MLD10 in the Prevention of Migraine in Adults

NCT02322333 | Completed Phase 2 Results

• 1 other identifier: MLD10-002
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Migraine

Outcome Measures

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

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

Secondary Outcomes (7)

• Headache Days

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

• Headache Duration

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

• Pain Severity

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

• Acute Medication Usage

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

• Migraine Disability Assessment Scale (MIDAS)

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

Study Arms (2)

MLD10

ACTIVE COMPARATOR

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

PLACEBO COMPARATOR

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

MLD10 DRUG

Also known as: elemental magnesium

MLD10

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• male or female, in otherwise good health, 18 to 65 years of age.
• 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.
• onset of migraine before age 50.
• stable history of migraine at least 3 months prior to screening.
• 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.
• 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.
• completion of online diary must be ≥ 80% compliance, unless otherwise approved by the Sponsor and/or Clinvest.

You may not qualify if:

• unable to understand the study requirements, the informed consent, or complete headache records as required per protocol.
• pregnant, actively trying to become pregnant, or breast-feeding.
• 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.
• experienced the following migraine variants: basilar migraine, aura without headache, familial hemiplegic migraine, complicated migraine, ophthalmoplegic migraine and retinal migraine within the last year.
• history of medication overuse headache (MOH) (Appendix II) in the 3 months prior to study enrollment or during the baseline phase.
• 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.
• history of substance abuse and/or dependence, in the opinion of the Investigator.
• history of impaired renal function that, in the investigator's opinion, contraindicates participation in this study.
• unstable neurological condition or a significantly abnormal neurological examination with focal signs or signs of increased intracranial pressure.
• suffers from a serious illness, or an unstable medical condition, one that could require hospitalization, or could increase the risk of adverse events.
• 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):
• Questions 4 or 5 on the suicidal ideation section
• Any question on any item in the suicidal behavior section
• 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.
• hypersensitivity, intolerance, or contraindication to the use of magnesium L-lactate dehydrate or any of its components.

Sponsors & Collaborators

• Pharmalyte Solutions LLC: lead
• Clinvest: collaborator

Study Sites (9)

The Research Center of Southern California

Carlsbad, California, 92011, United States

Location

San Francisco Clinical Research Center

San Francisco, California, 94109, United States

Location

Physician Associates of Florida Research Department

Oviedo, Florida, 32765, United States

Location

Dr. B. Abraham, P.C.

Snellville, Georgia, 30039, United States

Location

Westside Family Medical Center, P.C.

Kalamazoo, Michigan, 49009, United States

Location

StudyMetrix Research

City of Saint Peters, Missouri, 63303, United States

Location

Clinvest Research, LLC

Springfield, Missouri, 65807, United States

Location

Baptist Memorial Hospital

Memphis, Tennessee, 38020, United States

Location

Nashville Neuroscience Group

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

Magnesium

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals, Light; Metals

Results Point of Contact

• Title: Jim Sly MS
• Organization: Clinvest Research

jsly@clinvest.com

4178413673

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2014
• First Posted: December 23, 2014
• Study Start: March 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: October 9, 2020
• Results First Posted: October 9, 2020

Record last verified: 2020-09

Locations

US (9)