Trial Outcomes & Findings for Study to Assess the Efficacy of VLY-686 in Relieving Symptoms of Gastroparesis (NCT NCT02970968)

NCT ID: NCT02970968

Last Updated: 2024-08-06

Results Overview

The Gastroparesis Core Symptom Daily Diary (GCSDD) is a patient reported diary that asks patients to rate the worst occurrence of each cardinal symptom of gastroparesis (nausea severity, early satiety, postprandial fullness, bloating, and abdominal pain) in the past 24 hours on a Likert scale from 0 (no symptoms) to 5 (very severe). Change from baseline in average nausea severity score is calculated as the weekly average post value minus baseline value of the daily nausea severity score from the GCSDD. A negative change indicates improvement.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 152 participants
• Primary outcome timeframe: 4 weeks
• Results posted on: 2024-08-06

Participant Flow

Participant milestones

Measure	Tradipitant oral, 85 mg/day given bid	Placebo oral, matching placebo given bid
Overall Study STARTED	77	75
Overall Study COMPLETED	72	68
Overall Study NOT COMPLETED	5	7

Reasons for withdrawal

Measure	Tradipitant oral, 85 mg/day given bid	Placebo oral, matching placebo given bid
Overall Study Withdrawal by Subject	3	3
Overall Study Adverse Event	1	2
Overall Study Lost to Follow-up	1	1
Overall Study Non-Compliance	0	1

Baseline Characteristics

Study to Assess the Efficacy of VLY-686 in Relieving Symptoms of Gastroparesis

Baseline characteristics by cohort

Measure	Tradipitant n=77 Participants oral, 85 mg/day given bid	Placebo n=75 Participants oral, matching placebo given bid	Total n=152 Participants Total of all reporting groups
Age, Continuous	45.4 years STANDARD_DEVIATION 13.16 • n=5 Participants	46.4 years STANDARD_DEVIATION 13.46 • n=7 Participants	45.9 years STANDARD_DEVIATION 13.28 • n=5 Participants
Sex: Female, Male Female	69 Participants n=5 Participants	68 Participants n=7 Participants	137 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 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
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) White	66 Participants n=5 Participants	65 Participants n=7 Participants	131 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Disease Etiology Idiopathic	46 Participants n=5 Participants	45 Participants n=7 Participants	91 Participants n=5 Participants
Disease Etiology Diabetic	31 Participants n=5 Participants	30 Participants n=7 Participants	61 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: The ITT Population included any subject randomized into the study who received a dose of study medication and had at least 1 valid postbaseline efficacy measurement while on study medication. The ITT Population comprised 141 subjects.

The Gastroparesis Core Symptom Daily Diary (GCSDD) is a patient reported diary that asks patients to rate the worst occurrence of each cardinal symptom of gastroparesis (nausea severity, early satiety, postprandial fullness, bloating, and abdominal pain) in the past 24 hours on a Likert scale from 0 (no symptoms) to 5 (very severe). Change from baseline in average nausea severity score is calculated as the weekly average post value minus baseline value of the daily nausea severity score from the GCSDD. A negative change indicates improvement.

Outcome measures

Measure	Tradipitant n=73 Participants oral, 85 mg/day given bid	Placebo n=68 Participants oral, matching placebo given bid
Change From Baseline in Average Nausea Severity	-1.25 score on a scale (change from baseline) Interval -1.53 to -0.98	-0.73 score on a scale (change from baseline) Interval -1.02 to -0.44

SECONDARY outcome

Timeframe: 4 weeks

The Gastroparesis Core Symptom Daily Diary (GCSDD) is a patient reported diary that asks patients if they have had any nausea over the past 24 hours and if yes, to rate the worst occurrence in the past 24 hours on a Likert scale from 1 (very mild) to 5 (very severe). Change in weekly percentage of nausea-free days from baseline is calculated as weekly average post value minus baseline value. Baseline is defined as the average of all nonmissing values in the screening phase (4 weeks).

Outcome measures

Measure	Tradipitant n=73 Participants oral, 85 mg/day given bid	Placebo n=68 Participants oral, matching placebo given bid
Weekly % Nausea-Free Days	28.81 Percentage (%) of nausea-free days Interval 21.09 to 36.53	15.00 Percentage (%) of nausea-free days Interval 6.94 to 23.07

SECONDARY outcome

Timeframe: 4 weeks

The Gastroparesis Core Symptom Daily Diary (GCSDD) is a patient reported diary that asks patients if they have vomited in the past 24 hours and how many times they vomited in the past 24 hours. Change from baseline in the weekly average of daily vomiting frequency is calculated as the weekly average post value minus baseline value of the daily daily vomiting frequency from the GCSDD. Baseline is defined as the average of all non-missing values in the screening phase (4 weeks). A negative change indicates improvement.

Outcome measures

Measure	Tradipitant n=73 Participants oral, 85 mg/day given bid	Placebo n=68 Participants oral, matching placebo given bid
Daily Average Vomiting Frequency, Change From Baseline	-0.49 weekly average of daily vomit episodes Interval -0.64 to -0.34	-0.26 weekly average of daily vomit episodes Interval -0.42 to -0.1

SECONDARY outcome

Timeframe: 4 weeks

The GCSI is a subject reported outcome administered in-clinic with a 2-week recall period to measure the severity of symptoms in gastroparesis. The GCSI is composed of 9 items based on three subscales: post-prandial fullness/early satiety (4 items); nausea/vomiting (3 items), and bloating (2 items). The severity of each symptom is rated on a six-point Likert response scale. The minimal scale value = 0 (none) and the maximum scale value = 5 (very severe). GCSI Total score is constructed as the average of the three symptom sub-scales. Higher score is indicative of greater symptom severity.

Outcome measures

Measure	Tradipitant n=73 Participants oral, 85 mg/day given bid	Placebo n=68 Participants oral, matching placebo given bid
Gastroparesis Cardinal Symptom Index (GCSI), Change From Baseline	-0.93 score on a scale (change from baseline) Interval -1.14 to -0.73	-0.58 score on a scale (change from baseline) Interval -0.8 to -0.36

SECONDARY outcome

Timeframe: 4 weeks

The PAGI-SYM is a patient reported outcome which asks patients to describe the severity of their symptoms over the last two weeks to measure symptom severity for gastroparesis, functional dyspepsia, and gastroesophageal reflux disease. The measure consists of 20 symptom severity items, which cover the following domains: nausea/vomiting, fullness/early satiety, bloating, upper abdominal pain, heartburn/regurgitation, and lower abdominal pain. This questionnaire includes the Gastroparesis Cardinal Symptom Index (GCSI). The severity of each symptom is rated on a six-point Likert response scale. The minimal scale value = 0 (none) and the maximum scale value= 5 (very severe). PAGI-SYM Total score is constructed as the average of the six symptom sub-scales and a higher score is indicative of greater symptom severity.

Outcome measures

Measure	Tradipitant n=73 Participants oral, 85 mg/day given bid	Placebo n=68 Participants oral, matching placebo given bid
PAGI-SYM, Change From Baseline	-0.93 score on a scale (change from baseline) Interval -1.12 to -0.74	-0.65 score on a scale (change from baseline) Interval -0.86 to -0.45

SECONDARY outcome

Timeframe: 4 weeks

The Clinician Global Impression of Severity (CGI-S) is a 7-point scale on which the clinician rates the severity of the patient's gastroparesis at the time of the assessment and refers to the degree of illness at the time of the visit and during the 2 weeks before the visit. The CGI-S is rated on the following 7-point scale: 1: normal, not at all ill; 2: borderline ill: 3: mildly ill; 4: moderately ill; 5: markedly ill; 6: severely ill; 7: among the most extremely ill patients. Change from baseline is calculated as post value minus baseline value. A negative change indicates improvement.

Outcome measures

Measure	Tradipitant n=73 Participants oral, 85 mg/day given bid	Placebo n=68 Participants oral, matching placebo given bid
CGI-S, Change From Baseline	-1.13 score on a scale (change from baseline) Interval -1.36 to -0.91	-0.74 score on a scale (change from baseline) Interval -0.98 to -0.5

SECONDARY outcome

Timeframe: 4 weeks

The Patient Global Impression of Change (PGI-C) is a patient reported questionnaire with a 7-point rating scale where the participant rates his/her own improvement in overall symptoms relative to the baseline assessment. Is is rated as 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. Higher scores indicate a worse outcome.

Outcome measures

Measure	Tradipitant n=73 Participants oral, 85 mg/day given bid	Placebo n=68 Participants oral, matching placebo given bid
PGI-C	2.66 score on a scale (change from baseline) Interval 2.4 to 2.93	3.06 score on a scale (change from baseline) Interval 2.78 to 3.35

POST_HOC outcome

Timeframe: 4 weeks

Population: The baseline vomiting group subpopulation was defined as all subjects who reported at least 1 episode of vomiting during the screening period and consisted of 101 of 141 (72%) patients of the ITT population.

The Gastroparesis Core Symptom Daily Diary (GCSDD) is a patient reported diary that asks patients to rate the worst occurrence of each cardinal symptom of gastroparesis (nausea severity, early satiety, postprandial fullness, bloating, and abdominal pain) in the past 24 hours on a Likert scale from 0 (no symptoms) to 5 (very severe). Change from baseline in average nausea severity score is calculated as the weekly average post value minus baseline value of the daily nausea severity score from the GCSDD. A negative change indicates improvement.

Outcome measures

Measure	Tradipitant n=58 Participants oral, 85 mg/day given bid	Placebo n=43 Participants oral, matching placebo given bid
Change From Baseline in Average Nausea Severity; Baseline Vomiting Group	-1.43 score on a scale (change from baseline) Interval -1.72 to -1.14	-0.42 score on a scale (change from baseline) Interval -0.76 to -0.07

POST_HOC outcome

Timeframe: 4 weeks

Population: The baseline vomiting group subpopulation was defined as all subjects who reported at least 1 episode of vomiting during the screening period and consisted of 101 of 141 (72%) patients of the ITT population.

The Gastroparesis Core Symptom Daily Diary (GCSDD) is a patient reported diary that asks patients to rate the worst occurrence of each cardinal symptom of gastroparesis in the past 24 hours on a scale from 0 (no symptoms) to 5 (very severe).

Outcome measures

Measure	Tradipitant n=58 Participants oral, 85 mg/day given bid	Placebo n=43 Participants oral, matching placebo given bid
GCSDD, % Nausea-Free Days; Baseline Vomiting Group	32.3 Percentage (%) of nausea-free days Interval 23.8 to 40.8	7.6 Percentage (%) of nausea-free days Interval -2.3 to 17.5

POST_HOC outcome

Timeframe: 4 weeks

Population: The baseline vomiting group subpopulation was defined as all subjects who reported at least 1 episode of vomiting during the screening period and consisted of 101 of 141 (72%) patients of the ITT population.

The Gastroparesis Core Symptom Daily Diary (GCSDD) is a patient reported diary that asks patients to rate the worst occurrence of each cardinal symptom of gastroparesis in the past 24 hours on a scale from 0 (no symptoms) to 5 (very severe). Change from baseline is calculated as post value minus baseline value. A negative change indicates improvement.

Outcome measures

Measure	Tradipitant n=58 Participants oral, 85 mg/day given bid	Placebo n=43 Participants oral, matching placebo given bid
GCSDD, Daily Average Vomiting Frequency, Change From Baseline; Baseline Vomiting Group	-0.69 weekly average of daily vomit episodes Interval -0.89 to -0.49	-0.32 weekly average of daily vomit episodes Interval -0.56 to -0.08

POST_HOC outcome

Timeframe: 4 weeks

Population: The baseline vomiting group subpopulation was defined as all subjects who reported at least 1 episode of vomiting during the screening period and consisted of 101 of 141 (72%) patients of the ITT population.

The GCSI is a subject reported outcome administered in-clinic with a 2-week recall period to measure the severity of symptoms in gastroparesis. The GCSI is composed of 9 items based on three subscales: post-prandial fullness/early satiety (4 items); nausea/vomiting (3 items), and bloating (2 items). The severity of each symptom is rated on a six-point Likert response scale. The minimal scale value = 0 (none) and the maximum scale value = 5 (very severe). GCSI Total score is constructed as the average of the three symptom sub-scales. Higher score is indicative of greater symptom severity.

Outcome measures

Measure	Tradipitant n=58 Participants oral, 85 mg/day given bid	Placebo n=43 Participants oral, matching placebo given bid
Gastroparesis Cardinal Symptom Index (GCSI), Change From Baseline; Baseline Vomiting Group	-1.10 score on a scale (change from baseline) Interval -1.33 to -0.87	-0.60 score on a scale (change from baseline) Interval -0.88 to -0.32

POST_HOC outcome

Timeframe: 4 weeks

Population: The baseline vomiting group subpopulation was defined as all subjects who reported at least 1 episode of vomiting during the screening period and consisted of 101 of 141 (72%) patients of the ITT population.

The PAGI-SYM is a patient reported outcome which asks patients to describe the severity of their symptoms over the last two weeks to measure symptom severity for gastroparesis, functional dyspepsia, and gastroesophageal reflux disease. The measure consists of 20 symptom severity items, which cover the following domains: nausea/vomiting, fullness/early satiety, bloating, upper abdominal pain, heartburn/regurgitation, and lower abdominal pain. This questionnaire includes the Gastroparesis Cardinal Symptom Index (GCSI). The severity of each symptom is rated on a six-point Likert response scale. The minimal scale value = 0 (none) and the maximum scale value= 5 (very severe). PAGI-SYM Total score is constructed as the average of the six symptom sub-scales and a higher score is indicative of greater symptom severity.

Outcome measures

Measure	Tradipitant n=58 Participants oral, 85 mg/day given bid	Placebo n=43 Participants oral, matching placebo given bid
PAGI-SYM, Change From Baseline; Baseline Vomiting Group	-1.06 score on a scale (change from baseline) Interval -1.28 to -0.85	-0.69 score on a scale (change from baseline) Interval -0.95 to -0.43

POST_HOC outcome

Timeframe: 4 weeks

Population: The baseline vomiting group subpopulation was defined as all subjects who reported at least 1 episode of vomiting during the screening period and consisted of 101 of 141 (72%) patients of the ITT population.

The Clinician Global Impression of Severity (CGI-S) is a 7-point scale on which the clinician rates the severity of the patient's gastroparesis at the time of the assessment and refers to the degree of illness at the time of the visit and during the 2 weeks before the visit. The CGI-S is rates on the following 7-point scale: 1: normal, not at all ill; 2: borderline ill: 3: mildly ill; 4: moderately ill; 5: markedly ill; 6: severely ill; 7: among the most extremely ill patients. Change from baseline is calculated as post value minus baseline value. A negative change indicates improvement.

Outcome measures

Measure	Tradipitant n=58 Participants oral, 85 mg/day given bid	Placebo n=43 Participants oral, matching placebo given bid
CGI-S, Change From Baseline; Baseline Vomiting Group	-1.24 score on a scale (change from baseline) Interval -1.49 to -0.99	-0.79 score on a scale (change from baseline) Interval -1.08 to -0.49

POST_HOC outcome

Timeframe: 4 weeks

Population: The baseline vomiting group subpopulation was defined as all subjects who reported at least 1 episode of vomiting during the screening period and consisted of 101 of 141 (72%) patients of the ITT population.

The Patient Global Impression of Change (PGI-C) is a patient reported questionnaire with a 7-point rating scale where the participant rates his/her own improvement in overall symptoms relative to the baseline assessment. Is is rated as 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. Higher scores indicate a worse outcome.

Outcome measures

Measure	Tradipitant n=58 Participants oral, 85 mg/day given bid	Placebo n=43 Participants oral, matching placebo given bid
PGI-C; Baseline Vomiting Group	2.52 score on a scale (change from baseline) Interval 2.24 to 2.81	3.24 score on a scale (change from baseline) Interval 2.9 to 3.59

POST_HOC outcome

Timeframe: 4 weeks

Defined as a nausea score of very mild or better (≤1) in average daily nausea severity at week 4. Nausea severity is rated on a Likert scale from 0 (none) to 5 (very severe).

Outcome measures

Measure	Tradipitant n=73 Participants oral, 85 mg/day given bid	Placebo n=68 Participants oral, matching placebo given bid
Nausea Responder Rate (%)	32.9 Percentage (%) of nausea responders	11.8 Percentage (%) of nausea responders

POST_HOC outcome

Timeframe: 4 weeks

Population: The baseline vomiting group subpopulation was defined as all subjects who reported at least 1 episode of vomiting during the screening period and consisted of 101 of 141 (72%) patients of the ITT population.

Defined as a nausea score of very mild or better (≤1) in average daily nausea severity at week 4. Nausea severity is rated on a Likert scale from 0 (none) to 5 (very severe).

Outcome measures

Measure	Tradipitant n=58 Participants oral, 85 mg/day given bid	Placebo n=43 Participants oral, matching placebo given bid
Nausea Responder Rate (%); Baseline Vomiting Group	36.2 Percentage (%) of nausea responders	6.9 Percentage (%) of nausea responders

POST_HOC outcome

Timeframe: 4 weeks

Defined as a nausea score of 0 in at week 4. Nausea severity is rated on a Likert scale from 0 (none) to 5 (very severe).

Outcome measures

Measure	Tradipitant n=73 Participants oral, 85 mg/day given bid	Placebo n=68 Participants oral, matching placebo given bid
Complete Nausea Responder Rate (%)	15.07 Percentage (%) of participants	4.4 Percentage (%) of participants

POST_HOC outcome

Timeframe: 4 weeks

Population: The baseline vomiting group subpopulation was defined as all subjects who reported at least 1 episode of vomiting during the screening period and consisted of 101 of 141 (72%) patients of the ITT population.

Defined as a nausea score of 0 at week 4. Nausea severity is rated on a Likert scale from 0 (none) to 5 (very severe).

Outcome measures

Measure	Tradipitant n=58 Participants oral, 85 mg/day given bid	Placebo n=43 Participants oral, matching placebo given bid
Complete Nausea Responder Rate (%); Baseline Vomiting Group	17.24 Percentage (%) of participants	4.65 Percentage (%) of participants

POST_HOC outcome

Timeframe: 4 weeks

Defined as 1-point or greater improvement on their GCSI total score from baseline to week 4. The GCSI is a subject reported outcome. Part I consists of the traditional GCSI and severity rating of upper abdominal pain and severity of overall symptoms on a 0 (none) to 5 (very severe) Likert scale. Part II uses a 7-point rating scale for the subject to rate their own improvement relative to baseline. Symptoms are rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. The GCSI subscale scores, nausea/vomiting (3 items), postprandial fullness/early satiety (4 items), bloating (2 items), and upper abdominal pain (2 items), are calculated by taking the mean of non-missing items in each subscale; the subscale scores vary from 0 (none or absent) to 5 (very severe). The total score is calculated by taking the mean of the three subscales (except upper abdominal pain and overall symptom item).

Outcome measures

Measure	Tradipitant n=73 Participants oral, 85 mg/day given bid	Placebo n=68 Participants oral, matching placebo given bid
Percentage of Participants With Clinically Meaningful Improvement on Total GCSI Score	46.6 Percentage (%)	23.5 Percentage (%)

POST_HOC outcome

Timeframe: 4 weeks

Population: The baseline vomiting group subpopulation was defined as all subjects who reported at least 1 episode of vomiting during the screening period and consisted of 101 of 141 (72%) patients of the ITT population.

Defined as 1-point or greater improvement on their GCSI total score from baseline to week 4. The GCSI is a subject reported outcome. Part I consists of the traditional GCSI and severity rating of upper abdominal pain and severity of overall symptoms on a 0 (none) to 5 (very severe) Likert scale. Part II uses a 7-point rating scale for the subject to rate their own improvement relative to baseline. Symptoms are rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. The GCSI subscale scores, nausea/vomiting (3 items), postprandial fullness/early satiety (4 items), bloating (2 items), and upper abdominal pain (2 items), are calculated by taking the mean of non-missing items in each subscale; the subscale scores vary from 0 (none or absent) to 5 (very severe). The total score is calculated by taking the mean of the three subscales (except upper abdominal pain and overall symptom item).

Outcome measures

Measure	Tradipitant n=58 Participants oral, 85 mg/day given bid	Placebo n=43 Participants oral, matching placebo given bid
Percentage of Participants With Clinically Meaningful Improvement on Total GCSI Score; Baseline Vomiting Group	51.7 Percentage (%)	23.3 Percentage (%)

Adverse Events

Tradipitant

Serious events: 0 serious events

Other events: 31 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Measure	Tradipitant n=77 participants at risk oral, 85 mg/day given bid	Placebo n=75 participants at risk oral, matching placebo given bid
Nervous system disorders Syncope	0.00% 0/77 • 8 weeks All safety analyses are based on the safety population.	1.3% 1/75 • 8 weeks All safety analyses are based on the safety population.

Other adverse events

Measure	Tradipitant n=77 participants at risk oral, 85 mg/day given bid	Placebo n=75 participants at risk oral, matching placebo given bid
Gastrointestinal disorders Diarrhea	5.2% 4/77 • 8 weeks All safety analyses are based on the safety population.	4.0% 3/75 • 8 weeks All safety analyses are based on the safety population.
Gastrointestinal disorders Nausea	2.6% 2/77 • 8 weeks All safety analyses are based on the safety population.	6.7% 5/75 • 8 weeks All safety analyses are based on the safety population.
Gastrointestinal disorders Abdominal pain	2.6% 2/77 • 8 weeks All safety analyses are based on the safety population.	2.7% 2/75 • 8 weeks All safety analyses are based on the safety population.
Gastrointestinal disorders Abdominal pain upper	2.6% 2/77 • 8 weeks All safety analyses are based on the safety population.	0.00% 0/75 • 8 weeks All safety analyses are based on the safety population.
Gastrointestinal disorders Abdominal tenderness	1.3% 1/77 • 8 weeks All safety analyses are based on the safety population.	1.3% 1/75 • 8 weeks All safety analyses are based on the safety population.
Gastrointestinal disorders Constipation	1.3% 1/77 • 8 weeks All safety analyses are based on the safety population.	1.3% 1/75 • 8 weeks All safety analyses are based on the safety population.
Gastrointestinal disorders Dry mouth	2.6% 2/77 • 8 weeks All safety analyses are based on the safety population.	0.00% 0/75 • 8 weeks All safety analyses are based on the safety population.
Gastrointestinal disorders Gastroesophageal reflux disease	1.3% 1/77 • 8 weeks All safety analyses are based on the safety population.	1.3% 1/75 • 8 weeks All safety analyses are based on the safety population.
Nervous system disorders Dizziness	2.6% 2/77 • 8 weeks All safety analyses are based on the safety population.	2.7% 2/75 • 8 weeks All safety analyses are based on the safety population.
Nervous system disorders Headache	1.3% 1/77 • 8 weeks All safety analyses are based on the safety population.	4.0% 3/75 • 8 weeks All safety analyses are based on the safety population.
Nervous system disorders Somnolence	3.9% 3/77 • 8 weeks All safety analyses are based on the safety population.	0.00% 0/75 • 8 weeks All safety analyses are based on the safety population.
Nervous system disorders Migraine	1.3% 1/77 • 8 weeks All safety analyses are based on the safety population.	1.3% 1/75 • 8 weeks All safety analyses are based on the safety population.
Infections and infestations Urinary tract infection	1.3% 1/77 • 8 weeks All safety analyses are based on the safety population.	1.3% 1/75 • 8 weeks All safety analyses are based on the safety population.
General disorders Fatigue	3.9% 3/77 • 8 weeks All safety analyses are based on the safety population.	1.3% 1/75 • 8 weeks All safety analyses are based on the safety population.
Skin and subcutaneous tissue disorders Rash	2.6% 2/77 • 8 weeks All safety analyses are based on the safety population.	0.00% 0/75 • 8 weeks All safety analyses are based on the safety population.
Vascular disorders Hypertension	1.3% 1/77 • 8 weeks All safety analyses are based on the safety population.	1.3% 1/75 • 8 weeks All safety analyses are based on the safety population.
Psychiatric disorders Anxiety	2.6% 2/77 • 8 weeks All safety analyses are based on the safety population.	0.00% 0/75 • 8 weeks All safety analyses are based on the safety population.

Additional Information

Vanda Pharmaceuticals

Vanda Pharmaceuticals

Phone: 202-734-3400

Email: clinicaltrials@vandapharma.com

Results disclosure agreements

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