Trial Outcomes & Findings for Effects of Ondansetron in Obsessive-compulsive and Tic Disorders (NCT NCT03239210)

Last Updated: 2024-05-03

Results Overview

Change in brain activation is measured by parameter estimate of blood-oxygen-level dependent (BOLD) signal change in the insula cortex. BOLD signal is captured via functional MRI taken during MRI scanning sessions. Participants viewed "body-focused" videos (e.g., close-ups of a brush stroking a hand) alternating with control videos depicting similar types of movements but without body parts (e.g., a pen moving across a table) in an MRI scanner. Analysis examined change in brain activation between baseline and final during the viewing of body-focused videos compared to control videos. The outcome measure is the change in brain activation (Baseline minus Final) averaged across the right and left insula regions of interest.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

110 participants

Primary outcome timeframe

Baseline, Week 4

Results posted on

2024-05-03

Participant Flow

Participant milestones

Participant milestones
Measure	Ondansetron (OND) 24 mg/day for 4 weeks Ondansetron: 5-HT3 (serotonin receptor type 3) antagonist commonly used to treat nausea and vomiting	Placebo (PL) Placebo pill Placebo: placebo equivalent
Overall Study STARTED	33	29
Overall Study COMPLETED	27	24
Overall Study NOT COMPLETED	6	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Ondansetron (OND) 24 mg/day for 4 weeks Ondansetron: 5-HT3 (serotonin receptor type 3) antagonist commonly used to treat nausea and vomiting	Placebo (PL) Placebo pill Placebo: placebo equivalent
Overall Study Lost to Follow-up	2	2
Overall Study Withdrawal by subject (personal reasons)	2	2
Overall Study Withdrawal by subject (reported medical side effects)	2	1

Baseline Characteristics

Effects of Ondansetron in Obsessive-compulsive and Tic Disorders

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ondansetron (OND) n=27 Participants 24 mg/day for 4 weeks Ondansetron: 5-HT3 (serotonin receptor type 3) antagonist commonly used to treat nausea and vomiting	Placebo (PL) n=24 Participants Placebo pill Placebo: placebo equivalent	Total n=51 Participants Total of all reporting groups
Age, Continuous	31 years STANDARD_DEVIATION 9.96 • n=99 Participants	29 years STANDARD_DEVIATION 12.52 • n=107 Participants	30 years STANDARD_DEVIATION 11.16 • n=206 Participants
Sex: Female, Male Female	13 Participants n=99 Participants	14 Participants n=107 Participants	27 Participants n=206 Participants
Sex: Female, Male Male	14 Participants n=99 Participants	10 Participants n=107 Participants	24 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=99 Participants	6 Participants n=107 Participants	10 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	23 Participants n=99 Participants	18 Participants n=107 Participants	41 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	3 Participants n=99 Participants	1 Participants n=107 Participants	4 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	1 Participants n=99 Participants	2 Participants n=107 Participants	3 Participants n=206 Participants
Race (NIH/OMB) White	21 Participants n=99 Participants	20 Participants n=107 Participants	41 Participants n=206 Participants
Race (NIH/OMB) More than one race	2 Participants n=99 Participants	1 Participants n=107 Participants	3 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Region of Enrollment United States	27 participants n=99 Participants	24 participants n=107 Participants	51 participants n=206 Participants

PRIMARY outcome

Timeframe: Baseline, Week 4

Outcome measures

Outcome measures
Measure	Ondansetron (OND) n=26 Participants 24 mg/day for 4 weeks Ondansetron: 5-HT3 (serotonin receptor type 3) antagonist commonly used to treat nausea and vomiting	Placebo (PL) n=23 Participants Placebo pill Placebo: placebo equivalent
Change in Brain Activation - Insula Cortex	-0.071 Parameter estimate of BOLD Signal Change Standard Deviation 0.21	-0.0094 Parameter estimate of BOLD Signal Change Standard Deviation 0.23

PRIMARY outcome

Timeframe: Baseline, Week 4

Change in brain activation is measured by parameter estimate of blood-oxygen-level dependent (BOLD) signal change in the somatosensory cortex. BOLD signal is captured via functional MRI taken during MRI scanning sessions. Participants viewed "body-focused" videos (e.g., close-ups of a brush stroking a hand) alternating with control videos depicting similar types of movements but without body parts (e.g., a pen moving across a table) in an MRI scanner. Analysis examined change in brain activation between baseline and final during the viewing of body-focused videos compared to control videos. The outcome measure is the change in brain activation (Baseline minus Final) averaged across the right and left postcentral gyrus regions of interest.

Outcome measures

Outcome measures
Measure	Ondansetron (OND) n=26 Participants 24 mg/day for 4 weeks Ondansetron: 5-HT3 (serotonin receptor type 3) antagonist commonly used to treat nausea and vomiting	Placebo (PL) n=23 Participants Placebo pill Placebo: placebo equivalent
Change in Brain Activation - Somatosensory Cortex	-0.097 Parameter estimate of BOLD Signal Change Interval -0.12 to 0.09	-0.0052 Parameter estimate of BOLD Signal Change Interval -0.14 to 0.08

SECONDARY outcome

Timeframe: Baseline, Week 4

The SPS is a clinician-rated scale that assesses presence or absence of sensory phenomena. It contains a checklist with examples of different types of sensory phenomena, including physical sensations, "just right" sensations, incompleteness, general energy or inner tension buildup, and urges. The total score ranges from 0-15, with higher scores indicating more severe sensory phenomena. A score of 6 or more is defined as moderate or greater severity of sensory phenomena. An decrease in scores indicates severity decreased during the observational period.

Outcome measures

Outcome measures
Measure	Ondansetron (OND) n=27 Participants 24 mg/day for 4 weeks Ondansetron: 5-HT3 (serotonin receptor type 3) antagonist commonly used to treat nausea and vomiting	Placebo (PL) n=24 Participants Placebo pill Placebo: placebo equivalent
Change in Sensory Phenomena Scale (SPS) Score	1.646 score on a scale Standard Deviation 2.098	1.204 score on a scale Standard Deviation 2.143

SECONDARY outcome

Timeframe: Baseline, Week 4

Y-BOCS is designed to rate the severity and type of symptoms in patients with obsessive compulsive disorder. In general, the items depend on the patient's report; however, the final rating is based on the clinical judgement of the interviewer. The scale consists of 10 items summed to determine the level of symptom severity. The total score ranges from 0 to 40 with higher scores indicating greater symptom severity. A decrease in scores indicates symptom severity decreased during the observational period.

Outcome measures

Outcome measures
Measure	Ondansetron (OND) n=22 Participants 24 mg/day for 4 weeks Ondansetron: 5-HT3 (serotonin receptor type 3) antagonist commonly used to treat nausea and vomiting	Placebo (PL) n=22 Participants Placebo pill Placebo: placebo equivalent
Change in Yale-Brown Obsessive Compulsive Scale (Y-BOCS) Score	2.25 score on a scale Interval 1.52 to 5.75	1 score on a scale Interval 0.26 to 5.51

SECONDARY outcome

Timeframe: Baseline, Week 4

Population: Sample is based on 10 patients with motor/phonic tic symptoms.

The YGTSS is designed to rate the overall severity of motor and phonic tic symptoms across a range of dimensions: number, frequency, intensity, complexity, and interference. The total score is the sum of the 5 motor tic items and the 5 phonic (vocal) tic items and ranges from 0 to 50, with higher scores representing greater severity. A decrease in scores indicates severity decreased during the observational period.

Outcome measures

Outcome measures
Measure	Ondansetron (OND) n=5 Participants 24 mg/day for 4 weeks Ondansetron: 5-HT3 (serotonin receptor type 3) antagonist commonly used to treat nausea and vomiting	Placebo (PL) n=5 Participants Placebo pill Placebo: placebo equivalent
Change in Yale Global Tic Severity Scale (YGTSS) Score	1.4 score on a scale Standard Deviation 2.97	3.6 score on a scale Standard Deviation 6.99

Adverse Events

Ondansetron (OND)

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Placebo (PL)

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Nicolette Recchia

NYU Langone Health

Phone: 845-398-6563

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Other adverse events
Measure	Ondansetron (OND) n=33 participants at risk 24 mg/day for 4 weeks Ondansetron: 5-HT3 (serotonin receptor type 3) antagonist commonly used to treat nausea and vomiting	Placebo (PL) n=29 participants at risk Placebo pill Placebo: placebo equivalent
Gastrointestinal disorders Constipation	51.5% 17/33 • Adverse event data were collected through study completion, as necessary over the period of the trial (typically 4 weeks). Systematic; Participants filled out the Patient-Rated Inventory of Side Effects (PRISE) at every study visit. The study doctor reviewed each PRISE and monitored AEs throughout the trial.	3.4% 1/29 • Adverse event data were collected through study completion, as necessary over the period of the trial (typically 4 weeks). Systematic; Participants filled out the Patient-Rated Inventory of Side Effects (PRISE) at every study visit. The study doctor reviewed each PRISE and monitored AEs throughout the trial.
Nervous system disorders Headache	9.1% 3/33 • Adverse event data were collected through study completion, as necessary over the period of the trial (typically 4 weeks). Systematic; Participants filled out the Patient-Rated Inventory of Side Effects (PRISE) at every study visit. The study doctor reviewed each PRISE and monitored AEs throughout the trial.	17.2% 5/29 • Adverse event data were collected through study completion, as necessary over the period of the trial (typically 4 weeks). Systematic; Participants filled out the Patient-Rated Inventory of Side Effects (PRISE) at every study visit. The study doctor reviewed each PRISE and monitored AEs throughout the trial.
Gastrointestinal disorders Diarrhea	15.2% 5/33 • Adverse event data were collected through study completion, as necessary over the period of the trial (typically 4 weeks). Systematic; Participants filled out the Patient-Rated Inventory of Side Effects (PRISE) at every study visit. The study doctor reviewed each PRISE and monitored AEs throughout the trial.	3.4% 1/29 • Adverse event data were collected through study completion, as necessary over the period of the trial (typically 4 weeks). Systematic; Participants filled out the Patient-Rated Inventory of Side Effects (PRISE) at every study visit. The study doctor reviewed each PRISE and monitored AEs throughout the trial.
Nervous system disorders Dizziness	6.1% 2/33 • Adverse event data were collected through study completion, as necessary over the period of the trial (typically 4 weeks). Systematic; Participants filled out the Patient-Rated Inventory of Side Effects (PRISE) at every study visit. The study doctor reviewed each PRISE and monitored AEs throughout the trial.	6.9% 2/29 • Adverse event data were collected through study completion, as necessary over the period of the trial (typically 4 weeks). Systematic; Participants filled out the Patient-Rated Inventory of Side Effects (PRISE) at every study visit. The study doctor reviewed each PRISE and monitored AEs throughout the trial.
General disorders Fatigue	3.0% 1/33 • Adverse event data were collected through study completion, as necessary over the period of the trial (typically 4 weeks). Systematic; Participants filled out the Patient-Rated Inventory of Side Effects (PRISE) at every study visit. The study doctor reviewed each PRISE and monitored AEs throughout the trial.	6.9% 2/29 • Adverse event data were collected through study completion, as necessary over the period of the trial (typically 4 weeks). Systematic; Participants filled out the Patient-Rated Inventory of Side Effects (PRISE) at every study visit. The study doctor reviewed each PRISE and monitored AEs throughout the trial.
Gastrointestinal disorders Dry Mouth	3.0% 1/33 • Adverse event data were collected through study completion, as necessary over the period of the trial (typically 4 weeks). Systematic; Participants filled out the Patient-Rated Inventory of Side Effects (PRISE) at every study visit. The study doctor reviewed each PRISE and monitored AEs throughout the trial.	10.3% 3/29 • Adverse event data were collected through study completion, as necessary over the period of the trial (typically 4 weeks). Systematic; Participants filled out the Patient-Rated Inventory of Side Effects (PRISE) at every study visit. The study doctor reviewed each PRISE and monitored AEs throughout the trial.
Gastrointestinal disorders Nausea	6.1% 2/33 • Adverse event data were collected through study completion, as necessary over the period of the trial (typically 4 weeks). Systematic; Participants filled out the Patient-Rated Inventory of Side Effects (PRISE) at every study visit. The study doctor reviewed each PRISE and monitored AEs throughout the trial.	3.4% 1/29 • Adverse event data were collected through study completion, as necessary over the period of the trial (typically 4 weeks). Systematic; Participants filled out the Patient-Rated Inventory of Side Effects (PRISE) at every study visit. The study doctor reviewed each PRISE and monitored AEs throughout the trial.
Psychiatric disorders Restlessness	3.0% 1/33 • Adverse event data were collected through study completion, as necessary over the period of the trial (typically 4 weeks). Systematic; Participants filled out the Patient-Rated Inventory of Side Effects (PRISE) at every study visit. The study doctor reviewed each PRISE and monitored AEs throughout the trial.	6.9% 2/29 • Adverse event data were collected through study completion, as necessary over the period of the trial (typically 4 weeks). Systematic; Participants filled out the Patient-Rated Inventory of Side Effects (PRISE) at every study visit. The study doctor reviewed each PRISE and monitored AEs throughout the trial.
Gastrointestinal disorders Abdominal Discomfort	3.0% 1/33 • Adverse event data were collected through study completion, as necessary over the period of the trial (typically 4 weeks). Systematic; Participants filled out the Patient-Rated Inventory of Side Effects (PRISE) at every study visit. The study doctor reviewed each PRISE and monitored AEs throughout the trial.	3.4% 1/29 • Adverse event data were collected through study completion, as necessary over the period of the trial (typically 4 weeks). Systematic; Participants filled out the Patient-Rated Inventory of Side Effects (PRISE) at every study visit. The study doctor reviewed each PRISE and monitored AEs throughout the trial.
Nervous system disorders Tremors	3.0% 1/33 • Adverse event data were collected through study completion, as necessary over the period of the trial (typically 4 weeks). Systematic; Participants filled out the Patient-Rated Inventory of Side Effects (PRISE) at every study visit. The study doctor reviewed each PRISE and monitored AEs throughout the trial.	3.4% 1/29 • Adverse event data were collected through study completion, as necessary over the period of the trial (typically 4 weeks). Systematic; Participants filled out the Patient-Rated Inventory of Side Effects (PRISE) at every study visit. The study doctor reviewed each PRISE and monitored AEs throughout the trial.
Psychiatric disorders Insomnia	0.00% 0/33 • Adverse event data were collected through study completion, as necessary over the period of the trial (typically 4 weeks). Systematic; Participants filled out the Patient-Rated Inventory of Side Effects (PRISE) at every study visit. The study doctor reviewed each PRISE and monitored AEs throughout the trial.	6.9% 2/29 • Adverse event data were collected through study completion, as necessary over the period of the trial (typically 4 weeks). Systematic; Participants filled out the Patient-Rated Inventory of Side Effects (PRISE) at every study visit. The study doctor reviewed each PRISE and monitored AEs throughout the trial.
Psychiatric disorders Sleeping too much	3.0% 1/33 • Adverse event data were collected through study completion, as necessary over the period of the trial (typically 4 weeks). Systematic; Participants filled out the Patient-Rated Inventory of Side Effects (PRISE) at every study visit. The study doctor reviewed each PRISE and monitored AEs throughout the trial.	0.00% 0/29 • Adverse event data were collected through study completion, as necessary over the period of the trial (typically 4 weeks). Systematic; Participants filled out the Patient-Rated Inventory of Side Effects (PRISE) at every study visit. The study doctor reviewed each PRISE and monitored AEs throughout the trial.
Psychiatric disorders Vivid dreams	0.00% 0/33 • Adverse event data were collected through study completion, as necessary over the period of the trial (typically 4 weeks). Systematic; Participants filled out the Patient-Rated Inventory of Side Effects (PRISE) at every study visit. The study doctor reviewed each PRISE and monitored AEs throughout the trial.	3.4% 1/29 • Adverse event data were collected through study completion, as necessary over the period of the trial (typically 4 weeks). Systematic; Participants filled out the Patient-Rated Inventory of Side Effects (PRISE) at every study visit. The study doctor reviewed each PRISE and monitored AEs throughout the trial.
Skin and subcutaneous tissue disorders Rash	6.1% 2/33 • Adverse event data were collected through study completion, as necessary over the period of the trial (typically 4 weeks). Systematic; Participants filled out the Patient-Rated Inventory of Side Effects (PRISE) at every study visit. The study doctor reviewed each PRISE and monitored AEs throughout the trial.	0.00% 0/29 • Adverse event data were collected through study completion, as necessary over the period of the trial (typically 4 weeks). Systematic; Participants filled out the Patient-Rated Inventory of Side Effects (PRISE) at every study visit. The study doctor reviewed each PRISE and monitored AEs throughout the trial.
Respiratory, thoracic and mediastinal disorders Difficulty breathing	3.0% 1/33 • Adverse event data were collected through study completion, as necessary over the period of the trial (typically 4 weeks). Systematic; Participants filled out the Patient-Rated Inventory of Side Effects (PRISE) at every study visit. The study doctor reviewed each PRISE and monitored AEs throughout the trial.	0.00% 0/29 • Adverse event data were collected through study completion, as necessary over the period of the trial (typically 4 weeks). Systematic; Participants filled out the Patient-Rated Inventory of Side Effects (PRISE) at every study visit. The study doctor reviewed each PRISE and monitored AEs throughout the trial.
Nervous system disorders Light headed	3.0% 1/33 • Adverse event data were collected through study completion, as necessary over the period of the trial (typically 4 weeks). Systematic; Participants filled out the Patient-Rated Inventory of Side Effects (PRISE) at every study visit. The study doctor reviewed each PRISE and monitored AEs throughout the trial.	0.00% 0/29 • Adverse event data were collected through study completion, as necessary over the period of the trial (typically 4 weeks). Systematic; Participants filled out the Patient-Rated Inventory of Side Effects (PRISE) at every study visit. The study doctor reviewed each PRISE and monitored AEs throughout the trial.
Psychiatric disorders Increase in suicidal ideation	0.00% 0/33 • Adverse event data were collected through study completion, as necessary over the period of the trial (typically 4 weeks). Systematic; Participants filled out the Patient-Rated Inventory of Side Effects (PRISE) at every study visit. The study doctor reviewed each PRISE and monitored AEs throughout the trial.	3.4% 1/29 • Adverse event data were collected through study completion, as necessary over the period of the trial (typically 4 weeks). Systematic; Participants filled out the Patient-Rated Inventory of Side Effects (PRISE) at every study visit. The study doctor reviewed each PRISE and monitored AEs throughout the trial.
Reproductive system and breast disorders Menstrual irregularity	0.00% 0/33 • Adverse event data were collected through study completion, as necessary over the period of the trial (typically 4 weeks). Systematic; Participants filled out the Patient-Rated Inventory of Side Effects (PRISE) at every study visit. The study doctor reviewed each PRISE and monitored AEs throughout the trial.	3.4% 1/29 • Adverse event data were collected through study completion, as necessary over the period of the trial (typically 4 weeks). Systematic; Participants filled out the Patient-Rated Inventory of Side Effects (PRISE) at every study visit. The study doctor reviewed each PRISE and monitored AEs throughout the trial.
Renal and urinary disorders Frequent urination	0.00% 0/33 • Adverse event data were collected through study completion, as necessary over the period of the trial (typically 4 weeks). Systematic; Participants filled out the Patient-Rated Inventory of Side Effects (PRISE) at every study visit. The study doctor reviewed each PRISE and monitored AEs throughout the trial.	3.4% 1/29 • Adverse event data were collected through study completion, as necessary over the period of the trial (typically 4 weeks). Systematic; Participants filled out the Patient-Rated Inventory of Side Effects (PRISE) at every study visit. The study doctor reviewed each PRISE and monitored AEs throughout the trial.
Psychiatric disorders Decreased libido	0.00% 0/33 • Adverse event data were collected through study completion, as necessary over the period of the trial (typically 4 weeks). Systematic; Participants filled out the Patient-Rated Inventory of Side Effects (PRISE) at every study visit. The study doctor reviewed each PRISE and monitored AEs throughout the trial.	3.4% 1/29 • Adverse event data were collected through study completion, as necessary over the period of the trial (typically 4 weeks). Systematic; Participants filled out the Patient-Rated Inventory of Side Effects (PRISE) at every study visit. The study doctor reviewed each PRISE and monitored AEs throughout the trial.
Hepatobiliary disorders Transaminitis (transient)	0.00% 0/33 • Adverse event data were collected through study completion, as necessary over the period of the trial (typically 4 weeks). Systematic; Participants filled out the Patient-Rated Inventory of Side Effects (PRISE) at every study visit. The study doctor reviewed each PRISE and monitored AEs throughout the trial.	3.4% 1/29 • Adverse event data were collected through study completion, as necessary over the period of the trial (typically 4 weeks). Systematic; Participants filled out the Patient-Rated Inventory of Side Effects (PRISE) at every study visit. The study doctor reviewed each PRISE and monitored AEs throughout the trial.
Gastrointestinal disorders Heartburn	3.0% 1/33 • Adverse event data were collected through study completion, as necessary over the period of the trial (typically 4 weeks). Systematic; Participants filled out the Patient-Rated Inventory of Side Effects (PRISE) at every study visit. The study doctor reviewed each PRISE and monitored AEs throughout the trial.	0.00% 0/29 • Adverse event data were collected through study completion, as necessary over the period of the trial (typically 4 weeks). Systematic; Participants filled out the Patient-Rated Inventory of Side Effects (PRISE) at every study visit. The study doctor reviewed each PRISE and monitored AEs throughout the trial.
Skin and subcutaneous tissue disorders Pruritis	0.00% 0/33 • Adverse event data were collected through study completion, as necessary over the period of the trial (typically 4 weeks). Systematic; Participants filled out the Patient-Rated Inventory of Side Effects (PRISE) at every study visit. The study doctor reviewed each PRISE and monitored AEs throughout the trial.	3.4% 1/29 • Adverse event data were collected through study completion, as necessary over the period of the trial (typically 4 weeks). Systematic; Participants filled out the Patient-Rated Inventory of Side Effects (PRISE) at every study visit. The study doctor reviewed each PRISE and monitored AEs throughout the trial.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/33 • Adverse event data were collected through study completion, as necessary over the period of the trial (typically 4 weeks). Systematic; Participants filled out the Patient-Rated Inventory of Side Effects (PRISE) at every study visit. The study doctor reviewed each PRISE and monitored AEs throughout the trial.	3.4% 1/29 • Adverse event data were collected through study completion, as necessary over the period of the trial (typically 4 weeks). Systematic; Participants filled out the Patient-Rated Inventory of Side Effects (PRISE) at every study visit. The study doctor reviewed each PRISE and monitored AEs throughout the trial.
Nervous system disorders Poor concentration	0.00% 0/33 • Adverse event data were collected through study completion, as necessary over the period of the trial (typically 4 weeks). Systematic; Participants filled out the Patient-Rated Inventory of Side Effects (PRISE) at every study visit. The study doctor reviewed each PRISE and monitored AEs throughout the trial.	3.4% 1/29 • Adverse event data were collected through study completion, as necessary over the period of the trial (typically 4 weeks). Systematic; Participants filled out the Patient-Rated Inventory of Side Effects (PRISE) at every study visit. The study doctor reviewed each PRISE and monitored AEs throughout the trial.
Psychiatric disorders Anxiety	0.00% 0/33 • Adverse event data were collected through study completion, as necessary over the period of the trial (typically 4 weeks). Systematic; Participants filled out the Patient-Rated Inventory of Side Effects (PRISE) at every study visit. The study doctor reviewed each PRISE and monitored AEs throughout the trial.	3.4% 1/29 • Adverse event data were collected through study completion, as necessary over the period of the trial (typically 4 weeks). Systematic; Participants filled out the Patient-Rated Inventory of Side Effects (PRISE) at every study visit. The study doctor reviewed each PRISE and monitored AEs throughout the trial.
Nervous system disorders Poor coordination	0.00% 0/33 • Adverse event data were collected through study completion, as necessary over the period of the trial (typically 4 weeks). Systematic; Participants filled out the Patient-Rated Inventory of Side Effects (PRISE) at every study visit. The study doctor reviewed each PRISE and monitored AEs throughout the trial.	3.4% 1/29 • Adverse event data were collected through study completion, as necessary over the period of the trial (typically 4 weeks). Systematic; Participants filled out the Patient-Rated Inventory of Side Effects (PRISE) at every study visit. The study doctor reviewed each PRISE and monitored AEs throughout the trial.
General disorders General malaise	3.0% 1/33 • Adverse event data were collected through study completion, as necessary over the period of the trial (typically 4 weeks). Systematic; Participants filled out the Patient-Rated Inventory of Side Effects (PRISE) at every study visit. The study doctor reviewed each PRISE and monitored AEs throughout the trial.	0.00% 0/29 • Adverse event data were collected through study completion, as necessary over the period of the trial (typically 4 weeks). Systematic; Participants filled out the Patient-Rated Inventory of Side Effects (PRISE) at every study visit. The study doctor reviewed each PRISE and monitored AEs throughout the trial.
Skin and subcutaneous tissue disorders Increased perspiration	3.0% 1/33 • Adverse event data were collected through study completion, as necessary over the period of the trial (typically 4 weeks). Systematic; Participants filled out the Patient-Rated Inventory of Side Effects (PRISE) at every study visit. The study doctor reviewed each PRISE and monitored AEs throughout the trial.	0.00% 0/29 • Adverse event data were collected through study completion, as necessary over the period of the trial (typically 4 weeks). Systematic; Participants filled out the Patient-Rated Inventory of Side Effects (PRISE) at every study visit. The study doctor reviewed each PRISE and monitored AEs throughout the trial.