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CompletedNCT02322333Updated Oct 9, 2020Results posted

MLD10 in the Prevention of Migraine in Adults

A Phase 2/3 interventional study of MLD10 and Placebo in Migraine, sponsored by Pharmalyte Solutions LLC. Completed at 9 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-10-09.

Sponsored by Pharmalyte Solutions LLC · Phase 2/3, Interventional, and Prevention

Phase
Phase 2/3
Study type
Interventional
Enrollment
157
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

This is a double-blind, placebo-controlled, randomized, multi-center study. Subjects agreeing to participate in the study and meet the entry criteria assessed at the screening visit, will begin a 28 day baseline period to confirm their diagnosis, as well as establish baseline migraine characteristics. During this baseline period, subjects will continue treating their migraines as usual, simply recording the information in a daily headache diary. Subjects who, after completing the baseline, continue to meet entrance criteria will be eligible to enter into the treatment phase and be randomized according to the Clinvest generated randomization schedule. Approximately 142 subjects (71 subjects per arm) will be randomized and enter the treatment phase receiving MLD10 or placebo in a 1:1 design at 6 United States sites. Diary assessments will collect study medication adherence, pain severity, headache symptoms, acute medication usage, and unusual symptoms. Serum samples will be collected and analyzed for ionized magnesium, electrolytes, and creatinine.

Read the detailed description

This is a multi-center, double-blind, randomized, placebo-controlled, parallel study of MLD10 for the prevention of migraine headache. The study population will consist of approximately 142 male and female subjects between 18 and 65 years of age with frequent episodic migraine as defined by International Classification of Headache Disorders-3beta criteria. Two MLD10 (243 mg (milligrams) of elemental magnesium) or placebo caplets will be taken twice daily for a total daily dose of 486 mg.

VISIT 1 - SCREENING

The following will be completed at Visit 1:

  1. Obtain written Informed Consent. The informed consent will be obtained in accordance with Good Clinical Practices (GCP) and all applicable regulatory requirements from each subject prior to participation in the study.
  2. Verify Inclusion/Exclusion Criteria. Subjects will meet all the inclusion and none of the exclusion criteria.
  3. Obtain demographics (race, ethnicity, sex, date of birth)
  4. Obtain medical, medication, and headache history. Data collected will include medical history and diagnoses, age at onset of migraine and other pertinent migraine/headache history, history of acute and prophylactic headache medications within the past 30 days, and history of other recent/concomitant medications.
  5. Obtain date of last menstrual cycle and perform urine pregnancy test, if appropriate. Results of the pregnancy test must be negative to continue in study.
  6. Perform physical and neurological examinations.
  7. Measure vital signs (height, weight, resting heart rate, and blood pressure).
  8. Review Baseline Headache Diary. Subjects will be instructed to complete a daily online headache diary. Assessments to be captured are start/stop time, severity, associated symptoms, use of rescue medications, and unusual symptoms.
  9. Administer Columbia-Suicide Severity Rating Scale (C-SSRS).
  10. Schedule Visit 2.

VISIT 2 - RANDOMIZATION

  1. Verify Inclusion/Exclusion Criteria. Subjects must continue to meet all inclusion (including ≥ 3 days of migraine during baseline) and none of the exclusion criteria.
  2. Perform urine pregnancy test, if appropriate. Results of the pregnancy test must be negative to continue in study.
  3. Measure vital signs (weight, resting heart rate, and blood pressure).
  4. Record any changes to concomitant medications.
  5. Record any Serious Adverse Events (SAE) since signing the Informed Consent.
  6. Review Baseline Headache Diary for completeness and continuing eligibility.
  7. Randomize subject
  8. Review Month 1 Headache Diary instructions (same instructions as those discussed for Baseline Headache Diary).
  9. Dispense Month 1 study medication. Subjects will be instructed how to take study medication, prohibited medications/foods, dosage limitations of study medication, and storage requirements. Subjects will be instructed to return all used/partially used/unused study medication at next office visit and medications reconciliation will be performed to ensure a compliance of at least 80%. Subjects not complying at an 80% level will be withdrawn, unless otherwise approved by the Sponsor and/or Clinvest. (Estimated to be \< 10%)
  10. Administer C-SSRS.
  11. Administer MIDAS.
  12. Collect serum samples for electrolytes, creatinine, and ionized Mg.
  13. Schedule Visit 3.

VISIT 3 - END OF TREATMENT PERIOD MONTH 1

  1. Record any changes to concomitant medications.
  2. Record any Non-Serious Adverse Events (NSAE) and/or SAEs.
  3. Perform urine pregnancy test, if appropriate. Results of the pregnancy test must be negative to continue in study.
  4. Measure vital signs (weight, resting heart rate, and blood pressure).
  5. Review Month 1 Headache Diary for completeness.
  6. Review instructions for Month 2 Headache Diary (same instructions as those discussed for Month 1 Headache Diary).
  7. Collect Month 1 unused study medication and used packaging. Confirm 85% compliance of medication usage per study protocol.
  8. Dispense Month 2 study medication and review the dosage limitations of study medication, storage requirements, and to return all used/partially used/unused study medication at next office visit.
  9. Perform drug accountability.
  10. Administer C-SSRS.
  11. Collect serum samples for electrolytes, creatinine, and ionized Mg.
  12. Schedule Visit 4.

VISIT 4 - END OF TREATMENT PERIOD MONTH 2

  1. Record any changes to concomitant medications.
  2. Record any NSAEs/SAEs.
  3. Perform urine pregnancy test, if appropriate. Results of the pregnancy test must be negative to continue in study.
  4. Measure vital signs (weight, resting heart rate, and blood pressure).
  5. Review Month 2 Headache Diary for completeness.
  6. Review instructions for Month 3 Headache Diary (same instructions as those discussed for Month 2 Headache Diary).
  7. Collect Month 2 unused study medication and used packaging. Confirm 85% compliance for medication usage per study protocol.
  8. Dispense Month 3 study medication and review the dosage limitations of study medication, storage requirements, and to return all used/partially used/unused study medication at next office visit.
  9. Perform drug accountability.
  10. Administer C-SSRS.
  11. Collect serum samples for electrolytes, creatinine, and ionized Mg.
  12. Schedule Visit 5.

VISIT 5 - END OF TREATMENT PERIOD MONTH 3

  1. Record any changes to concomitant medications.
  2. Record any NSAEs/SAEs.
  3. Perform urine pregnancy test, if appropriate.
  4. Measure vital signs (weight, resting heart rate, and blood pressure)
  5. Perform physical/neurological examinations.
  6. Collect Month 4 unused study medication and used packaging.
  7. Perform drug accountability.
  8. Administer SGIC \& complete PGIC.
  9. Administer MIDAS.
  10. Administer C-SSRS.
  11. Collect serum samples for electrolytes, creatinine, and ionized Mg.
  12. Exit subject.
02

Conditions studied

  • Migraine

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03

In context

Migraine Disorders

1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.

This study's enrollment of 157 is above the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.

Browse Migraine Disorders studies →

Lead sponsor

Pharmalyte Solutions LLC is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. male or female, in otherwise good health, 18 to 65 years of age.
  2. history of frequent episodic migraine (3-14 migraine days per month) (with or without aura) according to the International Classification of Headache Disorders-3beta for at least 3 months.
  3. onset of migraine before age 50.
  4. stable history of migraine at least 3 months prior to screening.
  5. not currently taking a migraine preventive or has been taking preventive for at least 30 days prior to screening and agrees to not start, stop, or change medication and/or dosage during the study period.

  6. if female of childbearing potential, has a negative urine pregnancy test at Visits 1-5 and uses, or agrees to use, for the duration of the study, a medically acceptable form of contraception as listed:

    • complete abstinence from intercourse from 2 weeks prior to administration of study drug, throughout the study, and for 7 days after completion or premature discontinuation from the study; surgically sterile (hysterectomy or tubal ligation or otherwise incapable of pregnancy); sterilization of male partner when in a monogamous relationship; intrauterine device with published data showing lowest expected failure rate is less than 1% per year; double barrier method (i.e., 2 physical barriers OR 1 physical barrier plus spermicide) for a least 1 month prior to Visit 1 and throughout study; or hormonal contraceptives for at least 3 months prior to Visit 1 and throughout study.
  7. completion of online diary must be ≥ 80% compliance, unless otherwise approved by the Sponsor and/or Clinvest.

Exclusion criteria

Exclusion Criteria:

  1. unable to understand the study requirements, the informed consent, or complete headache records as required per protocol.
  2. pregnant, actively trying to become pregnant, or breast-feeding.
  3. diagnosed with International Classification of Headache Disorders-3beta criteria for Chronic Migraine within 3 months prior to screening, at the time of screening, and/or during the baseline period.
  4. experienced the following migraine variants: basilar migraine, aura without headache, familial hemiplegic migraine, complicated migraine, ophthalmoplegic migraine and retinal migraine within the last year.
  5. history of medication overuse headache (MOH) (Appendix II) in the 3 months prior to study enrollment or during the baseline phase.
  6. history of medication overuse (MO) of ergotamines, triptans, opioids, analgesics, NSAIDS and combination therapies, as defined by ICHD-3beta criteria and/or MO during baseline period.
  7. history of substance abuse and/or dependence, in the opinion of the Investigator.
  8. history of impaired renal function that, in the investigator's opinion, contraindicates participation in this study.
  9. unstable neurological condition or a significantly abnormal neurological examination with focal signs or signs of increased intracranial pressure.
  10. suffers from a serious illness, or an unstable medical condition, one that could require hospitalization, or could increase the risk of adverse events.

  11. has significant risk of suicide, defined as a "yes" answer to any of the following questions on the Columbia-Suicide Severity Rating Scale (C-SSRS), either at the screening visit (when assessing the prior 12 months) or at visit 2 (when assessing time since the screening visit):

    1. Questions 4 or 5 on the suicidal ideation section
    2. Any question on any item in the suicidal behavior section
  12. any psychiatric disorder with psychotic features, and/or any other psychiatric disorder not stable or well controlled, that would interfere in their ability to complete study activities.
  13. hypersensitivity, intolerance, or contraindication to the use of magnesium L-lactate dehydrate or any of its components.
  14. received any investigational agents within 30 days prior to Visit 1.
  15. plans to participate in another clinical study at any time during this study.
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
157 participants (actual)

Study arms

  • Active comparator
    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.

    Drug: MLD10

  • Placebo comparator
    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.

    Drug: Placebo

Interventions

  • DrugMLD10

    Also known as: elemental magnesium

  • DrugPlacebo
06

What researchers measure

Primary outcomes

  1. Migraine Headache Days

    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 \[simple analgesics combined with opioids or barbiturate with or without caffeine\]).

    Time frame: Day 1(Screening) - Day 116 (Visit 5 End of Study)

Secondary outcomes

  1. Headache Days

    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.

    Time frame: Day 1(Screening) - Day 116 (Visit 5 End of Study)

  2. Headache Duration

    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.

    Time frame: Day 1(Screening) - Day 116 (Visit 5 End of Study)

  3. Pain Severity

    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.

    Time frame: Day 1(Screening) - Day 116 (Visit 5 End of Study)

  4. Acute Medication Usage

    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.

    Time frame: Day 1(Screening) - Day 116 (Visit 5 End of Study)

  5. Migraine Disability Assessment Scale (MIDAS)

    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.

    Time frame: Day 29 (Randomization) & Day 116 (Visit 5 End of Study)

  6. Subject Global Impression of Change (SGIC)

    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.

    Time frame: Day 116 (Visit 5 End of Study)

  7. Physician Global Impression of Change (PGIC)

    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.

    Time frame: Day 116 (Visit 5 End of Study)

07

Results

Posted Oct 9, 2020

Participant flow

Participant flow — Overall Study
MilestoneMLD10Placebo
Started8077
Completed6361
Not completed1716

Outcome measures

PrimaryMigraine Headache Days

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 \[simple analgesics combined with opioids or barbiturate with or without caffeine\]).

Time frame:
Day 1(Screening) - Day 116 (Visit 5 End of Study)
Reported as:
Mean · Days
Migraine Headache Days
DaysMLD10Placebo
Baseline7.12 ± 2.946.92 ± 2.71
Treatment Period 35.53 ± 4.434.79 ± 4.20
SecondaryHeadache Days

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.

Time frame:
Day 1(Screening) - Day 116 (Visit 5 End of Study)
Reported as:
Mean · Days
Headache Days
DaysMLD10Placebo
Baseline9.01 ± 3.169.20 ± 3.70
Treatment Period 36.89 ± 5.366.25 ± 4.81
SecondaryHeadache Duration

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.

Time frame:
Day 1(Screening) - Day 116 (Visit 5 End of Study)
Reported as:
Mean · Minutes
Headache Duration
MinutesMLD10Placebo
Baseline410.03 ± 182.26396.48 ± 166.75
Treatment Period 1430.88 ± 242.35369.03 ± 188.78
Treatment Period 2443.89 ± 233.60364.21 ± 186.09
Treatment Period 3429.26 ± 228.59383.70 ± 204.06
SecondaryPain Severity

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.

Time frame:
Day 1(Screening) - Day 116 (Visit 5 End of Study)
Reported as:
Mean · units on a scale
Pain Severity
units on a scaleMLD10Placebo
Baseline2.16 ± 0.502.06 ± 0.37
Treatment Period 12.07 ± 0.541.93 ± 0.49
Treatment Period 21.99 ± 0.541.85 ± 0.53
Treatment Period 32.01 ± 0.491.86 ± 0.57
SecondaryAcute Medication Usage

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.

Time frame:
Day 1(Screening) - Day 116 (Visit 5 End of Study)
Reported as:
Mean · Medications
Acute Medication Usage
MedicationsMLD10Placebo
Baseline11.67 ± 7.6411.08 ± 6.10
Treatment Period 19.74 ± 8.158.13 ± 6.23
Treatment Period 29.12 ± 7.088.61 ± 8.38
Treatment Period 39.18 ± 8.408.25 ± 8.67
SecondaryMigraine Disability Assessment Scale (MIDAS)

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.

Time frame:
Day 29 (Randomization) & Day 116 (Visit 5 End of Study)
Reported as:
Mean · units on a scale
Migraine Disability Assessment Scale (MIDAS)
units on a scaleMLD10Placebo
Visit 233.94 ± 34.5627.03 ± 25.41
Visit 527.14 ± 33.9121.40 ± 18.64
SecondarySubject Global Impression of Change (SGIC)

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.

Time frame:
Day 116 (Visit 5 End of Study)
Reported as:
Mean · units on a scale
Subject Global Impression of Change (SGIC)
units on a scaleMLD10Placebo
Subject Global Impression of Change (SGIC)1.25 ± 0.9871.10 ± 1.23
SecondaryPhysician Global Impression of Change (PGIC)

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.

Time frame:
Day 116 (Visit 5 End of Study)
Reported as:
Mean · units on a scale
Physician Global Impression of Change (PGIC)
units on a scaleMLD10Placebo
Physician Global Impression of Change (PGIC)1.07 ± 1.091.06 ± 1.12

Adverse events

Collected over 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. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
MLD100/80 (0%)1/80 (1.3%)17/80 (21.3%)
Placebo0/77 (0%)1/77 (1.3%)15/77 (19.5%)
Most frequent serious events
Most frequent serious events
EventMLD10Placebo
OsteoarthritisMusculoskeletal and connective tissue disorders0/801/77
Myocardial infarctionCardiac disorders1/800/77
Most frequent other events
Most frequent other events
EventMLD10Placebo
DiarrhoeaGastrointestinal disorders11/805/77
DizzinessNervous system disorders6/801/77
NauseaGastrointestinal disorders4/805/77
Viral upper respiratory tract infectionInfections and infestations4/805/77
SinusitisInfections and infestations4/803/77

Baseline characteristics

Age, Continuous
Age, Continuous(years)MLD10PlaceboTotal
Mean41.35 ± 12.7244.74 ± 11.4143.01 ± 12.18
Sex: Female, Male
Sex: Female, Male(Participants)MLD10PlaceboTotal
Female7169140
Male9817
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)MLD10PlaceboTotal
Hispanic or Latino336
Not Hispanic or Latino7774151
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)MLD10PlaceboTotal
American Indian or Alaska Native011
Asian123
Native Hawaiian or Other Pacific Islander000
Black or African American51621
White6858126
More than one race101
Unknown or Not Reported505
08

Study locations

9 sites
  • The Research Center of Southern California
    Carlsbad, California 92011, United States
  • San Francisco Clinical Research Center
    San Francisco, California 94109, United States
  • Physician Associates of Florida Research Department
    Oviedo, Florida 32765, United States
  • Dr. B. Abraham, P.C.
    Snellville, Georgia 30039, United States
  • Westside Family Medical Center, P.C.
    Kalamazoo, Michigan 49009, United States
  • StudyMetrix Research
    Saint Peters, Missouri 63303, United States
  • Clinvest Research, LLC
    Springfield, Missouri 65807, United States
  • Baptist Memorial Hospital
    Memphis, Tennessee 38020, United States
  • Nashville Neuroscience Group
    Nashville, Tennessee 37203, United States
09

References and documents

Study documents

  • Study protocol · Apr 20, 2016
  • Statistical analysis plan · Jun 29, 2017

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 9, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02322333
Lead sponsor
Pharmalyte Solutions LLC
Collaborators
Clinvest
Responsible party
Sponsor
First posted
Dec 23, 2014
Start date
Mar 2015
Primary completion
Jun 2017
Completion
Jun 2017
Results posted
Oct 9, 2020
Last update
Oct 9, 2020

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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