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An Open-label, Long-term, Safety Study of Lasmiditan for the Acute Treatment of Migraine (GLADIATOR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02565186
Recruitment Status : Completed
First Posted : October 1, 2015
Results First Posted : August 25, 2020
Last Update Posted : August 25, 2020
Sponsor:
Collaborator:
CoLucid Pharmaceuticals
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Migraine Disorders
Intervention Drug: Lasmiditan
Enrollment 2171
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lasmiditan 100mg Lasmiditan 200mg
Hide Arm/Group Description Participants received oral dose of 100 milligrams (mg) Lasmiditan with in four hours of onset of migraine attack. If the migraine did not respond within 2 hours after first dose or if responded and recurred then a second dose was permitted within 24 hours after first dose. Participants received oral dose of 200mg Lasmiditan with in four hours of onset of migraine attack. If the migraine did not respond with in 2 hours after first dose or if responded and recurred then a second dose was permitted within 24 hours after first dose.
Period Title: Overall Study
Started 1046 1125
Received at Least One Dose of Study Drug 991 1039
Completed 466 504
Not Completed 580 621
Reason Not Completed
Adverse Event             113             148
Lost to Follow-up             102             93
Non-Compliance             57             55
Withdrawal by Subject             229             214
Physician Decision             18             16
Sponsor Request             5             9
Missing             1             0
Did Not Receive Study Drug             55             86
Arm/Group Title Lasmiditan 100mg Lasmiditan 200mg Total
Hide Arm/Group Description Participants received oral dose of 100mg Lasmiditan with in four hours of onset of migraine attack. If the migraine did not respond within 2 hours after first dose or if responded and recurred then a second dose was permitted within 24 hours after first dose. Participants received oral dose of 200mg Lasmiditan with in four hours of onset of migraine attack. If the migraine did not respond with in 2 hours after first dose or if responded and recurred then a second dose was permitted within 24 hours after first dose. Total of all reporting groups
Overall Number of Baseline Participants 1046 1125 2171
Hide Baseline Analysis Population Description
All randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1046 participants 1125 participants 2171 participants
42.5  (12.25) 43.4  (12.33) 43.0  (12.30)
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1046 participants 1123 participants 2169 participants
Female 882 957 1839
Male 164 166 330
[1]
Measure Analysis Population Description: All randomized participants with available gender data.
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1046 participants 1125 participants 2171 participants
Hispanic or Latino 208 240 448
Not Hispanic or Latino 833 880 1713
Unknown or Not Reported 5 5 10
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1046 participants 1125 participants 2171 participants
American Indian or Alaska Native 4 11 15
Asian 7 6 13
Native Hawaiian or Other Pacific Islander 4 6 10
Black or African American 203 194 397
White 805 884 1689
More than one race 11 14 25
Unknown or Not Reported 12 10 22
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 1046 participants 1125 participants 2171 participants
1041 1065 2106
United Kingdom Number Analyzed 1046 participants 1125 participants 2171 participants
5 38 43
Germany Number Analyzed 1046 participants 1125 participants 2171 participants
0 22 22
1.Primary Outcome
Title Number of Participants With at Least 1 Treatment Emergent Adverse Event
Hide Description

An AE with an onset on or within 48 hours after a dose of study drug, or an event that worsened in intensity within 48 hours of a dose of study drug was considered a treatment-emergent adverse event (TEAE).

A summary of serious adverse events (SAEs) and other non-serious adverse events (AEs), regardless of causality, were reported in the Reported Adverse Events module.

Time Frame Up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug.
Arm/Group Title Lasmiditan 100mg Lasmiditan 200mg
Hide Arm/Group Description:
Participants received oral dose of 100mg Lasmiditan with in four hours of onset of migraine attack. If the migraine did not respond within 2 hours after first dose or if responded and recurred then a second dose was permitted within 24 hours after first dose.
Participants received oral dose of 200mg Lasmiditan with in four hours of onset of migraine attack. If the migraine did not respond with in 2 hours after first dose or if responded and recurred then a second dose was permitted within 24 hours after first dose.
Overall Number of Participants Analyzed 991 1039
Measure Type: Number
Unit of Measure: Participants
447 545
2.Secondary Outcome
Title Percentage of Migraine Attacks With Pain Freedom (PF) at 2 Hours After Dose
Hide Description Pain freedom is defined as a reduction in headache severity from mild (1), moderate (2), or severe (3) at baseline to none (0).
Time Frame Up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who treated at least 1 qualifying migraine attack within 4 hours of onset.
Arm/Group Title Lasmiditan 100mg Lasmiditan 200mg
Hide Arm/Group Description:
Participants received oral dose of 100mg Lasmiditan with in four hours of onset of migraine attack. If the migraine did not respond within 2 hours after first dose or if responded and recurred then a second dose was permitted within 24 hours after first dose.
Participants received oral dose of 200mg Lasmiditan with in four hours of onset of migraine attack. If the migraine did not respond with in 2 hours after first dose or if responded and recurred then a second dose was permitted within 24 hours after first dose.
Overall Number of Participants Analyzed 954 1000
Overall Number of Units Analyzed
Type of Units Analyzed: Migraine Attacks
8837 8479
Measure Type: Number
Unit of Measure: Percentage of PF Migraine Attacks
26.7 32.2
3.Secondary Outcome
Title Percentage of Migraine Attacks With Most Bothersome Symptom-Free (MBS) at 2 Hours After Dose
Hide Description MBS-free, defined as the absence of the associated symptom of migraine (nausea, phonophobia, and/or photophobia) at 2 hours postdose that was identified predose as the most bothersome symptom.
Time Frame Up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who treated at least 1 qualifying migraine attack within 4 hours of onset.
Arm/Group Title Lasmiditan 100mg Lasmiditan 200mg
Hide Arm/Group Description:
Participants received oral dose of 100mg Lasmiditan with in four hours of onset of migraine attack. If the migraine did not respond within 2 hours after first dose or if responded and recurred then a second dose was permitted within 24 hours after first dose.
Participants received oral dose of 200mg Lasmiditan with in four hours of onset of migraine attack. If the migraine did not respond with in 2 hours after first dose or if responded and recurred then a second dose was permitted within 24 hours after first dose.
Overall Number of Participants Analyzed 954 1000
Overall Number of Units Analyzed
Type of Units Analyzed: Migraine Attacks
8045 7529
Measure Type: Number
Unit of Measure: Percentage of MBS-Free Migraine Attacks
37.2 40.8
4.Other Pre-specified Outcome
Title Percentage of Participants With Medical Resource Utilization
Hide Description Medical Resource utilization for any cardiovascular (CV) events and/or related resource utilization, such as visits to cardiologists, procedures, hospitalizations, new treatments or treatment adjustments for CV disease and any visits to an emergency room (ER) or physician's office for treatment of migraine was reported.
Time Frame Up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug.
Arm/Group Title Lasmiditan 100mg Lasmiditan 200mg
Hide Arm/Group Description:
Participants received oral dose of 100mg Lasmiditan with in four hours of onset of migraine attack. If the migraine did not respond within 2 hours after first dose or if responded and recurred then a second dose was permitted within 24 hours after first dose.
Participants received oral dose of 200mg Lasmiditan with in four hours of onset of migraine attack. If the migraine did not respond with in 2 hours after first dose or if responded and recurred then a second dose was permitted within 24 hours after first dose.
Overall Number of Participants Analyzed 991 1039
Measure Type: Number
Unit of Measure: Percentage of Participants
Visit to cardiologist 0.6 0.6
Visit to primary care 0.8 0.9
Visit to Other providers 0.1 0.2
Hospitalized 0.5 0.2
Procedures performed 0.8 0.6
ER visits or visits to Physicians Office 2.6 2.6
Time Frame Up to 12 Months
Adverse Event Reporting Description

All randomized participants who received at least one dose of study drug.

Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.

 
Arm/Group Title Lasmiditan 100mg Lasmiditan 200mg
Hide Arm/Group Description Participants received oral dose of 100mg Lasmiditan with in four hours of onset of migraine attack. If the migraine did not respond within 2 hours after first dose or if responded and recurred then a second dose was permitted within 24 hours after first dose. Participants received oral dose of 200mg Lasmiditan with in four hours of onset of migraine attack. If the migraine did not respond with in 2 hours after first dose or if responded and recurred then a second dose was permitted within 24 hours after first dose.
All-Cause Mortality
Lasmiditan 100mg Lasmiditan 200mg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/991 (0.00%)      0/1039 (0.00%)    
Hide Serious Adverse Events
Lasmiditan 100mg Lasmiditan 200mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   29/991 (2.93%)      36/1039 (3.46%)    
Cardiac disorders     
Angina pectoris  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Atrial fibrillation  1  1/991 (0.10%)  1 1/1039 (0.10%)  1
Atrial flutter  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Bradycardia  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Sinus node dysfunction  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Stress cardiomyopathy  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Gastrointestinal disorders     
Gastritis  1  0/991 (0.00%)  0 2/1039 (0.19%)  3
Gastrointestinal haemorrhage  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Hiatus hernia  1  0/991 (0.00%)  0 2/1039 (0.19%)  2
Obstructive pancreatitis  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Small intestinal obstruction  1  0/991 (0.00%)  0 2/1039 (0.19%)  2
General disorders     
Non-cardiac chest pain  1  2/991 (0.20%)  2 0/1039 (0.00%)  0
Hepatobiliary disorders     
Cholecystitis  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Cholecystitis acute  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Cholelithiasis  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Gallbladder disorder  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Infections and infestations     
Abscess limb  1  1/991 (0.10%)  2 0/1039 (0.00%)  0
Appendicitis perforated  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Bronchitis  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Carbuncle  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Cellulitis  1  2/991 (0.20%)  2 0/1039 (0.00%)  0
Coccidioidomycosis  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Diverticulitis  1  1/991 (0.10%)  2 1/1039 (0.10%)  1
Pneumonia  1  1/991 (0.10%)  1 2/1039 (0.19%)  2
Sepsis  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Sinusitis  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Subcutaneous abscess  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Urinary tract infection  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Injury, poisoning and procedural complications     
Femur fracture  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Head injury  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Intentional overdose  1  0/991 (0.00%)  0 2/1039 (0.19%)  2
Skin laceration  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Subdural haematoma  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Suture rupture  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Intervertebral disc protrusion  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Lumbar spinal stenosis  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma of colon  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Non-small cell lung cancer  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Thyroid cancer recurrent  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Nervous system disorders     
Hypoaesthesia  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Ischaemic stroke  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Relapsing-remitting multiple sclerosis  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Seizure  1  1/991 (0.10%)  1 1/1039 (0.10%)  1
Transient ischaemic attack  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Pregnancy, puerperium and perinatal conditions     
Abortion spontaneous  1  3/845 (0.36%)  3 1/887 (0.11%)  1
Abortion threatened  1  0/845 (0.00%)  0 1/887 (0.11%)  1
Psychiatric disorders     
Anxiety  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Depression  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Drug abuse  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Mental status changes  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Obsessive-compulsive disorder  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Schizoaffective disorder bipolar type  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Suicidal ideation  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Suicide attempt  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Renal and urinary disorders     
Acute kidney injury  1  1/991 (0.10%)  1 1/1039 (0.10%)  1
Nephrolithiasis  1  0/991 (0.00%)  0 2/1039 (0.19%)  2
Urinary incontinence  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Reproductive system and breast disorders     
Endometriosis  1  0/845 (0.00%)  0 1/887 (0.11%)  1
Haemorrhagic ovarian cyst  1  0/845 (0.00%)  0 1/887 (0.11%)  1
Ovarian cyst  1  0/845 (0.00%)  0 1/887 (0.11%)  1
Respiratory, thoracic and mediastinal disorders     
Bronchospasm  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Pharyngeal swelling  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Pulmonary embolism  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Upper airway obstruction  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Vascular disorders     
Hypertension  1  3/991 (0.30%)  3 0/1039 (0.00%)  0
Hypertensive urgency  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
1
Term from vocabulary, MedDRA 22.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lasmiditan 100mg Lasmiditan 200mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   446/991 (45.01%)      543/1039 (52.26%)    
Blood and lymphatic system disorders     
Anaemia  1  2/991 (0.20%)  2 1/1039 (0.10%)  1
Lymphadenopathy  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Cardiac disorders     
Bundle branch block left  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Palpitations  1  3/991 (0.30%)  6 5/1039 (0.48%)  5
Tachycardia  1  0/991 (0.00%)  0 2/1039 (0.19%)  3
Ear and labyrinth disorders     
Diplacusis  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Ear discomfort  1  0/991 (0.00%)  0 1/1039 (0.10%)  5
Ear pain  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Hypoacusis  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Tinnitus  1  4/991 (0.40%)  4 4/1039 (0.38%)  5
Vertigo  1  10/991 (1.01%)  15 24/1039 (2.31%)  53
Eye disorders     
Altered visual depth perception  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Blindness transient  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Cataract  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Conjunctivitis allergic  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Dyschromatopsia  1  0/991 (0.00%)  0 2/1039 (0.19%)  2
Eye disorder  1  0/991 (0.00%)  0 1/1039 (0.10%)  3
Iritis  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Metamorphopsia  1  0/991 (0.00%)  0 3/1039 (0.29%)  3
Miosis  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Papilloedema  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Photophobia  1  0/991 (0.00%)  0 2/1039 (0.19%)  2
Photopsia  1  3/991 (0.30%)  3 5/1039 (0.48%)  6
Strabismus  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Vision blurred  1  2/991 (0.20%)  2 6/1039 (0.58%)  8
Visual impairment  1  3/991 (0.30%)  7 8/1039 (0.77%)  23
Vitreous floaters  1  0/991 (0.00%)  0 2/1039 (0.19%)  2
Gastrointestinal disorders     
Abdominal discomfort  1  1/991 (0.10%)  1 5/1039 (0.48%)  5
Abdominal distension  1  2/991 (0.20%)  2 0/1039 (0.00%)  0
Abdominal hernia  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Abdominal pain  1  2/991 (0.20%)  2 1/1039 (0.10%)  1
Abdominal pain lower  1  0/991 (0.00%)  0 1/1039 (0.10%)  2
Abdominal pain upper  1  1/991 (0.10%)  1 3/1039 (0.29%)  3
Dental caries  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Diarrhoea  1  10/991 (1.01%)  10 6/1039 (0.58%)  12
Dyspepsia  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Epigastric discomfort  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Food poisoning  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Frequent bowel movements  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Gastritis  1  0/991 (0.00%)  0 2/1039 (0.19%)  2
Gastrointestinal inflammation  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Gastrooesophageal reflux disease  1  1/991 (0.10%)  1 2/1039 (0.19%)  2
Hiatus hernia  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Hypoaesthesia oral  1  1/991 (0.10%)  1 2/1039 (0.19%)  3
Irritable bowel syndrome  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Nausea  1  39/991 (3.94%)  47 55/1039 (5.29%)  81
Oral pain  1  1/991 (0.10%)  1 1/1039 (0.10%)  1
Paraesthesia oral  1  4/991 (0.40%)  4 1/1039 (0.10%)  1
Retching  1  1/991 (0.10%)  1 1/1039 (0.10%)  1
Swollen tongue  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Tooth disorder  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Toothache  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Vomiting  1  17/991 (1.72%)  18 11/1039 (1.06%)  12
General disorders     
Asthenia  1  15/991 (1.51%)  38 24/1039 (2.31%)  48
Chest discomfort  1  3/991 (0.30%)  64 4/1039 (0.38%)  8
Chills  1  0/991 (0.00%)  0 3/1039 (0.29%)  3
Discomfort  1  1/991 (0.10%)  1 3/1039 (0.29%)  3
Facial pain  1  0/991 (0.00%)  0 1/1039 (0.10%)  2
Fatigue  1  47/991 (4.74%)  90 64/1039 (6.16%)  159
Feeling abnormal  1  7/991 (0.71%)  11 8/1039 (0.77%)  9
Feeling cold  1  1/991 (0.10%)  1 1/1039 (0.10%)  3
Feeling drunk  1  2/991 (0.20%)  3 2/1039 (0.19%)  4
Feeling hot  1  0/991 (0.00%)  0 3/1039 (0.29%)  3
Feeling jittery  1  7/991 (0.71%)  9 5/1039 (0.48%)  11
Feeling of relaxation  1  1/991 (0.10%)  2 1/1039 (0.10%)  9
Gait disturbance  1  2/991 (0.20%)  3 4/1039 (0.38%)  6
Hunger  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Influenza like illness  1  1/991 (0.10%)  1 1/1039 (0.10%)  1
Injection site erythema  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Injection site swelling  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Malaise  1  3/991 (0.30%)  5 2/1039 (0.19%)  3
Non-cardiac chest pain  1  2/991 (0.20%)  2 4/1039 (0.38%)  4
Oedema  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Oedema peripheral  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Pyrexia  1  1/991 (0.10%)  1 1/1039 (0.10%)  1
Swelling face  1  1/991 (0.10%)  1 2/1039 (0.19%)  3
Hepatobiliary disorders     
Cholecystitis  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Cholelithiasis  1  0/991 (0.00%)  0 2/1039 (0.19%)  2
Sphincter of oddi dysfunction  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Immune system disorders     
Seasonal allergy  1  0/991 (0.00%)  0 2/1039 (0.19%)  2
Infections and infestations     
Acute sinusitis  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Atypical pneumonia  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Bacterial vaginosis  1  0/845 (0.00%)  0 1/887 (0.11%)  1
Body tinea  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Bronchitis  1  2/991 (0.20%)  2 3/1039 (0.29%)  3
Campylobacter gastroenteritis  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Conjunctivitis  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Fungal skin infection  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Furuncle  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Gastroenteritis  1  0/991 (0.00%)  0 2/1039 (0.19%)  2
Gastroenteritis viral  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Gingivitis  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Herpes zoster  1  2/991 (0.20%)  2 3/1039 (0.29%)  3
Influenza  1  2/991 (0.20%)  2 4/1039 (0.38%)  4
Labyrinthitis  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Lyme disease  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Nasopharyngitis  1  4/991 (0.40%)  4 9/1039 (0.87%)  9
Otitis externa  1  1/991 (0.10%)  1 1/1039 (0.10%)  1
Otitis media acute  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Pharyngitis  1  1/991 (0.10%)  1 1/1039 (0.10%)  1
Pharyngitis streptococcal  1  2/991 (0.20%)  2 2/1039 (0.19%)  2
Pneumonia  1  0/991 (0.00%)  0 2/1039 (0.19%)  2
Rhinitis  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Sinusitis  1  4/991 (0.40%)  4 8/1039 (0.77%)  8
Tooth abscess  1  1/991 (0.10%)  1 1/1039 (0.10%)  1
Upper respiratory tract infection  1  10/991 (1.01%)  10 6/1039 (0.58%)  6
Upper respiratory tract infection bacterial  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Urinary tract infection  1  5/991 (0.50%)  5 5/1039 (0.48%)  5
Viral infection  1  2/991 (0.20%)  2 1/1039 (0.10%)  1
Injury, poisoning and procedural complications     
Animal bite  1  1/991 (0.10%)  1 1/1039 (0.10%)  1
Arthropod bite  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Contusion  1  2/991 (0.20%)  4 2/1039 (0.19%)  2
Eye injury  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Foot fracture  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Hand fracture  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Joint dislocation  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Ligament rupture  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Ligament sprain  1  4/991 (0.40%)  4 0/1039 (0.00%)  0
Limb injury  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Maternal exposure during pregnancy  1  1/845 (0.12%)  1 0/887 (0.00%)  0
Muscle strain  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Road traffic accident  1  2/991 (0.20%)  2 0/1039 (0.00%)  0
Skin abrasion  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Skin laceration  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Investigations     
Aspartate aminotransferase increased  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Blood creatinine increased  1  2/991 (0.20%)  2 0/1039 (0.00%)  0
Blood glucose increased  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Blood phosphorus decreased  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Blood pressure decreased  1  0/991 (0.00%)  0 2/1039 (0.19%)  3
Blood pressure diastolic increased  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Blood pressure increased  1  2/991 (0.20%)  2 2/1039 (0.19%)  2
Blood triglycerides increased  1  0/991 (0.00%)  0 2/1039 (0.19%)  2
Electrocardiogram t wave biphasic  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Haematocrit decreased  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Heart rate decreased  1  0/991 (0.00%)  0 2/1039 (0.19%)  2
Heart rate increased  1  2/991 (0.20%)  2 1/1039 (0.10%)  1
Heart rate irregular  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Hepatic enzyme increased  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Norovirus test positive  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Urine analysis abnormal  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Weight increased  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
White blood cells urine positive  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Metabolism and nutrition disorders     
Decreased appetite  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Dehydration  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Hypercholesterolaemia  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Hypoglycaemia  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Obesity  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Type 2 diabetes mellitus  1  1/991 (0.10%)  1 2/1039 (0.19%)  2
Vitamin d deficiency  1  1/991 (0.10%)  1 3/1039 (0.29%)  3
Musculoskeletal and connective tissue disorders     
Arthralgia  1  3/991 (0.30%)  3 3/1039 (0.29%)  3
Back pain  1  5/991 (0.50%)  5 6/1039 (0.58%)  6
Bursitis  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Exostosis  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Fibromyalgia  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Foot deformity  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Joint instability  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Ligament laxity  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Limb discomfort  1  1/991 (0.10%)  12 9/1039 (0.87%)  17
Limb mass  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Muscle fatigue  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Muscle spasms  1  6/991 (0.61%)  7 6/1039 (0.58%)  8
Muscle twitching  1  5/991 (0.50%)  6 7/1039 (0.67%)  12
Muscular weakness  1  9/991 (0.91%)  23 16/1039 (1.54%)  49
Musculoskeletal chest pain  1  1/991 (0.10%)  1 2/1039 (0.19%)  2
Musculoskeletal stiffness  1  1/991 (0.10%)  1 2/1039 (0.19%)  3
Myalgia  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Neck pain  1  2/991 (0.20%)  2 1/1039 (0.10%)  1
Pain in extremity  1  2/991 (0.20%)  2 1/1039 (0.10%)  1
Plantar fasciitis  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Rotator cuff syndrome  1  0/991 (0.00%)  0 2/1039 (0.19%)  2
Spinal osteoarthritis  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Tendonitis  1  1/991 (0.10%)  1 1/1039 (0.10%)  1
Trigger finger  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Benign breast neoplasm  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Cholesteatoma  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Skin papilloma  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Uterine leiomyoma  1  1/845 (0.12%)  1 0/887 (0.00%)  0
Nervous system disorders     
Akathisia  1  2/991 (0.20%)  3 2/1039 (0.19%)  24
Altered state of consciousness  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Aphasia  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Ataxia  1  3/991 (0.30%)  11 7/1039 (0.67%)  31
Aura  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Balance disorder  1  7/991 (0.71%)  21 19/1039 (1.83%)  31
Cognitive disorder  1  4/991 (0.40%)  5 3/1039 (0.29%)  4
Coordination abnormal  1  0/991 (0.00%)  0 3/1039 (0.29%)  4
Disturbance in attention  1  2/991 (0.20%)  2 6/1039 (0.58%)  9
Dizziness  1  156/991 (15.74%)  336 220/1039 (21.17%)  647
Dysarthria  1  0/991 (0.00%)  0 2/1039 (0.19%)  2
Dysgeusia  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Dyskinesia  1  1/991 (0.10%)  1 1/1039 (0.10%)  1
Fine motor skill dysfunction  1  0/991 (0.00%)  0 3/1039 (0.29%)  5
Head discomfort  1  1/991 (0.10%)  1 5/1039 (0.48%)  7
Headache  1  3/991 (0.30%)  3 5/1039 (0.48%)  5
Hypersomnia  1  2/991 (0.20%)  2 1/1039 (0.10%)  2
Hypoaesthesia  1  13/991 (1.31%)  16 21/1039 (2.02%)  31
Lethargy  1  20/991 (2.02%)  36 14/1039 (1.35%)  34
Medication overuse headache  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Memory impairment  1  2/991 (0.20%)  2 2/1039 (0.19%)  3
Mental impairment  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Migraine  1  9/991 (0.91%)  10 9/1039 (0.87%)  9
Mononeuropathy  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Neuralgia  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Neuropathy peripheral  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Paraesthesia  1  53/991 (5.35%)  84 86/1039 (8.28%)  293
Parosmia  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Psychomotor hyperactivity  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Restless legs syndrome  1  5/991 (0.50%)  8 4/1039 (0.38%)  5
Sciatica  1  2/991 (0.20%)  2 0/1039 (0.00%)  0
Sedation  1  3/991 (0.30%)  9 5/1039 (0.48%)  7
Sensory disturbance  1  0/991 (0.00%)  0 1/1039 (0.10%)  2
Sinus headache  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Sleep paralysis  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Somnolence  1  77/991 (7.77%)  153 95/1039 (9.14%)  290
Speech disorder  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Stupor  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Syncope  1  0/991 (0.00%)  0 2/1039 (0.19%)  2
Tarsal tunnel syndrome  1  1/991 (0.10%)  2 0/1039 (0.00%)  0
Tension headache  1  0/991 (0.00%)  0 2/1039 (0.19%)  2
Tremor  1  8/991 (0.81%)  8 14/1039 (1.35%)  19
Visual field defect  1  2/991 (0.20%)  2 2/1039 (0.19%)  2
Psychiatric disorders     
Abnormal dreams  1  4/991 (0.40%)  8 6/1039 (0.58%)  23
Affect lability  1  1/991 (0.10%)  2 0/1039 (0.00%)  0
Agitation  1  2/991 (0.20%)  3 1/1039 (0.10%)  2
Anxiety  1  8/991 (0.81%)  12 9/1039 (0.87%)  9
Attention deficit/hyperactivity disorder  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Bipolar disorder  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Confusional state  1  0/991 (0.00%)  0 3/1039 (0.29%)  3
Depersonalisation/derealisation disorder  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Depressed mood  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Depression  1  4/991 (0.40%)  4 3/1039 (0.29%)  3
Disorientation  1  0/991 (0.00%)  0 8/1039 (0.77%)  11
Dysphoria  1  1/991 (0.10%)  1 3/1039 (0.29%)  3
Emotional distress  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Enuresis  1  1/991 (0.10%)  1 1/1039 (0.10%)  1
Euphoric mood  1  5/991 (0.50%)  7 11/1039 (1.06%)  22
Fear  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Hallucination  1  5/991 (0.50%)  5 3/1039 (0.29%)  3
Hallucination, auditory  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Hallucination, visual  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Hypnagogic hallucination  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Insomnia  1  5/991 (0.50%)  5 7/1039 (0.67%)  10
Irritability  1  1/991 (0.10%)  1 1/1039 (0.10%)  1
Listless  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Major depression  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Mental fatigue  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Mood swings  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Nervousness  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Nightmare  1  1/991 (0.10%)  2 3/1039 (0.29%)  7
Panic attack  1  0/991 (0.00%)  0 3/1039 (0.29%)  3
Phonophobia  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Restlessness  1  6/991 (0.61%)  7 5/1039 (0.48%)  6
Sleep disorder  1  1/991 (0.10%)  1 1/1039 (0.10%)  1
Suicidal ideation  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Renal and urinary disorders     
Calculus bladder  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Haematuria  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Hypertonic bladder  1  1/991 (0.10%)  1 1/1039 (0.10%)  1
Nephrolithiasis  1  1/991 (0.10%)  1 1/1039 (0.10%)  1
Proteinuria  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Renal pain  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Reproductive system and breast disorders     
Breast pain  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Dysmenorrhoea  1  0/845 (0.00%)  0 1/887 (0.11%)  1
Menstruation irregular  1  1/845 (0.12%)  1 0/887 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Aphonia  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Cough  1  0/991 (0.00%)  0 3/1039 (0.29%)  21
Dyspnoea  1  3/991 (0.30%)  3 3/1039 (0.29%)  3
Epistaxis  1  1/991 (0.10%)  1 1/1039 (0.10%)  1
Nasal odour  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Oropharyngeal pain  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Paranasal sinus discomfort  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Respiratory depression  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Rhinitis allergic  1  2/991 (0.20%)  2 0/1039 (0.00%)  0
Sinus congestion  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Throat tightness  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Skin and subcutaneous tissue disorders     
Acne  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Actinic keratosis  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Alopecia  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Blister  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Dermatitis  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Dermatitis contact  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Hyperhidrosis  1  2/991 (0.20%)  2 4/1039 (0.38%)  5
Ingrown hair  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Night sweats  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Pruritus  1  2/991 (0.20%)  5 1/1039 (0.10%)  1
Rash  1  3/991 (0.30%)  3 1/1039 (0.10%)  1
Rash papular  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Seborrhoeic dermatitis  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Skin burning sensation  1  1/991 (0.10%)  2 0/1039 (0.00%)  0
Skin mass  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Urticaria  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Vascular disorders     
Flushing  1  1/991 (0.10%)  1 3/1039 (0.29%)  4
Hot flush  1  3/991 (0.30%)  3 4/1039 (0.38%)  5
Hypertension  1  1/991 (0.10%)  1 2/1039 (0.19%)  2
Hypotension  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Orthostatic hypotension  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
Pallor  1  0/991 (0.00%)  0 1/1039 (0.10%)  1
Peripheral coldness  1  1/991 (0.10%)  1 0/1039 (0.00%)  0
1
Term from vocabulary, MedDRA 22.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
EMail: ClinicalTrials.gov@lilly.com
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02565186    
Other Study ID Numbers: 16890
H8H-CD-LAHL ( Other Identifier: Eli Lilly and Company )
2015-005674-37 ( EudraCT Number )
COL MIG-305 ( Other Identifier: Colucid )
First Submitted: September 29, 2015
First Posted: October 1, 2015
Results First Submitted: August 7, 2020
Results First Posted: August 25, 2020
Last Update Posted: August 25, 2020