Trial Outcomes & Findings for MLD10 in the Prevention of Migraine in Adults (NCT NCT02322333)
NCT ID: NCT02322333
Last Updated: 2020-10-09
Results Overview
Comparison of the mean change from baseline in the frequency of migraine headache days per 28-day period ending with the cessation of treatment period month 3 in subjects treated with MLD10 versus placebo. A migraine headache day will be defined as a calendar day (00:00 to 23:59) with 4 or more hours of migraine headache, fulfilling International Classification of Headache Disorders-3beta criteria, and/or any headache of any duration with the use of migraine-specific acute medications(s) (i.e. ergot alkaloids, ergot combinations, opioids, triptans, combination analgesics \[simple analgesics combined with opioids or barbiturate with or without caffeine\]).
COMPLETED
PHASE2/PHASE3
157 participants
Day 1(Screening) - Day 116 (Visit 5 End of Study)
2020-10-09
Participant Flow
Participant milestones
| Measure |
MLD10
Subjects randomized to MLD10 will be dispensed a 28 day supply of magnesium L-lactate dehydrate for daily treatment. A total of 120 caplets will be given each time at Visit 2, 3, and 4. Additional overage will be given to account for the 3 day window. Subjects will be instructed to take two caplets of study medication BID (twice a day) at about the same time each day. Subjects will be instructed regarding storage requirements and will be asked to return all used/partially used/unused medication containers at the next office visit.
MLD10
|
Placebo
Subjects randomized to placebo will be dispensed a 28 day supply of matching placebo for daily treatment. A total of 120 caplets will be given each time at Visit 2, 3, and 4. Additional overage will be given to account for the 3 day window. Subjects will be instructed to take two caplets of study medication BID (twice a day) at about the same time each day. Subjects will be instructed regarding storage requirements and will be asked to return all used/partially used/unused medication containers at the next office visit.
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
80
|
77
|
|
Overall Study
COMPLETED
|
63
|
61
|
|
Overall Study
NOT COMPLETED
|
17
|
16
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
MLD10 in the Prevention of Migraine in Adults
Baseline characteristics by cohort
| Measure |
MLD10
n=80 Participants
All study participants randomized to MLD10 arm
|
Placebo
n=77 Participants
All study participants randomized to Placebo arm
|
Total
n=157 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.35 years
STANDARD_DEVIATION 12.72 • n=5 Participants
|
44.74 years
STANDARD_DEVIATION 11.41 • n=7 Participants
|
43.01 years
STANDARD_DEVIATION 12.18 • n=5 Participants
|
|
Sex: Female, Male
Female
|
71 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
140 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
77 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
151 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
68 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
126 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1(Screening) - Day 116 (Visit 5 End of Study)Population: The modified intent-to-treat (mITT) population included all randomized subjects who received at least one dose of study drug and obtained at least one endpoint measurement after treating. The mITT population excluded 7 subjects from the MLD10 arm and 6 participants from the Placebo arm. Total mITT analysis population: MLD10 = 73, Placebo = 71.
Comparison of the mean change from baseline in the frequency of migraine headache days per 28-day period ending with the cessation of treatment period month 3 in subjects treated with MLD10 versus placebo. A migraine headache day will be defined as a calendar day (00:00 to 23:59) with 4 or more hours of migraine headache, fulfilling International Classification of Headache Disorders-3beta criteria, and/or any headache of any duration with the use of migraine-specific acute medications(s) (i.e. ergot alkaloids, ergot combinations, opioids, triptans, combination analgesics \[simple analgesics combined with opioids or barbiturate with or without caffeine\]).
Outcome measures
| Measure |
MLD10
n=73 Participants
Subjects randomized to MLD10 will be dispensed a 28 day supply of magnesium L-lactate dehydrate for daily treatment. A total of 120 caplets will be given each time at Visit 2, 3, and 4. Additional overage will be given to account for the 3 day window. Subjects will be instructed to take two caplets of study medication BID (twice a day) at about the same time each day. Subjects will be instructed regarding storage requirements and will be asked to return all used/partially used/unused medication containers at the next office visit.
MLD10
|
Placebo
n=71 Participants
Subjects randomized to placebo will be dispensed a 28 day supply of matching placebo for daily treatment. A total of 120 caplets will be given each time at Visit 2, 3, and 4. Additional overage will be given to account for the 3 day window. Subjects will be instructed to take two caplets of study medication BID (twice a day) at about the same time each day. Subjects will be instructed regarding storage requirements and will be asked to return all used/partially used/unused medication containers at the next office visit.
Placebo
|
|---|---|---|
|
Migraine Headache Days
Baseline
|
7.12 Days
Standard Deviation 2.94
|
6.92 Days
Standard Deviation 2.71
|
|
Migraine Headache Days
Treatment Period 3
|
5.53 Days
Standard Deviation 4.43
|
4.79 Days
Standard Deviation 4.20
|
SECONDARY outcome
Timeframe: Day 1(Screening) - Day 116 (Visit 5 End of Study)Population: The modified intent-to-treat (mITT) population included all randomized subjects who received at least one dose of study drug and obtained at least one endpoint measurement after treating. The mITT population excluded 7 subjects from the MLD10 arm and 6 participants from the Placebo arm. Total mITT analysis population: MLD10 = 73, Placebo = 71.
Comparison of the change from baseline of subjects treated with MLD10 versus placebo in the frequency of headache days during the 3 month treatment period. A headache day will be defined as any day not classified as a migraine day, but recorded headache of any severity and/or duration.
Outcome measures
| Measure |
MLD10
n=73 Participants
Subjects randomized to MLD10 will be dispensed a 28 day supply of magnesium L-lactate dehydrate for daily treatment. A total of 120 caplets will be given each time at Visit 2, 3, and 4. Additional overage will be given to account for the 3 day window. Subjects will be instructed to take two caplets of study medication BID (twice a day) at about the same time each day. Subjects will be instructed regarding storage requirements and will be asked to return all used/partially used/unused medication containers at the next office visit.
MLD10
|
Placebo
n=71 Participants
Subjects randomized to placebo will be dispensed a 28 day supply of matching placebo for daily treatment. A total of 120 caplets will be given each time at Visit 2, 3, and 4. Additional overage will be given to account for the 3 day window. Subjects will be instructed to take two caplets of study medication BID (twice a day) at about the same time each day. Subjects will be instructed regarding storage requirements and will be asked to return all used/partially used/unused medication containers at the next office visit.
Placebo
|
|---|---|---|
|
Headache Days
Baseline
|
9.01 Days
Standard Deviation 3.16
|
9.20 Days
Standard Deviation 3.70
|
|
Headache Days
Treatment Period 3
|
6.89 Days
Standard Deviation 5.36
|
6.25 Days
Standard Deviation 4.81
|
SECONDARY outcome
Timeframe: Day 1(Screening) - Day 116 (Visit 5 End of Study)Population: The modified intent-to-treat (mITT) population included all randomized subjects who received at least one dose of study drug and obtained at least one endpoint measurement after treating. The mITT population excluded 7 subjects from the MLD10 arm and 6 participants from the Placebo arm. Total mITT analysis population: MLD10 = 73, Placebo = 71.
Change from baseline (28 day period) in the total cumulative minutes of headache during each 28-day treatment period month 1, 2, \& 3 in subjects treated with MLD10 versus placebo. All headaches and/or migraines will be including in this outcome analysis.
Outcome measures
| Measure |
MLD10
n=73 Participants
Subjects randomized to MLD10 will be dispensed a 28 day supply of magnesium L-lactate dehydrate for daily treatment. A total of 120 caplets will be given each time at Visit 2, 3, and 4. Additional overage will be given to account for the 3 day window. Subjects will be instructed to take two caplets of study medication BID (twice a day) at about the same time each day. Subjects will be instructed regarding storage requirements and will be asked to return all used/partially used/unused medication containers at the next office visit.
MLD10
|
Placebo
n=71 Participants
Subjects randomized to placebo will be dispensed a 28 day supply of matching placebo for daily treatment. A total of 120 caplets will be given each time at Visit 2, 3, and 4. Additional overage will be given to account for the 3 day window. Subjects will be instructed to take two caplets of study medication BID (twice a day) at about the same time each day. Subjects will be instructed regarding storage requirements and will be asked to return all used/partially used/unused medication containers at the next office visit.
Placebo
|
|---|---|---|
|
Headache Duration
Baseline
|
410.03 Minutes
Standard Deviation 182.26
|
396.48 Minutes
Standard Deviation 166.75
|
|
Headache Duration
Treatment Period 1
|
430.88 Minutes
Standard Deviation 242.35
|
369.03 Minutes
Standard Deviation 188.78
|
|
Headache Duration
Treatment Period 2
|
443.89 Minutes
Standard Deviation 233.60
|
364.21 Minutes
Standard Deviation 186.09
|
|
Headache Duration
Treatment Period 3
|
429.26 Minutes
Standard Deviation 228.59
|
383.70 Minutes
Standard Deviation 204.06
|
SECONDARY outcome
Timeframe: Day 1(Screening) - Day 116 (Visit 5 End of Study)Population: The modified intent-to-treat (mITT) population included all randomized subjects who received at least one dose of study drug and obtained at least one endpoint measurement after treating. The mITT population excluded 7 subjects from the MLD10 arm and 6 participants from the Placebo arm. Total mITT analysis population: MLD10 = 73, Placebo = 71.
Change from baseline (28 day period) in the average pain severity at time of onset compared to each 28-day treatment period month 1, 2, \& 3 in subjects treated with MLD10 versus placebo. Headache pain severity was measured on a scale 1 = Mild, 2 = Moderate, 3 = Severe.
Outcome measures
| Measure |
MLD10
n=73 Participants
Subjects randomized to MLD10 will be dispensed a 28 day supply of magnesium L-lactate dehydrate for daily treatment. A total of 120 caplets will be given each time at Visit 2, 3, and 4. Additional overage will be given to account for the 3 day window. Subjects will be instructed to take two caplets of study medication BID (twice a day) at about the same time each day. Subjects will be instructed regarding storage requirements and will be asked to return all used/partially used/unused medication containers at the next office visit.
MLD10
|
Placebo
n=71 Participants
Subjects randomized to placebo will be dispensed a 28 day supply of matching placebo for daily treatment. A total of 120 caplets will be given each time at Visit 2, 3, and 4. Additional overage will be given to account for the 3 day window. Subjects will be instructed to take two caplets of study medication BID (twice a day) at about the same time each day. Subjects will be instructed regarding storage requirements and will be asked to return all used/partially used/unused medication containers at the next office visit.
Placebo
|
|---|---|---|
|
Pain Severity
Baseline
|
2.16 units on a scale
Standard Deviation 0.50
|
2.06 units on a scale
Standard Deviation 0.37
|
|
Pain Severity
Treatment Period 1
|
2.07 units on a scale
Standard Deviation 0.54
|
1.93 units on a scale
Standard Deviation 0.49
|
|
Pain Severity
Treatment Period 2
|
1.99 units on a scale
Standard Deviation 0.54
|
1.85 units on a scale
Standard Deviation 0.53
|
|
Pain Severity
Treatment Period 3
|
2.01 units on a scale
Standard Deviation 0.49
|
1.86 units on a scale
Standard Deviation 0.57
|
SECONDARY outcome
Timeframe: Day 1(Screening) - Day 116 (Visit 5 End of Study)Population: The modified intent-to-treat (mITT) population included all randomized subjects who received at least one dose of study drug and obtained at least one endpoint measurement after treating. The mITT population excluded 7 subjects from the MLD10 arm and 6 participants from the Placebo arm. Total mITT analysis population: MLD10 = 73, Placebo = 71.
Change from baseline (28 day period) in the total number of acute headache pain medications used during each 28 day treatment period month 1, 2, \& 3 in subjects treated with MLD10 versus placebo.
Outcome measures
| Measure |
MLD10
n=73 Participants
Subjects randomized to MLD10 will be dispensed a 28 day supply of magnesium L-lactate dehydrate for daily treatment. A total of 120 caplets will be given each time at Visit 2, 3, and 4. Additional overage will be given to account for the 3 day window. Subjects will be instructed to take two caplets of study medication BID (twice a day) at about the same time each day. Subjects will be instructed regarding storage requirements and will be asked to return all used/partially used/unused medication containers at the next office visit.
MLD10
|
Placebo
n=71 Participants
Subjects randomized to placebo will be dispensed a 28 day supply of matching placebo for daily treatment. A total of 120 caplets will be given each time at Visit 2, 3, and 4. Additional overage will be given to account for the 3 day window. Subjects will be instructed to take two caplets of study medication BID (twice a day) at about the same time each day. Subjects will be instructed regarding storage requirements and will be asked to return all used/partially used/unused medication containers at the next office visit.
Placebo
|
|---|---|---|
|
Acute Medication Usage
Treatment Period 1
|
9.74 Medications
Standard Deviation 8.15
|
8.13 Medications
Standard Deviation 6.23
|
|
Acute Medication Usage
Treatment Period 2
|
9.12 Medications
Standard Deviation 7.08
|
8.61 Medications
Standard Deviation 8.38
|
|
Acute Medication Usage
Treatment Period 3
|
9.18 Medications
Standard Deviation 8.40
|
8.25 Medications
Standard Deviation 8.67
|
|
Acute Medication Usage
Baseline
|
11.67 Medications
Standard Deviation 7.64
|
11.08 Medications
Standard Deviation 6.10
|
SECONDARY outcome
Timeframe: Day 29 (Randomization) & Day 116 (Visit 5 End of Study)Change from Visit 2 to Visit 5 in the total MIDAS score in subjects treated with MLD10 versus placebo. The MIDAS test determines how severely migraines affect daily functioning. The responses of a variety of questions will be scored according to the questionnaire's scoring guide. A total score will be calculated ranging from 0-93. A score of 0-5 indicates little or no disability, 6-10 mild disability, 11-20, moderate disability, 21+ severe disability.
Outcome measures
| Measure |
MLD10
n=80 Participants
Subjects randomized to MLD10 will be dispensed a 28 day supply of magnesium L-lactate dehydrate for daily treatment. A total of 120 caplets will be given each time at Visit 2, 3, and 4. Additional overage will be given to account for the 3 day window. Subjects will be instructed to take two caplets of study medication BID (twice a day) at about the same time each day. Subjects will be instructed regarding storage requirements and will be asked to return all used/partially used/unused medication containers at the next office visit.
MLD10
|
Placebo
n=77 Participants
Subjects randomized to placebo will be dispensed a 28 day supply of matching placebo for daily treatment. A total of 120 caplets will be given each time at Visit 2, 3, and 4. Additional overage will be given to account for the 3 day window. Subjects will be instructed to take two caplets of study medication BID (twice a day) at about the same time each day. Subjects will be instructed regarding storage requirements and will be asked to return all used/partially used/unused medication containers at the next office visit.
Placebo
|
|---|---|---|
|
Migraine Disability Assessment Scale (MIDAS)
Visit 2
|
33.94 units on a scale
Standard Deviation 34.56
|
27.03 units on a scale
Standard Deviation 25.41
|
|
Migraine Disability Assessment Scale (MIDAS)
Visit 5
|
27.14 units on a scale
Standard Deviation 33.91
|
21.40 units on a scale
Standard Deviation 18.64
|
SECONDARY outcome
Timeframe: Day 116 (Visit 5 End of Study)Comparison of SGIC at Visit 5 in subjects treated with MLD10 versus placebo. Global impression of change rated by the subject will be assessed using a 7-point Likert scale ranging from -3 to 3 with -3 = very much worse, -2 = much worse, -1 = minimally worse, 0 = no change, 1 = minimally improved, 2 = much improved, 3 = very much improved.
Outcome measures
| Measure |
MLD10
n=80 Participants
Subjects randomized to MLD10 will be dispensed a 28 day supply of magnesium L-lactate dehydrate for daily treatment. A total of 120 caplets will be given each time at Visit 2, 3, and 4. Additional overage will be given to account for the 3 day window. Subjects will be instructed to take two caplets of study medication BID (twice a day) at about the same time each day. Subjects will be instructed regarding storage requirements and will be asked to return all used/partially used/unused medication containers at the next office visit.
MLD10
|
Placebo
n=77 Participants
Subjects randomized to placebo will be dispensed a 28 day supply of matching placebo for daily treatment. A total of 120 caplets will be given each time at Visit 2, 3, and 4. Additional overage will be given to account for the 3 day window. Subjects will be instructed to take two caplets of study medication BID (twice a day) at about the same time each day. Subjects will be instructed regarding storage requirements and will be asked to return all used/partially used/unused medication containers at the next office visit.
Placebo
|
|---|---|---|
|
Subject Global Impression of Change (SGIC)
|
1.25 units on a scale
Standard Deviation 0.987
|
1.10 units on a scale
Standard Deviation 1.23
|
SECONDARY outcome
Timeframe: Day 116 (Visit 5 End of Study)Comparison of PGIC at Visit 5 in subjects treated with MLD10 versus placebo. The PGIC will be an impression of change rated by the investigator using a 7-point Likert scale ranging from -3 to 3 with -3 = very much worse, -2 = much worse, -1 = minimally worse, 0 = no change, 1 = minimally improved, 2 = much improved, 3 = very much improved.
Outcome measures
| Measure |
MLD10
n=80 Participants
Subjects randomized to MLD10 will be dispensed a 28 day supply of magnesium L-lactate dehydrate for daily treatment. A total of 120 caplets will be given each time at Visit 2, 3, and 4. Additional overage will be given to account for the 3 day window. Subjects will be instructed to take two caplets of study medication BID (twice a day) at about the same time each day. Subjects will be instructed regarding storage requirements and will be asked to return all used/partially used/unused medication containers at the next office visit.
MLD10
|
Placebo
n=77 Participants
Subjects randomized to placebo will be dispensed a 28 day supply of matching placebo for daily treatment. A total of 120 caplets will be given each time at Visit 2, 3, and 4. Additional overage will be given to account for the 3 day window. Subjects will be instructed to take two caplets of study medication BID (twice a day) at about the same time each day. Subjects will be instructed regarding storage requirements and will be asked to return all used/partially used/unused medication containers at the next office visit.
Placebo
|
|---|---|---|
|
Physician Global Impression of Change (PGIC)
|
1.07 units on a scale
Standard Deviation 1.09
|
1.06 units on a scale
Standard Deviation 1.12
|
Adverse Events
MLD10
Placebo
Serious adverse events
| Measure |
MLD10
n=80 participants at risk
All subjects randomized to MLD10 arm
|
Placebo
n=77 participants at risk
All subjects randomized to Placebo arm
|
|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
1.2%
1/80 • Number of events 1 • Day 1 (Screening) - Day 116 (Visit 5 End of Study) for Serious Adverse Events Day 29 (Randomization) - Day 116 (Visit 5 End of Study) for Non-Serious Adverse Events
|
0.00%
0/77 • Day 1 (Screening) - Day 116 (Visit 5 End of Study) for Serious Adverse Events Day 29 (Randomization) - Day 116 (Visit 5 End of Study) for Non-Serious Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/80 • Day 1 (Screening) - Day 116 (Visit 5 End of Study) for Serious Adverse Events Day 29 (Randomization) - Day 116 (Visit 5 End of Study) for Non-Serious Adverse Events
|
1.3%
1/77 • Number of events 1 • Day 1 (Screening) - Day 116 (Visit 5 End of Study) for Serious Adverse Events Day 29 (Randomization) - Day 116 (Visit 5 End of Study) for Non-Serious Adverse Events
|
Other adverse events
| Measure |
MLD10
n=80 participants at risk
All subjects randomized to MLD10 arm
|
Placebo
n=77 participants at risk
All subjects randomized to Placebo arm
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
13.8%
11/80 • Number of events 12 • Day 1 (Screening) - Day 116 (Visit 5 End of Study) for Serious Adverse Events Day 29 (Randomization) - Day 116 (Visit 5 End of Study) for Non-Serious Adverse Events
|
6.5%
5/77 • Number of events 6 • Day 1 (Screening) - Day 116 (Visit 5 End of Study) for Serious Adverse Events Day 29 (Randomization) - Day 116 (Visit 5 End of Study) for Non-Serious Adverse Events
|
|
Gastrointestinal disorders
Nausea
|
5.0%
4/80 • Number of events 4 • Day 1 (Screening) - Day 116 (Visit 5 End of Study) for Serious Adverse Events Day 29 (Randomization) - Day 116 (Visit 5 End of Study) for Non-Serious Adverse Events
|
6.5%
5/77 • Number of events 5 • Day 1 (Screening) - Day 116 (Visit 5 End of Study) for Serious Adverse Events Day 29 (Randomization) - Day 116 (Visit 5 End of Study) for Non-Serious Adverse Events
|
|
Infections and infestations
Viral upper respiratory tract infection
|
5.0%
4/80 • Number of events 4 • Day 1 (Screening) - Day 116 (Visit 5 End of Study) for Serious Adverse Events Day 29 (Randomization) - Day 116 (Visit 5 End of Study) for Non-Serious Adverse Events
|
6.5%
5/77 • Number of events 5 • Day 1 (Screening) - Day 116 (Visit 5 End of Study) for Serious Adverse Events Day 29 (Randomization) - Day 116 (Visit 5 End of Study) for Non-Serious Adverse Events
|
|
Nervous system disorders
Dizziness
|
7.5%
6/80 • Number of events 8 • Day 1 (Screening) - Day 116 (Visit 5 End of Study) for Serious Adverse Events Day 29 (Randomization) - Day 116 (Visit 5 End of Study) for Non-Serious Adverse Events
|
1.3%
1/77 • Number of events 1 • Day 1 (Screening) - Day 116 (Visit 5 End of Study) for Serious Adverse Events Day 29 (Randomization) - Day 116 (Visit 5 End of Study) for Non-Serious Adverse Events
|
|
Infections and infestations
Sinusitis
|
5.0%
4/80 • Number of events 5 • Day 1 (Screening) - Day 116 (Visit 5 End of Study) for Serious Adverse Events Day 29 (Randomization) - Day 116 (Visit 5 End of Study) for Non-Serious Adverse Events
|
3.9%
3/77 • Number of events 3 • Day 1 (Screening) - Day 116 (Visit 5 End of Study) for Serious Adverse Events Day 29 (Randomization) - Day 116 (Visit 5 End of Study) for Non-Serious Adverse Events
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place