MigrainePhase 2NCT00567086
Study to Assess the Safety, Tolerance and Efficacy of Tezampanel in Patients With Acute Migraine
A Phase 2 study testing TEZAMPANEL in people with Migraine, run by TorreyPines Therapeutics at 1 site in United States.
Trial summary
To evaluate the effects of a single sc administration of TEZAMPANEL at one of three different dosage levels compared to placebo, employing traditional measures of efficacy and safety in the treatment of a single episode of acute migraine. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine
- What is being tested?
- TEZAMPANEL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 306 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Aug 2007
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who meet all of the following inclusion criteria at screening should be considered for admission to the study:
- Males and females aged 18 to 65 years, inclusive.
- Females of childbearing potential must not be at risk for pregnancy during the study.
- Patients must meet IHS diagnostic criteria for migraine, with or without aura.
- Patients should have a history of 1 to 6 acute migraine headache attacks per month and 1 migraine headache within the past 30 days.
- Patients should have at least a 1-year history of migraine headaches.
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- Patients should have been ≤ 50 years of age at initial migraine onset.
- Patients must be able to distinguish migraine headaches as discreet headaches from other headaches, such as tension-type headaches. Additionally, patients should experience at least 48 hours of freedom from headaches between migraine attacks.
- Patients must have a complete medical history (including headache history), ECG, and a PE at screening including formal assessments of visual acuity (Snellen chart) and visual field integrity visit.
- Patients must be able to comprehend and satisfactorily comply with the protocol requirements, in the opinion of the investigator.
Who cannot join
- Patients who meet any of the following exclusion criteria at screening will not be eligible for participation in the study.
- Patients who also suffer from concomitant frequent, non-migraine headaches ≥6 days/month or who suffer frequent migraine as defined by an average of >6 attacks per month.
- Patients who fail to present with a migraine attack for treatment within 30 days of screening.
- Patients who have menstrual migraines: migraine attacks occur from days -2 through +3 (Day 1 is the first day of menstruation) of the menses but do not occur the rest of the month.
- Patients who have clinically significant active or unstable systemic, renal, hepatic, gastrointestinal, neurological, endocrine, metabolic, or psychiatric disease as determined by medical history and physical examination. Patients who are breast-feeding are excluded. Patients with a history of cardiovascular illness, such as ischemic stroke, ischemic heart disease, Prinzmetal's angina, and hypertension are excluded.
- Patients who have received any experimental drugs within one month prior to and one month subsequent to screening.
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- Patients who have taken a MAOI within 14 days prior to randomization
- Patients who are allergic or have shown hypersensitivity to compounds with similar pharmacology to TEZAMPANEL.
- Patients who have met the DSM-IV-TR criteria for any significant psychoactive substance use disorder (abuse, dependence, and/or withdrawal) within the past 90 days.
- Patients who have a clinically significant abnormal laboratory test result at screening.
- Patients who have a clinically notable vital sign abnormality at screening.
- Patients will be excluded if 2 consecutive urine drug screenings are positive.
- Patients will be excluded if there is evidence of a visual field disturbance.
- Patients who have participated in a previous TEZAMPANEL (NGX424 or LY293558) study.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Headache Centers
San Francisco, California, 64109
About this study
Official title: A Double-Blind, Placebo-Controlled, Parallel Group Multicenter Study to Assess the Safety, Tolerance and Efficacy of a Single Subcutaneous Dose of TEZAMPANEL in Patients With Acute Migraine
To evaluate the effects of a single sc administration of TEZAMPANEL at one of three different dosage levels compared to placebo, employing traditional measures of efficacy and safety in the treatment of a single episode of acute migraine.
Read the detailed description
Primary:
- Headache relief (headache response) defined as the percentage of patients in each treatment group who experience a decrease in pain from moderate or severe intensity pre-dose (baseline) to mild or no pain 2 hours after study drug administration and prior to use of rescue medication.
Secondary:
- Percentage of patients in each treatment group who are pain-free two hours after study drug administration, prior to the use of any rescue medication
- Sustained headache response rate (percentage of patients in each treatment group with headache response at Hour 2 and no rescue medication or headache recurrence from 2 through 24 hours)
- Sustained pain-free rate (percentage of patients in each treatment group who are pain free at Hour 2 with no rescue medication or headache recurrence from 2 through 48 hours)
- Recurrence rate (percentage of patients in each treatment group with an Hour 2 mild response or pain-free response who subsequently develop a headache rated as moderate to severe in intensity within 2 to 24 hours)
- Relapse rate (percentage of patients in each treatment group with an Hour 2 pain free response who subsequently develop a headache rated as moderate to severe in intensity within 2 to 48 hours
- Conditions
- Migraine
- Being tested
- TEZAMPANEL
- 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.
TEZAMPANELDrug
Also called NGX424MIG2001
Single Administration of: TEZAMPANEL 40 mg; TEZAMPANEL 70 mg; TEZAMPANEL 100 mg; Placebo (Sterile Water for Injection)
| Study group | Role | What they receive |
|---|---|---|
| A | Placebo comparator | Not described Receives: Drug: TEZAMPANEL |
| B | Experimental | Not described Receives: Drug: TEZAMPANEL |
| C | Experimental | Not described Receives: Drug: TEZAMPANEL |
| D | Experimental | Not described Receives: Drug: TEZAMPANEL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache pain intensity, associated symptoms, functional response questionnaires, time to meaningful pain relief.
Measured: 4 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2007 (estimated)
- Study startOct 2006
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- TorreyPines Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Michael F. Murphy, M.D., Ph.D., Study chair, TorreyPines Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00567086
- Sponsor's protocol ID
- NGX424MIG2001
- Status last verified
- Dec 2007
- First submitted
- 3 Dec 2007
- Last updated
- 4 Dec 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled, Parallel Group Multicenter Study to Assess the Safety, Tolerance and Efficacy of a Single Subcutaneous Dose of TEZAMPANEL in Patients With Acute Migraine
- ClinicalTrials.gov ID
- NCT00567086
- Acronym / sponsor ID
- NGX424MIG2001
- Conditions
- Migraine
- Keywords
- Migraine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- TorreyPines TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Study completion
- Aug 2007 (actual)
- First posted
- 4 Dec 2007 (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.
To evaluate the effects of a single sc administration of TEZAMPANEL at one of three different dosage levels compared to placebo, employing traditional measures of efficacy and safety in the treatment of a single episode of acute migraine.
Detailed description
Primary:
- Headache relief (headache response) defined as the percentage of patients in each treatment group who experience a decrease in pain from moderate or severe intensity pre-dose (baseline) to mild or no pain 2 hours after study drug administration and prior to use of rescue medication.
Secondary:
- Percentage of patients in each treatment group who are pain-free two hours after study drug administration, prior to the use of any rescue medication
- Sustained headache response rate (percentage of patients in each treatment group with headache response at Hour 2 and no rescue medication or headache recurrence from 2 through 24 hours)
- Sustained pain-free rate (percentage of patients in each treatment group who are pain free at Hour 2 with no rescue medication or headache recurrence from 2 through 48 hours)
- Recurrence rate (percentage of patients in each treatment group with an Hour 2 mild response or pain-free response who subsequently develop a headache rated as moderate to severe in intensity within 2 to 24 hours)
- Relapse rate (percentage of patients in each treatment group with an Hour 2 pain free response who subsequently develop a headache rated as moderate to severe in intensity within 2 to 48 hours
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | Placebo comparator | Drug: TEZAMPANEL |
| B | Experimental | Drug: TEZAMPANEL |
| C | Experimental | Drug: TEZAMPANEL |
| D | Experimental | Drug: TEZAMPANEL |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients who meet all of the following inclusion criteria at screening should be considered for admission to the study:
Key exclusion criteria (14 listed)
- Patients who meet any of the following exclusion criteria at screening will not be eligible for participation in the study.
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 |
|---|---|---|
| TEZAMPANELAlso: NGX424MIG2001Single Administration of: TEZAMPANEL 40 mg; TEZAMPANEL 70 mg; TEZAMPANEL 100 mg; Placebo (Sterile Water for Injection) | Drug | A, B, C, D |
Primary outcome
Headache pain intensity, associated symptoms, functional response questionnaires, time to meaningful pain relief.
Time frame: 4 Hours
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 4 Dec 2007.
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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.
Michael F. Murphy, M.D., Ph.D. study chair
TorreyPines Therapeutics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TEZAMPANEL in people with Migraine, run by TorreyPines Therapeutics at 1 site 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 10 inclusion and 14 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 4 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Headache pain intensity, associated symptoms, functional response questionnaires, time to meaningful pain relief. (time frame: 4 Hours). 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 4 Dec 2007.