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

NCT00567086 | Completed Phase 2

• 1 other identifier: NGX424MIG2001
• Study Type: interventional
• Target: 306
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Migraine

Keywords

Migraine

Outcome Measures

Primary Outcomes (1)

• Headache pain intensity, associated symptoms, functional response questionnaires, time to meaningful pain relief.

  4 Hours

Study Arms (4)

A

PLACEBO COMPARATOR

Drug: TEZAMPANEL

B

EXPERIMENTAL

Drug: TEZAMPANEL

C

EXPERIMENTAL

Drug: TEZAMPANEL

D

EXPERIMENTAL

Drug: TEZAMPANEL

Interventions

TEZAMPANEL DRUG

Single Administration of: TEZAMPANEL 40 mg; TEZAMPANEL 70 mg; TEZAMPANEL 100 mg; Placebo (Sterile Water for Injection)

Also known as: NGX424MIG2001

A; B; C; D

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females aged 18 to 65 years, inclusive.
• a. 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• TorreyPines Therapeutics: lead

Study Sites (1)

National Headache Centers

San Francisco, California, 64109, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

tezampanel

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Michael F. Murphy, M.D., Ph.D.

  TorreyPines Therapeutics

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 3, 2007
• First Posted: December 4, 2007
• Study Start: October 1, 2006
• Study Completion: August 1, 2007
• Last Updated: December 4, 2007

Record last verified: 2007-12

Locations

US (1)