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MigrainePhase 3NCT03275922

Efficacy & Safety Of Zomig Nasal Spray For Acute Migraine Treatment In Subjects 6 To 11 Years, With OLE

A Phase 3 study testing ZNS in people with Migraine, run by Impax Laboratories, LLC at 47 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

To evaluate the efficacy and safety of zolmitriptan nasal spray (ZNS) in the acute treatment of migraine headache in subjects ages 6 to 11 years. Part 1: Approximately 20 weeks (includes screening and double-blind treatment). Read more about this study

Who is it for?
Ages 6 to 11 years
Conditions the study is for
Migraine
What is being tested?
ZNS
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
374 participants
Where
47 sitesUnited States
Study dates
27 Nov 2017to 28 Sep 2020
Phase
Phase 3
Are there results?
None posted in the registry

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 6 to 11 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Parent or legal guardian is able to provide written informed consent and subject is able to provide assent.
  • Subjects ages 6 to 11 years throughout the double-blind portion of the studyAn established diagnosis of migraine
  • By history, average migraine frequency of ≥ 2 attacks per month lasting on average ≥ 3 hours per attack
  • By history, experiences at least 16 headache-free days per month on average

Who cannot join

  • History of ischemic or vasospastic heart disease, arrhythmias associated with accessory conduction pathways (eg, Wolff-Parkinson-White syndrome), cerebrovascular disease, hemiplegic or basilar artery migraine, peripheral vascular disease, ischemic bowel disease, uncontrolled hypertension, recent (within 24 hours) or use of another 5HT1 agonist, ergots or ergotamine-containing medications.
  • Any medical condition, including severe hepatic impairment, which, in the opinion of the investigator, may put the subject at increased risk with exposure to zolmitriptan, or may interfere with the safety or efficacy assessments.
  • Had an unacceptable adverse experience following previous use of any 5HT1B/1D agonist drug (in the opinion of the investigator).
  • Had not experienced satisfactory relief from migraine pain during prior treatment with 2 or more adequate courses of triptans.
  • Prior use of any nasal spray (triptan or dihydroergotamine [DHE]) for the acute treatment of migraine
  • Disease or anatomic abnormalities of the nasal cavity precluding or complicating the use of ZNS.

Trial locations and contacts

47 sites in 1 country.

47 sites in 1 country

United States47 sites

  • Akron Children's Hospital (site 139)

    Akron, Ohio, 44308

  • Dent Neurosciences Research Center (129)

    Amherst, New York, 14226

  • Advanced Research Center, Inc (134)

    Anaheim, California, 92805

  • Michigan Head-Pain and Neurological Institute (103)

    Ann Arbor, Michigan, 48104

  • Clinical Integrative Research Center of Atlanta (121)

    Atlanta, Georgia, 30328

  • NuDirections Clinical Research, LLC (159)

    Atlanta, Georgia, 30350

  • Children's Hospital Colorado (154)

    Aurora, Colorado, 80045

  • Northwest Clinical Research Center (132)

    Bellevue, Washington, 98007

  • OnSite Clinical Solutions, LLC (155)

    Charlotte, North Carolina, 28277

  • Pediatric Research of Charlottesville, LLC (104)

    Charlottesville, Virginia, 22902

  • Cincinnati Children's Hospital (140)

    Cincinnati, Ohio, 45229

  • Texas Neurology, P.A. (110)

    Dallas, Texas, 75214

  • Children's Medical Center Dallas (147)

    Dallas, Texas, 75235

  • iResearch Atlanta, LLC (146)

    Decatur, Georgia, 30030

  • Blue Sky Neurology (106)

    Englewood, Colorado, 80113

  • Sierra Medical Research (124)

    Fresno, California, 17601

  • Headache Wellness Center (Site 152)

    Greensboro, North Carolina, 27405

  • NW Florida Clinical Research Group, LLC (122)

    Gulf Breeze, Florida, 32561

  • Josephson Wallack Munshower Neurology P.C. (114)

    Indianapolis, Indiana, 46256

  • Clinical Neuroscience Solutions, Inc. (127)

    Jacksonville, Florida, 32256

  • Arkansas Children's Hospital (109)

    Little Rock, Arkansas, 72202

  • Kosair Charities Pediatric Clinical Research Unit (120)

    Louisville, Kentucky, 40202

  • Axcess Medical Research (126)

    Loxahatchee Groves, Florida, 33470

  • Marshfield Clinic (145)

    Marshfield, Wisconsin, 54449

  • Biotech Pharmaceutical Group (138)

    Miami, Florida, 33155

  • Sanitas Medical and Dental Institute/dba Sanitas Research, LLC (142)

    Miami, Florida, 33155

  • Access Clinical Trials, Inc. (151)

    Nashville, Tennessee, 37203

  • Laszlo J. Mate, M.D., P.A. (153)

    North Palm Beach, Florida, 33408

  • Clincial Neuroscience Solutions, Inc. (136)

    Orlando, Florida, 32801

  • Pediatric Neurology, PA (125)

    Orlando, Florida, 32819

  • Phoenix Children's Hospital (149)

    Phoenix, Arizona, 85016

  • Preferred Primary Care Physicians, Inc. (115)

    Pittsburgh, Pennsylvania, 15236

  • East Florida Research (143)

    Port Saint Lucie, Florida, 34983

  • Raleigh Neurology Associates, PA (113)

    Raleigh, North Carolina, 27607

  • Shailesh M. Asaikar, MD. Inc. DBA Child and Adolescent Neurology Consultatns (119)

    Sacramento, California, 95815

  • J. Lewis Research Inc. Foothill Family Clinic (107)

    Salt Lake City, Utah, 84109

  • Primary Children's Hospital Outpatient Services (117)

    Salt Lake City, Utah, 84113

  • Granger Medical Holladay (111)

    Salt Lake City, Utah, 84117

  • Meridian Clinical Research, LLC (130)

    Savannah, Georgia, 31406

  • Mercy Research (116)

    St Louis, Missouri, 63141

  • Ki Health Partners, LLC dba New England INstitute for Clinical Research (128)

    Stamford, Connecticut, 06905

  • Multicare Health System- Mary Bridge Pediatrics- Tacoma (158)

    Tacoma, Washington, 98405

  • Pedatric Epilepsy & Neurology Specialists (157)

    Tampa, Florida, 17601

  • IMMUNOe Research Centers (150)

    Thornton, Colorado, 80233

  • Clinical Research Center of NJ (123)

    Voorhees Township, New Jersey, 08043

  • Children's National Health System (141)

    Washington D.C., District of Columbia, 20010

  • Premiere Research Institute @ Palm Beach Neurology, PA (105)

    West Palm Beach, Florida, 33407

Other trials in United States

About this study

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Crossover Study To Evaluate The Efficacy And Safety Of Zolmitriptan Nasal Spray For The Treatment Of Acute Migraine In Subjects Ages 6 To 11 Years, With An Open-Label Extension

To evaluate the efficacy and safety of zolmitriptan nasal spray (ZNS) in the acute treatment of migraine headache in subjects ages 6 to 11 years.

Part 1: Approximately 20 weeks (includes screening and double-blind treatment).

  • Screening will be performed based on the inclusion exclusion criteria specified in the study protocol.
  • Randomize approximately 288 subjects into the double-blind crossover phase.

Part 2: Approximately 100 subjects who complete the double-blind crossover phase will enter part 2, a 6 month open-label safety extension (OLE).

Efficacy will be evaluated in the double-blind part of the trial. Safety will be evaluated in both the double-blind and the OLE.

Conditions
Migraine
Being tested
Placebo ZNS, ZNS
Keywords
Migraine, Headache, Pain, Efficacy, Pediatric
Medical subject headings
Migraine Disorders, Headache, Pain

What participants receive

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

  • Placebo ZNSDrug

    Also called Placebo

    Placebo Zolmitriptan Nasal Spray

  • ZNSDrug

    Zolmitriptan Nasal Spray

Study groups in NCT03275922
Study groupRoleWhat they receive
Run-in - ZNS - Placebo - OLEOtherAfter Run-in period, subjects will be randomized to ZNS followed by placebo ZNS. Upon successful completion of Part 1, subjects may enroll into OLE (Part 2).
Receives: Drug: Placebo ZNS; Drug: ZNS
Run-in - Placebo - ZNS - OLEOtherAfter Run-in period, subjects will be randomized to placebo ZNS followed by ZNS. Upon successful completion of Part 1, subjects may enroll into OLE (Part 2).
Receives: Drug: Placebo ZNS; Drug: ZNS

What is being measured

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

  1. Pain-free status at 2 hours post treatment

    Headache pain intensity is assessed by the subjects immediately prior to treatment and 2 hours post-dose using a 4-point headache pain intensity scale (severe = 3, moderate = 2, mild = 1, or none = 0).

    Measured: 2 hours post-dose

Secondary outcomes (3)

  1. Proportion of subjects who achieve pain-free status at 24 hours post-dose

    The headache pain intensity is assessed by the subjects using a 4-point headache pain intensity scale (severe = 3, moderate = 2, mild = 1, or none = 0).

    Measured: 24 hours post-dose

  2. Headache response at 24 hours post-dose

    The subject diary captures the headache severity using a 4-point headache pain intensity scale (severe = 3, moderate = 2, mild = 1, or none = 0). Headache response is defined as a reduction in moderate (2) or severe (3) pain to mild (1) or no (0) pain at 24 hour post-dose.

    Measured: 24 hours post-dose

  3. Sustained headache response at 24 hours post-dose

    Sustained headache response is defined as a reduction in migraine headache pain intensity from severe or moderate to mild or none at 2 hours which is then maintained (without a return to moderate or severe pain) at 24 hours with no use of rescue medication prior to the 24 hour assessment.

    Measured: 24 hours post-dose

Timeline

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

  1. First posted8 Sep 2017
  2. Study start27 Nov 2017
  3. Primary completion2 Jul 2020
  4. Study completion28 Sep 2020

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
Crossover
Model description
A Multicenter, Randomized, Double-blind, Placebo-controlled, Crossover Study
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
374 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03275922
Sponsor's protocol ID
IPX229-B16-01
Status last verified
Jul 2020
First submitted
6 Sep 2017
Last updated
11 Jan 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ZNS in people with Migraine, run by Impax Laboratories, LLC at 47 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 4 inclusion and 6 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 11 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 47 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Pain-free status at 2 hours post treatment (time frame: 2 hours post-dose). 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 NCT03275922.

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 11 Jan 2021.

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