Acute Treatment Trial in Adult Subjects With Migraines



Status:Recruiting
Conditions:Migraine Headaches
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - Any
Updated:3/31/2019
Start Date:March 25, 2019
End Date:November 20, 2019
Contact:Robert Berman, MD
Email:clinicaltrials@biohavenpharma.com
Phone:203-404-0410

Use our guide to learn which trials are right for you!

BHV3500-201: Phase II: Double-Blind, Randomized, Placebo Controlled, Dose-Ranging Trial of BHV-3500 for the Acute Treatment of Migraine

This study will evaluate the safety and efficacy of three different intranasal dose levels of
BHV-3500, relative to placebo, in the acute treatment of moderate to severe migraine.


Inclusion Criteria:

1. Subject has at least 1-year history of migraines (with or without aura), consistent with
a diagnosis according to the International Classification of Headache Disorder, 3rd
Edition, Beta version [1] including the following:

1. Migraine attacks present for more than 1 year with the age of onset prior to 50 years
of age

2. Migraine attacks, on average, lasting about 4-72 hours if untreated

3. Not more than 8 attacks of moderate to severe intensity per month within the last 3
months

4. At least 2 consistent migraine headache attacks of moderate or severe intensity in
each of the 3 months prior to the Screening Visit and maintains this requirement
during the Screening period

5. Less than 15 days with headache (migraine or non-migraine) per month in each of the 3
months prior to the Screening Visit and maintains this requirement during the
Screening Period.

6. Subjects on prophylactic migraine medication are permitted to remain on therapy
provided they have been on a stable dose for at least 3 months prior to screening
visit and the dose is not expected to change during the course of the study.

7. Subjects with contraindications for use of triptans may be included provided they meet
all other study entry criteria.

Exclusion Criteria:

Key Exclusion Criteria:

1. Subject with a history of HIV disease

2. Subject history with current evidence of uncontrolled, unstable or recently diagnosed
cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and
cerebral ischemia. Subjects with Myocardial Infarction (MI), Acute Coronary Syndrome
(ACS), Percutaneous Coronary Intervention (PCI), cardiac surgery, stroke or transient
ischemic attack (TIA) during the 6 months prior to screening.

3. Uncontrolled hypertension (high blood pressure), or uncontrolled diabetes (however
subjects can be included who have stable hypertension and/or diabetes for at least 3
months prior to being enrolled).

4. Subject has a current diagnosis of major depression, other pain syndromes, psychiatric
conditions (e.g., schizophrenia), dementia, or significant neurological disorders
(other than migraine) that, in the Investigator's opinion might interfere with study
assessments.

5. Subject has a history of gastric, or small intestinal surgery (including Gastric
Bypass, Gastric Banding, Gastric Sleeve, Gastric Balloon, etc.), or has disease that
causes malabsorption.

6. The subject has a history of current or evidence of any significant and/ or unstable
medical conditions (e.g., history of congenital heart disease or arrhythmia, known
suspected infection, hepatitis B or C, or cancer) that, in the Investigator's opinion,
would expose them to undue risk of a significant adverse event (AE) or interfere with
assessments of safety or efficacy during the course of the trial.

7. History of, treatment for, or evidence of, alcohol or drug abuse within the past 12
months or subjects who have met DSM-V criteria [15] for any significant substance use
disorder within the past 12 months from the date of the screening visit.

8. History of nasal surgery in the 6 months preceding the screening visit.

9. Participation in any other investigational clinical trial while participating in this
clinical trial.
We found this trial at
80
sites
Santa Monica, California 90404
Phone: 310-315-1456
?
mi
from
Santa Monica, CA
Click here to add this to my saved trials
One Utah Avenue
Cherry Hill, New Jersey 08002
856-857-9500
?
mi
from
Cherry Hill, NJ
Click here to add this to my saved trials
911 E. Hallandale Beach Blvd
Hallandale Beach, Florida 33009
954-455-5757
?
mi
from
Hallandale Beach, FL
Click here to add this to my saved trials
77 West Granada Boulevard
Ormond Beach, Florida 32174
Phone: 386-236-2456
?
mi
from
Ormond Beach, FL
Click here to add this to my saved trials
Albuquerque, New Mexico
Phone: 505-224-2735
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
Amherst, New York
Phone: 716-558-5670
?
mi
from
Amherst, NY
Click here to add this to my saved trials
Ann Arbor, Michigan 48104
Phone: 734-677-6000
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
Austin, Texas 78703
Phone: 512-380-9925
?
mi
from
Austin, TX
Click here to add this to my saved trials
Bellevue, Washington
Phone: 425-453-0404
?
mi
from
Bellevue, WA
Click here to add this to my saved trials
3800 Houma Boulevard
Biloxi, Mississippi 39531
Phone: 228-206-1283
?
mi
from
Biloxi, MS
Click here to add this to my saved trials
Boston, Massachusetts 02135
Phone: 617-477-4868
?
mi
from
Boston, MA
Click here to add this to my saved trials
Bronx, New York 10461
Phone: 929-263-3831
?
mi
from
Bronx, NY
Click here to add this to my saved trials
Chalmette, Louisiana 70043
Phone: 504-418-6040
?
mi
from
Chalmette, LA
Click here to add this to my saved trials
Charleston, South Carolina 29406
Phone: 843-725-5067
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Charlotte, North Carolina 28209
Phone: 704-527-6672
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Charlottesville, Virginia 22911
Phone: 434-817-2442
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
10575 Springfield Pike
Cincinnati, Ohio 45215
Phone: 937-912-4444
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
4400 North High Street
Columbus, Ohio 43214
Phone: 614-745-8863
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Dakota Dunes, South Dakota 57049
Phone: 605-232-9000
?
mi
from
Dakota Dunes, SD
Click here to add this to my saved trials
Dallas, Texas 75231
Phone: 214-369-2600
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Dayton, Ohio 45432
Phone: 937-912-4444
?
mi
from
Dayton, OH
Click here to add this to my saved trials
Decatur, Georgia 30030
Phone: 404-537-1281
?
mi
from
Decatur, GA
Click here to add this to my saved trials
Denver, Colorado 80210
Phone: 720-588-2557
?
mi
from
Denver, CO
Click here to add this to my saved trials
Encino, California 91316
Phone: 818-705-7451
?
mi
from
Encino, CA
Click here to add this to my saved trials
Fort Worth, Texas 76104
Phone: 817-348-0228
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
Greensboro, North Carolina 27408
Phone: 336-574-8020
?
mi
from
Greensboro, NC
Click here to add this to my saved trials
Greensboro, North Carolina 27405
Phone: 336-574-8000
?
mi
from
Greensboro, NC
Click here to add this to my saved trials
Houston, Texas
Phone: 713-838-2022
?
mi
from
Houston, TX
Click here to add this to my saved trials
Jacksonville, Florida 32216
Phone: 904-281-5757
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
Kansas City, Missouri 64114
Phone: 816-943-0770
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
Kenosha, Wisconsin 53142
Phone: 262-925-1280
?
mi
from
Kenosha, WI
Click here to add this to my saved trials
?
mi
from
Knoxville, TN
Click here to add this to my saved trials
La Mesa, California 91942
Phone: 619-567-1550
?
mi
from
La Mesa, CA
Click here to add this to my saved trials
4551 U.S. 90
Lake City, Florida 32055
Phone: 386-438-8977
?
mi
from
Lake City, FL
Click here to add this to my saved trials
Lake Jackson, Texas 77566
Phone: 979-529-9440
?
mi
from
Lake Jackson, TX
Click here to add this to my saved trials
Lemon Grove, California 91945
Phone: 619-303-6130
?
mi
from
Lemon Grove, CA
Click here to add this to my saved trials
Little Rock, Arkansas 72205
Phone: 501-224-1348
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
Long Beach, California 90806
Phone: 562-304-1742
?
mi
from
Long Beach, CA
Click here to add this to my saved trials
Los Alamitos, California 90720
Phone: 714-827-3668
?
mi
from
Los Alamitos, CA
Click here to add this to my saved trials
Magnolia, Texas 77355
Phone: 832-847-9187
?
mi
from
Magnolia, TX
Click here to add this to my saved trials
Marlborough, Massachusetts 01752
Phone: 508-251-2686
?
mi
from
Marlborough, MA
Click here to add this to my saved trials
Memphis, Tennessee 38119
Phone: 901-843-1045
?
mi
from
Memphis, TN
Click here to add this to my saved trials
Miami, Florida 33243
Phone: 305-589-3125
?
mi
from
Miami, FL
Click here to add this to my saved trials
Miami, Florida 33012
Phone: 305-819-1551
?
mi
from
Miami, FL
Click here to add this to my saved trials
Minneapolis, Minnesota 55402
Phone: 763-744-1140
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
Mobile, Alabama 36608
Phone: 251-414-1984
?
mi
from
Mobile, AL
Click here to add this to my saved trials
Mount Pleasant, South Carolina 29464
Phone: 843-856-3784
?
mi
from
Mount Pleasant, SC
Click here to add this to my saved trials
Nashville, Tennessee 37203
Phone: 615-329-0197
?
mi
from
Nashville, TN
Click here to add this to my saved trials
New Orleans, Louisiana 70119
Phone: 504-821-8158
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
New Orleans, Louisiana 70124
Phone: 504-336-2667
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
Newport Beach, California 92660
Phone: 949-752-7910
?
mi
from
Newport Beach, CA
Click here to add this to my saved trials
465 South Washington Street
North Attleboro, Massachusetts 02760
Phone: 508-316-4268
?
mi
from
North Attleboro, MA
Click here to add this to my saved trials
North Kansas City, Missouri 64116
Phone: 816-691-5373
?
mi
from
North Kansas City, MO
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73102
Phone: 405-831-5905
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Orlando, Florida 32806
Phone: 407-425-5100
?
mi
from
Orlando, FL
Click here to add this to my saved trials
2010 Wilshire Boulevard
Panorama City, California 91402
Phone: 818-532-6880
?
mi
from
Panorama City, CA
Click here to add this to my saved trials
Plymouth, Minnesota 55441
Phone: 763-744-1140
?
mi
from
Plymouth, MN
Click here to add this to my saved trials
Portland, Oregon 97210
Phone: 503-972-9803
?
mi
from
Portland, OR
Click here to add this to my saved trials
Prairie Village, Kansas 66206
Phone: 913-381-7180
?
mi
from
Prairie Village, KS
Click here to add this to my saved trials
Raleigh, North Carolina 27609
Phone: 919-783-4895
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
Rochester, New York 14609
Phone: 585-288-0890
?
mi
from
Rochester, NY
Click here to add this to my saved trials
Saint Louis, Missouri 63141
Phone: 314-567-3377
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
3862 Mexico Road
Saint Peters, Missouri 63303
Phone: 636-387-5100
?
mi
from
Saint Peters, MO
Click here to add this to my saved trials
Salem, Oregon 97301
Phone: 503-540-0100
?
mi
from
Salem, OR
Click here to add this to my saved trials
Salt Lake City, Utah 84107
Phone: 801-288-0607
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
San Antonio, Texas 78229
Phone: 346-704-7660
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Francisco, California 94102
Phone: 415-423-4055
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
Savannah, Georgia 31406
Phone: 912-358-5190
?
mi
from
Savannah, GA
Click here to add this to my saved trials
Springfield, Missouri 65802
Phone: 417-831-2048
?
mi
from
Springfield, MO
Click here to add this to my saved trials
Springfield, Missouri 65807
Phone: 417-841-3672
?
mi
from
Springfield, MO
Click here to add this to my saved trials
Stamford, Connecticut 06905
Phone: 203-914-1903
?
mi
from
Stamford, CT
Click here to add this to my saved trials
Tampa, Florida
Phone: 727-347-8839
?
mi
from
Tampa, FL
Click here to add this to my saved trials
Tomball, Texas 77375
Phone: 281-517-0550
?
mi
from
Tomball, TX
Click here to add this to my saved trials
Virginia Beach, Virginia 23454
Phone: 757-233-9280
?
mi
from
Virginia Beach, VA
Click here to add this to my saved trials
Walnut creek, California 94598
Phone: 925-930-7267
?
mi
from
Walnut creek, CA
Click here to add this to my saved trials
Watertown, Massachusetts 02472
Phone: 617-744-1310
?
mi
from
Watertown, MA
Click here to add this to my saved trials
Wauconda, Illinois 60084
Phone: 847-526-2151
?
mi
from
Wauconda, IL
Click here to add this to my saved trials
West Palm Beach, Florida 33407
Phone: 561-845-0500
?
mi
from
West Palm Beach, FL
Click here to add this to my saved trials
Williamsville, New York 14221
Phone: 716-626-6320
?
mi
from
Williamsville, NY
Click here to add this to my saved trials
1202 Medical Center Drive
Wilmington, North Carolina 28401
Phone: 910-799-5500
?
mi
from
Wilmington, NC
Click here to add this to my saved trials