Nuedexta for the Prevention and Modification of Disease Progression in Episodic Migraine
Condition: Episodic Migraine
MeSH terms: Migraine Disorders; Disease Progression
Intervention: Dextromethorphan and quinidine; Placebo
Intervention MeSH terms: Quinidine; Dextromethorphan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 76.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Episodic Migraine; Migraine; Headache

Summary:

      The purpose of this study is to evaluate the efficacy and effectiveness of daily
      dextromethorphan/quinidine (Nuedexta) in reducing the frequency and progression of episodic
      migraine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  male or female, in otherwise good health, 18 to 65 years of age.

          -  history of frequent episodic migraine for at least 3 months as defined by 6-14
             migraine days per month with or without aura according to the ICHD-3beta or a migraine
             treated with an ergot or triptan which resulted in relief.

          -  onset of migraine before age 50.

          -  stable history of headache at least 3 months prior to screening.

          -  if using daily migraine preventive medications for migraine or for other medical
             conditions (e.g. propranolol being used for hypertension) and has been on a stable
             dose and regimen for at least 2 months prior to beginning the baseline period.

          -  female, of childbearing potential, and agrees to maintain true abstinence or use (or
             have their partner use) one of the listed methods of birth control for the duration of
             the study: hormonal contraceptive, intrauterine device (IUD), condoms, diaphragm,
             and/or vasectomy. The use of barrier contraceptive (condom or diaphragm) should always
             be supplemented with the use of a spermicide. Note: To be considered not of
             childbearing potential, subject must be 6 weeks post-surgical bilateral oophorectomy,
             hysterectomy, or bilateral tubal ligation, or postmenopausal for at least one year.

        Exclusion Criteria:

          -  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.

          -  female of childbearing potential not using adequate contraceptive measures.

          -  experienced the following migraine variants: basilar migraine, aura without headache,
             familial hemiplegic migraine, complicated migraine, ophthalmoplegic migraine and
             retinal migraine.

          -  history of Medication Overuse Headache (Appendix II) in the 3 months prior to study
             enrollment or during the baseline phase.

          -  history of acute migraine treatment greater than 14 days per month in 3 months prior
             to screening.

          -  history of 3 or more failed preventative medications due to lack of efficacy for
             prophylactic treatment of migraine after an adequate therapeutic trial.

          -  received onabotulinumtoxinA injections within 3 months prior to screening and/or will
             receive onabotulinumtoxinA injections during the study.

          -  abused, in the opinion of the Investigator, any of the following drugs, currently or
             within the past 1 year: opioids, alcohol, barbiturates, benzodiazepine, cocaine.

          -  taken, or plans to take: a monoamine oxidase inhibitor (MAOI) including herbal
             preparations containing St. John's wort (Hypericum perforatum) within 14 days of Visit
             1, concomitant medications and/or foods containing dextromethorphan, quinidine,
             quinine, mefloquine, paxil, dicyclomine, digitalis, thioridazine or pimozide
             (medications that prolong QT interval) anytime within the 2 weeks prior to screening
             through 2 weeks post final study treatment.

          -  history of hypersensitivity to medications containing dextromethorphan.

          -  history of hypersensitivity to medications or foods containing quinidine.

          -  at an increased risk of developing serotonin syndrome, in the opinion of the
             investigator.

          -  history of impaired hepatic or 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.

          -  cardiovascular disease (ischemic heart disease, including angina pectoris, myocardial
             infarction, documented silent ischemia, or with Prinzmetal's angina); has symptoms of
             ischemic heart disease, ischemic abdominal syndromes, peripheral vascular disease or
             Raynaud's Syndrome.

          -  ECG results outside normal limits (> 470 msec), prolonged QT interval, congenital long
             QT syndrome, torsades de pointes, or complete AV block.

          -  has uncontrolled hypertension (≥ 140/90mmHg in either the systolic or diastolic
             measurements in 2 out of 3 BP readings at screening).

          -  serious illness, or an unstable medical condition, one that could require
             hospitalization, or could increase the risk of adverse events, in the opinion of the
             investigator.

          -  any psychiatric disorder with psychotic features and any other psychiatric disorder
             not stable or well controlled, that would interfere in their ability to complete study
             activities.

          -  received any investigational agents within 30 days prior to Visit 1.

          -  plans to participate in another clinical study at any time during this study.