MLD10 in the Prevention of Migraine in Adults

• Status: Completed
• Trial end date: 2017-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pharmalyte Solutions LLC
• Collaborator: Clinvest

Criteria

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:

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.