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A Phase II Study to Assess the Safety, Tolerability and Efficacy of Xanamem™ in Subjects With Mild Dementia Due to AD (XanADu) (XanADu)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02727699
Recruitment Status : Completed
First Posted : April 5, 2016
Results First Posted : May 6, 2021
Last Update Posted : May 6, 2021
Sponsor:
Collaborator:
ICON Clinical Research
Information provided by (Responsible Party):
Actinogen Medical

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Dementia, Alzheimer Type
Interventions Drug: Xanamem™
Drug: Placebo (for Xanamem™)
Enrollment 185
Recruitment Details Subjects were recruited based on physician referral between March 2017 to November 2018 when enrolment completed. This was a global, multi-center study involving 27 study sites, of which, 24 sites had randomised subjects to the study.The study planned to enrol 7 to 10 subjects at each study site.
Pre-assignment Details It was planned that approximately 174 subjects would be enrolled to ensure 156 subjects would complete the 12 week double-blind study period (78 subjects in each treatment group). At study-end, in total, 457 subjects were screened, of whom 185 subjects were randomised (91:94 Xanamem to placebo) to the study with 171 subjects completed.
Arm/Group Title Xanamem™ Placebo
Hide Arm/Group Description

Oral Xanamem™ capsules 10mg, to be administered once daily

Xanamem™: Xanamem™ is formulated in green and cream coloured size 3, Coni-Snap shaped gelatin capsules as an excipient blend at a dose of 10mg. It contains active pharmaceutical ingredient of UE2343 (Laboratory code for Xanamem)

Matching placebo which is identical in appearance to the test product except that it contains no active ingredient, to be administered once daily

Placebo (for Xanamem™): Excipient blend capsules manufactured to mimic Xanamem™ capsules

Period Title: Overall Study
Started 91 94
Completed 82 89
Not Completed 9 5
Reason Not Completed
Adverse Event             2             0
Withdrawal by Subject             5             3
Protocol Violation             0             1
Physician Decision             0             1
Lost to Follow-up             1             0
Sponsor Decision             1             0
Arm/Group Title Xanamem™ Placebo Total
Hide Arm/Group Description

Oral Xanamem™ capsules 10mg, to be administered once daily

Xanamem™: Xanamem™ is formulated in green and cream coloured size 3, Coni-Snap shaped gelatin capsules as an excipient blend at a dose of 10mg. It contains active pharmaceutical ingredient of UE2343

Matching placebo which is identical in appearance to the test product except that it contains no active ingredient, to be administered once daily

Placebo (for Xanamem™): Excipient blend capsules manufactured to mimic Xanamem™ capsules

Total of all reporting groups
Overall Number of Baseline Participants 91 94 185
Hide Baseline Analysis Population Description
The FAS comprised all subjects randomised who received at least one dose of study drug and had at least one valid post-baseline measurement where changes from Baseline were analysed. Demographic data and subject characteristics at Baseline were summarised overall and by treatment, group using descriptive summary statistics for the Full Analysis Set (FAS) to include: age, gender and race. Baseline characteristic results of height, weight, BMI were also summarised overall and by treatment group.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 91 participants 94 participants 185 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
19
  20.9%
24
  25.5%
43
  23.2%
>=65 years
72
  79.1%
70
  74.5%
142
  76.8%
Age, Continuous   [1] 
Median (Standard Deviation)
Unit of measure:  Years
Number Analyzed 91 participants 94 participants 185 participants
71.3  (8.71) 70.8  (8.20) 71.0  (8.43)
[1]
Measure Description: Age was calculated as (informed consent year-birth year).
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 91 participants 94 participants 185 participants
Female
52
  57.1%
54
  57.4%
106
  57.3%
Male
39
  42.9%
40
  42.6%
79
  42.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 91 participants 94 participants 185 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
4
   4.4%
3
   3.2%
7
   3.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
17
  18.7%
13
  13.8%
30
  16.2%
White
65
  71.4%
74
  78.7%
139
  75.1%
More than one race NA [1]  NA [1]  NA [2] 
Unknown or Not Reported
0
   0.0%
2
   2.1%
2
   1.1%
[1]
Data not available (NA)
[2]
Total not calculated because data are not available (NA) in one or more arms.
Region of Enrollment   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 91 participants 94 participants 185 participants
United States 53 55 108
United Kingdom 14 15 29
Australia 24 24 48
[1]
Measure Description: Subject Allocation By Study Sites by Country Region
Height   [1] 
Mean (Standard Deviation)
Unit of measure:  Centimetres (cm)
Number Analyzed 91 participants 94 participants 185 participants
165.49  (9.665) 166.36  (8.964) 165.94  (9.295)
[1]
Measure Analysis Population Description: Number of subjects in the specified category with non-missing values in the Full Analysis Set (FAS).
Body Mass Index (BMI)   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Kilogram / square meter (kg/m^2)
Number Analyzed 91 participants 94 participants 185 participants
27.31  (5.024) 27.08  (6.570) 27.19  (5.855)
[1]
Measure Description: The overall mean (SD) Body Mass Index (BMI) of subjects was 27.19 (5.855) kg/m^2 and ranged from 17.9 kg/m^2 to 52.5 kg/m^2.
[2]
Measure Analysis Population Description: Baseline value is defined as the latest observation prior to or on the date of the first dose of study drug.
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilogram (kg)
Number Analyzed 91 participants 94 participants 185 participants
74.90  (15.964) 74.88  (18.774) 74.89  (17.424)
1.Primary Outcome
Title ADAS-Cog v14
Hide Description Change in Alzheimer's Disease Assessment Scales - Cognitive Subscale Score, version 14 (ADAS-Cog v14) Total scores of ADAS Cog 14 range from 0 to 90, with higher scores indicating greater disease severity.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The ADAS-cog v14 includes the following 14 items, with a Total scoring range of 0 - 90. Higher scores indicate greater disease severity
Arm/Group Title Xanamem™ Placebo
Hide Arm/Group Description:

Oral Xanamem™ capsules 10mg, to be administered once daily

Xanamem™: Xanamem™ is formulated in green and cream coloured size 3, Coni-Snap shaped gelatin capsules as an excipient blend at a dose of 10mg. It contains active pharmaceutical ingredient of UE2343

Matching placebo which is identical in appearance to the test product except that it contains no active ingredient, to be administered once daily

Placebo (for Xanamem™): Excipient blend capsules manufactured to mimic Xanamem™ capsules

Overall Number of Participants Analyzed 86 92
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.5  (6.47) -0.7  (6.65)
2.Primary Outcome
Title AD COMposite Scores
Hide Description

Change in AD COMposite Scores (ADCOMs- ADCOMs, composite score is derived from a weighted linear combination of items from commonly used outcome scales Cognitive Subscale Version 14 [ADAS-Cog v14], Clinical Dementia Rating Scale - Sum of Boxes [CDR-SOB], and Mini-Mental Status Examination [MMSE]. Th ADCOMs range: 0 - 1.97, whereas a lover score is interpreted as a better result.

Included scales:

ADAS-Cog v14 (range: 0-90): A lower score is indicative of better cognition, a higher score indicates higher cognitive impairment.

CDR-SUB (range: 0-18): A lower score is indicative of better cognition, a higher score indicates higher cognitive impairment.

MMSE (range: 0-30): A higher score is indicative of better cognition, a lower score indicates higher cognitive impairment.

Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ADCOMs, composite score (0 - 1.97) is derived from ADAS-Cog v14, CDR-SOB, and MMSE. Analysis of Change from Baseline to Week 12/EOT (end of treatment) in ADCOMs from the Full Analysis Set (FAS).
Arm/Group Title Xanamem™ Placebo
Hide Arm/Group Description:

Oral Xanamem™ capsules 10mg, to be administered once daily

Xanamem™: Xanamem™ is formulated in green and cream coloured size 3, Coni-Snap shaped gelatin capsules as an excipient blend at a dose of 10mg. It contains active pharmaceutical ingredient of UE2343

Matching placebo which is identical in appearance to the test product except that it contains no active ingredient, to be administered once daily

Placebo (for Xanamem™): Excipient blend capsules manufactured to mimic Xanamem™ capsules

Overall Number of Participants Analyzed 86 92
Mean (Standard Deviation)
Unit of Measure: score on a scale
0.02472  (0.144135) 0.01908  (0.151502)
3.Secondary Outcome
Title RAVLT
Hide Description Change in Rey Auditory Verbal Learning Test (RAVLT) RAVLT will be administered using five trials, with individual scores from 0-15. The total score is the combined score of all five trials, ranging from 0 to 75, whereas a lower score is considered a worse outcome and a higher score a better outcome.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis of Change from Baseline to Week 12/EOT in RAVLT from the Full Analysis Set (FAS).
Arm/Group Title Xanamem™ Placebo
Hide Arm/Group Description:

Oral Xanamem™ capsules 10mg, to be administered once daily

Xanamem™: Xanamem™ is formulated in green and cream coloured size 3, Coni-Snap shaped gelatin capsules as an excipient blend at a dose of 10mg. It contains active pharmaceutical ingredient of UE2343

Matching placebo which is identical in appearance to the test product except that it contains no active ingredient, to be administered once daily

Placebo (for Xanamem™): Excipient blend capsules manufactured to mimic Xanamem™ capsules

Overall Number of Participants Analyzed 86 92
Mean (Standard Deviation)
Unit of Measure: score on a scale
Recall List A - Total number of correct words Number Analyzed 86 participants 90 participants
0.3  (6.54) 0.4  (6.31)
Recall List B - Number of correct words Number Analyzed 86 participants 90 participants
0.3  (1.63) 0.1  (1.30)
Final recall of List A - Number of correct words Number Analyzed 85 participants 90 participants
0.2  (3.14) 0.4  (2.40)
4.Secondary Outcome
Title CDR-SOB
Hide Description

Change in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SOB) The CDR is obtained through semi-structured interviews of patients and informants, and cognitive functioning is rated in six domains of functioning: memory, orientation, judgement and problem solving, community affairs, home and hobbies, and personal care.

Each domain is rated on a five-point scale of functioning as follows: 0, no impairment; 0.5, questionable impairment; 1, mild impairment; 2, moderate impairment; and 3, severe impairment.

The CDR-SOB is based on summing each of the domain box scores, with scores ranging from 0-18, whereas lower scores represent better outcomes and higher scores worse outcomes.

Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
CDR-SOB score (0 - 18) is a sum of all six items of CDR-SOB. CDR-SOB score will be analysed for each visit as actual values and change from Baseline.
Arm/Group Title Xanamem™ Placebo
Hide Arm/Group Description:

Oral Xanamem™ capsules 10mg, to be administered once daily

Xanamem™: Xanamem™ is formulated in green and cream coloured size 3, Coni-Snap shaped gelatin capsules as an excipient blend at a dose of 10mg. It contains active pharmaceutical ingredient of UE2343

Matching placebo which is identical in appearance to the test product except that it contains no active ingredient, to be administered once daily

Placebo (for Xanamem™): Excipient blend capsules manufactured to mimic Xanamem™ capsules

Overall Number of Participants Analyzed 85 91
Mean (Standard Deviation)
Unit of Measure: score on a scale
0.25  (1.276) 0.16  (1.325)
5.Secondary Outcome
Title MMSE
Hide Description Change in Mini-Mental Status Examination (MMSE) MMSE total score (0 - 30) is a sum of all 30 point questionnaire of MMSE. A score of 20 to 24 suggests mild dementia, 13 to 20 suggests moderate dementia, and less than 12 indicates severe dementia.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
MMSE is a 30 point questionnaire used to screen for dementia and to estimate the severity and progression of cognitive impairment. MMSE will be analysed for each visit as actual values and change from Baseline.
Arm/Group Title Xanamem™ Placebo
Hide Arm/Group Description:

Oral Xanamem™ capsules 10mg, to be administered once daily

Xanamem™: Xanamem™ is formulated in green and cream coloured size 3, Coni-Snap shaped gelatin capsules as an excipient blend at a dose of 10mg. It contains active pharmaceutical ingredient of UE2343

Matching placebo which is identical in appearance to the test product except that it contains no active ingredient, to be administered once daily

Placebo (for Xanamem™): Excipient blend capsules manufactured to mimic Xanamem™ capsules

Overall Number of Participants Analyzed 86 91
Mean (Standard Deviation)
Unit of Measure: score on a scale
0.2  (3.09) -0.2  (2.85)
6.Secondary Outcome
Title NPI (Neuropsychiatric Inventory)
Hide Description

Change in Neuropsychiatric Inventory (NPI) The NPI includes questions to ten behavioural and two neurodegenerative domains.

Raters recorded neuropsychiatric symptoms using a 1-4 scale for frequency and a 1-3 scale for severity for each item in the instrument, with the score for each domain being: domain score = frequency x severity.

The total score is calculated by adding the scores of the first 10 domain scores.

The two neurodegenerative items are not included in the NPI total score as they form part of the depression syndrome in some patients and were specifically excluded from the dysphoria subscale of the NPI in order to allow that subscale to focus on mood symptoms.

The total NPI-score minimum is 0 and the maximum 144. A lower score is considered a better outcome, a higher score a worse outcome.

Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The NPI total score is calculated by multiplying the frequency and severity rates per domain (maximum score per domain is 12) and then calculating the total of all domains (total NPI-score minimum is 0 and maximum 144). Total distress score (0 - 60) will summarised descriptively. NPI total score will not be calculated if any sub item is missing.
Arm/Group Title Xanamem™ Placebo
Hide Arm/Group Description:

Oral Xanamem™ capsules 10mg, to be administered once daily

Xanamem™: Xanamem™ is formulated in green and cream coloured size 3, Coni-Snap shaped gelatin capsules as an excipient blend at a dose of 10mg. It contains active pharmaceutical ingredient of UE2343

Matching placebo which is identical in appearance to the test product except that it contains no active ingredient, to be administered once daily

Placebo (for Xanamem™): Excipient blend capsules manufactured to mimic Xanamem™ capsules

Overall Number of Participants Analyzed 85 92
Mean (Standard Deviation)
Unit of Measure: units on a scale
NPI Total Score 0.9  (8.67) 0.8  (9.09)
Delusions 0.0  (0.38) 0.1  (0.87)
Hallucinations 0.1  (0.60) 0.0  (0.36)
Agitation/Aggression 0.2  (2.02) 0.2  (1.91)
Depression/Dysphoria 0.0  (1.34) 0.0  (1.91)
Anxiety 0.1  (1.70) -0.4  (2.08)
Elation/Euphoria 0.1  (0.92) 0.0  (0.67)
Apathy/Indifference 0.0  (2.18) 0.3  (2.11)
Disinhibition 0.1  (1.15) 0.1  (1.03)
Irritability/Lability 0.1  (1.94) 0.5  (2.17)
Aberrant Motor Behavior -0.1  (2.98) 0.2  (2.37)
Sleep 0.2  (2.47) 0.0  (1.83)
Appetite and Eating Disorders 0.1  (3.18) -0.1  (2.02)
7.Secondary Outcome
Title NTB - Executive Domain
Hide Description

Change in Neuropsychological Test Batteries (NTB) - Executive Domains: Controlled Oral Word Association - Test (COWAT) and Total Correct Response (CFT) Total NTB score is the sum of COWAT and CFT. During the COWAT test, the subject is asked to mention as many words as possible beginning with different letters (F, A, S) within 1 minute each. The number of words for each letter is recorded, the score is the sum of all words. There is no minimum or maximum score, whereas more words indicate a better outcome.

During the CFT test, the subject is given 1 minute to produce as many unique words as possible within a semantic category. The subject's score is the number of unique correct words.

There is no minimum or maximum score whereas a score of under 14 is interpreted as concerning regarding cognition.

Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Total NTB score is the sum of 'Total correct response' of Category Fluency Test (CFT) and 'Total number of correct words' of Controlled Oral Word Association Test (COWAT). Each score ('Total correct response' of CFT and 'Total number of correct word' of COWAT) will also be analysed.
Arm/Group Title Xanamem™ Placebo
Hide Arm/Group Description:

Oral Xanamem™ capsules 10mg, to be administered once daily

Xanamem™: Xanamem™ is formulated in green and cream coloured size 3, Coni-Snap shaped gelatin capsules as an excipient blend at a dose of 10mg. It contains active pharmaceutical ingredient of UE2343

Matching placebo which is identical in appearance to the test product except that it contains no active ingredient, to be administered once daily

Placebo (for Xanamem™): Excipient blend capsules manufactured to mimic Xanamem™ capsules

Overall Number of Participants Analyzed 86 91
Mean (Standard Deviation)
Unit of Measure: score on a scale
COWAT Total Correct Words 0.5  (8.08) 0.5  (8.12)
CTF Total Correct Responses 0.3  (8.53) -0.7  (6.28)
NTB Total Score 0.8  (11.50) -0.2  (9.84)
8.Other Pre-specified Outcome
Title Pregnancy Test
Hide Description Women of childbearing potential only. Serum pregnancy test at screening and a urine pregnancy test at all subsequent clinic visits
Time Frame Screening, baseline, Week 4, Week, 8, Week 12, Week 16
Outcome Measure Data Not Reported
9.Other Pre-specified Outcome
Title Optional PD Assessment - Changes in Pharmacodynamic (PD) Measures of Testosterone
Hide Description This assessment will be carried out on subjects who consented to this optional test. PD sample will be collected at pre-dose at each required visit
Time Frame Screening, baseline, Week 4, Week, 8, Week 12, Week 16
Outcome Measure Data Not Reported
10.Other Pre-specified Outcome
Title Optional PD Assessment - Changes in Pharmacodynamic (PD) Measures of Androstenedione
Hide Description This assessment will be carried out on subjects who consented to this optional test. PD sample will be collected at pre-dose at each required visit
Time Frame Screening, baseline, Week 4, Week, 8, Week 12, Week 16
Outcome Measure Data Not Reported
11.Other Pre-specified Outcome
Title Optional PD Assessment - Changes in Pharmacodynamic (PD) Measures of Dehydroepiandrosterone Sulfate (DHEAS)
Hide Description This assessment will be carried out on subjects who consented to this optional test. PD sample will be collected at pre-dose at each required visit
Time Frame Screening, baseline, Week 4, Week, 8, Week 12, Week 16
Outcome Measure Data Not Reported
12.Other Pre-specified Outcome
Title Optional PD Assessment - Changes in Pharmacodynamic (PD) Measures of Adrenocorticotropic Hormone (ACTH)
Hide Description This assessment will be carried out on subjects who consented to this optional test. PD sample will be collected at pre-dose at each required visit
Time Frame Screening, baseline, Week 4, Week, 8, Week 12, Week 16
Outcome Measure Data Not Reported
13.Other Pre-specified Outcome
Title Change in Pharmacokinetics (PK), Including Analysis of Cortisol Levels
Hide Description This assessment will be carried out on subjects who consented to this optional test. PD sample will be collected at pre-dose at each required visit
Time Frame Baseline, Week 4, Week 8, Week 12 and Unscheduled Safety Visit
Outcome Measure Data Not Reported
14.Other Pre-specified Outcome
Title NTSS-6
Hide Description Change in Neuropathy Total Symptom Score (NTSS-6)
Time Frame Screening, Baseline, Week 4, Week 8, Week 12, Week 16, Ad Hoc and Unscheduled Safety Visit
Outcome Measure Data Not Reported
15.Other Pre-specified Outcome
Title NFM
Hide Description Change in Nerve Function Monitoring (NFM)
Time Frame Screening, Baseline, Week 4, Week 8, Week 12, Week 16
Outcome Measure Data Not Reported
16.Other Pre-specified Outcome
Title Vital Signs
Hide Description Change in Vital Signs (including Heart Rate, Blood Pressure, Body Weight, BMI)
Time Frame Screening, Baseline, Week 4, Week 8, Week 12, Week 16, Unscheduled Safety Visit
Outcome Measure Data Not Reported
17.Other Pre-specified Outcome
Title Metabolic Function
Hide Description Change in Metabolic Function Test Results of Lipids, Glucose, Hemoglobin A1c (HbA1c)
Time Frame Baseline, Week 12
Outcome Measure Data Not Reported
18.Other Pre-specified Outcome
Title Clinical Safety Laboratory Values
Hide Description Change in Clinical Safety Laboratory Values (biochemistry, hematology, urine examination)
Time Frame Screening, Baseline, Week 4, Week 8, Week 12, Week 16
Outcome Measure Data Not Reported
19.Other Pre-specified Outcome
Title AEs
Hide Description Incidence of Adverse Events (AEs)
Time Frame Screening, Baseline, Week 4, Week 8, Week 12, Week 16, Ad Hoc
Outcome Measure Data Not Reported
20.Other Pre-specified Outcome
Title ECG
Hide Description Change in Electrocardiogram (ECG) Values
Time Frame Screening, Baseline, Week 4, Week 8, Week 12, Week 16
Outcome Measure Data Not Reported
21.Other Pre-specified Outcome
Title CSSRS
Hide Description Change in Scores of Columbia Suicide Severity Rating Scale (CSSRS)
Time Frame Screening, Week 4, Week 8, Week 12, Week 16
Outcome Measure Data Not Reported
Time Frame Median treatment duration (weeks) was 12 weeks (range: 0.14, 13.0 weeks) for subjects in the Xanamem group and 12 weeks (range: 0.14, 13.1 weeks) for subjects in the placebo group.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Xanamem™ Placebo
Hide Arm/Group Description

Oral Xanamem™ capsules 10mg, to be administered once daily

Xanamem™: Xanamem™ is formulated in green and cream coloured size 3, Coni-Snap shaped gelatin capsules as an excipient blend at a dose of 10mg. It contains active pharmaceutical ingredient of UE2343

Matching placebo which is identical in appearance to the test product except that it contains no active ingredient, to be administered once daily

Placebo (for Xanamem™): Excipient blend capsules manufactured to mimic Xanamem™ capsules

All-Cause Mortality
Xanamem™ Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/91 (0.00%)   0/94 (0.00%) 
Hide Serious Adverse Events
Xanamem™ Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   4/91 (4.40%)   4/94 (4.26%) 
Cardiac disorders     
Acute myocardial infarction  1  0/91 (0.00%)  1/94 (1.06%) 
Infections and infestations     
Pneumonia  1  2/91 (2.20%)  0/94 (0.00%) 
Influenza  1  0/91 (0.00%)  1/94 (1.06%) 
Injury, poisoning and procedural complications     
Fall  1  0/91 (0.00%)  1/94 (1.06%) 
Rib Fracture  1  0/91 (0.00%)  1/94 (1.06%) 
Investigations     
Vibration test abnormal  1  1/91 (1.10%)  0/94 (0.00%) 
Musculoskeletal and connective tissue disorders     
Musculoskeletal Chest Pain  1  1/91 (1.10%)  0/94 (0.00%) 
Nervous system disorders     
Transient Ischaemic Attack  1  0/91 (0.00%)  1/94 (1.06%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary Cavitation  1  1/91 (1.10%)  0/94 (0.00%) 
1
Term from vocabulary, MedDRA 19.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Xanamem™ Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   66/91 (72.53%)   54/94 (57.45%) 
Gastrointestinal disorders     
Gastrointestinal Disorders, Diarrhoea  1  6/91 (6.59%)  5/94 (5.32%) 
Infections and infestations     
Infections and Infestations  1  15/91 (16.48%)  12/94 (12.77%) 
Musculoskeletal and connective tissue disorders     
Musculoskeletal and Connective Tissue Disorders  1  13/91 (14.29%)  12/94 (12.77%) 
Nervous system disorders     
Nervous system disorders, Headache,Dizziness  1  40/91 (43.96%)  34/94 (36.17%) 
1
Term from vocabulary, MedDRA 19.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director of Drug Development & Strategy
Organization: Actinogen Medical Limited
Phone: +61289647401
EMail: info@actinogen.com.au
Layout table for additonal information
Responsible Party: Actinogen Medical
ClinicalTrials.gov Identifier: NCT02727699    
Other Study ID Numbers: ACW0002
First Submitted: March 21, 2016
First Posted: April 5, 2016
Results First Submitted: September 15, 2020
Results First Posted: May 6, 2021
Last Update Posted: May 6, 2021