- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02176018
Nuedexta for the Prevention and Modification of Disease Progression in Episodic Migraine
A Randomized Pilot Study of Nuedexta for the Prevention and Modification of Disease Progression in Episodic Migraine
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Illinois
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Rockford, Illinois, United States, 61104
- Swedish American Neuro and Headache Center
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Mississippi
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Ridgeland, Mississippi, United States, 39157
- The Headache Center
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Missouri
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Saint Peters, Missouri, United States, 63303
- StudyMetrix Research, LLC
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Springfield, Missouri, United States, 65807
- Clinvest
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New York
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Plainview, New York, United States, 11803
- Island Neurological Associates, PC
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Nuedexta
One capsule will be taken (dextromethorphan HB and quinidine sulfate, 20 mg/10 mg) daily for seven days.
On the eight day and for the remainder of the study 2 capsule will be taken twice a day.
Medication will be taking daily for a total of 3 months.
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Other Names:
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Placebo Comparator: Placebo
One capsule will be taken of placebo to match daily for seven days.
On the eight day and for the remainder of the study 2 capsule will be taken twice a day.
Medication will be taking daily for a total of 3 months.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Headache Days in Each Treatment Period Month
Time Frame: Treatment Month 1, Treatment Month 2, and End of Treatment Period Month 3 (Day 116)
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The average number of headache days at treatment period months 1, 2, and 3 (28 day periods for each month) for the Nuedexta arm and the Placebo arm.
Headache days were defined as any patient reported head pain during the prior 24 hour period.
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Treatment Month 1, Treatment Month 2, and End of Treatment Period Month 3 (Day 116)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Headache Days in Treatment Period Month 3
Time Frame: End of Treatment Period Month 3 (Day 116)
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The average number of headache days at treatment period month 3 (28 day period) for the Nuedexta arm and the Placebo arm.
Headache days were defined as any patient reported head pain during the prior 24 hour period.
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End of Treatment Period Month 3 (Day 116)
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Migraine Days in Each Treatment Period Month
Time Frame: Treatment Month 1, Month 2, and End of Treatment Period Month 3 (Day 116)
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The average number of migraine days at treatment period months 1, 2, and 3 (28 day periods for each month) for the Nuedexta arm and the Placebo arm.
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Treatment Month 1, Month 2, and End of Treatment Period Month 3 (Day 116)
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Headache Severity in Each Treatment Period Month
Time Frame: Treatment Month 1, Month 2, and End of Treatment Period Month 3 (Day 116)
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The average headache severity at treatment period months 1, 2, and 3 (28 day periods for each month) for the Nuedexta arm and the Placebo arm.
Headache pain severity was measured on a scale from 1 = Mild, to 3 = Severe.
Higher numbers indicating more severe headache pain.
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Treatment Month 1, Month 2, and End of Treatment Period Month 3 (Day 116)
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Headache Duration in Each Treatment Period Month
Time Frame: Treatment Month 1, Month 2, and End of Treatment Period Month 3 (Day 116)
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The average headache duration (time of onset to pain free) at treatment period months 1, 2, and 3 (28 day periods for each month) for the Nuedexta arm and the Placebo arm.
Headache duration was measured in hours.
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Treatment Month 1, Month 2, and End of Treatment Period Month 3 (Day 116)
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50% Headache Reduction
Time Frame: Baseline (Day 0) to Treatment Period Month 3 (Day 116)
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The number of subjects with at least a 50% reduction in number of headache days comparing baseline to each visit (treatment period months 1, 2, and 3: 28 day for each month) in the Nuedexta arm vs. the placebo arm.
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Baseline (Day 0) to Treatment Period Month 3 (Day 116)
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Acute Medication Use in Each Treatment Period Month
Time Frame: Treatment Month 1, Month 2, and End of Treatment Period Month 3 (Day 116)
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The average number of doses of acute medication taken at treatment period months 1, 2, and 3 (28 day periods for each month) for the Nuedexta arm and the Placebo arm
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Treatment Month 1, Month 2, and End of Treatment Period Month 3 (Day 116)
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Migraine Disability Assessment Scale (MIDAS)
Time Frame: Visit 2 (Day 28) to Visit 5 (Day 116)
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MIDAS scores at Visit 2 and Visit 5 (end of treatment period month 3). The MIDAS is a questionnaire consisting of five (5) "how many days in the last 3 months..." questions. Thus the range for the MIDAS is from, 0 to a maximum possible score 93 (31 days X 3 months). The MIDAS is scored according to the following: 0-5, MIDAS Grade I, Little or No Disability 6-10, MIDAS Grade II, Mild Disability 11-20, MIDAS Grade III, Moderate Disability 21+, MIDAS Grade IV, Severe Disability |
Visit 2 (Day 28) to Visit 5 (Day 116)
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Headache Health Score
Time Frame: Visit 2 (Day 28), Visit 3 (Day 57), Visit 4 (Day 85), and Visit 5 (Day 116)
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Headache Health Score at Visit 2 (Day 28), Visit 3 (Day 57), Visit 4 (Day 85), and Visit 5 (Day 116) for the Nuedexta arm and the placebo arm.
The Headache Health Score is measured using a scale from 0 to 100, with higher scores indicating less headache impact on the subject's life.
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Visit 2 (Day 28), Visit 3 (Day 57), Visit 4 (Day 85), and Visit 5 (Day 116)
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Adverse Events
Time Frame: Baseline (Day 0) to Treatment Period Month 3 (Day 116)
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Compare the number of adverse events in the Nuedexta arm vs. the placebo arm.
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Baseline (Day 0) to Treatment Period Month 3 (Day 116)
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Disease Attributes
- Headache Disorders, Primary
- Headache Disorders
- Disease Progression
- Migraine Disorders
- Physiological Effects of Drugs
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Anti-Infective Agents
- Muscarinic Antagonists
- Cholinergic Antagonists
- Cholinergic Agents
- Enzyme Inhibitors
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Membrane Transport Modulators
- Cytochrome P-450 Enzyme Inhibitors
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Cytochrome P-450 CYP2D6 Inhibitors
- Respiratory System Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Antimalarials
- Antitussive Agents
- Adrenergic alpha-Antagonists
- Dextromethorphan
- Quinidine
Other Study ID Numbers
- 14-001AV
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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