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

NCT02176018 | Completed Phase 2 Results

• 1 other identifier: 14-001AV
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Episodic Migraine

Keywords

Episodic Migraine; Migraine; Headache

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (9)

• Headache Days in Treatment Period Month 3

  End of Treatment Period Month 3 (Day 116)

• Migraine Days in Each Treatment Period Month

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

• Headache Severity in Each Treatment Period Month

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

• Headache Duration in Each Treatment Period Month

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

• 50% Headache Reduction

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

Study Arms (2)

Nuedexta

ACTIVE COMPARATOR

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.

Drug: Dextromethorphan and quinidine

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Dextromethorphan and quinidine DRUG

Also known as: Nuedexta

Nuedexta

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cady, Roger, M.D.: lead
• Avanir Pharmaceuticals: collaborator

Study Sites (5)

Swedish American Neuro and Headache Center

Rockford, Illinois, 61104, United States

Location

The Headache Center

Ridgeland, Mississippi, 39157, United States

Location

StudyMetrix Research, LLC

City of Saint Peters, Missouri, 63303, United States

Location

Clinvest

Springfield, Missouri, 65807, United States

Location

Island Neurological Associates, PC

Plainview, New York, 11803, United States

Location

MeSH Terms

Conditions

Migraine Disorders; Headache

Interventions

dextromethorphan - quinidine combination

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Jim Sly
• Organization: Clinvest Research

jsly@clinvest.com

4178413673

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2014
• First Posted: June 26, 2014
• Study Start: August 1, 2014
• Primary Completion: February 1, 2017
• Study Completion: March 1, 2017
• Last Updated: April 3, 2018
• Results First Posted: April 3, 2018

Record last verified: 2018-03

Locations

US (5)