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Episodic MigrainePhase 2NCT02176018

Nuedexta for the Prevention and Modification of Disease Progression in Episodic Migraine

A Phase 2 study testing Dextromethorphan and quinidine in people with Episodic Migraine, run by Cady, Roger, M.D. at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Episodic Migraine
What is being tested?
Dextromethorphan and quinidine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
76 participants
Where
5 sitesUnited States
Study dates
Aug 2014to Mar 2017
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 22Show fewer
  • 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.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • StudyMetrix Research, LLC

    City of Saint Peters, Missouri, 63303

  • Island Neurological Associates, PC

    Plainview, New York, 11803

  • The Headache Center

    Ridgeland, Mississippi, 39157

  • Swedish American Neuro and Headache Center

    Rockford, Illinois, 61104

  • Clinvest

    Springfield, Missouri, 65807

Other trials in United States

About this study

Official title: A Randomized Pilot Study of Nuedexta for the Prevention and Modification of Disease Progression in Episodic Migraine

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.

Read the detailed description

This is a double-blind, placebo-controlled, randomized, multi-center study to be conducted at the Headache Care Center in Springfield, MO and two other clinics in the United States. Approximately 45 subjects, 18 to 65 years of age, with frequent episodic migraine (6-14 days per month), with (1.2) or without aura (1.1) as defined by ICHD-3beta, will enter a 1-month baseline period to confirm the migraine diagnosis, as well as establish baseline characteristics. At Visit 1, subjects must not have a history of utilization of acute treatment greater than 14 days per month in the preceding 3 month period. Subjects must have a current history of ICHD-3beta migraine with 6-14 migraine days per month in the 3 months prior to the study enrollment. Eligible subjects will be randomly assigned to one of two groups in a 1:1 ratio. Randomization will occur using a computer-generated allocation schedule. Subjects meeting entrance criteria as determined both at screening and through the review of the baseline headache diary will be given the lowest available allocation number for that site. Migraine preventative use is permitted if the subject has been on a stable does for at least 2 months prior to screening and has not failed more than 3 migraine preventatives due to lack of efficacy. The study will consist of 5 office visits per subject: Visit 1 - screening, Visit 2 - randomization, and Visits 3 to 5 - three-month treatment period. During the baseline period, the subject will treat migraines with their current preferred acute treatment of choice.

Being tested
Dextromethorphan and quinidine, Placebo
Keywords
Episodic Migraine, Migraine, Headache
Medical subject headings
Migraine Disorders, Headache

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dextromethorphan and quinidineDrug

    Also called Nuedexta

  • PlaceboDrug

Study groups in NCT02176018
Study groupRoleWhat they receive
NuedextaActive comparatorOne 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.
Receives: Drug: Dextromethorphan and quinidine
PlaceboPlacebo comparatorOne 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.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Headache Days in Each Treatment Period Month

    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.

    Measured: Treatment Month 1, Treatment Month 2, and End of Treatment Period Month 3 (Day 116)

Secondary outcomes (9)

  1. Headache Days in Treatment Period Month 3

    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.

    Measured: End of Treatment Period Month 3 (Day 116)

  2. Migraine Days in Each Treatment Period Month

    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.

    Measured: Treatment Month 1, Month 2, and End of Treatment Period Month 3 (Day 116)

  3. Headache Severity in Each Treatment Period Month

    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.

    Measured: Treatment Month 1, Month 2, and End of Treatment Period Month 3 (Day 116)

  4. Headache Duration in Each Treatment Period Month

    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.

    Measured: Treatment Month 1, Month 2, and End of Treatment Period Month 3 (Day 116)

  5. 50% Headache Reduction

    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.

    Measured: Baseline (Day 0) to Treatment Period Month 3 (Day 116)

  6. Acute Medication Use in Each Treatment Period Month

    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

    Measured: Treatment Month 1, Month 2, and End of Treatment Period Month 3 (Day 116)

  7. Migraine Disability Assessment Scale (MIDAS)

    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

    Measured: Visit 2 (Day 28) to Visit 5 (Day 116)

  8. Headache Health Score

    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.

    Measured: Visit 2 (Day 28), Visit 3 (Day 57), Visit 4 (Day 85), and Visit 5 (Day 116)

  9. Adverse Events

    Compare the number of adverse events in the Nuedexta arm vs. the placebo arm.

    Measured: Baseline (Day 0) to Treatment Period Month 3 (Day 116)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2014 (estimated)
  2. Study startAug 2014
  3. Primary completionFeb 2017
  4. Study completionMar 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02176018
Sponsor's protocol ID
14-001AV
Status last verified
Mar 2018
First submitted
25 Jun 2014
Last updated
3 Apr 2018
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dextromethorphan and quinidine in people with Episodic Migraine, run by Cady, Roger, M.D. at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Headache Days in Each Treatment Period Month (time frame: Treatment Month 1, Treatment Month 2, and End of Treatment Period Month 3 (Day 116)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02176018.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2018; AzTrials last refreshed its copy on 7 Nov 2026.

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