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Episodic MigrainePhase 3RESTORNCT02569853

DFN-11 Injection in Episodic Migraine With or Without Aura

A Phase 3 study testing DFN-11 in people with Episodic Migraine, run by Dr. Reddy's Laboratories Limited at 16 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

Safety and Efficacy of DFN-11 in patients with episodic migraines with or without aura. 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?
DFN-11
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
268 participants
Where
16 sitesUnited States
Study dates
21 Sep 2015to 26 Feb 2018
Phase
Phase 3
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

  • 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

Who cannot join

  • 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
Show all 36Show fewer
  • 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).
  • Subjects with a history of cluster headaches
  • Subjects with the diagnosis of "probable migraine" (ICHD II)
  • Ischemic coronary artery disease (CAD): including but not limited to angina pectoris, history of myocardial infarction or documented silent ischemia or coronary artery vasospasm, including Prinzmetal's angina
  • Subjects with Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders
  • Subjects with a history of congenital heart disease
  • A history of uncontrolled hypertension or screening systolic/diastolic > 140/90 mmHg
  • Have peripheral vascular disease including but not limited to ischemic bowel disease (IBD) and Raynaud's disease.
  • Any abnormal physiology and/or pathology which, in the opinion of the Investigator or Sponsor, which would be contraindicated for study participation and would not allow the objectives of the study to be met
  • Subjects who show any clinical laboratory or electrocardiogram (ECG) abnormality that in the opinion of the Investigator would endanger the subject or interfere with the study conduct. If the results of the clinical laboratory or ECG are outside of normal reference range the subject may still be enrolled but only if these findings are determined to be not clinically significant by the Investigator. This determination must be recorded in the subject's source document prior to enrolment.
  • Fridericia's corrected QT (QTcF) interval greater than 450 msec
  • Severe renal impairment (creatinine > 2 mg/dl)
  • Serum total bilirubin > 2.0 mg/dL
  • Serum aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase > 2.5 times the upper limit of normal
  • Subjects with uncontrolled diabetes mellitus, or a glycosylated hemoglobin (HbA1c) > 7.0%, or with diabetes mellitus requiring insulin
  • A history of alcohol or substance use disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Edition V (DSM-V) (including marijuana) within 1 year prior to screening
  • Current treatment with antipsychotics or use of antipsychotics within 30 days of screening
  • A history of or current neurological or psychiatric impairment, including but not limited to psychosis, current major depression, bipolar disorder or cognitive dysfunction that, in the opinion of the Investigator, would compromise data collection
  • Subjects who have received treatment with an investigational drug or device within 30 days of the screening visit or participated in a central nervous system clinical trial in the 3 months prior to screening
  • Subjects with any other medical condition that, in the judgment of the Investigator and/or Medical Monitor, would confound the objectives of the study (e.g., positive screening test for human immunodeficiency virus [HIV], hepatitis B surface antigen positive or hepatitis C positive, a known history of systemic lupus erythematosis)
  • Subjects who plan to donate blood, sperm, or oocytes during the study and for 30 days after the last dose of study medication
  • Subjects who are employees or immediate relatives of the employees of the Sponsor, any of its affiliates or partners, or of the study center

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

United States16 sites

  • Dr. Reddy's Investigational Site #12

    Albuquerque, New Mexico, 87102

  • Dr. Reddy's Investigational Site #19

    Ann Arbor, Michigan, 48104

  • Dr. Reddy's Investigational Site #27

    Boise, Idaho, 83716

  • Dr. Reddy's Investigational Site #15

    Cleveland, Ohio, 44122

  • Dr. Reddy's Investigational Site #14

    Dallas, Texas, 75231

  • Dr. Reddy's Investigational Site #26

    Greensboro, North Carolina, 27405

  • Dr. Reddy's Investigational Site #16

    Hurst, Texas, 76054

  • Dr. Reddy's Investigational Site #24

    Jacksonville, Florida, 32256

  • Dr. Reddy's Investigational Site #23

    Maitland, Florida, 32751

  • Dr. Reddy's Investigational Site #25

    Memphis, Tennessee, 38119

  • Dr. Reddy's Investigational Site #21

    Mt. Pleasant, South Carolina, 29464

  • Dr. Reddy's Investigational Site #18

    Santa Monica, California, 80404

  • Dr. Reddy's Investigational Site #13

    Springfield, Missouri, 65807

  • Dr. Reddy's Investigational Site #20

    Watertown, Massachusetts, 02472

  • Dr. Reddy's Investigational Site #17

    West Jordan, Utah, 84088

  • Dr. Reddy's Investigational Site #10

    Williamsville, New York, 14221

Other trials in United States

About this study

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

Being tested
DFN-11, Placebo

What participants receive

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

  • DFN-11Drug

  • PlaceboOther

Study groups in NCT02569853
Study groupRoleWhat they receive
DFN-11ExperimentalDFN-11 active injection upon occurrence of migraine
Receives: Drug: DFN-11
PlaceboPlacebo comparatorPlacebo injection upon occurrence of migraine
Receives: Other: Placebo

What is being measured

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

  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

    Measured: 2 hours

Secondary outcomes (1)

  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

    Measured: 1 hour

Timeline

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

  1. First posted7 Oct 2015 (estimated)
  2. Study start21 Sep 2015
  3. Primary completion30 May 2017
  4. Study completion26 Feb 2018

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
268 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02569853
Sponsor's protocol ID
DFN-11-CD-004
Acronym
RESTOR
Status last verified
Jun 2018
First submitted
1 Oct 2015
Last updated
26 Jul 2018
Data monitoring committee
No

Publications

  • 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.

    PubMed 30112726

  • 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.

    PubMed 30112725

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing DFN-11 in people with Episodic Migraine, run by Dr. Reddy's Laboratories Limited at 16 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 5 inclusion and 36 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 26 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 26 Jul 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?

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 (time frame: 2 hours). 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 NCT02569853, which also lists 2 linked publications.

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 26 Jul 2018.

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