    1
         Physician decision
    -
    -
    1
         Adverse event, non-fatal
    -
    3
    1

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Neflamapimod TID
    Reporting group description
    		 40 mg capsules administered orally TID with food for 16 weeks; subjects followed the TID regimen if Screening weight was ≥80 kg

    Reporting group title
    Neflamapimod BID
    Reporting group description
    		 40 mg capsules administered orally BID with food for 16 weeks; subjects followed the BID regimen if Screening weight was <80 kg

    Reporting group title
    Placebo
    Reporting group description
    		 40 mg matching placebo capsules administered orally TID or BID with food for 16 weeks; subjects followed the TID regimen if Screening weight was ≥80 kg and the BID regimen if Screening weight was <80 kg

    Reporting group values
    		 Neflamapimod TID Neflamapimod BID Placebo Total
    Number of subjects
    		 20 26 45 91
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 2 2 7 11
        From 65-84 years
    		 18 23 36 77
        85 years and over
    		 0 1 2 3
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 72.2 (59 to 84) 74.5 (63 to 85) 72.1 (62 to 87) -
    Gender categorical
    Units: Subjects
        Female
    		 1 7 6 14
        Male
    		 19 19 39 77

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Neflamapimod TID
    Reporting group description
    		 40 mg capsules administered orally TID with food for 16 weeks; subjects followed the TID regimen if Screening weight was ≥80 kg

    Reporting group title
    Neflamapimod BID
    Reporting group description
    		 40 mg capsules administered orally BID with food for 16 weeks; subjects followed the BID regimen if Screening weight was <80 kg

    Reporting group title
    Placebo
    Reporting group description
    		 40 mg matching placebo capsules administered orally TID or BID with food for 16 weeks; subjects followed the TID regimen if Screening weight was ≥80 kg and the BID regimen if Screening weight was <80 kg

    Primary: NTB (Neuropsychological Test Battery)

    		 Close Top of page
    End point title
    		 NTB (Neuropsychological Test Battery)
    End point description
    Change from Baseline to Week 16 in the composite score of a study-specific Cogstate Neuropsychological Test Battery (NTB), including assessments of attention, executive function, and visuospatial function in neflamapimod treated-subjects as compared to the placebo-treated subjects, as analyzed using the Mixed Model Repeated Measures (MMRM) analysis method. The following six tests will be included in the composite: (1) Cogstate Detection test (DET), (2) Cogstate Identification test (IDN), (3) Cogstate One Card Learning test (OCL), (4) Cogstate One Back test (ONB), (5) Letter Fluency Test, (6) Category Fluency Test (CFT). Each score on the individual tests will be converted to a z-score, and then a total z-score will be calculated, in which each test is weighted equally. The change in total z-score in neflamapimod vs. placebo-recipients will be analyzed. As the analysis is based on z-scores, there is no minimum or maximum value.
    End point type
    Primary
    End point timeframe
    16 weeks
    End point values
    		 Neflamapimod TID Neflamapimod BID Placebo
    Number of subjects analysed
    19
    20
    37
    Units: Z-Score by Time on Study
    arithmetic mean (standard error)
        Baseline
    0.06 ± 0.17
    0.02 ± 0.15
    0.05 ± 0.11
        Week 4
    0.17 ± 0.14
    -0.08 ± 0.18
    -0.05 ± 0.13
        Week 8
    0.28 ± 0.16
    -0.12 ± 0.18
    0.05 ± 0.17
        Week 16
    0.21 ± 0.18
    -0.08 ± 0.21
    -0.03 ± 0.14
    Statistical analysis title
    		 Linear Mixed Effects (LME)
    Statistical analysis description
    This was an exploratory trial and no explicit a priori hypothesis was established and contained in the protocol. As such, no formal power calculations were conducted. The primary objective of the study was to evaluate the effects of neflamapimod on cognition, and accordingly the primary endpoint was change in combined z-score of the six tests in the NTB, analyzed by Linear Mixed Effects (LME) model for repeated measures.
    Comparison groups
    Neflamapimod TID v Neflamapimod BID v Placebo
    Number of subjects included in analysis
    76
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.049 [2]
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.175
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.001
         upper limit
    		 0.345
    Notes
    [1] - Change from baseline analyzed by linear mixed effects model for repeated measures. Comparison of all NFMD vs. Placebo was not significant. p=0.015 (cohen’s D effect size=0.52) for NFMD 40mg TID vs. combined other groups; p=0.049 (effect size=0.47) for NFMD 40mg TID vs. placebo.
    [2] - Comparison of NFMD 40mg TID vs. placebo is reported. Comparison of all NFMD vs. Placebo was not significant. p=0.015 (cohen’s D effect size=0.52) for NFMD 40mg TID vs. combined other groups .

    Secondary: Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB)

    		 Close Top of page
    End point title
    		 Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB)
    End point description
    Change in Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) score based on semi-quantitative scoring of each domain (box) evaluating cognitive impairment in milder and more progressive forms of dementia, in neflamapimod-treated subjects compared to placebo-recipients. The domain (box) scores will be calculated for a Sum of Boxes score. Secondary efficacy endpoints will utilize the same analysis method and model as the primary endpoint.
    End point type
    Secondary
    End point timeframe
    16 weeks
    End point values
    		 Neflamapimod TID Neflamapimod BID Placebo
    Number of subjects analysed
    20
    20
    37
    Units: Change from Baseline by Time on Study
    arithmetic mean (standard error)
        Week 8
    0.11 ± 0.2
    0.19 ± 0.3
    0.76 ± 0.25
        Week 16
    0.34 ± 0.2
    0.34 ± 0.18
    0.86 ± 0.32
    Statistical analysis title
    		 Linear Mixed Effects (LME)
    Statistical analysis description
    Due to Covid19 restrictions on clinical research CDR-SB evaluations were conducted remotely (i.e., via telephone or video conference, with the subject and informant at home rather than in person at the clinical site). However, within the study at home visits resulted in significantly better scores (~0.8 points lower, p=0.02). As the baseline visits were all conducted onsite, and at home CDR-SB visits has not been validated, the change analysis reported includes only data from onsite visits.
    Comparison groups
    Neflamapimod TID v Neflamapimod BID v Placebo
    Number of subjects included in analysis
    77
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.17 [3]
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.54
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.34
         upper limit
    		 0.24
    Notes
    [3] - p=0.028 for combined combined NFMD vs. placebo.

    Secondary: Mini-Mental State Examination (MMSE)

    		 Close Top of page
    End point title
    		 Mini-Mental State Examination (MMSE)
    End point description
    Change in Mini-Mental State Examination (MMSE) with respect to orientation, memory, concentration, language, and praxis (scores ranging from 0 to 30 with lower scores indicating greater cognitive impairment), in neflamapimod-treated subjects compared to placebo-recipients. Secondary efficacy endpoints will utilize the same analysis method and model as the primary endpoint.
    End point type
    Secondary
    End point timeframe
    16 weeks
    End point values
    		 Neflamapimod TID Neflamapimod BID Placebo
    Number of subjects analysed
    20
    21
    41
    Units: Change from Baseline by Time on Study
    arithmetic mean (standard error)
        Week 8
    0.11 ± 0.74
    0.08 ± 0.64
    -0.59 ± 0.38
        Week 16
    -0.85 ± 0.49
    -1.75 ± 0.67
    -0.53 ± 0.49
    Statistical analysis title
    		 Linear Mixed Effects (LME)
    Comparison groups
    Neflamapimod TID v Neflamapimod BID v Placebo
    Number of subjects included in analysis
    82
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.2 [4]
    Method
    		 Mixed models analysis
    Confidence interval
    Notes
    [4] - There were no significant differences between treatment groups.

    Secondary: Neuropsychiatric Inventory (NPI-10)

    		 Close Top of page
    End point title
    		 Neuropsychiatric Inventory (NPI-10)
    End point description
    Change in Neuropsychiatric Inventory (NPI-10) domains, specifically depression (dysphoria), anxiety, hallucinations, and agitation/aggression, in neflamapimod-treated subjects compared to placebo-recipients. Responses indicating subject has a problem with a particular sub-domain lead to questions of the caregiver rating the frequency of the symptoms on a 4-point scale, severity on a 3-point scale, and the distress the symptoms cause them on a 5-point scale. Secondary efficacy endpoints will utilize the same analysis method and model as the primary endpoint.
    End point type
    Secondary
    End point timeframe
    16 weeks
    End point values
    		 Neflamapimod TID Neflamapimod BID Placebo
    Number of subjects analysed
    19
    20
    37
    Units: Total Score by Time on Study
    arithmetic mean (standard error)
        Baseline
    11.3 ± 2.8
    10.5 ± 1.9
    10.9 ± 1.5
        Week 4
    9.2 ± 2.2
    10 ± 2.2
    8.9 ± 1.5
        Week 8
    7.3 ± 1.9
    8.9 ± 1.8
    9.2 ± 1.6
        Week 16
    7.6 ± 2.0
    10.9 ± 2.4
    11.0 ± 1.9
    Statistical analysis title
    		 Linear Mixed Effects (LME)
    Comparison groups
    Neflamapimod TID v Neflamapimod BID v Placebo
    Number of subjects included in analysis
    76
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 > 0.2 [5]
    Method
    		 Mixed models analysis
    Confidence interval
    Notes
    [5] - There were no significant differences between the treatment groups for total NPI-10 score. For hallucinations there was a significant treatment effect (p=0.019,LME for repeated measures) for NFMD 40mg TID vs. placebo. p=0.05 for all NFMD vs. placebo.

    Secondary: Timed Up and Go (TUG)

    		 Close Top of page
    End point title
    		 Timed Up and Go (TUG)
    End point description
    Change in Timed Up and Go Test (TUG) to assess mobility (score of >15 seconds indicates subject has increased risk of falls) in neflamapimod-treated subjects compared to placebo-recipients. Secondary efficacy endpoints will utilize the same analysis method and model as the primary endpoint.
    End point type
    Secondary
    End point timeframe
    16 weeks
    End point values
    		 Neflamapimod TID Neflamapimod BID Placebo
    Number of subjects analysed
    20
    20
    37
    Units: Change from Baseline by Time on Study
    arithmetic mean (standard error)
        Week 8
    -0.2 ± 0.5
    1.0 ± 0.9
    0.4 ± 0.4
        Week 16
    -1.4 ± 1.0
    1.3 ± 0.7
    1.5 ± 0.9
    Statistical analysis title
    		 Linear Mixed Effects (LME)
    Comparison groups
    Neflamapimod TID v Neflamapimod BID v Placebo
    Number of subjects included in analysis
    77
    Analysis specification
    Pre-specified
    Analysis type
    		 other [6]
    P-value
    		 = 0.28 [7]
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    -2.56
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.84
         upper limit
    		 -0.28
    Notes
    [6] - Change from baseline analyzed by linear mixed effects model for repeated measures. In the comparison of the combined NFMD groups vs. placebo, there was significant reduction in the time required to complete the TUG test (i.e. improvement) with neflamapimod treatment (p=0.04, difference of -1.36 sec, 95% CI -0.04 to -2.69). A significant difference favoring neflamapimod treatment was also noted for the comparison of NFMD TID vs. placebo (p=0.028, difference of –2.56 sec, 95% CI -0.28 to -4.84).
    [7] - Comparison of NFMD 40mg TID vs. placebo is reported. For the comparison of the combined NFMD groups vs. placebo, p=0.044.

    Secondary: International Shopping List Test (ISLT)

    		 Close Top of page
    End point title
    		 International Shopping List Test (ISLT)
    End point description
    Change in International Shopping List Test (ISLT) immediate and delayed recall and recognition will be used to assess episodic memory in neflamapimod-treated subjects compared to placebo-recipients. Secondary efficacy endpoints will utilize the same analysis method as the primary endpoint.
    End point type
    Secondary
    End point timeframe
    16 weeks
    End point values
    		 Neflamapimod TID Neflamapimod BID Placebo
    Number of subjects analysed
    20
    20
    41
    Units: ISLT immediate recall score
    arithmetic mean (standard error)
        Change from Baseline to Week 4
    0.29 ± 1.08
    -1.24 ± 0.61
    0.11 ± 0.54
        Change from Baseline to Week 8
    2.11 ± 1.66
    -0.75 ± 1.37
    0.41 ± 0.65
        Change from Baseline to Week 16
    0.30 ± 1.04
    0.11 ± 0.99
    -0.15 ± 0.46
    Statistical analysis title
    		 Linear Mixed Effects (LME)
    Comparison groups
    Neflamapimod TID v Neflamapimod BID v Placebo
    Number of subjects included in analysis
    81
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.2 [8]
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.32
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.27
         upper limit
    		 1.91
    Notes
    [8] - No significant treatment group differences were identified.

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    AEs occurring from when the subject signed the ICF until the last study event were collected. Any AEs occurring before the start of treatment (i.e., before the first dose of the investigational product) were recorded in the medical history.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    Neflamapimod TID
    Reporting group description
    		 -

    Reporting group title
    Neflamapimod BID
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Neflamapimod TID Neflamapimod BID Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 20 (0.00%)
    3 / 26 (11.54%)
    4 / 45 (8.89%)
         number of deaths (all causes)
    0
    2
    0
         number of deaths resulting from adverse events
    0
    2
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Diagnosis of brain tumor
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 26 (3.85%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Head injury
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 26 (3.85%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    New brain lesions of unclear etiology
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 26 (3.85%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intraparenchymal hemorrhage
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 26 (0.00%)
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Blood and lymphatic system disorders
    Internal bleeding
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 26 (0.00%)
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Gastrointestinal disorders
    Hematochezia
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 26 (0.00%)
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma exacerbation
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 26 (0.00%)
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Neflamapimod TID Neflamapimod BID Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 20 (40.00%)
    8 / 26 (30.77%)
    17 / 45 (37.78%)
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    1 / 20 (5.00%)
    5 / 26 (19.23%)
    4 / 45 (8.89%)
         occurrences all number
    1
    5
    5
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 20 (15.00%)
    1 / 26 (3.85%)
    2 / 45 (4.44%)
         occurrences all number
    3
    1
    3
    Tremor
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 26 (0.00%)
    3 / 45 (6.67%)
         occurrences all number
    0
    0
    3
    Gastrointestinal disorders
    Diarrhea
         subjects affected / exposed
    3 / 20 (15.00%)
    0 / 26 (0.00%)
    5 / 45 (11.11%)
         occurrences all number
    3
    0
    5
    Nausea
         subjects affected / exposed
    1 / 20 (5.00%)
    2 / 26 (7.69%)
    3 / 45 (6.67%)
         occurrences all number
    1
    2
    3

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sun May 19 03:06:41 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA