Study of the Safety and Effectiveness of NXN-188 for the Acute Treatment of Migraine Attacks With Aura

• Status: Unknown status
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The following study is being conducted to explore the safety and effectiveness of a new chemical entity called NXN-188 in subjects with a history of migraine with aura. In this study subjects will treat two attacks of migraine with aura during the aura phase - once with placebo and once with NXN-188.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Danish Headache Center
• Collaborator: NeurAxon Inc.

Criteria

Inclusion Criteria:

1. Male or female migraineurs with aura between 18 and 65 years old, inclusive

2. Meets the following criteria for migraine headache with aura:

• Diagnosed with a history of migraine with aura

• Aura consisting of at least one of the following, but no muscle weakness or paralysis:

• Fully reversible visual symptoms (e.g. flickering lights, spots, lines, loss of vision)

• Fully reversible sensory symptoms (e.g. pins and needles, numbness)

• Fully reversible dysphasia (speech disturbance)

• Aura has at least two of the following characteristics:

• Visual symptoms affecting just one side of the field of vision and/or sensory symptoms affecting just one side of the body

• At least one aura symptom develops gradually over more than 5 minutes and/or different aura symptoms occur one after the other over more than 5 minutes

• Each symptom lasts from 5-60 minutes

3. At least one migraine headache with aura every 8-weeks and resulting in moderate to severe pain (on a 4-point categorical scale) within 2 hours of the onset of aura.

4. Migraine pain following aura in at least 75% of occurrences

5. The subject has a body mass index (BMI) within the range of 18 to 32

6. The subject is in general good health as determined by the medical history, physical exam, clinical laboratory tests, vital signs [heart rate (HR) and blood pressure (BP; after a 3-minute sitting period)] and ECG

• ALT cannot be above 1.5x upper limit of normal; creatinine and urea must be within normal limits

7. The subject must be able to speak, read, and understand Danish sufficiently to understand the nature of the study, to provide written informed consent, and complete all study assessments

8. The subject is willing and able to comply with all testing requirements defined in the protocol

9. All females will avoid pregnancy at least 10 days before Visit 1, during the study and up until 3 months after Visit 2

10. Women of childbearing potential must be using a reliable form of contraception. A reliable form of contraception is defined as follows:

• sterilisation (via hysterectomy or bilateral tubal ligation)

• sterilisation of partner

• IUD,

• birth control pills on stable dose for at least three months before Visit 1, and one month after visit 2.

• Medroxyprogesterone acetate (Depo-Provera) or etonogestrel (implanon) active for at least three months prior to the study and with continued administration at intervals sufficient to maintain contraceptive efficacy throughout the study period and at least one month after visit 2. Males must use condoms as contraception.

Exclusion Criteria:

1. Presence of any clinically significant condition that would preclude study participation, as evaluated by the investigator

2. Are pregnant or lactating

3. History of significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, rheumatologic, autoimmune, or metabolic disease

4. Receiving any medication that, in the opinion of the Investigator or designee, may pose a risk of compromising tolerance or compliance

5. Are known to or suspected to be currently abusing alcohol or drugs, or have a history (within the past 12 months) of active alcohol or drug abuse

6. Participation in another drug or biologic study within 30 days preceding randomization into this study or during participation in this study

7. Subjects who are unable or unwilling, in the opinion of the Investigator, to comply with all study procedures and cooperate fully with study center staff