NCT00959751

Phase 2 Study of the Safety and Effectiveness of a Single Oral Dose of NXN-188 for the Treatment of Moderate to Severe Migraine Headache Without Aura

Completed Phase 2 Results posted Last updated 12 July 2014

What this trial tests

Phase 2 trial testing NXN-188 in Migraine Without Aura in 195 participants. Completed in 1 March 2010.

Timeline

1 July 2009

Primary endpoint
1 February 2010

1 March 2010

Quick facts

Lead sponsor	NeurAxon Inc.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	195
Start date	1 July 2009
Primary completion	1 February 2010
Estimated completion	1 March 2010
Sites	4 locations across United States

Drugs / interventions tested

• NXN-188 — full drug profile →
• Placebo

Conditions studied

• Migraine Without Aura — all drugs for Migraine Without Aura →

Sponsor

NeurAxon Inc. — full company profile →

Who can join

Adults 18 to 65, any sex, with Migraine Without Aura. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Headache Relief (Modified LOCF - Efficacy Evaluable Analysis Set)
  Time frame: 2 hours
  Headache relief at 2 hours post administration defined as reduction from Baseline moderate or severe score to mild or none.
• Headache Recurrence (Modified LOCF - Efficacy Evaluable Analysis Set)
  Time frame: 4 hours
  Headache recurrence is defined as any subject that experiences headache relief at the given time point (i.e., 2 hours or 4 hours), who did not use rescue medication and who experienced a worsening of their headache to moderate or severe within 24 hours following study drug administration. The denominator is the number of subjects who experienced headache relief at 2 hours/4 hours.

Sponsor's own description

This is a a multi-center, randomized, double-blind, parallel group, and placebo controlled, two-arm study of a single oral dose of NXN-188 for the treatment of acute migraine headache without aura. Up to 120 migraineurs will be enrolled. Approximately 60 subjects having a headache history of migraine without aura will complete each of the two treatment arms to evaluate NXN-188 600 mg or placebo.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Targeted Nitric Oxide Synthase Inhibitors for Migraine.
   Pradhan AA, Bertels Z, Akerman S. · · 2018 · cited 98× · PMID 29516436 · DOI 10.1007/s13311-018-0614-7