Study Assessing Efficacy and Safety of AKST4290 in Subjects With Parkinson's Disease on Stable Dopaminergic Treatment (TEAL)

• ClinicalTrials.gov Identifier: NCT04369430
• Recruitment Status: Completed
• First Posted: April 30, 2020
• Results First Posted: October 10, 2022
• Last Update Posted: October 10, 2022
• Sponsor: Alkahest, Inc.
• Information provided by (Responsible Party): Alkahest, Inc.

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Parkinson Disease
• Interventions: Drug: AKST4290; Drug: Placebo
• Enrollment: 110

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	AKST4290	Placebo
Arm/Group Description	Subjects will receive AKST4290, 400 mg twice daily, for 12 weeks. AKST4290: Oral AKST4290	Subjects will receive placebo, twice daily, for 12 weeks. Placebo: Oral Placebo
Period Title: Overall Study
Started	55	55
Completed	46	47
Not Completed	9	8
Reason Not Completed
Adverse Event	2	3
Death	1	0
Withdrawal by Subject	4	3
COVID concern, Sponsor's decision	2	1
Lost to Follow-up	0	1

Baseline Characteristics

Arm/Group Title		AKST4290	Placebo	Total
Arm/Group Description		Subjects will receive AKST4290, 400 mg twice daily, for 12 weeks. AKST4290: Oral AKST4290	Subjects will receive placebo, twice daily, for 12 weeks. Placebo: Oral Placebo	Total of all reporting groups
Overall Number of Baseline Participants		55	55	110
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	55 participants	55 participants	110 participants
		63.1 (8.07)	64.9 (6.74)	64.0 (7.45)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	55 participants	55 participants	110 participants
	Female	21 38.2%	21 38.2%	42 38.2%
	Male	34 61.8%	34 61.8%	68 61.8%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	55 participants	55 participants	110 participants
	Hispanic or Latino	0 0.0%	0 0.0%	0 0.0%
	Not Hispanic or Latino	55 100.0%	55 100.0%	110 100.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	55 participants	55 participants	110 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	0 0.0%	0 0.0%	0 0.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	1 1.8%	1 1.8%	2 1.8%
	White	54 98.2%	53 96.4%	107 97.3%
	More than one race	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	0 0.0%	1 1.8%	1 0.9%
Education; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	55 participants	55 participants	110 participants
	Grade School	30 54.5%	27 49.1%	57 51.8%
	University	14 25.5%	19 34.5%	33 30.0%
	Masters	9 16.4%	9 16.4%	18 16.4%
	PhD/Medical School	2 3.6%	0 0.0%	2 1.8%
Baseline BMI; Mean (Standard Deviation); Unit of measure: (kg/m^2)
	Number Analyzed	55 participants	55 participants	110 participants
		28.12 (4.986)	27.91 (4.417)	28.02 (4.689)
Disease Duration [1]; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	52 participants	55 participants	107 participants
		5.71 (3.138)	7.62 (5.467)	6.69 (4.571)
		[1] Measure Analysis Population Description: Disease duration was not captured for 3 subjects who were randomized but not treated.
Modified Hoehn and Yahr; Measure Type: Count of Participants; Unit of measure: Participants
No signs of disease	Number Analyzed	55 participants	55 participants	110 participants
		0 0.0%	0 0.0%	0 0.0%
Unilateral disease	Number Analyzed	55 participants	55 participants	110 participants
		5 9.1%	5 9.1%	10 9.1%
Unilateral plus axial involvement	Number Analyzed	55 participants	55 participants	110 participants
		5 9.1%	6 10.9%	11 10.0%
Bilateral disease, without impairment of balance	Number Analyzed	55 participants	55 participants	110 participants
		32 58.2%	32 58.2%	64 58.2%
Mild bilateral disease, with recovery on pull test	Number Analyzed	55 participants	55 participants	110 participants
		13 23.6%	12 21.8%	25 22.7%
Movement Disorder Society's Unified PD Rating Scale (MDS-UPDRS) Part 3 in the off-medication state [1] [2]; Mean (Standard Deviation); Unit of measure: Score on a scale
	Number Analyzed	52 participants	55 participants	107 participants
		35.2 (14.17)	38.5 (12.44)	36.9 (13.35)
		[1] Measure Description: Sum of the corresponding items for Part 3 of the Movement Disorder Society's Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (33 scores based on 18 questions with several right, left, or both body distribution scores) in the off-medication state. Each Parkinsonian sign or symptom is rated on a 5-point Likert-type scale (ranging from 0 to 4), with higher scores indicating more severe impairment. The minimum score on the MDS-UPDRS Part 3 is 0 and the maximum is 132.; [2] Measure Analysis Population Description: MDPRS Part 3 in the off-medication state was not captured for 3 subjects who were randomized but not treated.

Outcome Measures

1. Primary Outcome

Title	Change in Motor Function During Levodopa Withdrawal.
Description	Movement Disorder Society's Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Part 3 Motor Examination has 33 scores based on 18 questions with several right, left, or both body distribution scores. Each Parkinsonian sign or symptom is rated on a 5-point Likert-type scale (ranging from 0 to 4), with higher scores indicating more severe impairment. The minimum score on the MDS-UPDRS Part 3 is 0 and the maximum is 132. Outcome is the mean change from Baseline in motor function during the practically defined off-medication state, defined as at least 12 hours off levodopa, at Week 12, with lower score representing better outcome.
Time Frame	Baseline to 12 weeks

Outcome Measure Data

Analysis Population Description

Modified Intent-to-Treat/Evaluables (Subjects with nonmissing Baseline and primary endpoint data)

Arm/Group Title	AKST4290	Placebo
Arm/Group Description:	Subjects will receive AKST4290, 400 mg twice daily, for 12 weeks. AKST4290: Oral AKST4290	Subjects will receive placebo, twice daily, for 12 weeks. Placebo: Oral Placebo
Overall Number of Participants Analyzed	45	45
Least Squares Mean (Standard Error); Unit of Measure: score on a scale
	-4.210 (1.1844)	-5.114 (1.1839)

2. Secondary Outcome

Title	Safety as Assessed by the Incidence, Seriousness and Severity of Adverse Events (AEs).
Description	Incidence of treatment-emergent adverse events (TEAEs) and serious TEAEs, grouped by severity, relationship to study treatment, and AEs leading to discontinuation of study participation. Incidence was presented as number of subject with TEAEs and serious TEAEs, grouped by severity, relationship to study treatment, and AEs leading to discontinuation of study participation, throughout study duration.
Time Frame	Baseline to week 14

Outcome Measure Data

Analysis Population Description

Safety Population (all subjects who received at least one dose of the study medication). Subjects with different severity or relationship to study treatment will be counted only once at the highest grade of event.

Arm/Group Title	AKST4290	Placebo
Arm/Group Description:	Subjects will receive AKST4290, 400 mg twice daily, for 12 weeks. AKST4290: Oral AKST4290	Subjects will receive placebo, twice daily, for 12 weeks. Placebo: Oral Placebo
Overall Number of Participants Analyzed	52	55
Measure Type: Number; Unit of Measure: participants
Subjects with any TEAEs - Severity : Mild	12	17
Subjects with any TEAEs - Severity : Moderate	6	9
Subjects with any TEAEs - Severity : Severe	1	0
Subjects with any Serious TEAEs - Severity : Mild	0	0
Subjects with any Serious TEAEs - Severity : Moderate	0	3
Subjects with any Serious TEAEs - Severity : Severe	1	0
Subjects with any TEAEs - Relationship to Study Treatment: Unrelated	9	14
Subjects with any TEAEs - Relationship to Study Treatment: Possibly Related	10	11
Subjects with any TEAEs - Relationship to Study Treatment: Definitely Related	0	1
Subjects with any Serious TEAEs - Relationship to Study Treatment: Unrelated	1	3
Subjects with any Serious TEAEs - Relationship to Study Treatment: Possibly Related	0	0
Subjects with any Serious TEAEs - Relationship to Study Treatment: Definitely Related	0	3
Subjects with any TEAEs - AEs leading to discontinuation of study participation	2	2
Subjects with any Serious TEAEs - AEs leading to discontinuation of study participation	0	1

3. Secondary Outcome

Title	Evaluation of Laboratory Changes.
Description	Incidence of of abnormalities or clinically significant changes from Baseline in laboratory test data (chemistry, hematology, coagulation, and urinalysis). Incidence was presented as number of subjects abnormal labs indicating serious condition occurred within the analysis population throughout study duration.
Time Frame	Baseline to week 14

Outcome Measure Data

Analysis Population Description

Safety Population (all subjects who received at least one dose of the study medication).

Arm/Group Title	AKST4290	Placebo
Arm/Group Description:	Subjects will receive AKST4290, 400 mg twice daily, for 12 weeks. AKST4290: Oral AKST4290	Subjects will receive placebo, twice daily, for 12 weeks. Placebo: Oral Placebo
Overall Number of Participants Analyzed	52	55
Measure Type: Count of Participants; Unit of Measure: Participants
Abnormal Blood Chemistry Labs	18 34.6%	12 21.8%
Abnormal Hematology Labs	2 3.8%	1 1.8%
Abnormal Urinalysis Labs	0 0.0%	0 0.0%
Abnormal Coagulation Labs	2 3.8%	4 7.3%

4. Secondary Outcome

Title	Evaluation of Vital Sign Changes.
Description	Incidence of abnormalities or clinically-significant changes from Baseline in Vital sign measurements (blood pressure as measured in mmHg, heart rate as measured in beats per minute, and temperature as measured in degrees Fahrenheit or Celsius). Incidence was presented as number of subjects with abnormalities or clinically-significant changes from Baseline in Vital sign measurements within the analysis group throughout study duration.
Time Frame	Baseline to week 12

Outcome Measure Data

Analysis Population Description

Safety Population (all subjects who received at least one dose of the study medication); only Abnormal, Clinically Significant incidences were reported in the Outcome Measure Data Table.

Arm/Group Title	AKST4290	Placebo
Arm/Group Description:	Subjects will receive AKST4290, 400 mg twice daily, for 12 weeks. AKST4290: Oral AKST4290	Subjects will receive placebo, twice daily, for 12 weeks. Placebo: Oral Placebo
Overall Number of Participants Analyzed	46	48
Measure Type: Count of Participants; Unit of Measure: Participants
	0 0.0%	2 4.2%

5. Secondary Outcome

Title	Evaluation of Electrocardiogram Changes.
Description	Incidence of abnormalities or clinically-significant changes from Baseline in 12-lead electrocardiogram (ECG) QT-interval. Incidence was presented as number of subject with ECG changes throughout study duration.
Time Frame	Baseline to week 12

Outcome Measure Data

Analysis Population Description

Safety Population (all subjects who received at least one dose of the study medication)

Arm/Group Title	AKST4290	Placebo
Arm/Group Description:	Subjects will receive AKST4290, 400 mg twice daily, for 12 weeks. AKST4290: Oral AKST4290	Subjects will receive placebo, twice daily, for 12 weeks. Placebo: Oral Placebo
Overall Number of Participants Analyzed	45	47
Measure Type: Count of Participants; Unit of Measure: Participants
Normal	35 77.8%	26 55.3%
Abnormal, Not Clinically Significant	10 22.2%	16 34.0%
Abnormal, Clinically Significant	0 0.0%	5 10.6%

6. Secondary Outcome

Title	The Movement Disorder Society's Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts 1-4, Change From Baseline During the On-medication State.
Description	The MDS-UPDRS has 4 components (details below). The rating for each item is from 0 (normal) to 4 (severe). The score for each Part is obtained from the sum of the corresponding item scores, with higher scores indicating more severe impairment. Part I, Non-Motor Aspects (Mentation, Behavior, and Mood) of Experiences of Daily Living (13 items), score range is 0-52. Part II, Motor Aspects of Experiences of Daily Living (13 items), score range is 0-52. Part III, Motor Examination (33 items), score range is 0-132. Part IV, Motor Complications (6 items), score range is 0-24. The outcome is the mean change from Baseline motor function during the on-medication state at Week 12, with lower value representing a better outcome.
Time Frame	Baseline to week 12

Outcome Measure Data

Analysis Population Description

Modified Intent-to-Treat/Evaluables (All subjects with nonmissing Baseline and primary endpoint data)

Arm/Group Title	AKST4290	Placebo
Arm/Group Description:	Subjects will receive AKST4290, 400 mg twice daily, for 12 weeks. AKST4290: Oral AKST4290	Subjects will receive placebo, twice daily, for 12 weeks. Placebo: Oral Placebo
Overall Number of Participants Analyzed	45	45
Least Squares Mean (Standard Error); Unit of Measure: score on a scale
MDS-UPDRS Part 1	-0.412 (0.4581)	-0.827 (0.4581)
MDS-UPDRS Part 2	-0.929 (0.4552)	0.023 (0.4552)
MDS-UPDRS Part 3	-1.340 (1.0729)	-1.300 (1.0728)
MDS-UPDRS Part 4	-0.130 (0.3129)	-0.160 (0.3129)

7. Secondary Outcome

Title	The Montreal Cognitive Assessment (MoCA), Change From Baseline in MoCA During the On-medication State.
Description	The Montreal Cognitive Assessment (MoCA) is a neuropsychological tool that requires approximately 15 minutes to assess the following domains: attention, executive function, memory, language, visuoconstructional skills, and orientation. MoCA scores range between 0 and 30, with higher scores indicating more intact cognition. The MoCA is administered at Baseline and Week 12 in the on-medication state. The total score will be summarized at each scheduled time point. The outcome is mean change from baseline in MoCA during the on-medication state at Week 12, with higher value representing a better outcome.
Time Frame	Baseline to week 12

Outcome Measure Data

Analysis Population Description

Modified Intent-to-Treat/Evaluables (All subjects with nonmissing Baseline and primary endpoint data)

Arm/Group Title	AKST4290	Placebo
Arm/Group Description:	Subjects will receive AKST4290, 400 mg twice daily, for 12 weeks. AKST4290: Oral AKST4290	Subjects will receive placebo, twice daily, for 12 weeks. Placebo: Oral Placebo
Overall Number of Participants Analyzed	43	44
Least Squares Mean (Standard Error); Unit of Measure: score on a scale
	0.0 (0.23)	-0.2 (0.23)

8. Secondary Outcome

Title	The Schwab and England Activities of Daily Living (SE-ADL) Scale, Change From Baseline in SE-ADL During the On-medication State.
Description	The SE-ADL evaluates patients' perceptions of global functional capacity and dependence. Scoring is expressed in terms of percentage, in 10 steps from 100 to 0 (100% indicates completely independent, 0% indicates bedridden with impaired vegetative functions), so that the lower the score, the worse the functional status. Scores will be summarized descriptively at each scheduled time point (i.e. n, %) by treatment group. A Generalized Estimating Equations (GEE) for alternating logistic regression (ALR) with an exchangeable working correlation structure will be employed to analyze change from baseline. Outcome is mean change from baseline in SE-ADL during the on-medication state at Week 12, with higher values represents a better outcome.
Time Frame	Baseline to week 12

Outcome Measure Data

Analysis Population Description

Modified Intent-to-Treat/Evaluables (All subjects with nonmissing Baseline and primary endpoint data)

Arm/Group Title	AKST4290	Placebo
Arm/Group Description:	Subjects will receive AKST4290, 400 mg twice daily, for 12 weeks. AKST4290: Oral AKST4290	Subjects will receive placebo, twice daily, for 12 weeks. Placebo: Oral Placebo
Overall Number of Participants Analyzed	45	45
Least Squares Mean (Standard Error); Unit of Measure: score on a scale
	1.7 (0.91)	1.7 (0.92)

9. Secondary Outcome

Title	The Clinical Impression of Severity Index - PD (CISI-PD), Change From Baseline in CISI-PD During the On-medication State.
Description	The CISI-PD is a severity index formed by four items (motor signs, disability, motor complications, and cognitive status), rated 0 (not at all) to 6 (very severe or completely disabled). A total score is calculated by summing the item scores, total scores range from 0-24. The outcome is the mean change from baseline in CISI-PD during the on-medication state at Week 12, with lower score represents a better outcome.
Time Frame	Baseline to week 12

Outcome Measure Data

Analysis Population Description

Modified Intent-to-Treat/Evaluables (All subjects with nonmissing Baseline and primary endpoint data)

Arm/Group Title	AKST4290	Placebo
Arm/Group Description:	Subjects will receive AKST4290, 400 mg twice daily, for 12 weeks. AKST4290: Oral AKST4290	Subjects will receive placebo, twice daily, for 12 weeks. Placebo: Oral Placebo
Overall Number of Participants Analyzed	45	45
Least Squares Mean (Standard Error); Unit of Measure: score on a scale
	-0.662 (0.2867)	-0.271 (0.2867)

10. Secondary Outcome

Title	The Parkinson's Disease Quality of Life Questionnaire-39 (PDQ-39), Change From Baseline in PDQ-39 During the On-medication State.
Description	The PDQ-39 is a patient-reported outcome of 39 questions relating to 8 key areas of health and daily activities, including both motor and non-motor symptoms. The eight dimensions include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. It is scored on a scale of 0-100 with lower scores indicating better health and high scores indicating more severe symptoms, applying to all dimensions reported in the data table. Outcome is the mean change from baseline in PDQ-39 during the on-medication state at Week 12, with lower score represents a better outcome.
Time Frame	Baseline to week 12

Outcome Measure Data

Analysis Population Description

Modified Intent-to-Treat/Evaluables (All subjects with nonmissing Baseline and primary endpoint data)

Arm/Group Title	AKST4290	Placebo
Arm/Group Description:	Subjects will receive AKST4290, 400 mg twice daily, for 12 weeks. AKST4290: Oral AKST4290	Subjects will receive placebo, twice daily, for 12 weeks. Placebo: Oral Placebo
Overall Number of Participants Analyzed	45	45
Least Squares Mean (Standard Error); Unit of Measure: score on a scale
Mobility	-5.021 (1.8531)	-0.744 (1.8531)
Activities of Daily Living	-5.557 (1.6972)	-3.022 (1.6972)
Emotional Well-Being	-7.299 (1.7185)	-4.602 (1.7184)
Stigma	-6.372 (1.4910)	-2.602 (1.4912)
Social Support	-3.996 (1.7285)	-0.788 (1.7285)
Cognition	-5.415 (1.5881)	-5.693 (1.5881)
Communication	-5.736 (1.5486)	-1.826 (1.5488)
Bodily Discomfort	-5.660 (2.2787)	-5.594 (2.2786)
PDQ-39 Single Index	-5.649 (1.1485)	-3.107 (1.1484)

11. Secondary Outcome

Title	The Sheehan-Suicidality Tracking Scale (S-STS), Change From Baseline in S-STS During the On-medication State.
Description	The standard version of the S-STS is a 16-item scale that assesses the seriousness of suicidality phenomena on a Likert-type scale (0-4) ranging from "not at all" (0) to "extremely" (4), where higher scores indicate more risk of suicidality. It also assesses the frequency of key phenomena and the overall time spent in suicidality. Total score is a sum of all items; total score ranges from 0-64. Outcome is the mean change from baseline in S-STS during the on-medication state at Week 12, with higher score represents a worse outcome.
Time Frame	Baseline to week 12

Outcome Measure Data

Analysis Population Description

Modified Intent-to-Treat/Evaluables (All subjects with nonmissing Baseline and primary endpoint data)

Arm/Group Title	AKST4290	Placebo
Arm/Group Description:	Subjects will receive AKST4290, 400 mg twice daily, for 12 weeks. AKST4290: Oral AKST4290	Subjects will receive placebo, twice daily, for 12 weeks. Placebo: Oral Placebo
Overall Number of Participants Analyzed	45	45
Least Squares Mean (Standard Error); Unit of Measure: score on a scale
	0.0 (0.00)	0.0 (0.00)

12. Secondary Outcome

Title	10-meter Timed Walk, Change in Baseline 10-meter Timed Walk During the on and Off-medication State
Description	The 10-meter walk test is a commonly used tool for assessing gait speed in individuals with gait limitations. Gait speed is positively correlated with the amount of community ambulation and quality of life, and it is an important measure of mobility in individuals with PD, with higher value corresponds to better mobility. Outcome is the mean change from baseline comfortable walking speed (gait), fast walking speed (gait), during the on and off-medication state at Week 12, with higher score represents a better outcome.
Time Frame	Baseline to week 12

Outcome Measure Data

Analysis Population Description

Modified Intent-to-Treat/Evaluables (All subjects with nonmissing Baseline and primary endpoint data)

Arm/Group Title	AKST4290	Placebo
Arm/Group Description:	Subjects will receive AKST4290, 400 mg twice daily, for 12 weeks. AKST4290: Oral AKST4290	Subjects will receive placebo, twice daily, for 12 weeks. Placebo: Oral Placebo
Overall Number of Participants Analyzed	45	44
Least Squares Mean (Standard Error); Unit of Measure: m/s
Comfortable Walking Speed (Off-medication)	0.091 (0.0326)	0.084 (0.0329)
Comfortable Walking Speed (On-medication)	0.030 (0.0293)	0.041 (0.0295)
Fast Walking Speed (Off-medication)	0.107 (0.0413)	0.150 (0.0417)
Fast Walking Speed (On-medication)	0.041 (0.0405)	0.075 (0.0407)

13. Secondary Outcome

Title	Hauser 3-Day Patient Diary, Change in Baseline Mean Time Spent With and Without Troublesome Dyskinesia as Measured by the Hauser 3-Day Patient Diary
Description	The Hauser Patient Diary was developed to assess functional status over a period of time in patients with motor fluctuations and dyskinesia by recording patient motor state for half-hour intervals over a 24-hour period. The outcome is mean change of Mean Time Spent with and without troublesome dyskinesia from Baseline at Week 12. ON/OFF-time is time when medication is providing/not providing benefit with regard to mobility, slowness, and stiffness, respectively. Troublesome dyskinesia is defined as dyskinesia that interfere with function or causes meaningful discomfort. Bad time is defined as the sum of off time and on time with troublesome dyskinesia. Lower value represents a better outcome. Good time is defined as the on time without dyskinesia plus on time with non-troublesome dyskinesia. Higher value represents a better outcome.
Time Frame	Baseline to week 12

Outcome Measure Data

Analysis Population Description

Modified Intent-to-Treat/Evaluables (All subjects with nonmissing Baseline and primary endpoint data)

Arm/Group Title	AKST4290	Placebo
Arm/Group Description:	Subjects will receive AKST4290, 400 mg twice daily, for 12 weeks. AKST4290: Oral AKST4290	Subjects will receive placebo, twice daily, for 12 weeks. Placebo: Oral Placebo
Overall Number of Participants Analyzed	45	45
Least Squares Mean (Standard Error); Unit of Measure: hours
Mean Bad Time	-1.1 (1.06)	-1.3 (1.06)
Mean Good time	1.7 (1.24)	0.4 (1.24)

Adverse Events

Time Frame	Baseline to Week 14
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	AKST4290	Placebo
Arm/Group Description	Subjects will receive AKST4290, 400 mg twice daily, for 12 weeks. AKST4290: Oral AKST4290	Subjects will receive placebo, twice daily, for 12 weeks. Placebo: Oral Placebo
All-Cause Mortality
	AKST4290	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	1/52 (1.92%)	0/55 (0.00%)
Serious Adverse Events
	AKST4290	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	1/52 (1.92%)	3/55 (5.45%)
General disorders
Sudden cardiac death † 1	1/52 (1.92%)	0/55 (0.00%)
Infections and infestations
Clostridium difficile colitis † 1	0/52 (0.00%)	1/55 (1.82%)
Injury, poisoning and procedural complications
Meniscus injury † 1	0/52 (0.00%)	1/55 (1.82%)
Psychiatric disorders
Neuropsychiatric syndrome † 1	0/52 (0.00%)	1/55 (1.82%)
1 Term from vocabulary, MedDRA 23.0; † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	AKST4290	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	8/52 (15.38%)	11/55 (20.00%)
Gastrointestinal disorders
Nausea † 1	3/52 (5.77%)	0/55 (0.00%)
General disorders
Fatigue † 1	3/52 (5.77%)	0/55 (0.00%)
Injury, poisoning and procedural complications
Fall † 1	0/52 (0.00%)	3/55 (5.45%)
Investigations
Electrocardiogram QT prolonged † 1	1/52 (1.92%)	4/55 (7.27%)
Musculoskeletal and connective tissue disorders
Back pain † 1	1/52 (1.92%)	4/55 (7.27%)
1 Term from vocabulary, MedDRA 23.0; † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

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.

Institution and its employees and agents, and Principal Investigator shall not disclose to any third party or use for any purpose other than in the fulfillment of their respective obligations hereunder, any data, records or other information disclosed to Institution and Principal Investigator by Sponsor or Clinical Research Organization, or generated as a result of this Study, without the prior written consent of Sponsor (or PPD as the case may be) (hereinafter, collectively "Information").

Results Point of Contact

• Name/Title: Clinical Development
• Organization: Alkahest, Inc.
• Phone: (650) 801-0474
• EMail: trials@alkahest.com

• Responsible Party: Alkahest, Inc.
• ClinicalTrials.gov Identifier: NCT04369430
• Other Study ID Numbers: AKST4290-211
• First Submitted: April 13, 2020
• First Posted: April 30, 2020
• Results First Submitted: April 11, 2022
• Results First Posted: October 10, 2022
• Last Update Posted: October 10, 2022