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A Study of LY2951742 in Participants With Migraine

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ClinicalTrials.gov Identifier: NCT01625988
Recruitment Status : Completed
First Posted : June 22, 2012
Results First Posted : January 9, 2020
Last Update Posted : January 9, 2020
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 Migraine Headache
Interventions Drug: LY2951742
Drug: Placebo
Enrollment 218
Recruitment Details  
Pre-assignment Details  
Arm/Group Title LY2951742 Placebo
Hide Arm/Group Description LY2951742: 150 milligrams (mg), subcutaneous (SC) injection on Day 1 and then once every other week for a total of 6 doses during the 12-week Treatment Period. Placebo: 0.9% Sodium Chloride, Untied States Pharmacopoeia (USP), SC injection on Day 1 and then once every other week for a total of 6 doses during the 12-week Treatment Period.
Period Title: Overall Study
Started 108 [1] 110
Received at Least One Dose of Study Drug 107 110
Completed 94 97
Not Completed 14 13
Reason Not Completed
Lost to Follow-up             5             6
Withdrawal by Subject             8             3
Adverse Event             0             1
Lack of Efficacy             0             1
Randomized Inappropriately             1             0
Protocol Violation             0             2
[1]
One participant was randomized inappropriately and was discontinued before start of study treatment.
Arm/Group Title LY2951742 Placebo Total
Hide Arm/Group Description LY2951742: 150 milligrams (mg), subcutaneous (SC) injection on Day 1 and then once every other week for a total of 6 doses during the 12-week Treatment Period. Placebo: 0.9% Sodium Chloride, USP, SC injection on Day 1 and then once every other week for a total of 6 doses during the 12-week Treatment Period. Total of all reporting groups
Overall Number of Baseline Participants 107 110 217
Hide Baseline Analysis Population Description
All participants who received at least one dose of study drug.
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 107 participants 109 participants 216 participants
40.9  (11.4) 41.9  (11.7) 41.4  (11.5)
[1]
Measure Analysis Population Description: All participants who received at least one dose of study drug and had baseline Age data.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 107 participants 110 participants 217 participants
Female 88 96 184
Male 19 14 33
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 107 participants 110 participants 217 participants
Hispanic or Latino 11 13 24
Not Hispanic or Latino 96 97 193
Unknown or Not Reported 0 0 0
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 107 participants 110 participants 217 participants
American Indian or Alaska Native 0 1 1
Asian 2 2 4
Native Hawaiian or Other Pacific Islander 0 2 2
Black or African American 25 26 51
White 76 74 150
More than one race 2 2 4
Unknown or Not Reported 2 3 5
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 107 participants 110 participants 217 participants
107 110 217
1.Primary Outcome
Title Mean Change From Baseline in the Number of Migraine Headache Days in the Last 28-day Period of the 12-week Treatment Phase
Hide Description The criteria for a migraine headache was adapted from the standard International Headache Society (IHS) International Classification of Headache Disorders II guidelines 1.1 and 1.2 (ICHD-II, Cephalgia 2004). The definition of a migraine headache was a headache with or without aura, of ≥30 minutes (min) duration, and with both ("A" and "B") required features from the IHS ICHD-II definition. Required feature "A" includes at least 2 of the following headache characteristics: unilateral location, pulsatile quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity. Required feature "B" includes at least 1 of the following during the headache: nausea and/or vomiting, or photophobia and phonophobia. Least square (LS) means were calculated using mixed model repeated measures (MMRM) with baseline value, treatment, month, and treatment-by-month interaction as fixed effects and participant as random effect.
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with a valid 28-day baseline assessment of migraine headache days who received at least 1 dose of study treatment and had evaluable postbaseline headache data.
Arm/Group Title LY2951742 Placebo
Hide Arm/Group Description:
LY2951742: 150 milligrams (mg), subcutaneous (SC) injection on Day 1 and then once every other week for a total of 6 doses during the 12-week Treatment Period.
Placebo: 0.9% Sodium Chloride, USP, SC injection on Day 1 and then once every other week for a total of 6 doses during the 12-week Treatment Period.
Overall Number of Participants Analyzed 106 110
Least Squares Mean (Standard Error)
Unit of Measure: Migraine headache days
-4.2  (0.30) -3.0  (0.29)
2.Secondary Outcome
Title Mean Change From Baseline in the Number of Headache Days in the Last 28-day Period of the 12-week Treatment Phase
Hide Description Number of calendar days on which a headache lasts ≥4 hours which includes migraines, probable migraines (PM) and nonmigraines. Criteria for migraine headache (MH) was adapted from standard IHS ICHD-II guidelines 1.1 and 1.2 (Cephalgia 2004). Definition of MH was headache with or without aura, of ≥30 min duration, and with both ("A" and "B") required features from IHS ICHD-II definition. Required feature "A" includes ≥2 of following headache characteristics: unilateral location, pulsatile quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity. Required feature "B" includes at least 1 of following during headache: nausea and/or vomiting, or photophobia and phonophobia. PM is headache with or without aura, but missing 1 feature needed to fulfill all criteria for MH. LS means were calculated using MMRM with baseline value, gender, treatment, month, and treatment-by-month interaction as fixed effects and participant as random effect.
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with a valid 28-day baseline assessment of migraine headache days who received at least 1 dose of study treatment and had evaluable postbaseline headache data.
Arm/Group Title LY2951742 Placebo
Hide Arm/Group Description:
LY2951742: 150 milligrams (mg), subcutaneous (SC) injection on Day 1 and then once every other week for a total of 6 doses during the 12-week Treatment Period.
Placebo: 0.9% Sodium Chloride, USP, SC injection on Day 1 and then once every other week for a total of 6 doses during the 12-week Treatment Period.
Overall Number of Participants Analyzed 106 110
Least Squares Mean (Standard Error)
Unit of Measure: Headache days
-4.9  (0.40) -3.7  (0.40)
3.Secondary Outcome
Title Mean Change From Baseline in the Number of Migraine Attacks in the Last 28-day Period of the 12-week Treatment Phase
Hide Description A migraine attack was defined as beginning on any day a migraine headache day was recorded and ending when a migraine headache-free day occurred. The criteria for a migraine headache was adapted from the standard IHS ICHD-II guidelines 1.1 and 1.2 (Cephalgia 2004). The definition of a migraine headache was a headache with or without aura, of ≥30 minutes duration, and with both ("A" and "B") required features from the IHS ICHD-II definition. Required feature "A" includes at least 2 of the following headache characteristics: unilateral location, pulsatile quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity. Required feature "B" includes at least 1 of the following during the headache: nausea and/or vomiting, or photophobia and phonophobia. LS means were calculated using MMRM with baseline value, gender, treatment, month, and treatment-by-month interaction as fixed effects and participant as random effect.
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with a valid 28-day baseline assessment of migraine headache days who received at least 1 dose of study treatment and had evaluable postbaseline headache data.
Arm/Group Title LY2951742 Placebo
Hide Arm/Group Description:
LY2951742: 150 milligrams (mg), subcutaneous (SC) injection on Day 1 and then once every other week for a total of 6 doses during the 12-week Treatment Period.
Placebo: 0.9% Sodium Chloride, USP, SC injection on Day 1 and then once every other week for a total of 6 doses during the 12-week Treatment Period.
Overall Number of Participants Analyzed 106 110
Least Squares Mean (Standard Error)
Unit of Measure: Migraine attacks
-3.1  (0.23) -2.3  (0.24)
4.Secondary Outcome
Title Percentage of Responders
Hide Description Percentage of participants with greater than 50% reduction in the number of migraine headache days in a 28-day period. The criteria for a migraine headache was adapted from the standard International Headache Society (IHS) International Classification of Headache Disorders II guidelines 1.1 and 1.2 (ICHD-II, Cephalgia 2004). The definition of a migraine headache was a headache with or without aura, of ≥30 minutes duration, and with both ("A" and "B") required features from the IHS ICHD-II definition. Required feature "A" includes at least 2 of the following headache characteristics: unilateral location, pulsatile quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity. Required feature "B" includes at least 1 of the following during the headache: nausea and/or vomiting, or photophobia and phonophobia.
Time Frame Baseline, 4, 8, and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with a valid 28-day baseline assessment of migraine headache days who received at least 1 dose of study treatment and had evaluable postbaseline headache data during the time period of analysis.
Arm/Group Title LY2951742 Placebo
Hide Arm/Group Description:
LY2951742 (LY): 150 milligrams (mg), subcutaneous (SC) injection on Day 1 and then once every other week for a total of 6 doses during the 12-week Treatment Period.
Placebo: 0.9% Sodium Chloride, USP, SC injection on Day 1 and then once every other week for a total of 6 doses during the 12-week Treatment Period.
Overall Number of Participants Analyzed 107 110
Measure Type: Number
Unit of Measure: Percentage of participants
Week 4 Number Analyzed 62 participants 41 participants
57.9 37.3
Week 8 Number Analyzed 66 participants 47 participants
61.7 42.7
Week 12 Number Analyzed 69 participants 47 participants
64.5 42.7
Time Frame [Not Specified]
Adverse Event Reporting Description All participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
 
Arm/Group Title LY2951742 Treatment Period Placebo Treatment Period LY2951742 Posttreatment Period Placebo Posttreatment Period
Hide Arm/Group Description LY2951742: 150 mg, SC injection on Day 1 and then once every other week for a total of 6 doses during the 12-week Treatment Period. Placebo: 0.9% Sodium Chloride, USP, SC injection on Day 1 and then once every other week for a total of 6 doses during the 12-week Treatment Period. LY2951742: The LY2951742 posttreatment period reporting group includes participants who received 150 mg LY2951742, completed the 12-week treatment period, and entered the posttreatment period. The posttreatment period began after Week 12 and lasted up to 12 weeks. Note: participants who discontinued early in the treatment phase did not enter the 12-week posttreatment follow-up period. Placebo: The Placebo posttreatment period reporting group includes participants who received 0.9% Sodium Chloride, USP; completed the 12-week treatment period; and entered the posttreatment period. The posttreatment period began after Week 12 and lasted up to 12 weeks. Note: participants who discontinued early in the treatment phase did not enter the 12-week posttreatment follow-up period.
All-Cause Mortality
LY2951742 Treatment Period Placebo Treatment Period LY2951742 Posttreatment Period Placebo Posttreatment Period
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
LY2951742 Treatment Period Placebo Treatment Period LY2951742 Posttreatment Period Placebo Posttreatment Period
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/107 (0.00%)      1/110 (0.91%)      2/98 (2.04%)      3/103 (2.91%)    
Gastrointestinal disorders         
Abdominal pain  1  0/107 (0.00%)  0 0/110 (0.00%)  0 0/98 (0.00%)  0 1/103 (0.97%)  1
Large intestine perforation  1  0/107 (0.00%)  0 0/110 (0.00%)  0 0/98 (0.00%)  0 1/103 (0.97%)  1
Vomiting  1  0/107 (0.00%)  0 0/110 (0.00%)  0 0/98 (0.00%)  0 1/103 (0.97%)  1
Hepatobiliary disorders         
Bile duct stone  1  0/107 (0.00%)  0 0/110 (0.00%)  0 0/98 (0.00%)  0 1/103 (0.97%)  1
Infections and infestations         
Diverticulitis  1  0/107 (0.00%)  0 0/110 (0.00%)  0 0/98 (0.00%)  0 1/103 (0.97%)  1
Sepsis  1  0/107 (0.00%)  0 0/110 (0.00%)  0 0/98 (0.00%)  0 1/103 (0.97%)  1
Injury, poisoning and procedural complications         
Procedural pain  1  0/107 (0.00%)  0 1/110 (0.91%)  1 0/98 (0.00%)  0 0/103 (0.00%)  0
Pregnancy, puerperium and perinatal conditions         
Abortion spontaneous  1  0/88 (0.00%)  0 0/96 (0.00%)  0 1/80 (1.25%)  1 0/90 (0.00%)  0
Reproductive system and breast disorders         
Menorrhagia  1  0/88 (0.00%)  0 0/96 (0.00%)  0 0/80 (0.00%)  0 1/90 (1.11%)  1
Vascular disorders         
Peripheral vascular disorder  1  0/107 (0.00%)  0 0/110 (0.00%)  0 1/98 (1.02%)  1 0/103 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
LY2951742 Treatment Period Placebo Treatment Period LY2951742 Posttreatment Period Placebo Posttreatment Period
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   36/107 (33.64%)      30/110 (27.27%)      6/98 (6.12%)      2/103 (1.94%)    
Gastrointestinal disorders         
Nausea  1  4/107 (3.74%)  4 9/110 (8.18%)  10 0/98 (0.00%)  0 1/103 (0.97%)  1
General disorders         
Injection site pain  1  18/107 (16.82%)  65 7/110 (6.36%)  14 0/98 (0.00%)  0 0/103 (0.00%)  0
Infections and infestations         
Upper respiratory tract infection  1  13/107 (12.15%)  16 10/110 (9.09%)  11 4/98 (4.08%)  5 0/103 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Arthralgia  1  4/107 (3.74%)  4 6/110 (5.45%)  8 2/98 (2.04%)  2 1/103 (0.97%)  1
Back pain  1  7/107 (6.54%)  7 8/110 (7.27%)  8 0/98 (0.00%)  0 0/103 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
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.
Arteaus Therapeutics executed the contracts and trial, and the Principal Investigators are restricted by any original contractual disclosure restrictions or agreements with Arteaus Therapeutics.
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
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01625988    
Other Study ID Numbers: ART-01
ART-01 ( Other Identifier: Eli Lilly and Company )
First Submitted: June 20, 2012
First Posted: June 22, 2012
Results First Submitted: November 18, 2019
Results First Posted: January 9, 2020
Last Update Posted: January 9, 2020