Trial Outcomes & Findings for A Double-blind Study to Evaluate the Safety of Glutamic Acid Decarboxylase Gene Transfer in Parkinson's Participants (NCT NCT05603312)

NCT ID: NCT05603312

Last Updated: 2025-09-05

Results Overview

The primary outcome measure is the safety of treatment with AAV-GAD, assessed by the absence of IMP-related treatment-emergent adverse events.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 14 participants
• Primary outcome timeframe: Baseline to Week 26
• Results posted on: 2025-09-05

Participant Flow

Participants were recruited from 6 medical centers in the United States (US). A total of 14 participants were enrolled in the study.

Participant milestones

Measure	AAV-GAD Low Dose Bilateral infusion of AAV-GAD Low Dose into the STN	AAV-GAD High Dose Bilateral infusion of AAV-GAD High Dose into the STN	Sham Surgery Sham infusion
Overall Study STARTED	5	5	4
Overall Study COMPLETED	5	5	4
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Double-blind Study to Evaluate the Safety of Glutamic Acid Decarboxylase Gene Transfer in Parkinson's Participants

Baseline characteristics by cohort

Measure	AAV-GAD Low Dose n=5 Participants Bilateral infusion of AAV-GAD Low Dose into the STN	AAV-GAD High Dose n=5 Participants Bilateral infusion of AAV-GAD High Dose into the STN	Sham Surgery n=4 Participants Sham infusion	Total n=14 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	9 Participants n=4 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	11 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	14 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	14 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	5 participants n=5 Participants	5 participants n=7 Participants	4 participants n=5 Participants	14 participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline to Week 26

The primary outcome measure is the safety of treatment with AAV-GAD, assessed by the absence of IMP-related treatment-emergent adverse events.

Outcome measures

Measure	AAV-GAD Low Dose n=5 Participants Bilateral infusion of AAV-GAD Low Dose into the STN	AAV-GAD High Dose n=5 Participants Bilateral infusion of AAV-GAD High Dose into the STN	Sham Surgery n=4 Participants Sham infusion
Incidence of Adverse Events Related to the Treatment	0 Participants	1 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline to Week 26

The primary outcome measure is the safety of treatment with AAV-GAD, assessed by the absence of IMP-related serious treatment-emergent adverse events.

Outcome measures

Measure	AAV-GAD Low Dose n=5 Participants Bilateral infusion of AAV-GAD Low Dose into the STN	AAV-GAD High Dose n=5 Participants Bilateral infusion of AAV-GAD High Dose into the STN	Sham Surgery n=4 Participants Sham infusion
Incidence of Serious Adverse Events Related to the Treatment	0 Participants	0 Participants	0 Participants

Adverse Events

AAV-GAD Low Dose

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

AAV-GAD High Dose

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Sham Surgery

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	AAV-GAD Low Dose n=5 participants at risk Bilateral infusion of AAV-GAD Low Dose into the STN	AAV-GAD High Dose n=5 participants at risk Bilateral infusion of AAV-GAD High Dose into the STN	Sham Surgery n=4 participants at risk Sham infusion
General disorders Catheter site haemorrhage	20.0% 1/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	0.00% 0/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	0.00% 0/4 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.
Nervous system disorders Freezing phenomenon	20.0% 1/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	0.00% 0/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	0.00% 0/4 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.
Renal and urinary disorders Urinary retention	0.00% 0/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	0.00% 0/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	25.0% 1/4 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.

Other adverse events

Measure	AAV-GAD Low Dose n=5 participants at risk Bilateral infusion of AAV-GAD Low Dose into the STN	AAV-GAD High Dose n=5 participants at risk Bilateral infusion of AAV-GAD High Dose into the STN	Sham Surgery n=4 participants at risk Sham infusion
Investigations Red blood cells urine positive	0.00% 0/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	0.00% 0/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	25.0% 1/4 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.
Cardiac disorders Palpitations	0.00% 0/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	20.0% 1/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	0.00% 0/4 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.
Eye disorders Eye swelling	0.00% 0/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	20.0% 1/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	0.00% 0/4 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.
Eye disorders Periorbital oedema	20.0% 1/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	0.00% 0/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	0.00% 0/4 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.
Eye disorders Vision blurred	0.00% 0/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	20.0% 1/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	0.00% 0/4 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.
Gastrointestinal disorders Dry mouth	0.00% 0/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	0.00% 0/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	25.0% 1/4 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.
Gastrointestinal disorders Vomiting	0.00% 0/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	20.0% 1/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	0.00% 0/4 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.
General disorders Fatigue	20.0% 1/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	40.0% 2/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	0.00% 0/4 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.
General disorders Gait disturbance	0.00% 0/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	0.00% 0/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	25.0% 1/4 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.
General disorders Peripheral swelling	0.00% 0/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	20.0% 1/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	0.00% 0/4 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.
Infections and infestations Acute sinusitis	0.00% 0/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	20.0% 1/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	0.00% 0/4 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.
Infections and infestations Urinary tract infection	20.0% 1/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	0.00% 0/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	25.0% 1/4 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	0.00% 0/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	25.0% 1/4 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.
Injury, poisoning and procedural complications Confusion postoperative	20.0% 1/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	0.00% 0/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	0.00% 0/4 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.
Injury, poisoning and procedural complications Eye contusion	0.00% 0/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	20.0% 1/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	0.00% 0/4 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.
Investigations Reflex test abnormal	0.00% 0/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	20.0% 1/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	0.00% 0/4 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.
Injury, poisoning and procedural complications Fall	20.0% 1/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	0.00% 0/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	0.00% 0/4 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.
Investigations Computerised tomogram abnormal	20.0% 1/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	20.0% 1/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	0.00% 0/4 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.
Investigations Haematocrit decreased	0.00% 0/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	20.0% 1/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	0.00% 0/4 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	20.0% 1/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	0.00% 0/4 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.
Musculoskeletal and connective tissue disorders Muscle rigidity	0.00% 0/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	0.00% 0/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	25.0% 1/4 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	20.0% 1/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	0.00% 0/4 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	20.0% 1/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	0.00% 0/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	0.00% 0/4 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.
Musculoskeletal and connective tissue disorders Pain in extremity	20.0% 1/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	0.00% 0/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	0.00% 0/4 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.
Musculoskeletal and connective tissue disorders Torticollis	0.00% 0/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	0.00% 0/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	25.0% 1/4 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.
Nervous system disorders Balance disorder	0.00% 0/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	0.00% 0/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	25.0% 1/4 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.
Nervous system disorders Cognitive disorder	0.00% 0/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	20.0% 1/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	0.00% 0/4 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.
Nervous system disorders Dyskinesia	20.0% 1/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	20.0% 1/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	25.0% 1/4 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.
Nervous system disorders Facial spasm	0.00% 0/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	20.0% 1/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	0.00% 0/4 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.
Nervous system disorders Head discomfort	0.00% 0/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	20.0% 1/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	0.00% 0/4 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.
Nervous system disorders Headache	20.0% 1/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	60.0% 3/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	0.00% 0/4 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.
Nervous system disorders Hyperreflexia	0.00% 0/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	20.0% 1/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	0.00% 0/4 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.
Nervous system disorders Hypoaesthesia	0.00% 0/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	20.0% 1/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	0.00% 0/4 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.
Nervous system disorders On and off phenomenon	0.00% 0/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	0.00% 0/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	25.0% 1/4 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.
Nervous system disorders Paraesthesia	20.0% 1/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	0.00% 0/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	0.00% 0/4 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.
Psychiatric disorders Anxiety	0.00% 0/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	0.00% 0/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	25.0% 1/4 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.
Psychiatric disorders Confusional state	0.00% 0/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	20.0% 1/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	0.00% 0/4 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.
Psychiatric disorders Hallucination, visual	0.00% 0/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	20.0% 1/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	0.00% 0/4 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.
Psychiatric disorders Mental status changes	0.00% 0/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	20.0% 1/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	0.00% 0/4 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	20.0% 1/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	0.00% 0/4 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	20.0% 1/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	0.00% 0/4 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.
Vascular disorders Flushing	0.00% 0/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	0.00% 0/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	25.0% 1/4 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.
Vascular disorders Thrombophlebitis	0.00% 0/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	20.0% 1/5 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.	0.00% 0/4 • From the signing of the Informed Consent Form to Week 26 Safety was evaluated by vital signs, neurological and physical examinations, electrocardiograms, radiographic imaging, and clinical laboratory tests. Treatment-related AEs were reported in 1 participant. This participant (high-dose group) experienced mild confusion and a mild headache perioperatively. These events started on the day of surgery and resolved the same day and 11 days later, respectively. All other AEs and all SAEs were assessed by the Investigator as unrelated to the study drug.

Additional Information

Program Manager

MeiraGTx, LLC

Phone: 646-860-7982

Email: patients@meiragtx.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place