NCT00172094

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
189

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2003

Shorter than P25 for phase_2

Geographic Reach
1 country

22 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

December 31, 2003

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2004

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

June 3, 2021

Status Verified

May 1, 2021

Enrollment Period

6 months

First QC Date

September 9, 2005

Last Update Submit

May 30, 2021

Conditions

Migraine Headache

Keywords

Migraine

Outcome Measures

Primary Outcomes (1)

  • 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]

    2 hours post-dose

Secondary Outcomes (13)

  • Pain-free rate at 2 hours post-dose

    2 hours post-dose

  • Response rate up to 48 (±24) hours post-dose

    48 hours post-dose

  • Recurrence rate of migraine headache within 24 hours post dose

    24 hours post-dose

  • Time to recurrence of migraine within 24 hours post-dose

    24 hours post-dose

  • Area under the migraine pain curve in visual analogue scale (VAS) 0 4 hours post-dose

    4 hours post-dose

  • +8 more secondary outcomes

Study Arms (3)

1

PLACEBO COMPARATOR

PLACEBO

Drug: PLACEBO

2

EXPERIMENTAL

400 mg 1776 powder

Drug: NPS 1776 (400 mg)

3

EXPERIMENTAL

1776 (800 mg)

Drug: NPS 1776 (800 mg)

Interventions

NPS 1776 (800 mg)DRUG

NPS 1776 (800 mg) powder

Also known as: NPS 1776
3
PLACEBODRUG

Placebo in non-carbonated fruit flavored drink (150 ml)

1
NPS 1776 (400 mg)DRUG

NPS1776 in powdered form to be mixed with a non-carbonated fruit flavored drink

Also known as: NPS1776
2

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

Medical Affiliated Research Center

Huntsville, Alabama, 35801, United States

Location

Clinical Study Centers, LLC

Little Rock, Arkansas, 72205, United States

Location

North County Neurological Associates

Oceanside, California, 92056, United States

Location

San Francisco Clinical Research Center

San Francisco, California, 94109, United States

Location

Clinical Innovations

Santa Ana, California, 92705, United States

Location

California Medical Clinic for Headache

Santa Monica, California, 90404, United States

Location

The New England Center for Headache

Stamford, Connecticut, 06902, United States

Location

University Clinical Research, Inc

Pembroke Pines, Florida, 33024, United States

Location

Diamond Headache Clinic

Chicago, Illinois, 60614, United States

Location

MedTrial Boston

Wellesley Hills, Massachusetts, 02481, United States

Location

Michigan Head-Pain & Neurological Institute

Ann Arbor, Michigan, 48104, United States

Location

Mercy Health Research

Chesterfield, Missouri, 63017, United States

Location

Headache Care Center/ Clinvest

Springfield, Missouri, 65804, United States

Location

University of Medicine and Dentistry, New Jersey School of Osteopathic Medicine

Moorestown, New Jersey, 08057, United States

Location

Neuroscience Center of Northern New Jersey

Morristown, New Jersey, 07960, United States

Location

Headache Wellness Center

Greensboro, North Carolina, 27401, United States

Location

Piedmont Medical Research Associates

Winston-Salem, North Carolina, 27103, United States

Location

Neurology Ctr. of Ohio

Toledo, Ohio, 43623, United States

Location

The Neurology Clinic

Portland, Oregon, 37210, United States

Location

Thomas Jefferson University Hospital/ Jefferson Headache Center

Philadelphia, Pennsylvania, 19107, United States

Location

Houston Headache Clinic

Houston, Texas, 77004, United States

Location

Neurology & Neurosurgery Associates of Tacoma, Inc., PS

Tacoma, Washington, 98405, United States

Location

Related Links

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Study Director

    Takeda

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 15, 2005

Study Start

December 31, 2003

Primary Completion

June 30, 2004

Study Completion

July 31, 2004

Last Updated

June 3, 2021

Record last verified: 2021-05

Locations

US(22)