An Efficacy and Safety Study of DFN-02 (Sumatriptan Nasal Spray 10 mg)

NCT02856802 | Completed Phase 2 Results

• 1 other identifier: DFN-02-CD-012
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 9

Brief Summary

A safety and efficacy study of DFN-02 (Sumatriptan Nasal Spray 10 mg), being conducted at multiple centers in the United States.

Conditions

Migraine Headaches

Keywords

Aura

Outcome Measures

Primary Outcomes (1)

• Number of Participants Free From Headache Pain at 2 Hours After the First Dose of Study Medication Taken for a Migraine Attack With Moderate to Severe Headache Pain During the Double-blind Treatment Period 1 (DB1).

  Freedom from headache pain at 2 hours after the first dose of study medication taken within one hour after experiencing a migraine attack of moderate to severe headache pain during the DB1 treatment period, e.g., headache pain rating of moderate \[Grade 2\] or severe \[Grade 3\] predose and reduced to none \[Grade 0\] postdose). Mild headache pain was recorded as Grade 1. If the subject was not able to use study medication for the first migraine after randomization, they were instructed to use the study medication for the next attack. If the subject experienced insufficient relief from the first dose of study medication, they were permitted to take a second dose of study medication or rescue medication 2 or more hours after the first dose, and only after completing the 2 hours' postdose assessments. If no relief was experienced from the first dose of study medication after 2 hours only rescue medication could be administered. Maximum 2 doses of study medication per 24 hours.

  2 hours after study medication administration

Secondary Outcomes (2)

• Number of Participants With Absence of Most Bothersome Symptom (MBS) Among Nausea, Photophobia and Phonophobia at 2 Hours (DB1)

  2 hours after study medication administration

• Number of Participants With Headache Pain Freedom at 2 Hours Postdose in the Double-blind Treatment Period 2 (DB2)

  2 hours after study medication administration

Study Arms (2)

DFN-02

EXPERIMENTAL

Participants self-administered a single-dose of DFN-02 (sumatriptan 10-mg/100 μL nasal spray) intranasally within one hour of an acute migraine pain episode.

Drug: Sumatriptan 10 mg Nasal Spray

Placebo

OTHER

Participants self-administered a single-dose of DFN-02 placebo nasal spray matching DFN-02 intranasally within one hour of an acute migraine pain episode.

Other: Sumatriptan Placebo Nasal Spray

Interventions

Sumatriptan 10 mg Nasal Spray DRUG

100 μL nasal spray once

Also known as: Sumatriptan

DFN-02

Sumatriptan Placebo Nasal Spray OTHER

100 μL nasal spray once

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A history of episodic migraine who experience an average of 2 to 8 migraine attacks per month for at least the past 12 months, with no more than 14 headache days per month, and with 48 hours of headache free time between migraine headaches
• Patients who have migraine with or without aura. If migraine with aura, the aura cannot last longer than 60 minutes.
• Patients who are willing and able to:
• Evaluate and record pain, migraine symptoms, and study medication effectiveness information in real-time using a diary for the duration of the study;
• Record each instance of the use of study medication and rescue medication in a patient diary in real-time for the duration of the study;
• Comply with all other study procedures and scheduling requirements.

You may not qualify if:

• Minors, even if they are in the specified study age range
• Medication overuse:
• Opioids ≥ 10 days during the 90 days prior to screening
• Combination medications (e.g., Fiorinal®) ≥ 10 days during the 90 days prior to screening (only applies if combination medication contains an opioid and/or barbiturate)
• Nonsteroidal Anti-inflammatory Drugs or other simple medications ˃ 14 days a month during the 90 days prior to screening
• Triptans or ergots ≥ 10 days a month during the 90 days prior to screening
• Treated with onabotulinumtoxinA (Botox®) or other botulinum toxin treatment within 4 months prior to screening for migraine prophylaxis (patients who were treated with same for cosmetic purposes may be allowed on a case-by-case basis after approval from the Medical Monitor)
• A history of or current neurological or psychiatric impairment, or cognitive dysfunction that, in the opinion of the Investigator, would compromise data collection
• Use of antipsychotics at least 15 days prior to randomization
• Patients who received treatment with an investigational drug or device within 30 days prior to randomization, or within 3 months if associated with central nervous system
• Patients who participated in a central nervous system clinical trial within 3 months prior to randomization
• Patients who test positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody serology testing
• Patients who are employees or immediate relatives of the employees of the Sponsor, any of its affiliates or partners, or of the clinical study research site

Sponsors & Collaborators

• Upsher-Smith Laboratories: lead

Study Sites (9)

Site 30

San Diego, California, 92108, United States

Location

Site 11

Santa Monica, California, 90404, United States

Location

Site 31

Boston, Massachusetts, 02131, United States

Location

Site 18

Ann Arbor, Michigan, 48104, United States

Location

Site 02

Albuquerque, New Mexico, 87102, United States

Location

Site 29

Rochester, New York, 14609, United States

Location

Site 25

Williamsville, New York, 14221, United States

Location

Site 33

Mt. Pleasant, South Carolina, 29464, United States

Location

Site 28

West Jordan, Utah, 84088, United States

Location

Related Publications (2)

• Lipton RB, Munjal S, Brand-Schieber E, Rapoport AM. DFN-02, Sumatriptan 10 mg Nasal Spray with Permeation Enhancer, for the Acute Treatment of Migraine: A Randomized, Double-Blind, Placebo-Controlled Study Assessing Functional Disability and Subject Satisfaction with Treatment. CNS Drugs. 2019 Apr;33(4):375-382. doi: 10.1007/s40263-019-00614-6.

  PMID: 30877622 DERIVED

• Lipton RB, Munjal S, Brand-Schieber E, Rapoport AM. DFN-02 (Sumatriptan 10 mg With a Permeation Enhancer) Nasal Spray vs Placebo in the Acute Treatment of Migraine: A Double-Blind, Placebo-Controlled Study. Headache. 2018 May;58(5):676-687. doi: 10.1111/head.13309.

  PMID: 29878341 DERIVED

MeSH Terms

Conditions

Migraine Disorders; Epilepsy

Interventions

Sumatriptan; Nasal Sprays

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Aerosols; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Clinical Operations
• Organization: Upsher-Smith Laboratories, LLC

uslinfo@upsher-smith.com

(763) 315-2000

Study Officials

• Sagar Munjal, MD

  Dr. Reddy's Laboratories, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: July 29, 2016
• First Posted: August 5, 2016
• Study Start: July 11, 2016
• Primary Completion: February 10, 2017
• Study Completion: February 10, 2017
• Last Updated: March 30, 2021
• Results First Posted: March 30, 2021

Record last verified: 2020-12

Locations

US (9)