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Completed Phase 2Phase 3 Interventional Results available

MLD10 in the Prevention of Migraine in Adults

ClinicalTrials.gov ID: NCT02322333

Public ClinicalTrials.gov record NCT02322333. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 6, 2026, 10:00 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of MLD10 in the Prevention of Migraine Headache in Adults

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT02322333
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2, Phase 3
Lead sponsor
Pharmalyte Solutions LLC
Industry
Enrollment
157 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 65 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 28, 2015
Primary completion
May 31, 2017
Completion
May 31, 2017
Last update posted
Oct 8, 2020

2015 – 2017

United States locations

U.S. sites
9
U.S. states
6
U.S. cities
9
Facility City State ZIP Site status
The Research Center of Southern California Carlsbad California 92011
San Francisco Clinical Research Center San Francisco California 94109
Physician Associates of Florida Research Department Oviedo Florida 32765
Dr. B. Abraham, P.C. Snellville Georgia 30039
Westside Family Medical Center, P.C. Kalamazoo Michigan 49009
StudyMetrix Research City of Saint Peters Missouri 63303
Clinvest Research, LLC Springfield Missouri 65807
Baptist Memorial Hospital Memphis Tennessee 38020
Nashville Neuroscience Group Nashville Tennessee 37203

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02322333, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 8, 2020 · Synced Sep 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT02322333 live on ClinicalTrials.gov.

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