Back to resultsSafety and Efficacy of NPS 1776 in the Acute Treatment of Migraine Headaches
Primary Purpose
Migraine Headache
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
NPS 1776 (800 mg)
PLACEBO
NPS 1776 (400 mg)
Sponsored by
About this trial
This is an interventional treatment trial for Migraine Headache focused on measuring Migraine
Eligibility Criteria
Inclusion Criteria: Diagnosis of migraine for at least a year prior to screening. Experiences 2-10 migraine headaches per month (with at least 24 hours between episodes) and no more than 15 headache days per month in the 3 months prior to screening. Ability and willingness to arrive at the investigator's center within 1 hour (±5 min) of migraine pain onset (defined as pain that is consistent with the subject's usual migraine and is of at least moderate severity). Ability and willingness to abstain from taking medications not allowed by the protocol and to meet phone and check-in criteria. Ability and willingness to undergo a comprehensive urine toxicology screen for both licit and illicit drugs. Ability and willingness to complete a migraine-history diary from screening to treatment with study drug and a migraine-treatment diary from discharge through the remainder of the 24-hour period following study-drug treatment. Exclusion Criteria: Unstable or uncontrolled significant metabolic, hepatic, renal, hematological, pulmonary, gastrointestinal, urological, neurological (except migraine headaches), or psychiatric disorders. Severe or acute cardiovascular or cerebrovascular disease, uncontrolled hypertension, or basilar or hemiplegic migraines. History of hypersensitivity, allergies, or nonresponse to valproic acid. Have taken VPA or other AED in the 30 days prior to screening, or are taking a migraine prophylaxis treatment other than a stable dose of propranolol or tricyclic antidepressant. Migraine attacks that in the investigator's opinion are associated with intractable nausea and/or vomiting. Any acute or chronic condition that in the investigator's opinion would limit the subject's ability to complete and/or participate in this clinical study or would place the subject at increased risk. Have newly started or changed the dose of either feverfew or magnesium (above 200 mg, the amount in common daily supplements) within 3 months prior to screening.
Sites / Locations
- Medical Affiliated Research Center
- Clinical Study Centers, LLC
- North County Neurological Associates
- San Francisco Clinical Research Center
- Clinical Innovations
- California Medical Clinic for Headache
- The New England Center for Headache
- University Clinical Research, Inc
- Diamond Headache Clinic
- MedTrial Boston
- Michigan Head-Pain & Neurological Institute
- Mercy Health Research
- Headache Care Center/ Clinvest
- University of Medicine and Dentistry, New Jersey School of Osteopathic Medicine
- Neuroscience Center of Northern New Jersey
- Headache Wellness Center
- Piedmont Medical Research Associates
- Neurology Ctr. of Ohio
- The Neurology Clinic
- Thomas Jefferson University Hospital/ Jefferson Headache Center
- Houston Headache Clinic
- Neurology & Neurosurgery Associates of Tacoma, Inc., PS
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
1
2
3
Arm Description
PLACEBO
400 mg 1776 powder
1776 (800 mg)
Outcomes
Primary Outcome Measures
The response rate at 2 hours post-dose such that the percentage of subjects whose migraine pain-intensity score is none [0] or mild [1] at 2 hours post-dose, after a baseline pain intensity of moderate [2] or severe [3]
Secondary Outcome Measures
Pain-free rate at 2 hours post-dose
Response rate up to 48 (±24) hours post-dose
Recurrence rate of migraine headache within 24 hours post dose
Time to recurrence of migraine within 24 hours post-dose
Area under the migraine pain curve in visual analogue scale (VAS) 0 4 hours post-dose
VAS pain reduction: peak pain reduction in VAS score 0-4 hours post-dose
Presence of nausea/vomiting, sensitivity to sound/light, skin sensitivity (cutaneous allodynia), intracranial sensitivity
Brush allodynia
Muscle tenderness
Functional disability
Use of rescue medication
Time to meaningful pain relief
Global Subject Impression (GSI)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00172094
Brief Title
Safety and Efficacy of NPS 1776 in the Acute Treatment of Migraine Headaches
Official Title
A Phase 2 Safety and Efficacy Study of NPS 1776 for the Acute Treatment of Migraine Headaches
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
December 31, 2003 (Actual)
Primary Completion Date
June 30, 2004 (Actual)
Study Completion Date
July 31, 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shire
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study was to evaluate the effectiveness and safety of a single oral dose of NPS 1776 in the acute treatment of migraine pain and associated symptoms.
Detailed Description
Migraine, the most common cause of recurrent severe or disabling headache, is diagnosed on the basis of a clinical history of intermittent headache with autonomic, constitutional, and neurologic disturbances.
Many antiepileptic drugs (AEDs) have demonstrated efficacy as acute and/or prophylaxis therapy for migraine, even though the mechanism of action of the various AEDs is poorly understood.
NPS 1776, isovaleramide, is a neutral aliphatic amide. The mechanism by which NPS 1776 exerts its therapeutic actions in nonclinical animal models of disease is unclear. The same is true for many antiepileptics on the market today. NPS 1776 does not appear to bind directly to various CNS receptor centers, although it shows a broad range of anticonvulsant activity in multiple animal models of seizures. This broad profile of anticonvulsant activity is similar to that of valproic acid (VPA), and may also predict NPS 1776 efficacy in the treatment of migraine.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Headache
Keywords
Migraine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
189 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Placebo Comparator
Arm Description
PLACEBO
Arm Title
2
Arm Type
Experimental
Arm Description
400 mg 1776 powder
Arm Title
3
Arm Type
Experimental
Arm Description
1776 (800 mg)
Intervention Type
Drug
Intervention Name(s)
NPS 1776 (800 mg)
Other Intervention Name(s)
NPS 1776
Intervention Description
NPS 1776 (800 mg) powder
Intervention Type
Drug
Intervention Name(s)
PLACEBO
Intervention Description
Placebo in non-carbonated fruit flavored drink (150 ml)
Intervention Type
Drug
Intervention Name(s)
NPS 1776 (400 mg)
Other Intervention Name(s)
NPS1776
Intervention Description
NPS1776 in powdered form to be mixed with a non-carbonated fruit flavored drink
Primary Outcome Measure Information:
Title
The response rate at 2 hours post-dose such that the percentage of subjects whose migraine pain-intensity score is none [0] or mild [1] at 2 hours post-dose, after a baseline pain intensity of moderate [2] or severe [3]
Time Frame
2 hours post-dose
Secondary Outcome Measure Information:
Title
Pain-free rate at 2 hours post-dose
Time Frame
2 hours post-dose
Title
Response rate up to 48 (±24) hours post-dose
Time Frame
48 hours post-dose
Title
Recurrence rate of migraine headache within 24 hours post dose
Time Frame
24 hours post-dose
Title
Time to recurrence of migraine within 24 hours post-dose
Time Frame
24 hours post-dose
Title
Area under the migraine pain curve in visual analogue scale (VAS) 0 4 hours post-dose
Time Frame
4 hours post-dose
Title
VAS pain reduction: peak pain reduction in VAS score 0-4 hours post-dose
Time Frame
4 hours post-dose
Title
Presence of nausea/vomiting, sensitivity to sound/light, skin sensitivity (cutaneous allodynia), intracranial sensitivity
Time Frame
24 hours post-dose
Title
Brush allodynia
Time Frame
24 hours post-dose
Title
Muscle tenderness
Time Frame
24 hours post-dose
Title
Functional disability
Time Frame
24 hours post-dose
Title
Use of rescue medication
Time Frame
4 hours post-dose
Title
Time to meaningful pain relief
Time Frame
2 hours post-dose
Title
Global Subject Impression (GSI)
Time Frame
24 hours post-dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of migraine for at least a year prior to screening.
Experiences 2-10 migraine headaches per month (with at least 24 hours between episodes) and no more than 15 headache days per month in the 3 months prior to screening.
Ability and willingness to arrive at the investigator's center within 1 hour (±5 min) of migraine pain onset (defined as pain that is consistent with the subject's usual migraine and is of at least moderate severity).
Ability and willingness to abstain from taking medications not allowed by the protocol and to meet phone and check-in criteria.
Ability and willingness to undergo a comprehensive urine toxicology screen for both licit and illicit drugs.
Ability and willingness to complete a migraine-history diary from screening to treatment with study drug and a migraine-treatment diary from discharge through the remainder of the 24-hour period following study-drug treatment.
Exclusion Criteria:
Unstable or uncontrolled significant metabolic, hepatic, renal, hematological, pulmonary, gastrointestinal, urological, neurological (except migraine headaches), or psychiatric disorders.
Severe or acute cardiovascular or cerebrovascular disease, uncontrolled hypertension, or basilar or hemiplegic migraines.
History of hypersensitivity, allergies, or nonresponse to valproic acid.
Have taken VPA or other AED in the 30 days prior to screening, or are taking a migraine prophylaxis treatment other than a stable dose of propranolol or tricyclic antidepressant.
Migraine attacks that in the investigator's opinion are associated with intractable nausea and/or vomiting.
Any acute or chronic condition that in the investigator's opinion would limit the subject's ability to complete and/or participate in this clinical study or would place the subject at increased risk.
Have newly started or changed the dose of either feverfew or magnesium (above 200 mg, the amount in common daily supplements) within 3 months prior to screening.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
Medical Affiliated Research Center
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Clinical Study Centers, LLC
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
North County Neurological Associates
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
San Francisco Clinical Research Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Facility Name
Clinical Innovations
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
California Medical Clinic for Headache
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
The New England Center for Headache
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06902
Country
United States
Facility Name
University Clinical Research, Inc
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Diamond Headache Clinic
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614
Country
United States
Facility Name
MedTrial Boston
City
Wellesley Hills
State/Province
Massachusetts
ZIP/Postal Code
02481
Country
United States
Facility Name
Michigan Head-Pain & Neurological Institute
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104
Country
United States
Facility Name
Mercy Health Research
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Headache Care Center/ Clinvest
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
University of Medicine and Dentistry, New Jersey School of Osteopathic Medicine
City
Moorestown
State/Province
New Jersey
ZIP/Postal Code
08057
Country
United States
Facility Name
Neuroscience Center of Northern New Jersey
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
Headache Wellness Center
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Facility Name
Piedmont Medical Research Associates
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Neurology Ctr. of Ohio
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
Facility Name
The Neurology Clinic
City
Portland
State/Province
Oregon
ZIP/Postal Code
37210
Country
United States
Facility Name
Thomas Jefferson University Hospital/ Jefferson Headache Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Houston Headache Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Neurology & Neurosurgery Associates of Tacoma, Inc., PS
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.ahsnet.org
Description
American Headache Society - Site dedicated to the study and treatment of headaches of all types including but not limited to migraines.
Learn more about this trial
Safety and Efficacy of NPS 1776 in the Acute Treatment of Migraine Headaches
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