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Study to Assess the Safety, Tolerance and Efficacy of Tezampanel in Patients With Acute Migraine

This study has been completed.
Sponsor:
Information provided by:
TorreyPines Therapeutics
ClinicalTrials.gov Identifier:
NCT00567086
First received: December 3, 2007
Last updated: NA
Last verified: December 2007
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Migraine
Drug: TEZAMPANEL
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by TorreyPines Therapeutics:

Primary Outcome Measures:
  • Headache pain intensity, associated symptoms, functional response questionnaires, time to meaningful pain relief. [ Time Frame: 4 Hours ] [ Designated as safety issue: No ]

Enrollment: 306
Study Start Date: October 2006
Study Completion Date: August 2007
Arms Assigned Interventions
Placebo Comparator: A Drug: TEZAMPANEL
Single Administration of: TEZAMPANEL 40 mg; TEZAMPANEL 70 mg; TEZAMPANEL 100 mg; Placebo (Sterile Water for Injection)
Other Name: NGX424MIG2001
Experimental: B Drug: TEZAMPANEL
Single Administration of: TEZAMPANEL 40 mg; TEZAMPANEL 70 mg; TEZAMPANEL 100 mg; Placebo (Sterile Water for Injection)
Other Name: NGX424MIG2001
Experimental: C Drug: TEZAMPANEL
Single Administration of: TEZAMPANEL 40 mg; TEZAMPANEL 70 mg; TEZAMPANEL 100 mg; Placebo (Sterile Water for Injection)
Other Name: NGX424MIG2001
Experimental: D Drug: TEZAMPANEL
Single Administration of: TEZAMPANEL 40 mg; TEZAMPANEL 70 mg; TEZAMPANEL 100 mg; Placebo (Sterile Water for Injection)
Other Name: NGX424MIG2001

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
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who meet all of the following inclusion criteria at screening should be considered for admission to the study:

    1. Males and females aged 18 to 65 years, inclusive.

      a. Females of childbearing potential must not be at risk for pregnancy during the study.

    2. Patients must meet IHS diagnostic criteria for migraine, with or without aura.
    3. Patients should have a history of 1 to 6 acute migraine headache attacks per month and 1 migraine headache within the past 30 days.
    4. Patients should have at least a 1-year history of migraine headaches.
    5. Patients should have been ≤ 50 years of age at initial migraine onset.
    6. 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.
    7. 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.
    8. Patients must be able to comprehend and satisfactorily comply with the protocol requirements, in the opinion of the investigator.

Exclusion Criteria:

  • Patients who meet any of the following exclusion criteria at screening will not be eligible for participation in the study.

    1. 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.
    2. Patients who fail to present with a migraine attack for treatment within 30 days of screening.
    3. 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.
    4. 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.
    5. Patients who have received any experimental drugs within one month prior to and one month subsequent to screening.
    6. Patients who have taken a MAOI within 14 days prior to randomization
    7. Patients who are allergic or have shown hypersensitivity to compounds with similar pharmacology to TEZAMPANEL.
    8. 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.
    9. Patients who have a clinically significant abnormal laboratory test result at screening.
    10. Patients who have a clinically notable vital sign abnormality at screening.
    11. Patients will be excluded if 2 consecutive urine drug screenings are positive.
    12. Patients will be excluded if there is evidence of a visual field disturbance.
    13. Patients who have participated in a previous TEZAMPANEL (NGX424 or LY293558) study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00567086

Locations
United States, California
National Headache Centers
San Francisco, California, United States, 64109
Sponsors and Collaborators
TorreyPines Therapeutics
Investigators
Study Chair: Michael F. Murphy, M.D., Ph.D. TorreyPines Therapeutics
  More Information

No publications provided

Responsible Party: Susan Mellberg, TorreyPines Therapeutics
ClinicalTrials.gov Identifier: NCT00567086     History of Changes
Other Study ID Numbers: NGX424MIG2001
Study First Received: December 3, 2007
Last Updated: December 3, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by TorreyPines Therapeutics:
Migraine

Additional relevant MeSH terms:
Migraine Disorders
Brain Diseases
Central Nervous System Diseases
Headache Disorders
Headache Disorders, Primary
Nervous System Diseases

ClinicalTrials.gov processed this record on November 27, 2014