Migraine HeadachePhase 2NCT00172094
Safety and Efficacy of NPS 1776 in the Acute Treatment of Migraine Headaches
A Phase 2 study testing NPS 1776 (800 mg) and NPS 1776 (400 mg) in people with Migraine Headache, run by Shire at 22 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Migraine Headache
- What is being tested?
- NPS 1776 (800 mg) and NPS 1776 (400 mg)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 189 participants
- Where
- 22 sitesUnited States
- Study dates
- 31 Dec 2003to 31 Jul 2004
- Phase
- Phase 2
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
Michigan Head-Pain & Neurological Institute
Ann Arbor, Michigan, 48104
Mercy Health Research
Chesterfield, Missouri, 63017
Diamond Headache Clinic
Chicago, Illinois, 60614
Headache Wellness Center
Greensboro, North Carolina, 27401
Houston Headache Clinic
Houston, Texas, 77004
Medical Affiliated Research Center
Huntsville, Alabama, 35801
Clinical Study Centers, LLC
Little Rock, Arkansas, 72205
University of Medicine and Dentistry, New Jersey School of Osteopathic Medicine
Moorestown, New Jersey, 08057
Neuroscience Center of Northern New Jersey
Morristown, New Jersey, 07960
North County Neurological Associates
Oceanside, California, 92056
University Clinical Research, Inc
Pembroke Pines, Florida, 33024
Thomas Jefferson University Hospital/ Jefferson Headache Center
Philadelphia, Pennsylvania, 19107
The Neurology Clinic
Portland, Oregon, 37210
San Francisco Clinical Research Center
San Francisco, California, 94109
Clinical Innovations
Santa Ana, California, 92705
California Medical Clinic for Headache
Santa Monica, California, 90404
Headache Care Center/ Clinvest
Springfield, Missouri, 65804
The New England Center for Headache
Stamford, Connecticut, 06902
Neurology & Neurosurgery Associates of Tacoma, Inc., PS
Tacoma, Washington, 98405
Neurology Ctr. of Ohio
Toledo, Ohio, 43623
MedTrial Boston
Wellesley Hills, Massachusetts, 02481
Piedmont Medical Research Associates
Winston-Salem, North Carolina, 27103
About this study
Official title: A Phase 2 Safety and Efficacy Study of NPS 1776 for the Acute Treatment of Migraine Headaches
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.
Read the 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.
- Conditions
- Migraine Headache
- Being tested
- NPS 1776 (800 mg), PLACEBO, NPS 1776 (400 mg)
- Keywords
- Migraine
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NPS 1776 (800 mg)Drug
Also called NPS 1776
NPS 1776 (800 mg) powder
PLACEBODrug
Placebo in non-carbonated fruit flavored drink (150 ml)
NPS 1776 (400 mg)Drug
Also called NPS1776
NPS1776 in powdered form to be mixed with a non-carbonated fruit flavored drink
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | PLACEBO Receives: Drug: PLACEBO |
| 2 | Experimental | 400 mg 1776 powder Receives: Drug: NPS 1776 (400 mg) |
| 3 | Experimental | 1776 (800 mg) Receives: Drug: NPS 1776 (800 mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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]
Measured: 2 hours post-dose
Secondary outcomes (13)
Pain-free rate at 2 hours post-dose
Measured: 2 hours post-dose
Response rate up to 48 (±24) hours post-dose
Measured: 48 hours post-dose
Recurrence rate of migraine headache within 24 hours post dose
Measured: 24 hours post-dose
Time to recurrence of migraine within 24 hours post-dose
Measured: 24 hours post-dose
Area under the migraine pain curve in visual analogue scale (VAS) 0 4 hours post-dose
Measured: 4 hours post-dose
VAS pain reduction: peak pain reduction in VAS score 0-4 hours post-dose
Measured: 4 hours post-dose
Presence of nausea/vomiting, sensitivity to sound/light, skin sensitivity (cutaneous allodynia), intracranial sensitivity
Measured: 24 hours post-dose
Brush allodynia
Measured: 24 hours post-dose
Muscle tenderness
Measured: 24 hours post-dose
Functional disability
Measured: 24 hours post-dose
Use of rescue medication
Measured: 4 hours post-dose
Time to meaningful pain relief
Measured: 2 hours post-dose
Global Subject Impression (GSI)
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.
- First posted15 Sep 2005 (estimated)
- Study start31 Dec 2003
- Primary completion30 Jun 2004
- Study completion31 Jul 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00172094
- Sponsor's protocol ID
- CL1776-005
- Status last verified
- May 2021
- First submitted
- 9 Sep 2005
- Last updated
- 3 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Safety and Efficacy Study of NPS 1776 for the Acute Treatment of Migraine Headaches
- ClinicalTrials.gov ID
- NCT00172094
- Acronym / sponsor ID
- CL1776-005
- Conditions
- Migraine Headache
- Keywords
- Migraine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 31 Dec 2003 (actual)
- Primary completion
- 30 Jun 2004 (actual)
- Study completion
- 31 Jul 2004 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: PLACEBOPLACEBO |
| 2 | Experimental | Drug: NPS 1776 (400 mg)400 mg 1776 powder |
| 3 | Experimental | Drug: NPS 1776 (800 mg)1776 (800 mg) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NPS 1776 (800 mg)Also: NPS 1776NPS 1776 (800 mg) powder | Drug | 3 |
| PLACEBOPlacebo in non-carbonated fruit flavored drink (150 ml) | Drug | 1 |
| NPS 1776 (400 mg)Also: NPS1776NPS1776 in powdered form to be mixed with a non-carbonated fruit flavored drink | Drug | 2 |
Primary outcome
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
13 secondary outcomes
Pain-free rate at 2 hours post-dose
Time frame: 2 hours post-dose
Response rate up to 48 (±24) hours post-dose
Time frame: 48 hours post-dose
Recurrence rate of migraine headache within 24 hours post dose
Time frame: 24 hours post-dose
Time to recurrence of migraine within 24 hours post-dose
Time frame: 24 hours post-dose
Area under the migraine pain curve in visual analogue scale (VAS) 0 4 hours post-dose
Time frame: 4 hours post-dose
VAS pain reduction: peak pain reduction in VAS score 0-4 hours post-dose
Time frame: 4 hours post-dose
Presence of nausea/vomiting, sensitivity to sound/light, skin sensitivity (cutaneous allodynia), intracranial sensitivity
Time frame: 24 hours post-dose
Brush allodynia
Time frame: 24 hours post-dose
Muscle tenderness
Time frame: 24 hours post-dose
Functional disability
Time frame: 24 hours post-dose
Use of rescue medication
Time frame: 4 hours post-dose
Time to meaningful pain relief
Time frame: 2 hours post-dose
Global Subject Impression (GSI)
Time frame: 24 hours post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2021.
- American Headache Society - Site dedicated to the study and treatment of headaches of all types including but not limited to migraines.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NPS 1776 (800 mg) and NPS 1776 (400 mg) in people with Migraine Headache, run by Shire at 22 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 6 inclusion and 7 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 3 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jun 2021.