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Multiple Doses of AT-1501-A201 in Adults With ALS

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ClinicalTrials.gov Identifier: NCT04322149
Recruitment Status : Completed
First Posted : March 26, 2020
Results First Posted : June 28, 2023
Last Update Posted : June 28, 2023
Sponsor:
Information provided by (Responsible Party):
Eledon Pharmaceuticals ( Anelixis Therapeutics, LLC )

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Amyotrophic Lateral Sclerosis
Intervention Drug: AT-1501
Enrollment 54
Recruitment Details  
Pre-assignment Details  
Arm/Group Title AT-1501 1.0 mg/kg AT-1501 2.0 mg/kg AT-1501 4.0 mg/kg AT-1501 8.0 mg/kg
Hide Arm/Group Description This group received a 1.0 mg/kg dose administered as an 1-hour IV infusion. Each participant received 6 bi-weekly (every other week) infusions of AT-1501 over an 11-week period. This group received a 2.0 mg/kg dose administered as an 1-hour IV infusion. Each participant received 6 bi-weekly (every other week) infusions of AT-1501 over an 11-week period. This group received a 4.0 mg/kg dose administered as an 1-hour IV infusion. Each participant received 6 bi-weekly (every other week) infusions of AT-1501 over an 11-week period. This group received a 8.0 mg/kg dose administered as an 1-hour IV infusion. Each participant received 6 bi-weekly (every other week) infusions of AT-1501 over an 11-week period.
Period Title: Overall Study
Started 9 9 18 18
Completed 8 7 18 16
Not Completed 1 2 0 2
Reason Not Completed
Adverse Event             1             1             0             0
Withdrawal by Subject             0             0             0             2
Undergoing cancer treatment & was unable to return to site to complete EOS visit within window             0             1             0             0
Arm/Group Title AT-1501 1.0 mg/kg AT-1501 2.0 mg/kg AT-1501 4.0 mg/kg AT-1501 8.0 mg/kg Total
Hide Arm/Group Description This group received a 1.0 mg/kg dose administered as an 1-hour IV infusion. Each participant received 6 bi-weekly (every other week) infusions of AT-1501 over an 11-week period. This group received a 2.0 mg/kg dose administered as an 1-hour IV infusion. Each participant received 6 bi-weekly (every other week) infusions of AT-1501 over an 11-week period. This group received a 4.0 mg/kg dose administered as an 1-hour IV infusion. Each participant received 6 bi-weekly (every other week) infusions of AT-1501 over an 11-week period. This group received a 8.0 mg/kg dose administered as an 1-hour IV infusion. Each participant received 6 bi-weekly (every other week) infusions of AT-1501 over an 11-week period. Total of all reporting groups
Overall Number of Baseline Participants 9 9 18 18 54
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 9 participants 18 participants 18 participants 54 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
7
  77.8%
6
  66.7%
15
  83.3%
11
  61.1%
39
  72.2%
>=65 years
2
  22.2%
3
  33.3%
3
  16.7%
7
  38.9%
15
  27.8%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants 9 participants 18 participants 18 participants 54 participants
61.2  (6.5) 59  (14.76) 56.4  (8.53) 60.3  (11.11) 59  (10.29)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 9 participants 18 participants 18 participants 54 participants
Female
3
  33.3%
2
  22.2%
6
  33.3%
8
  44.4%
19
  35.2%
Male
6
  66.7%
7
  77.8%
12
  66.7%
10
  55.6%
35
  64.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 9 participants 18 participants 18 participants 54 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
3
  16.7%
3
   5.6%
Not Hispanic or Latino
9
 100.0%
9
 100.0%
18
 100.0%
15
  83.3%
51
  94.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 9 participants 18 participants 18 participants 54 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
  11.1%
1
   5.6%
0
   0.0%
2
   3.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
9
 100.0%
8
  88.9%
17
  94.4%
18
 100.0%
52
  96.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
ALSFRS-R Total Score at Screening   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 9 participants 9 participants 18 participants 18 participants 54 participants
41.1  (3.02) 40.2  (1.92) 39.7  (3.69) 39.2  (2.65) 39.9  (3.0)
[1]
Measure Description: The ALS Functional Rating Scale - Revised (ALSFRS-R) measures 12 aspects of physical function, ranging from one's ability to swallow and use utensils to climbing stairs and breathing. Each function is scored from 4 (normal) to 0 (no ability), with a maximum total score of 48 and a minimum total score of 0. Function scores are summed to compute the total score.
ALSFRS-R Subdomain at Screening   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
 Number Analyzed 9 participants 9 participants 18 participants 18 participants 54 participants
Dyspnea 4  (0) 3.8  (0.44) 3.7  (0.59) 3.8  (0.43) 3.8  (0.46)
Orthopnea 4.0  (0) 3.8  (0.67) 3.9  (0.32) 3.9  (0.24) 3.9  (0.35)
Respiratory Insufficiency 4.0  (0) 4.0  (0) 3.9  (0.47) 3.7  (0.57) 3.9  (0.44)
[1]
Measure Description: Measure Description: The ALS Functional Rating Scale - Revised (ALSFRS-R) measures 12 aspects of physical function, ranging from one's ability to swallow and use utensils to climbing stairs and breathing. The functions reported individually for this study are dyspnea, orthopnea, and respiratory insufficiency. The functions are scored from 4 (normal) to 0 (no ability).
ALSFRS-R Total Score at Baseline   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 9 participants 9 participants 18 participants 18 participants 54 participants
40.4  (3.17) 40.0  (2.0) 39.6  (3.99) 38.6  (3.96) 39.5  (3.56)
[1]
Measure Description: The ALS Functional Rating Scale - Revised (ALSFRS-R) measures 12 aspects of physical function, ranging from one's ability to swallow and use utensils to climbing stairs and breathing. Each function is scored from 4 (normal) to 0 (no ability), with a maximum total score of 48 and a minimum total score of 0. Function scores are summed to compute the total score.
ALSFRS-R Subdomain at Baseline   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
 Number Analyzed 9 participants 9 participants 18 participants 18 participants 54 participants
Dyspnea 4.0  (0) 3.7  (0.50) 3.6  (0.85) 3.8  (0.55) 3.7  (0.62)
Orthopnea 4.0  (0) 3.8  (0.67) 3.8  (0.38) 3.9  (0.24) 3.9  (0.37)
Respiratory Insufficiency 4.0  (0) 4.0  (0) 3.9  (0.47) 3.7  (0.59) 3.9  (0.45)
[1]
Measure Description: Measure Description: The ALS Functional Rating Scale - Revised (ALSFRS-R) measures 12 aspects of physical function, ranging from one's ability to swallow and use utensils to climbing stairs and breathing. The functions reported individually for this study are dyspnea, orthopnea, and respiratory insufficiency. The functions are scored from 4 (normal) to 0 (no ability).
Time Since ALS Symptom Onset  
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 9 participants 9 participants 18 participants 18 participants 54 participants
610.2  (340.20) 647.2  (388.67) 705.0  (580.30) 631.4  (431.02) 655.1  (457.45)
Time Since ALS Diagnosis  
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 9 participants 9 participants 18 participants 18 participants 54 participants
251.9  (241.52) 101.6  (75.32) 244.8  (204.40) 219.1  (174.57) 231.5  (188.57)
1.Primary Outcome
Title Safety and Tolerability
Hide Description Incidence of adverse events (AEs) reported as number of participants with at least one TEAE (Treatment Emergent Adverse Event) and at least one SAE (Serious Adverse Event).
Time Frame Up to 18 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set. All enrolled patients.
Arm/Group Title AT-1501 1.0 mg/kg AT-1501 2.0 mg/kg AT-1501 4.0 mg/kg AT-1501 8.0 mg/kg
Hide Arm/Group Description:
This group received a 1.0 mg/kg dose administered as an 1-hour IV infusion. Each participant received 6 bi-weekly (every other week) infusions of AT-1501 over an 11-week period.

administered as an 1-hour IV infusion. Each participant received 6 bi-weekly (every other week) infusions of AT-1501 over an 11-week period.

This group received a 2.0 mg/kg dose administered as an 1-hour IV infusion. Each participant received 6 bi-weekly (every other week) infusions of AT-1501 over an 11-week period.
This group received a 4.0 mg/kg dose administered as an 1-hour IV infusion. Each participant received 6 bi-weekly (every other week) infusions of AT-1501 over an 11-week period.
This group received a 8.0 mg/kg dose administered as an 1-hour IV infusion. Each participant received 6 bi-weekly (every other week) infusions of AT-1501 over an 11-week period.
Overall Number of Participants Analyzed 9 9 18 18
Measure Type: Number
Unit of Measure: participants
Number of Subjects with at Least One TEAE 8 8 10 16
Number of Subjects with at Least One SAE 0 1 0 0
2.Primary Outcome
Title Safety and Tolerability
Hide Description Incidence of adverse events (AEs) reported as number of TEAEs (Treatment Emergent Adverse Events) having occurred.
Time Frame Up to 18 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set. All enrolled patients.
Arm/Group Title AT-1501 1.0 mg/kg AT-1501 2.0 mg/kg AT-1501 4.0 mg/kg AT-1501 8.0 mg/kg
Hide Arm/Group Description:
This group received a 1.0 mg/kg dose administered as an 1-hour IV infusion. Each participant received 6 bi-weekly (every other week) infusions of AT-1501 over an 11-week period.

administered as an 1-hour IV infusion. Each participant received 6 bi-weekly (every other week) infusions of AT-1501 over an 11-week period.

This group received a 2.0 mg/kg dose administered as an 1-hour IV infusion. Each participant received 6 bi-weekly (every other week) infusions of AT-1501 over an 11-week period.
This group received a 4.0 mg/kg dose administered as an 1-hour IV infusion. Each participant received 6 bi-weekly (every other week) infusions of AT-1501 over an 11-week period.
This group received a 8.0 mg/kg dose administered as an 1-hour IV infusion. Each participant received 6 bi-weekly (every other week) infusions of AT-1501 over an 11-week period.
Overall Number of Participants Analyzed 9 9 18 18
Measure Type: Number
Unit of Measure: TEAEs
30 66 54 67
Time Frame All serious adverse events were collected from the time of informed consent to 4 weeks after a patient's last dose of investigational product. All adverse events were collected from the first administration of investigational product until completion of the final visit, up to 15 weeks.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AT-1501 1.0 mg/kg AT-1501 2.0 mg/kg AT-1501 4.0 mg/kg AT-1501 8.0 mg/kg
Hide Arm/Group Description This group received a 1.0 mg/kg dose administered as an 1-hour IV infusion. Each participant received 6 bi-weekly (every other week) infusions of AT-1501 over an 11-week period. This group received a 2.0 mg/kg dose administered as an 1-hour IV infusion. Each participant received 6 bi-weekly (every other week) infusions of AT-1501 over an 11-week period. This group received a 4.0 mg/kg dose administered as an 1-hour IV infusion. Each participant received 6 bi-weekly (every other week) infusions of AT-1501 over an 11-week period. This group received a 8.0 mg/kg dose administered as an 1-hour IV infusion. Each participant received 6 bi-weekly (every other week) infusions of AT-1501 over an 11-week period.
All-Cause Mortality
AT-1501 1.0 mg/kg AT-1501 2.0 mg/kg AT-1501 4.0 mg/kg AT-1501 8.0 mg/kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/9 (0.00%)   0/18 (0.00%)   0/18 (0.00%) 
Hide Serious Adverse Events
AT-1501 1.0 mg/kg AT-1501 2.0 mg/kg AT-1501 4.0 mg/kg AT-1501 8.0 mg/kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   1/9 (11.11%)   0/18 (0.00%)   0/18 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Tonsil cancer †  0/9 (0.00%)  1/9 (11.11%)  0/18 (0.00%)  0/18 (0.00%) 
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
AT-1501 1.0 mg/kg AT-1501 2.0 mg/kg AT-1501 4.0 mg/kg AT-1501 8.0 mg/kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   8/9 (88.89%)   8/9 (88.89%)   10/18 (55.56%)   16/18 (88.89%) 
Cardiac disorders         
Atrial fibrillation †  0/9 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  1/18 (5.56%) 
Nodal rhythm †  0/9 (0.00%)  0/9 (0.00%)  1/18 (5.56%)  0/18 (0.00%) 
Ear and labyrinth disorders         
Tinnitus †  0/9 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  1/18 (5.56%) 
Eye disorders         
Eye swelling †  0/9 (0.00%)  0/9 (0.00%)  1/18 (5.56%)  0/18 (0.00%) 
Periorbital oedema †  0/9 (0.00%)  0/9 (0.00%)  1/18 (5.56%)  0/18 (0.00%) 
Gastrointestinal disorders         
Nausea †  0/9 (0.00%)  1/9 (11.11%)  1/18 (5.56%)  2/18 (11.11%) 
Abdominal discomfort †  0/9 (0.00%)  0/9 (0.00%)  1/18 (5.56%)  1/18 (5.56%) 
Constipation †  0/9 (0.00%)  0/9 (0.00%)  2/18 (11.11%)  0/18 (0.00%) 
Dysphagia †  0/9 (0.00%)  1/9 (11.11%)  0/18 (0.00%)  1/18 (5.56%) 
Vomiting †  0/9 (0.00%)  1/9 (11.11%)  1/18 (5.56%)  0/18 (0.00%) 
Abdominal pain upper †  1/9 (11.11%)  0/9 (0.00%)  0/18 (0.00%)  0/18 (0.00%) 
Diarrhoea †  1/9 (11.11%)  0/9 (0.00%)  0/18 (0.00%)  0/18 (0.00%) 
Lip swelling †  0/9 (0.00%)  1/9 (11.11%)  0/18 (0.00%)  0/18 (0.00%) 
Salivary hypersecretion †  0/9 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  1/18 (5.56%) 
General disorders         
Fatigue †  4/9 (44.44%)  3/9 (33.33%)  0/18 (0.00%)  7/18 (38.89%) 
Asthenia †  0/9 (0.00%)  1/9 (11.11%)  0/18 (0.00%)  1/18 (5.56%) 
Peripheral swelling †  0/9 (0.00%)  2/9 (22.22%)  0/18 (0.00%)  0/18 (0.00%) 
Feeling jittery †  1/9 (11.11%)  0/9 (0.00%)  0/18 (0.00%)  0/18 (0.00%) 
Gait disturbance †  0/9 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  1/18 (5.56%) 
Malaise †  0/9 (0.00%)  1/9 (11.11%)  0/18 (0.00%)  0/18 (0.00%) 
Non-cardiac chest pain †  0/9 (0.00%)  1/9 (11.11%)  0/18 (0.00%)  0/18 (0.00%) 
Pain †  0/9 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  1/18 (5.56%) 
Swelling †  0/9 (0.00%)  1/9 (11.11%)  0/18 (0.00%)  0/18 (0.00%) 
Immune system disorders         
Seasonal allergy †  0/9 (0.00%)  1/9 (11.11%)  0/18 (0.00%)  0/18 (0.00%) 
Infections and infestations         
Nasopharyngitis †  0/9 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  3/18 (16.67%) 
Candida infection †  0/9 (0.00%)  1/9 (11.11%)  0/18 (0.00%)  0/18 (0.00%) 
Cystitis †  0/9 (0.00%)  0/9 (0.00%)  1/18 (5.56%)  0/18 (0.00%) 
Fungal infection †  0/9 (0.00%)  1/9 (11.11%)  0/18 (0.00%)  0/18 (0.00%) 
Herpes zoster †  0/9 (0.00%)  1/9 (11.11%)  0/18 (0.00%)  0/18 (0.00%) 
Sinusitis †  0/9 (0.00%)  1/9 (11.11%)  0/18 (0.00%)  0/18 (0.00%) 
Upper respiratory tract infection †  0/9 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  1/18 (5.56%) 
Urinary tract infection †  0/9 (0.00%)  1/9 (11.11%)  0/18 (0.00%)  0/18 (0.00%) 
Injury, poisoning and procedural complications         
Fall †  0/9 (0.00%)  3/9 (33.33%)  5/18 (27.78%)  4/18 (22.22%) 
Contusion †  0/9 (0.00%)  1/9 (11.11%)  2/18 (11.11%)  1/18 (5.56%) 
Eye contusion †  0/9 (0.00%)  1/9 (11.11%)  1/18 (5.56%)  0/18 (0.00%) 
Hand fracture †  0/9 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  2/18 (11.11%) 
Skin abrasion †  0/9 (0.00%)  1/9 (11.11%)  1/18 (5.56%)  0/18 (0.00%) 
Skin laceration †  0/9 (0.00%)  0/9 (0.00%)  2/18 (11.11%)  0/18 (0.00%) 
Extra-axial haemorrhage †  0/9 (0.00%)  0/9 (0.00%)  1/18 (5.56%)  0/18 (0.00%) 
Foot fracture †  0/9 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  1/18 (5.56%) 
Post lumbar puncture syndrome †  0/9 (0.00%)  0/9 (0.00%)  1/18 (5.56%)  0/18 (0.00%) 
Post-traumatic pain †  1/9 (11.11%)  0/9 (0.00%)  0/18 (0.00%)  0/18 (0.00%) 
Scratch †  0/9 (0.00%)  0/9 (0.00%)  1/18 (5.56%)  0/18 (0.00%) 
Superficial injury of eye †  0/9 (0.00%)  0/9 (0.00%)  1/18 (5.56%)  0/18 (0.00%) 
Investigations         
Blood pressure increased †  0/9 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  1/18 (5.56%) 
Cardiac murmur †  0/9 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  1/18 (5.56%) 
Weight decreased †  0/9 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  1/18 (5.56%) 
Metabolism and nutrition disorders         
Decreased appetite †  0/9 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  1/18 (5.56%) 
Hyponatraemia †  0/9 (0.00%)  0/9 (0.00%)  1/18 (5.56%)  0/18 (0.00%) 
Musculoskeletal and connective tissue disorders         
Muscle spasms †  2/9 (22.22%)  2/9 (22.22%)  0/18 (0.00%)  2/18 (11.11%) 
Arthralgia †  0/9 (0.00%)  1/9 (11.11%)  2/18 (11.11%)  2/18 (11.11%) 
Muscular weakness †  1/9 (11.11%)  1/9 (11.11%)  1/18 (5.56%)  2/18 (11.11%) 
Musculoskeletal stiffness †  2/9 (22.22%)  1/9 (11.11%)  0/18 (0.00%)  0/18 (0.00%) 
Neck pain †  1/9 (11.11%)  2/9 (22.22%)  0/18 (0.00%)  0/18 (0.00%) 
Joint range of motion decreased †  0/9 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  1/18 (5.56%) 
Joint swelling †  0/9 (0.00%)  0/9 (0.00%)  1/18 (5.56%)  0/18 (0.00%) 
Muscle twitching †  1/9 (11.11%)  0/9 (0.00%)  0/18 (0.00%)  0/18 (0.00%) 
Soft tissue swelling †  0/9 (0.00%)  1/9 (11.11%)  0/18 (0.00%)  0/18 (0.00%) 
Tendonitis †  0/9 (0.00%)  1/9 (11.11%)  0/18 (0.00%)  0/18 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Malignant melanoma †  0/9 (0.00%)  0/9 (0.00%)  1/18 (5.56%)  0/18 (0.00%) 
Nervous system disorders         
Headache †  3/9 (33.33%)  2/9 (22.22%)  3/18 (16.67%)  3/18 (16.67%) 
Dizziness †  2/9 (22.22%)  1/9 (11.11%)  1/18 (5.56%)  1/18 (5.56%) 
Hypoaesthesia †  1/9 (11.11%)  2/9 (22.22%)  0/18 (0.00%)  0/18 (0.00%) 
Somnolence †  0/9 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  2/18 (11.11%) 
Aphasia †  0/9 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  1/18 (5.56%) 
Migraine †  0/9 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  1/18 (5.56%) 
Muscle spasticity †  0/9 (0.00%)  1/9 (11.11%)  0/18 (0.00%)  0/18 (0.00%) 
Neuropathy peripheral †  1/9 (11.11%)  0/9 (0.00%)  0/18 (0.00%)  0/18 (0.00%) 
Paraesthesia †  0/9 (0.00%)  0/9 (0.00%)  1/18 (5.56%)  0/18 (0.00%) 
Speech disorder †  0/9 (0.00%)  0/9 (0.00%)  1/18 (5.56%)  0/18 (0.00%) 
Psychiatric disorders         
Depression †  2/9 (22.22%)  1/9 (11.11%)  0/18 (0.00%)  1/18 (5.56%) 
Affect lability †  1/9 (11.11%)  0/9 (0.00%)  0/18 (0.00%)  0/18 (0.00%) 
Anxiety †  0/9 (0.00%)  1/9 (11.11%)  0/18 (0.00%)  0/18 (0.00%) 
Confusional state †  1/9 (11.11%)  0/9 (0.00%)  0/18 (0.00%)  0/18 (0.00%) 
Disorientation †  0/9 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  1/18 (5.56%) 
Mental status changes †  0/9 (0.00%)  1/9 (11.11%)  0/18 (0.00%)  0/18 (0.00%) 
Middle insomnia †  0/9 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  1/18 (5.56%) 
Suicidal ideation †  0/9 (0.00%)  1/9 (11.11%)  0/18 (0.00%)  0/18 (0.00%) 
Renal and urinary disorders         
Micturition urgency †  0/9 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  1/18 (5.56%) 
Pollakiuria †  0/9 (0.00%)  0/9 (0.00%)  1/18 (5.56%)  0/18 (0.00%) 
Urinary incontinence †  0/9 (0.00%)  1/9 (11.11%)  0/18 (0.00%)  0/18 (0.00%) 
Reproductive system and breast disorders         
Prostatitis †  1/9 (11.11%)  0/9 (0.00%)  0/18 (0.00%)  0/18 (0.00%) 
Vulvovaginal pruritus †  0/9 (0.00%)  1/9 (11.11%)  0/18 (0.00%)  0/18 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Dyspnoea †  1/9 (11.11%)  1/9 (11.11%)  1/18 (5.56%)  2/18 (11.11%) 
Cough †  0/9 (0.00%)  1/9 (11.11%)  0/18 (0.00%)  1/18 (5.56%) 
Nasal congestion †  0/9 (0.00%)  1/9 (11.11%)  0/18 (0.00%)  1/18 (5.56%) 
Dysphonia †  0/9 (0.00%)  1/9 (11.11%)  0/18 (0.00%)  0/18 (0.00%) 
Epistaxis †  0/9 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  1/18 (5.56%) 
Oropharyngeal pain †  0/9 (0.00%)  1/9 (11.11%)  0/18 (0.00%)  0/18 (0.00%) 
Orthopnoea †  0/9 (0.00%)  1/9 (11.11%)  0/18 (0.00%)  0/18 (0.00%) 
Productive cough †  0/9 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  1/18 (5.56%) 
Respiratory tract congestion †  0/9 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  1/18 (5.56%) 
Rhinitis allergic †  0/9 (0.00%)  1/9 (11.11%)  0/18 (0.00%)  0/18 (0.00%) 
Throat clearing †  0/9 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  1/18 (5.56%) 
Skin and subcutaneous tissue disorders         
Actinic keratosis †  1/9 (11.11%)  0/9 (0.00%)  0/18 (0.00%)  0/18 (0.00%) 
Dermatitis contact †  1/9 (11.11%)  0/9 (0.00%)  0/18 (0.00%)  0/18 (0.00%) 
Hyperhidrosis †  0/9 (0.00%)  1/9 (11.11%)  0/18 (0.00%)  0/18 (0.00%) 
Pruritus †  0/9 (0.00%)  0/9 (0.00%)  1/18 (5.56%)  0/18 (0.00%) 
Rash †  0/9 (0.00%)  0/9 (0.00%)  0/18 (0.00%)  1/18 (5.56%) 
Vascular disorders         
Flushing †  0/9 (0.00%)  0/9 (0.00%)  1/18 (5.56%)  0/18 (0.00%) 
Hypertension †  0/9 (0.00%)  0/9 (0.00%)  1/18 (5.56%)  0/18 (0.00%) 
†
Indicates events were collected by systematic assessment
[Not Specified]
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.
PI will not submit any results of the Study until after the first to occur: publication of the trial results, notification by Sponsor the trial submission is no longer planned, or the 18 month anniversary of the completion or early termination of the trial. A copy of any proposed publication or disclosure of the results of the Study will be given to Sponsor for review at least 30 days prior to the date of submission for publication (including abstracts) or of public disclosure
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Laura Batterman
Organization: Eledon Pharmaceuticals
Phone: 949-874-3487
EMail: lbatterman@eledon.com
Layout table for additonal information
Responsible Party: Eledon Pharmaceuticals ( Anelixis Therapeutics, LLC )
ClinicalTrials.gov Identifier: NCT04322149    
Other Study ID Numbers: AT-1501-A201
First Submitted: March 20, 2020
First Posted: March 26, 2020
Results First Submitted: May 10, 2023
Results First Posted: June 28, 2023
Last Update Posted: June 28, 2023