Trial Outcomes & Findings for A Study in Migraine Prevention (NCT NCT01184508)
NCT ID: NCT01184508
Last Updated: 2018-09-12
Results Overview
The definition of a migraine (a headache lasting 4 to 72 hours) was based on the International Headache Society (IHS) diagnostic criteria. The number of migraine attacks per month was normalized to a 28-day month and calculated as the (number of migraine attacks\*28 days)/number of days in the specified month.
TERMINATED
PHASE2
87 participants
Baseline and Month 3
2018-09-12
Participant Flow
Prior to randomization, participants completed screening and washout followed by a 28-day baseline period to determine the number of migraine attacks participants experienced without the use of preventative medications. Participant Flow and results based on participants, post-randomization (12-week treatment and 4-week follow-up periods combined).
Participant milestones
| Measure |
Placebo
Capsules administered orally, once daily, for 12 weeks.
|
LY2300559
300 milligrams (mg) administered orally as two 150-mg capsules, once daily, for 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
42
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
45
|
41
|
|
Overall Study
COMPLETED
|
29
|
27
|
|
Overall Study
NOT COMPLETED
|
16
|
15
|
Reasons for withdrawal
| Measure |
Placebo
Capsules administered orally, once daily, for 12 weeks.
|
LY2300559
300 milligrams (mg) administered orally as two 150-mg capsules, once daily, for 12 weeks.
|
|---|---|---|
|
Overall Study
Sponsor Decision
|
5
|
2
|
|
Overall Study
Adverse Event
|
4
|
6
|
|
Overall Study
Lack of Efficacy
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Protocol Violation
|
3
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
|
Overall Study
Randomized, Not Treated
|
0
|
1
|
Baseline Characteristics
A Study in Migraine Prevention
Baseline characteristics by cohort
| Measure |
Placebo
n=45 Participants
Capsules administered orally, once daily, for 12 weeks.
|
LY2300559
n=41 Participants
300 milligrams (mg) administered orally as two 150-mg capsules, once daily, for 12 weeks.
|
Total
n=86 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.3 years
STANDARD_DEVIATION 10.09 • n=5 Participants
|
41.4 years
STANDARD_DEVIATION 12.17 • n=7 Participants
|
42.4 years
STANDARD_DEVIATION 11.10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
42 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
45 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
26.5 kilograms per square meter (kg/m^2)
STANDARD_DEVIATION 3.65 • n=5 Participants
|
26.3 kilograms per square meter (kg/m^2)
STANDARD_DEVIATION 5.13 • n=7 Participants
|
26.4 kilograms per square meter (kg/m^2)
STANDARD_DEVIATION 4.39 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Month 3Population: Randomized participants (pts) who had at least 4 migraines and/or probable migraine headaches during the baseline period, who received at least 1 dose of study drug, and for whom had at least 1 post-randomization efficacy data for the specified endpoint was available.
The definition of a migraine (a headache lasting 4 to 72 hours) was based on the International Headache Society (IHS) diagnostic criteria. The number of migraine attacks per month was normalized to a 28-day month and calculated as the (number of migraine attacks\*28 days)/number of days in the specified month.
Outcome measures
| Measure |
Placebo
n=31 Participants
Capsules administered orally, once daily, for 12 weeks.
|
LY2300559
n=33 Participants
300 milligrams (mg) administered orally as two 150-mg capsules, once daily, for 12 weeks.
|
|---|---|---|
|
Change From Baseline to 12 Week Endpoint in the Number of Migraine Attacks
Month 3
|
3.4 migraine attacks
Standard Deviation 1.88
|
2.8 migraine attacks
Standard Deviation 2.08
|
|
Change From Baseline to 12 Week Endpoint in the Number of Migraine Attacks
Baseline
|
5.2 migraine attacks
Standard Deviation 1.03
|
5.5 migraine attacks
Standard Deviation 1.50
|
SECONDARY outcome
Timeframe: Baseline and Month 3Population: Randomized participants who had at least 4 migraines and/or probable migraine headaches during the baseline period, who received at least 1 dose of study drug, and for whom at least 1 post-randomization efficacy data for the specified endpoint was available.
The participant-reported severity of migraines was rated on a 3-point categorical scale (Mild, Moderate, or Severe). Participants could report a severity of none (score = 0), mild (1), moderate (2), or severe (3). In general, if a headache was mild, daily activities could be resumed and little to no medication was taken. Moderate headaches required medication and effected daily activities. Severe headaches were debilitating and required medication. If a participant had multiple migraines during Month 3 (normalized to 28 days), the most severe migraine was analyzed.
Outcome measures
| Measure |
Placebo
n=31 Participants
Capsules administered orally, once daily, for 12 weeks.
|
LY2300559
n=33 Participants
300 milligrams (mg) administered orally as two 150-mg capsules, once daily, for 12 weeks.
|
|---|---|---|
|
Change From Baseline to 12 Week Endpoint in Severity of Migraine Intensity (Mild, Moderate, Severe)
Moderate, Baseline
|
8 participants
|
12 participants
|
|
Change From Baseline to 12 Week Endpoint in Severity of Migraine Intensity (Mild, Moderate, Severe)
Moderate, Month 3
|
7 participants
|
14 participants
|
|
Change From Baseline to 12 Week Endpoint in Severity of Migraine Intensity (Mild, Moderate, Severe)
Severe, Baseline
|
23 participants
|
21 participants
|
|
Change From Baseline to 12 Week Endpoint in Severity of Migraine Intensity (Mild, Moderate, Severe)
Mild, Baseline
|
0 participants
|
0 participants
|
|
Change From Baseline to 12 Week Endpoint in Severity of Migraine Intensity (Mild, Moderate, Severe)
Mild, Month 3
|
3 participants
|
0 participants
|
|
Change From Baseline to 12 Week Endpoint in Severity of Migraine Intensity (Mild, Moderate, Severe)
Severe, Month 3
|
10 participants
|
4 participants
|
SECONDARY outcome
Timeframe: Baseline and Month 3Population: Randomized participants (pts) who had at least 4 migraines/probable migraines during the baseline period, who received at least 1 dose of study drug, and had at least 1 post-randomization efficacy data for the specified endpoint.No data collected for aura and vomiting's migraine symptoms.
The duration of migraine symptoms was the amount of time from the beginning of each individual migraine attack to the end of each migraine attack. Two attacks separated by \<24 hours were considered part of the same migraine and duration was calculated as such. Migraine symptoms included photophobia, phonophobia, nausea, and vomiting. No data collected for aura and vomiting's migraine symptoms.
Outcome measures
| Measure |
Placebo
n=31 Participants
Capsules administered orally, once daily, for 12 weeks.
|
LY2300559
n=31 Participants
300 milligrams (mg) administered orally as two 150-mg capsules, once daily, for 12 weeks.
|
|---|---|---|
|
Change From Baseline to 12 Week Endpoint in Average Duration of Migraine Symptoms
Duration of Phonophobia, Month 3
|
17.1 hours
Standard Deviation 19.98
|
17.4 hours
Standard Deviation 11.19
|
|
Change From Baseline to 12 Week Endpoint in Average Duration of Migraine Symptoms
Duration of Nausea, Baseline
|
12.8 hours
Standard Deviation 12.15
|
13.9 hours
Standard Deviation 17.61
|
|
Change From Baseline to 12 Week Endpoint in Average Duration of Migraine Symptoms
Duration of Photophobia, Baseline
|
15.3 hours
Standard Deviation 12.75
|
18.3 hours
Standard Deviation 12.70
|
|
Change From Baseline to 12 Week Endpoint in Average Duration of Migraine Symptoms
Duration of Photophobia, Month 3
|
16.3 hours
Standard Deviation 19.80
|
18.7 hours
Standard Deviation 13.87
|
|
Change From Baseline to 12 Week Endpoint in Average Duration of Migraine Symptoms
Duration of Phonophobia, Baseline
|
15.7 hours
Standard Deviation 10.59
|
16.4 hours
Standard Deviation 12.54
|
|
Change From Baseline to 12 Week Endpoint in Average Duration of Migraine Symptoms
Duration of Nausea, Month 3
|
17.5 hours
Standard Deviation 16.26
|
14.1 hours
Standard Deviation 10.42
|
SECONDARY outcome
Timeframe: Baseline and Month 3Population: Randomized participants (pts) who had at least 4 migraines and/or probable migraine headaches during the baseline period, who received at least 1 dose of study drug, and for whom at least 1 post-randomization efficacy data for the specified endpoint was available.
A migraine day was any day with a migraine attack (a headache lasting 4 to 72 hours). The number of migraine days per month was normalized to a 28-day month and calculated as the (number of migraine days\*28)/number of days in the specified month.
Outcome measures
| Measure |
Placebo
n=31 Participants
Capsules administered orally, once daily, for 12 weeks.
|
LY2300559
n=33 Participants
300 milligrams (mg) administered orally as two 150-mg capsules, once daily, for 12 weeks.
|
|---|---|---|
|
Mean Change From Baseline to 12 Week Endpoint in the Number of Migraine Days
Baseline
|
8.8 migraine days
Standard Deviation 2.56
|
10.5 migraine days
Standard Deviation 4.47
|
|
Mean Change From Baseline to 12 Week Endpoint in the Number of Migraine Days
Month 3
|
6.3 migraine days
Standard Deviation 3.77
|
4.9 migraine days
Standard Deviation 3.80
|
SECONDARY outcome
Timeframe: Baseline(Day 28) and Week 12 (Day 84)Population: Randomized participants who had at least 4 migraines and/or probable migraine headaches during the baseline period, who received at least 1 dose of study drug and, for whom at least 1 post-randomization efficacy data for the specified endpoint was available.
The CGI-I was a 1-item scale that measured the clinician's perception of the improvement in migraine symptoms compared with the start of treatment. Scores ranged from 1 (very much improved) to 7 (very much worse). A score of 4 indicated no change.
Outcome measures
| Measure |
Placebo
n=31 Participants
Capsules administered orally, once daily, for 12 weeks.
|
LY2300559
n=33 Participants
300 milligrams (mg) administered orally as two 150-mg capsules, once daily, for 12 weeks.
|
|---|---|---|
|
Change From Baseline to 12 Week Endpoint in Clinical Global Impression of Improvement (CGI-I)
Week 12
|
3.0 units on a scale
Interval 1.0 to 5.0
|
2.0 units on a scale
Interval 1.0 to 5.0
|
|
Change From Baseline to 12 Week Endpoint in Clinical Global Impression of Improvement (CGI-I)
Baseline
|
4.0 units on a scale
Interval 4.0 to 4.0
|
4.0 units on a scale
Interval 3.0 to 5.0
|
SECONDARY outcome
Timeframe: Baseline (Day 28) and Week 12 (Day 84)Population: Randomized participants who had at least 4 migraines and/or probable migraine headaches during the baseline period, who received at least 1 dose of study drug, and for whom at least 1 post-randomization efficacy data for the specified endpoint was available.
The PGI-I was a 1-item scale that measured the participant's perception of improvement in migraine symptoms compared with the start of treatment. Scores ranged from 1 (very much improved) to 7 (very much worse). A score of 4 indicated no change.
Outcome measures
| Measure |
Placebo
n=31 Participants
Capsules administered orally, once daily, for 12 weeks.
|
LY2300559
n=33 Participants
300 milligrams (mg) administered orally as two 150-mg capsules, once daily, for 12 weeks.
|
|---|---|---|
|
Change From Baseline to 12 Week Endpoint in Patient's Global Impression of Improvement (PGI-I)
Baseline
|
4.0 units on a scale
Interval 4.0 to 5.0
|
4.0 units on a scale
Interval 3.0 to 5.0
|
|
Change From Baseline to 12 Week Endpoint in Patient's Global Impression of Improvement (PGI-I)
Week 12
|
2.5 units on a scale
Interval 1.0 to 5.0
|
2.0 units on a scale
Interval 1.0 to 5.0
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Randomized participants who had at least 4 migraines and/or probable migraine headaches during the baseline period, who received at least 1 dose of study drug, and for whom at least 1 post-randomization efficacy data for the specified endpoint was available.
The MSQ was a 14-item self-administered scale that assessed the participant's perception of quality of life for 3 dimensions \[role restriction or restrictive function (Items 1-7), role prevention or preventive function (Items 8-11), and emotional function (Items 12-14)\]. Participants rated each item from 1 (none of the time) to 6 (all of the time). Since each item was presented as a negative statement, participant responses were recoded before item scores were calculated. Then, dimension scores were calculated as the sum of the recoded items for that specific dimension. Each dimension score was transformed into a score that ranged from 0 to 100. The transformation formula for the restrictive function = \[(dimension score-7)\*100\]/35, for the preventive function = \[(dimension score-4)\*100\]/20, and for the emotional function = \[(dimension score-3)\*100\]/15. A lower score indicated a poorer quality of life associated with that domain.
Outcome measures
| Measure |
Placebo
n=31 Participants
Capsules administered orally, once daily, for 12 weeks.
|
LY2300559
n=33 Participants
300 milligrams (mg) administered orally as two 150-mg capsules, once daily, for 12 weeks.
|
|---|---|---|
|
Change From Baseline to 12 Week Endpoint in Migraine-Specific Quality of Life Questionnaire (MSQ) Score
Preventive Function Score, Baseline
|
79.0 units on a scale
Standard Deviation 16.09
|
76.4 units on a scale
Standard Deviation 20.24
|
|
Change From Baseline to 12 Week Endpoint in Migraine-Specific Quality of Life Questionnaire (MSQ) Score
Emotional Function Score, Baseline
|
70.8 units on a scale
Standard Deviation 20.20
|
70.3 units on a scale
Standard Deviation 26.83
|
|
Change From Baseline to 12 Week Endpoint in Migraine-Specific Quality of Life Questionnaire (MSQ) Score
Emotional Function Score, Week 12
|
84.7 units on a scale
Standard Deviation 19.24
|
88.0 units on a scale
Standard Deviation 14.40
|
|
Change From Baseline to 12 Week Endpoint in Migraine-Specific Quality of Life Questionnaire (MSQ) Score
Restrictive Function Score, Baseline
|
62.8 units on a scale
Standard Deviation 15.20
|
59.0 units on a scale
Standard Deviation 17.71
|
|
Change From Baseline to 12 Week Endpoint in Migraine-Specific Quality of Life Questionnaire (MSQ) Score
Restrictive Function Score, Week 12
|
74.6 units on a scale
Standard Deviation 18.44
|
80.1 units on a scale
Standard Deviation 15.62
|
|
Change From Baseline to 12 Week Endpoint in Migraine-Specific Quality of Life Questionnaire (MSQ) Score
Preventive Function Score, Week 12
|
85.5 units on a scale
Standard Deviation 17.08
|
89.4 units on a scale
Standard Deviation 11.49
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Randomized participants who had at least 4 migraines and/or probable migraine headaches during the baseline period, who received at least 1 dose of study drug, and for whom at least 1 post-randomization efficacy data for the specified endpoint was available.
MIBS-4 was a 4-item self-administered scale that assessed the impact of headaches on the participant's life between headache attacks. Each item measured a specific domain (impairment in work or school, impairment in family and social life, difficulty making plans or commitments, or emotional/affective and cognitive distress). For each item and domain, scores were weighted as follows: Don't know (0), Never (0), Rarely (1), Some of the time (2), Much of the time (3), and All of the time (4). The overall weighted score was the sum of the domain scores and ranged from 0 to 16. Higher scores indicated a greater impact of headaches on the participant's life between headache attacks.
Outcome measures
| Measure |
Placebo
n=31 Participants
Capsules administered orally, once daily, for 12 weeks.
|
LY2300559
n=33 Participants
300 milligrams (mg) administered orally as two 150-mg capsules, once daily, for 12 weeks.
|
|---|---|---|
|
Change From Baseline to 12 Week Endpoint in Migraine Interictal Burden Scale (MIBS-4) Overall Weighted Score
Baseline
|
4.0 units on a scale
Standard Deviation 3.72
|
3.0 units on a scale
Standard Deviation 3.21
|
|
Change From Baseline to 12 Week Endpoint in Migraine Interictal Burden Scale (MIBS-4) Overall Weighted Score
Week 12
|
2.3 units on a scale
Standard Deviation 3.15
|
2.1 units on a scale
Standard Deviation 2.34
|
SECONDARY outcome
Timeframe: Baseline and Week 8 (1 to 3 hours postdose), Weeks 2 and 4 (predose and 1 to 3 hours postdose), Week 12 (predose, 1 to 3 hours postdose, and 5 hours postdose)Population: Participants who received at least 1 dose of study drug and had at least 1 evaluable pharmacokinetic sample.
Outcome measures
| Measure |
Placebo
n=41 Participants
Capsules administered orally, once daily, for 12 weeks.
|
LY2300559
300 milligrams (mg) administered orally as two 150-mg capsules, once daily, for 12 weeks.
|
|---|---|---|
|
Pharmacokinetics: Area Under the Plasma Concentration-Time Curve at the Steady State (AUCtau,ss) of LY2300559
|
479000 nanogram*hours per milliliter (ng*h/mL)
Interval 131000.0 to 1156000.0
|
—
|
SECONDARY outcome
Timeframe: Month 3Population: Randomized participants who had at least 4 migraines and/or probable migraine headaches during the baseline period, who received at least 1 dose of study drug, and for whom at least 1 post-randomization efficacy data for the specified endpoint was available.
Participants were allowed to use a pre-approved list of medications for the treatment of breakthrough migraines during the study, as long as the treatments were the same as those used and reported during the baseline period. Any medications or procedures to prevent migraines were not allowed. Percentage of participants = (number of participants using breakthrough medication/total number of participants)\*100. Each month was normalized to a 28-day month.
Outcome measures
| Measure |
Placebo
n=21 Participants
Capsules administered orally, once daily, for 12 weeks.
|
LY2300559
n=22 Participants
300 milligrams (mg) administered orally as two 150-mg capsules, once daily, for 12 weeks.
|
|---|---|---|
|
Percentage of Participants Using Breakthrough Medications
|
95.2 percentage of participants
|
86.4 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 12Population: Randomized participants who had at least 4 migraines and/or probable migraine headaches during the baseline period, who received at least 1 dose of study drug, and for whom at least 1 post-randomization efficacy data for the specified endpoint was available.
Participants were allowed to use a pre-approved list of medications for the treatment of breakthrough migraines during the study, as long as the treatments were the same as those used and reported during the baseline period. Any medications or procedures to prevent migraines were not allowed. The mean number was calculated by the breakthrough (BH) medications (meds) per migraine used by each participant per month. Each month was normalized to a 28-day month.
Outcome measures
| Measure |
Placebo
n=19 Participants
Capsules administered orally, once daily, for 12 weeks.
|
LY2300559
n=17 Participants
300 milligrams (mg) administered orally as two 150-mg capsules, once daily, for 12 weeks.
|
|---|---|---|
|
Change From Baseline to 12 Week Endpoint in Breakthrough Treatment Therapy for Acute Migraine Attacks
|
0.34 BH meds/migraine by participants/month
Standard Deviation 0.6
|
-0.03 BH meds/migraine by participants/month
Standard Deviation 0.6
|
Adverse Events
Placebo
LY2300559
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=45 participants at risk
Capsules administered orally, once daily, for 12 weeks.
|
LY2300559
n=41 participants at risk
300 milligrams (mg) administered orally as two 150-mg capsules, once daily, for 12 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
4.4%
2/45 • Number of events 2 • Baseline up to Week 16
|
0.00%
0/41 • Baseline up to Week 16
|
|
Gastrointestinal disorders
Constipation
|
4.4%
2/45 • Number of events 2 • Baseline up to Week 16
|
4.9%
2/41 • Number of events 2 • Baseline up to Week 16
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/45 • Baseline up to Week 16
|
4.9%
2/41 • Number of events 2 • Baseline up to Week 16
|
|
Gastrointestinal disorders
Nausea
|
8.9%
4/45 • Number of events 5 • Baseline up to Week 16
|
9.8%
4/41 • Number of events 4 • Baseline up to Week 16
|
|
Gastrointestinal disorders
Vomiting
|
4.4%
2/45 • Number of events 2 • Baseline up to Week 16
|
0.00%
0/41 • Baseline up to Week 16
|
|
General disorders
Fatigue
|
11.1%
5/45 • Number of events 5 • Baseline up to Week 16
|
17.1%
7/41 • Number of events 7 • Baseline up to Week 16
|
|
General disorders
Feeling abnormal
|
4.4%
2/45 • Number of events 2 • Baseline up to Week 16
|
0.00%
0/41 • Baseline up to Week 16
|
|
General disorders
Therapeutic response unexpected
|
4.4%
2/45 • Number of events 2 • Baseline up to Week 16
|
2.4%
1/41 • Number of events 1 • Baseline up to Week 16
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/45 • Baseline up to Week 16
|
4.9%
2/41 • Number of events 2 • Baseline up to Week 16
|
|
Infections and infestations
Upper respiratory tract infection
|
4.4%
2/45 • Number of events 2 • Baseline up to Week 16
|
4.9%
2/41 • Number of events 2 • Baseline up to Week 16
|
|
Infections and infestations
Urinary tract infection
|
4.4%
2/45 • Number of events 2 • Baseline up to Week 16
|
0.00%
0/41 • Baseline up to Week 16
|
|
Infections and infestations
Viral infection
|
0.00%
0/45 • Baseline up to Week 16
|
4.9%
2/41 • Number of events 2 • Baseline up to Week 16
|
|
Investigations
Alanine aminotransferase increased
|
2.2%
1/45 • Number of events 1 • Baseline up to Week 16
|
19.5%
8/41 • Number of events 8 • Baseline up to Week 16
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/45 • Baseline up to Week 16
|
19.5%
8/41 • Number of events 8 • Baseline up to Week 16
|
|
Investigations
Blood creatine phosphokinase increased
|
4.4%
2/45 • Number of events 2 • Baseline up to Week 16
|
2.4%
1/41 • Number of events 1 • Baseline up to Week 16
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/45 • Baseline up to Week 16
|
4.9%
2/41 • Number of events 2 • Baseline up to Week 16
|
|
Investigations
Weight increased
|
4.4%
2/45 • Number of events 2 • Baseline up to Week 16
|
4.9%
2/41 • Number of events 2 • Baseline up to Week 16
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.2%
1/45 • Number of events 1 • Baseline up to Week 16
|
4.9%
2/41 • Number of events 2 • Baseline up to Week 16
|
|
Nervous system disorders
Dizziness
|
11.1%
5/45 • Number of events 6 • Baseline up to Week 16
|
0.00%
0/41 • Baseline up to Week 16
|
|
Nervous system disorders
Dysgeusia
|
4.4%
2/45 • Number of events 2 • Baseline up to Week 16
|
0.00%
0/41 • Baseline up to Week 16
|
|
Nervous system disorders
Somnolence
|
4.4%
2/45 • Number of events 2 • Baseline up to Week 16
|
7.3%
3/41 • Number of events 3 • Baseline up to Week 16
|
|
Psychiatric disorders
Insomnia
|
4.4%
2/45 • Number of events 2 • Baseline up to Week 16
|
0.00%
0/41 • Baseline up to Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/45 • Baseline up to Week 16
|
4.9%
2/41 • Number of events 2 • Baseline up to Week 16
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
4.4%
2/45 • Number of events 2 • Baseline up to Week 16
|
0.00%
0/41 • Baseline up to Week 16
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.4%
2/45 • Number of events 2 • Baseline up to Week 16
|
0.00%
0/41 • Baseline up to Week 16
|
|
Vascular disorders
Flushing
|
4.4%
2/45 • Number of events 2 • Baseline up to Week 16
|
0.00%
0/41 • Baseline up to Week 16
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60