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A Study Of Galcanezumab In Participants With Episodic Cluster Headache

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ClinicalTrials.gov Identifier: NCT02397473
Recruitment Status : Completed
First Posted : March 25, 2015
Results First Posted : March 13, 2019
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Episodic Cluster Headache
Interventions Drug: Galcanezumab
Drug: Placebo
Enrollment 109
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Galcanezumab 300mg
Hide Arm/Group Description

Participants received placebo once a month for 2 months by subcutaneous (SC) injection.

Participants did not receive any intervention during post treatment follow-up phase.

Participants received Galcanezumab 300mg once a month for two months by subcutaneous (SC) injection.

Participants did not receive any intervention during post treatment follow-up phase.

Period Title: Treatment Phase
Started 57 52
Received at Least One Dose of Study Drug 57 49
Completed 45 45
Not Completed 12 7
Reason Not Completed
Adverse Event             1             2
Lack of Efficacy             8             1
Lost to Follow-up             1             0
Withdrawal by Subject             2             1
Protocol Violation(did not receive drug)             0             3
Period Title: Post Treatment Follow-up Phase
Started 50 [1] 47
Completed 47 45
Not Completed 3 2
Reason Not Completed
Lack of Efficacy             1             1
Lost to Follow-up             1             0
Protocol Violation             1             0
Withdrawal by Subject             0             1
[1]
Participants who discontinued treatment period had an option to enter post treatment phase.
Arm/Group Title Placebo Galcanezumab 300mg Total
Hide Arm/Group Description

Participants received placebo once a month for 2 months by SC injection.

Participants did not receive any intervention during post treatment follow-up phase.

Participants received Galcanezumab 300mg once a month for two months by SC injection.

Participants did not receive any intervention during post treatment follow-up phase.

Total of all reporting groups
Overall Number of Baseline Participants 57 49 106
Hide Baseline Analysis Population Description
All randomized participants who received at least one dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 57 participants 49 participants 106 participants
45.40  (11.32) 47.49  (10.74) 46.37  (11.05)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants 49 participants 106 participants
Female 10 8 18
Male 47 41 88
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants 49 participants 106 participants
Hispanic or Latino 4 3 7
Not Hispanic or Latino 45 41 86
Unknown or Not Reported 8 5 13
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants 49 participants 106 participants
American Indian or Alaska Native 0 0 0
Asian 1 1 2
Native Hawaiian or Other Pacific Islander 0 0 0
Black or African American 4 2 6
White 47 43 90
More than one race 5 3 8
Unknown or Not Reported 0 0 0
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants 49 participants 106 participants
Greece 1 2 3
Canada 1 1 2
Netherlands 1 2 3
Belgium 4 4 8
United States 18 16 34
Finland 2 1 3
Denmark 2 1 3
Italy 11 9 20
United Kingdom 1 1 2
France 5 4 9
Germany 4 2 6
Spain 7 6 13
Weekly Cluster Headache Attacks  
Mean (Standard Deviation)
Unit of measure:  Cluster Headache Attacks per week
Number Analyzed 57 participants 49 participants 106 participants
17.30  (10.05) 17.82  (10.12) 17.54  (10.04)
Lifetime suicidal ideation prior to screening  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants 49 participants 106 participants
5 9 14
Lifetime suicidal behavior prior to screening  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants 49 participants 106 participants
0 1 1
1.Primary Outcome
Title Overall Mean Change From Baseline in Number of Weekly Cluster Headache Attacks
Hide Description Number of cluster headache attacks was recorded daily by study participants in their ePRO Diary. Overall mean change from baseline is derived from the average of weeks 1 to 3 from mixed model repeated measures (MMRM) analysis. Least Square (LS) means were calculated using MMRM model with treatment, sex, pooled investigative site, week, baseline, and treatment by week as fixed effects.
Time Frame Baseline, Week 1 through Week 3
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline measurement.
Arm/Group Title Placebo Galcanezumab 300mg
Hide Arm/Group Description:

Participants received placebo once a month for two months by SC injection.

Participants did not receive any intervention during post treatment follow-up phase.

Participants received Galcanezumab 300mg once a month for two months by SC injection.

Participants did not receive any intervention during post treatment follow-up phase.

Overall Number of Participants Analyzed 57 49
Least Squares Mean (Standard Error)
Unit of Measure: Cluster Headache Attacks per Week
-5.22  (1.33) -8.69  (1.42)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Galcanezumab 300mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.036
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean Difference
Estimated Value -3.47
Confidence Interval (2-Sided) 95%
-6.72 to -0.23
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.63
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With 50% or Greater Reduction From Baseline in the Weekly Number of Cluster Headache Attacks
Hide Description Number of cluster headache attacks was recorded daily by study participants in their ePRO Diary. Percentage of participants with 50% or greater reduction from baseline at week 3 was analyzed using Koch's nonparametric randomization-based analysis of covariance method. This method adjusted for pooled investigative site by including it as a stratification variable. It also adjusted for sex and baseline value.
Time Frame Baseline, Week 3
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline measurement.
Arm/Group Title Placebo Galcanezumab 300mg
Hide Arm/Group Description:

Participants received placebo once a month for two months by SC injection.

Participants did not receive any intervention during post treatment follow-up phase.

Participants received Galcanezumab 300mg once a month for two months by SC injection.

Participants did not receive any intervention during post treatment follow-up phase.

Overall Number of Participants Analyzed 53 46
Measure Type: Number
Unit of Measure: percentage of participants
56.60 76.09
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Galcanezumab 300mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.040
Comments [Not Specified]
Method ANCOVA
Comments Koch's nonparametric randomization-based ANCOVA.
3.Secondary Outcome
Title Overall Mean Change From Baseline in Number of Weekly Cluster Headache Attacks
Hide Description Number of cluster headache attacks was recorded daily by study participants in their ePRO Diary. Overall mean change from baseline is derived from the average of weeks 1 to 8 from MMRM analysis. Least Square (LS) means were calculated using MMRM model with treatment, sex, pooled investigative site, week, baseline, and treatment by week as fixed effects.
Time Frame Baseline, Week 1 through Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline measurement.
Arm/Group Title Placebo Galcanezumab 300mg
Hide Arm/Group Description:

Participants received placebo once a month for two months by SC injection.

Participants did not receive any intervention during post treatment follow-up phase.

Participants received Galcanezumab 300mg once a month for two months by SC injection.

Participants did not receive any intervention during post treatment follow-up phase.

Overall Number of Participants Analyzed 57 49
Least Squares Mean (Standard Error)
Unit of Measure: Cluster Headache Attacks per Week
-9.97  (0.95) -10.80  (1.00)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Galcanezumab 300mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.493
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean Difference
Estimated Value -0.83
Confidence Interval (2-Sided) 95%
-3.23 to 1.57
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.20
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants Reporting a Score of 1 or 2 on the Patient Global Impression of Improvement (PGI-I)
Hide Description PGI-I requests participants to mark the box that best describes their cluster headache condition since they started taking the medicine. The options in the displayed boxes are represented on a 7-point scale, with 1 = very much better, 2 = much better, 3 = a little better, 4 = no change, 5 = a little worse, 6 = much worse, and 7 = very much worse. Percentage of participants were derived with a generalized linear mixed model repeated measures method with treatment, sex, baseline cluster headache attack category, month, and treatment by month as fixed effects.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had PGI-I measurement at week4.
Arm/Group Title Placebo Galcanezumab 300mg
Hide Arm/Group Description:

Participants received placebo once a month for two months by SC injection.

Participants did not receive any intervention during post treatment follow-up phase.

Participants received Galcanezumab 300mg once a month for two months by SC injection.

Participants did not receive any intervention during post treatment follow-up phase.

Overall Number of Participants Analyzed 49 44
Measure Type: Number
Unit of Measure: percentage of participants
46.4 72.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Galcanezumab 300mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.016
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.046
Confidence Interval (2-Sided) 95%
1.242 to 7.469
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Participants Reporting a Score of 1 or 2 on the Patient Global Impression of Improvement (PGI-I)
Hide Description PGI-I requests participants to mark the box that best describes their cluster headache condition since they started taking the medicine. The options in the displayed boxes are represented on a 7-point scale, with 1 = very much better, 2 = much better, 3 = a little better, 4 = no change, 5 = a little worse, 6 = much worse, and 7 = very much worse. Percentage of participants were derived with a generalized linear mixed model repeated measures method with treatment, sex, baseline cluster headache attack category, month, and treatment by month as fixed effects.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had PGI-I measurement at week 8.
Arm/Group Title Placebo Galcanezumab 300mg
Hide Arm/Group Description:

Participants received placebo once a month for two months by SC injection.

Participants did not receive any intervention during post treatment follow-up phase.

Participants received Galcanezumab 300mg once a month for two months by SC injection.

Participants did not receive any intervention during post treatment follow-up phase.

Overall Number of Participants Analyzed 40 38
Measure Type: Number
Unit of Measure: percentage of participants
66.1 71.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Galcanezumab 300mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.575
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.312
Confidence Interval (2-Sided) 95%
.502 to 3.426
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Participants With 50% or Greater Reduction From Baseline in Number of Weekly Cluster Headache Attacks
Hide Description Number of cluster headache attacks was recorded daily by study participants in their ePRO Diary. Mean percentage of participants is derived from the average of weeks 1 to 8 from generalized linear mixed model repeated measures method with treatment, sex, week, treatment by week, and baseline as fixed effects.
Time Frame Baseline, Week 1 through Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline measurement.
Arm/Group Title Placebo Galcanezumab 300mg
Hide Arm/Group Description:

Participants received placebo once a month for two months by SC injection.

Participants did not receive any intervention during post treatment follow-up phase.

Participants received Galcanezumab 300mg once a month for two months by SC injection.

Participants did not receive any intervention during post treatment follow-up phase.

Overall Number of Participants Analyzed 57 49
Measure Type: Number
Unit of Measure: percentage of participants
70.4 69.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Galcanezumab 300mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.910
Comments [Not Specified]
Method Mixed Models Analysis
Comments Pseudo-likelihood-based repeated measures.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value .965
Confidence Interval (2-Sided) 95%
.512 to 1.819
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Percentage of Participants With 30% or Greater Reduction From Baseline in Number of Weekly Cluster Headache Attacks
Hide Description Number of cluster headache attacks was recorded daily by study participants in their ePRO Diary. Mean percentage of participants is derived from the average of weeks 1 to 8 from generalized linear mixed model repeated measures with treatment, sex, week, treatment by week and baseline as fixed effects.
Time Frame Baseline, Week 1 through Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline measurement.
Arm/Group Title Placebo Galcanezumab 300mg
Hide Arm/Group Description:

Participants received placebo once a month for two months by SC injection.

Participants did not receive any intervention during post treatment follow-up phase.

Participants received Galcanezumab 300mg once a month for two months by SC injection.

Participants did not receive any intervention during post treatment follow-up phase.

Overall Number of Participants Analyzed 57 49
Measure Type: Number
Unit of Measure: percentage of participants
78.9 77.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Galcanezumab 300mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.841
Comments [Not Specified]
Method Mixed Models Analysis
Comments Pseudolikelihood-based repeated measures model
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.929
Confidence Interval (2-Sided) 95%
0.449 to 1.923
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Pharmacokinetics (PK): Serum Concentration of Galcanezumab
Hide Description [Not Specified]
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had measurable PK samples.
Arm/Group Title Galcanezumab 300mg
Hide Arm/Group Description:

Participants received Galcanezumab 300mg once a month for two months by SC injection.

Participants did not receive any intervention during post treatment follow-up phase.

Overall Number of Participants Analyzed 45
Mean (Standard Deviation)
Unit of Measure: Nanogram per Milliliter (ng/mL)
20200  (6880)
9.Secondary Outcome
Title Pharmacokinetics (PK): Serum Concentration of Galcanezumab
Hide Description [Not Specified]
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had measurable PK samples.
Arm/Group Title Galcanezumab 300mg
Hide Arm/Group Description:

Participants received Galcanezumab 300mg once a month for two months by SC injection.

Participants did not receive any intervention during post treatment follow-up phase.

Overall Number of Participants Analyzed 45
Mean (Standard Deviation)
Unit of Measure: Nanogram per Milliliter (ng/mL)
26400  (11200)
10.Secondary Outcome
Title Percentage of Participants Developing Anti-Drug Antibodies (ADA) to Galcanezumab
Hide Description Treatment emergent (TE) ADA evaluable participant is considered to be TE ADA+ if the subject has at least one post-baseline titer that is a 4-fold or greater increase in titer from baseline measurement. If baseline result is ADA Not Present, then the participant is TE ADA+ if there is at least one post-baseline result of ADA present with titer >= 1: 20.
Time Frame Baseline through Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had non-missing baseline ADA result, and at least one non-missing post baseline ADA result.
Arm/Group Title Placebo Galcanezumab 300mg
Hide Arm/Group Description:

Participants received placebo once a month for two months by SC injection.

Participants did not receive any intervention during post treatment follow-up phase.

Participants received Galcanezumab 300mg once a month for two months by SC injection.

Participants did not receive any intervention during post treatment follow-up phase.

Overall Number of Participants Analyzed 53 48
Measure Type: Number
Unit of Measure: percentage of participants
0 0
11.Secondary Outcome
Title Percentage of Participants With Suicidal Ideation Assessed by Columbia - Suicide Severity Rating Scale (C-SSRS)
Hide Description C-SSRS captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The scale includes suggested questions to solicit the type of information needed to determine if a suicide-related thought or behavior occurred. Some questions are binary responses (yes/no) and some are on a scale of 1 (low severity) to 5 (high severity). Suicidal ideation: a "yes" answer to any of 5 suicidal ideation questions: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods without intent to act, active suicidal ideation with some intent to act without specific plan, active suicidal ideation with specific plan and intent.
Time Frame Month 1 through Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had at least one post baseline C-SSRS assessment.
Arm/Group Title Placebo Galcanezumab 300mg
Hide Arm/Group Description:

Participants received placebo once a month for two months by SC injection.

Participants did not receive any intervention during post treatment follow-up phase.

Participants received Galcanezumab 300mg once a month for two months by SC injection.

Participants did not receive any intervention during post treatment follow-up phase.

Overall Number of Participants Analyzed 54 49
Measure Type: Number
Unit of Measure: percentage of participants
0 0
12.Secondary Outcome
Title Percentage of Participants With Suicidal Behaviors Assessed by Columbia - Suicide Severity Rating Scale (C-SSRS)
Hide Description C-SSRS captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The scale includes suggested questions to solicit the type of information needed to determine if a suicide-related thought or behavior occurred. Some questions are binary responses (yes/no) and some are on a scale of 1 (low severity) to 5 (high severity). Suicidal behavior: a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide.
Time Frame Month 1 through Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had at least one post baseline C-SSRS assessment.
Arm/Group Title Placebo Galcanezumab 300mg
Hide Arm/Group Description:

Participants received placebo once a month for two months by SC injection.

Participants did not receive any intervention during post treatment follow-up phase.

Participants received Galcanezumab 300mg once a month for two months by SC injection.

Participants did not receive any intervention during post treatment follow-up phase.

Overall Number of Participants Analyzed 54 49
Measure Type: Number
Unit of Measure: percentage of participants
0 0
Time Frame 6 Months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo - Treatment Phase Galcanezumab 300mg - Treatment Phase Placebo - Post Treatment Phase Galcanezumab 300mg - Post Treatment Phase
Hide Arm/Group Description Participants received placebo once a month for two months by SC injection. Participants received Galcanezumab 300mg once a month for two months by SC injection. Participants didn't receive any intervention. Participants didn't receive any intervention.
All-Cause Mortality
Placebo - Treatment Phase Galcanezumab 300mg - Treatment Phase Placebo - Post Treatment Phase Galcanezumab 300mg - Post Treatment Phase
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/57 (0.00%)      0/49 (0.00%)      0/50 (0.00%)      0/47 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo - Treatment Phase Galcanezumab 300mg - Treatment Phase Placebo - Post Treatment Phase Galcanezumab 300mg - Post Treatment Phase
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/57 (0.00%)      0/49 (0.00%)      2/50 (4.00%)      0/47 (0.00%)    
Nervous system disorders         
Cluster headache  1  0/57 (0.00%)  0 0/49 (0.00%)  0 1/50 (2.00%)  1 0/47 (0.00%)  0
Renal and urinary disorders         
Nephrolithiasis  1  0/57 (0.00%)  0 0/49 (0.00%)  0 1/50 (2.00%)  1 0/47 (0.00%)  0
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo - Treatment Phase Galcanezumab 300mg - Treatment Phase Placebo - Post Treatment Phase Galcanezumab 300mg - Post Treatment Phase
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/57 (7.02%)      7/49 (14.29%)      3/50 (6.00%)      1/47 (2.13%)    
General disorders         
Injection site pain  1  0/57 (0.00%)  0 4/49 (8.16%)  4 0/50 (0.00%)  0 0/47 (0.00%)  0
Infections and infestations         
Nasopharyngitis  1  1/57 (1.75%)  1 3/49 (6.12%)  3 3/50 (6.00%)  3 1/47 (2.13%)  1
Musculoskeletal and connective tissue disorders         
Back pain  1  3/57 (5.26%)  3 0/49 (0.00%)  0 0/50 (0.00%)  0 0/47 (0.00%)  0
1
Term from vocabulary, MedDRA 20.1
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.
All information provided to Investigator &/or Institution by Lilly or Lilly-designated representatives, or generated by Investigator &/or institution in connection with Study, will be kept in confidence and not used for any purpose not expressly provided in the Agreement for at least 5 years after termination or conclusion of Study, except to the extent that Lilly gives Investigator &/or Institution written permission or particular information is required by laws or regulations to be disclosed.
Results Point of Contact
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02397473     History of Changes
Other Study ID Numbers: 15780
I5Q-MC-CGAL ( Other Identifier: Eli Lilly and Company )
2015-000149-22 ( EudraCT Number )
First Submitted: March 19, 2015
First Posted: March 25, 2015
Results First Submitted: February 8, 2019
Results First Posted: March 13, 2019
Last Update Posted: March 13, 2019