NCT02569853

Brief Summary

Safety and Efficacy of DFN-11 in patients with episodic migraines with or without aura.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
268

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 21, 2015

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

October 1, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 7, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2017

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2018

Completed
5 months until next milestone

Results Posted

Study results publicly available

July 26, 2018

Completed
Last Updated

July 26, 2018

Status Verified

June 1, 2018

Enrollment Period

1.7 years

First QC Date

October 1, 2015

Results QC Date

June 27, 2018

Last Update Submit

July 23, 2018

Conditions

Episodic Migraine

Outcome Measures

Primary Outcomes (1)

  • The Percentage of Subjects in the Double-blind Period Who Are Pain Free at 2 Hours After Dosing as Reported by the Subject in the eDiary

    2 hours

Secondary Outcomes (1)

  • The Percentage of Subjects in the Double-blind Period Who Are Pain Free at 1 Hour After Dosing as Reported by the Subject in the eDiary

    1 hour

Study Arms (2)

DFN-11

EXPERIMENTAL

DFN-11 active injection upon occurrence of migraine

Drug: DFN-11

Placebo

PLACEBO COMPARATOR

Placebo injection upon occurrence of migraine

Other: Placebo

Interventions

DFN-11DRUG
DFN-11
PlaceboOTHER
Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • If female, a subject must have a negative serum pregnancy test at screening, does not plan to become pregnant during the study, and is not lactating
  • If female, a subject also must have a negative urine pregnancy test at all subsequent study visits after the Screening Visit, and agree to practice a reliable form of contraception or abstinence during the study. Acceptable forms of contraception include implants, injectables, combined oral contraceptives, an intrauterine device, a vasectomized partner, an exclusively female partner, and double-barrier methods.
  • If male (with female partner), a subject must agree to practice a reliable form of contraception or abstinence during the study.
  • A history of episodic migraine who experience 2 to 6 migraine attacks a month for at least the past 12 months with no more than 14 migraine headache days per month, and with 48 hours of headache free time between migraine headaches
  • Have migraine with or without aura; if with aura, the aura cannot last longer than 60 minutes

You may not qualify if:

  • Minors, even if they are in specified study age range
  • Medication overuse headache as defined by ICHD II:
  • Opioids ≥ 10 days a month during the 90 days prior to screening
  • Combination medications (e.g., Fiorinal®) ≥ 10 days a month during the 90 days prior to screening
  • Nonsteroidal anti-inflammatory drugs (NSAIDs) 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
  • Subjects treated with onabotulinumtoxin A (Botox®) or other botulinum toxin treatment; or history of receiving such treatment during the 180 days prior to screening
  • On unstable dosages of migraine prophylactic medications during the 30 days prior to and through screening
  • Taking mini-prophylaxis for menstrual migraine
  • Subjects with hemiplegic or basilar migraine or other forms of neurologically complicated migraine
  • Subjects who have prolonged aura (i.e., more than 1 hour)
  • Cerebrovascular disease including but not limited to a history of stroke or transient ischemic attack (TIA)
  • A history of migralepsy (seizure following a migraine) or a concurrent diagnosis of seizure disorder
  • Subjects who cannot differentiate between a migraine headache and tension-type or cluster headache or other types of headache
  • Subjects with a history of more than occasional (based on Investigator's judgment) tension-type headache (distinct from migraine headache days count).
  • +21 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Dr. Reddy's Investigational Site #18

Santa Monica, California, 80404, United States

Location

Dr. Reddy's Investigational Site #24

Jacksonville, Florida, 32256, United States

Location

Dr. Reddy's Investigational Site #23

Maitland, Florida, 32751, United States

Location

Dr. Reddy's Investigational Site #27

Boise, Idaho, 83716, United States

Location

Dr. Reddy's Investigational Site #20

Watertown, Massachusetts, 02472, United States

Location

Dr. Reddy's Investigational Site #19

Ann Arbor, Michigan, 48104, United States

Location

Dr. Reddy's Investigational Site #13

Springfield, Missouri, 65807, United States

Location

Dr. Reddy's Investigational Site #12

Albuquerque, New Mexico, 87102, United States

Location

Dr. Reddy's Investigational Site #10

Williamsville, New York, 14221, United States

Location

Dr. Reddy's Investigational Site #26

Greensboro, North Carolina, 27405, United States

Location

Dr. Reddy's Investigational Site #15

Cleveland, Ohio, 44122, United States

Location

Dr. Reddy's Investigational Site #21

Mt. Pleasant, South Carolina, 29464, United States

Location

Dr. Reddy's Investigational Site #25

Memphis, Tennessee, 38119, United States

Location

Dr. Reddy's Investigational Site #14

Dallas, Texas, 75231, United States

Location

Dr. Reddy's Investigational Site #16

Hurst, Texas, 76054, United States

Location

Dr. Reddy's Investigational Site #17

West Jordan, Utah, 84088, United States

Location

Related Publications (2)

  • Landy S, Munjal S, Brand-Schieber E, Rapoport AM. Efficacy and safety of DFN-11 (sumatriptan injection, 3 mg) in adults with episodic migraine: a multicenter, randomized, double-blind, placebo-controlled study. J Headache Pain. 2018 Aug 15;19(1):69. doi: 10.1186/s10194-018-0881-z.

    PMID: 30112726DERIVED

  • Landy S, Munjal S, Brand-Schieber E, Rapoport AM. Efficacy and safety of DFN-11 (sumatriptan injection, 3 mg) in adults with episodic migraine: an 8-week open-label extension study. J Headache Pain. 2018 Aug 15;19(1):70. doi: 10.1186/s10194-018-0882-y.

    PMID: 30112725DERIVED

Results Point of Contact

Title
Director, Clinical Development
Organization
Dr. Reddy's
ebrandschieber@drreddys.com
609-375-9900

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2015

First Posted

October 7, 2015

Study Start

September 21, 2015

Primary Completion

May 30, 2017

Study Completion

February 26, 2018

Last Updated

July 26, 2018

Results First Posted

July 26, 2018

Record last verified: 2018-06

Locations

US(16)