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Study of NXN 188 for the Treatment of Migraine With Aura

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ClinicalTrials.gov Identifier: NCT00920686
Recruitment Status : Completed
First Posted : June 15, 2009
Results First Posted : August 11, 2014
Last Update Posted : August 11, 2014
Sponsor:
Information provided by (Responsible Party):
NeurAxon Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Migraine With Aura
Interventions Drug: NXN-188
Drug: placebo
Drug: sumatriptan succinate
Enrollment 239
Recruitment Details First Patient Screened: 17 June 2009 Last Patient: 17 December 2009
Pre-assignment Details Subjects meeting eligibility requirements at Screening were randomized at Visit 1 to NXN-188 600 mg, sumatriptan 100 mg or placebo in a 1:1:1 ratio. Randomized subjects were instructed to take study drug when they experienced a mild to moderate migraine headache with aura. Sunbjects not meeting the dosing criteria were discontinued from the study.
Arm/Group Title Placebo NXN-188 600 mg Sumatriptan Succinate 100 mg
Hide Arm/Group Description 3 x 0 mg capsules 3 x 200 mg capsules 1 x 100 mg, 2 x 0 mg capsules
Period Title: Overall Study
Started 82 82 75
Completed 63 60 62
Not Completed 19 22 13
Reason Not Completed
Lost to Follow-up             2             3             1
Study drug dosing criteria not met             17             19             12
Arm/Group Title Placebo NXN-188 600 mg Sumatriptan Succinate 100 mg Total
Hide Arm/Group Description 3 x 0 mg capsules 3 x 200 mg capsules 1 x 100 mg, 2 x 0 mg capsules Total of all reporting groups
Overall Number of Baseline Participants 63 60 62 185
Hide Baseline Analysis Population Description
Safety population
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 63 participants 60 participants 62 participants 185 participants
37.2  (10.90) 41.4  (13.02) 41.2  (12.03) 39.9  (12.10)
[1]
Measure Description: Safety Population - included all subjects who were randomized and dosed with study drug.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants 60 participants 62 participants 185 participants
Female
43
  68.3%
49
  81.7%
9
  14.5%
101
  54.6%
Male
20
  31.7%
11
  18.3%
53
  85.5%
84
  45.4%
[1]
Measure Description: Safety Population - included all subjects who were randomized and dosed with study drug.
Ethnicity (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants 60 participants 62 participants 185 participants
Hispanic or Latino
3
   4.8%
6
  10.0%
3
   4.8%
12
   6.5%
Not Hispanic or Latino
60
  95.2%
54
  90.0%
59
  95.2%
173
  93.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Description: Safety Population - included all subjects who were randomized and dosed with study drug.
Race (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants 60 participants 62 participants 185 participants
American Indian or Alaska Native
1
   1.6%
0
   0.0%
0
   0.0%
1
   0.5%
Asian
0
   0.0%
1
   1.7%
0
   0.0%
1
   0.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   1.7%
0
   0.0%
1
   0.5%
Black or African American
9
  14.3%
10
  16.7%
8
  12.9%
27
  14.6%
White
53
  84.1%
47
  78.3%
54
  87.1%
154
  83.2%
More than one race
0
   0.0%
1
   1.7%
0
   0.0%
1
   0.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Description: Safety Population - included all subjects who were randomized and dosed with study drug.
Weight   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 63 participants 60 participants 62 participants 185 participants
76.6  (16.95) 76.3  (16.61) 74.2  (14.50) 75.7  (16.00)
[1]
Measure Description: Safety Population - included all subjects who were randomized and dosed with study drug.
Height   [1] 
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 63 participants 60 participants 62 participants 185 participants
169.5  (9.01) 167.8  (8.67) 166.3  (8.82) 167.9  (8.89)
[1]
Measure Description: Safety Population - included all subjects who were randomized and dosed with study drug.
Body Mass Index (BMI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 63 participants 60 participants 62 participants 185 participants
26.5  (4.54) 27.0  (5.31) 26.9  (4.48) 26.8  (4.76)
[1]
Measure Description: Safety Population - included all subjects who were randomized and dosed with study drug.
Applicable Aura Symptoms for Qualifying Migraine   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 63 participants 60 participants 62 participants 185 participants
Flickering lights 33 40 39 112
Spots 43 43 43 129
Lines 13 12 11 36
Loss of Vision 22 18 22 62
Pins and needles 11 15 9 35
Numbness 7 10 11 28
Dysphasia (speech disturbance) 7 6 7 20
[1]
Measure Description:

Safety Population - included all subjects who were randomized and dosed with study drug.

Subject may have reported more than one aura symptom.

Type of Migraine   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 63 participants 60 participants 62 participants 185 participants
Without Aura 35 31 29 95
With Aura 61 59 62 182
[1]
Measure Description: Subjects are counted once within each type where at least one migraine is recorded.
Number of Previous Migraines per month   [1] 
Mean (Standard Deviation)
Unit of measure:  Migraines per month
Number Analyzed 63 participants 60 participants 62 participants 185 participants
1.6  (0.59) 1.5  (0.50) 1.5  (0.50) 1.5  (0.53)
[1]
Measure Description: Number of Previous Migraines for each subject was based on the total number of migraine entries reported on the Migraine History CRF.
1.Primary Outcome
Title Time (Hours) to First Use of Rescue Medication
Hide Description [Not Specified]
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set included all those subjects randomized who had dosed with study drug and had at least one (1) post study drug administration observation for headache severity. The Efficacy Evaluable Analysis Set, included all subjects with an imputed (LOCF) HSS at both the 2 hour time point and the 4 hour time point.
Arm/Group Title Placebo NXN-188 Sumatriptan Succinate
Hide Arm/Group Description:
Three capsules containing placebo
600 mg of NXN-188 provided as 3 x 200 mg capsules.
100 mg of sumatriptan succinate provided as 1 capsule containing 100 mg of sumatriptan and 2 capsules containing placebo
Overall Number of Participants Analyzed 63 60 62
Median (Inter-Quartile Range)
Unit of Measure: hours
NA [1] 
(10.1 to NA)
NA [1] 
(6.4 to NA)
NA [1] 
(NA to NA)
[1]
The median time to rescue was not estimable by Kaplan-Meier because an insufficient number of subjects took rescue medication in this data set for any dose group.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, NXN-188
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6407
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
2.Secondary Outcome
Title Headache Relief and Recurrence (Observed Cases)
Hide Description

Headache relief is defined as a ≥ 1-point reduction from baseline in Headache Severity Score. The Headache Severity Score is a four-point scale: 0=no pain; 1 = mild pain; 2 = moderate pain; and 3 = severe pain.

Headache recurrence is defined as any subject that experiences headache relief within 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.

Time Frame 2, 4 and up to 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Number of subjects who experienced headache relief within 4 hours
Arm/Group Title Placebo NXN-188 600 mg Sumatriptan Succinate 100 mg
Hide Arm/Group Description:
3 x 0 mg capsules
3 x 200 mg capsules
1 x 100 mg, 2 x 0 mg capsules
Overall Number of Participants Analyzed 60 62 63
Measure Type: Number
Unit of Measure: percentage of participants
Headache Relief - 2 hours 59.6 62.0 69.1
Headache Relief - 4 hours 73.5 81.1 81.8
Headache Recurrence 5.6 11.1 13.9
3.Secondary Outcome
Title 2 Hours Post Administration - Incidence of Complete Headache Relief, Photophobia, Phonophobia and Nausea
Hide Description

Complete headache relief is defined as reduction of headache severity from moderate or severe to absent.

Presence of Photophobia and Phonophobia measured on a 2-point scale: 0 = absent; 1 = present

Nausea was measured on a 4-point scale: 0 = no nausea; 1 = mild nausea; 2 = moderate nausea; 3 = severe nausea

Time Frame 2 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Number of subjects with headache relief at 2 hours.
Arm/Group Title Placebo NXN-188 600 mg Sumatriptan Succinate 100 mg
Hide Arm/Group Description:
3 x 0 mg capsules
3 x 200 mg capsules
1 x 100 mg, 2 x 0 mg capsules
Overall Number of Participants Analyzed 47 50 55
Measure Type: Number
Unit of Measure: Participants
Complete Headache Relief-Observed Cases 12 6 12
Photophobia-Shift from Baseline (present-absent) 16 14 30
Phonophobia-Shift from Baseline (present-absent) 18 30 22
Nausea Score-Improvement from Baseline 18 17 23
4.Secondary Outcome
Title 4 Hours Post Administration - Incidence of Complete Headache Relief, Photophobia, Phonophobia and Nausea
Hide Description

Complete headache relief is defined as reduction of headache severity from moderate or severe to absent.

Presence of Photophobia and Phonophobia measured on a 2-point scale: 0 = absent; 1 = present

Nausea was measured on a 4-point scale: 0 = no nausea; 1 = mild nausea; 2 = moderate nausea; 3 = severe nausea

Time Frame 4 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Number of subjects with headache relief at 4 hours.
Arm/Group Title Placebo NXN-188 600 mg Sumatriptan Succinate 100 mg
Hide Arm/Group Description:
3 x 0 mg capsules
3 x 200 mg capsules
1 x 100 mg, 2 x 0 mg capsules
Overall Number of Participants Analyzed 49 43 44
Measure Type: Number
Unit of Measure: Participants
Complete Headache Relief-Observed Cases 21 19 22
Photophobia-Shift from Baseline (present-absent) 31 29 30
Phonophobia-Shift from Baseline (present-absent) 25 25 21
Nausea Score-Improvement from Baseline 23 26 29
5.Secondary Outcome
Title 24 Hours Post Administration - Incidence of Complete Headache Relief, Photophobia, Phonophobia and Nausea
Hide Description

Complete headache relief is defined as reduction of headache severity from moderate or severe to absent.

Presence of Photophobia and Phonophobia measured on a 2-point scale: 0 = absent; 1 = present

Nausea was measured on a 4-point scale: 0 = no nausea; 1 = mild nausea; 2 = moderate nausea; 3 = severe nausea

Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Number of subjects with headache relief at 24 hours.
Arm/Group Title Placebo NXN-188 600 mg Sumatriptan Succinate
Hide Arm/Group Description:
3 x 0 mg capsules
3 x 200 mg capsules
1 x 100 mg, 2 x 0 mg capsules
Overall Number of Participants Analyzed 62 56 58
Measure Type: Number
Unit of Measure: Participants
Complete Headache Relief-Observed Cases 37 35 38
Photophobia-Shift from Baseline (present-absent) 51 49 48
Phonophobia-Shift from Baseline (present-absent) 47 41 38
Nausea Score-Improvement from Baseline 39 40 44
Overall Eval-Study Medication-(Good/Excellent) 24 30 35
Time Frame AE data were collected beginning at Randomization until 30 days after study drug administration.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo NXN-188 Sumatriptan Succinate
Hide Arm/Group Description Three placebo capsules were provided. All capsules were taken at the same time. 600 mg NXN-188. Three capsules each containing 200 mg of NXN-188 were provided. All capsules were taken at the same time. 100 mg sumatriptan. Three capsules, one containing 100 mg sumatriptan succinate and two placebo-containing capsules were provided. All capsules were taken at the same time.
All-Cause Mortality
Placebo NXN-188 Sumatriptan Succinate
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo NXN-188 Sumatriptan Succinate
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/63 (0.00%)      0/60 (0.00%)      0/62 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Placebo NXN-188 Sumatriptan Succinate
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/63 (25.40%)      17/60 (28.33%)      13/62 (20.97%)    
Ear and labyrinth disorders       
Hyperacusis * 1  2/63 (3.17%)  2 1/60 (1.67%)  1 1/62 (1.61%)  1
Eye disorders       
Photophobia * 1  2/63 (3.17%)  2 1/60 (1.67%)  1 1/62 (1.61%)  1
Gastrointestinal disorders       
Nausea * 1  4/63 (6.35%)  4 4/60 (6.67%)  4 8/62 (12.90%)  8
Vomiting * 1  3/63 (4.76%)  3 2/60 (3.33%)  2 0/62 (0.00%)  0
Dry Mouth * 1  2/63 (3.17%)  2 0/60 (0.00%)  0 0/62 (0.00%)  0
General disorders       
Fatigue * 1  1/63 (1.59%)  1 2/60 (3.33%)  2 0/62 (0.00%)  0
Investigations       
Blood calcium increased * 1  0/63 (0.00%)  0 2/60 (3.33%)  2 0/62 (0.00%)  0
Nervous system disorders       
Dizziness * 1  1/63 (1.59%)  1 3/60 (5.00%)  3 1/62 (1.61%)  1
Paresthesia * 1  0/63 (0.00%)  0 0/60 (0.00%)  0 2/62 (3.23%)  2
Respiratory, thoracic and mediastinal disorders       
Pharyngolaryngeal Pain * 1  1/63 (1.59%)  1 2/60 (3.33%)  2 0/62 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (11.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Sponsor may request the Investigator or Institution not to publish or disclose information related to the clinical study.
Results Point of Contact
Name/Title: Thomas Lategan, PhD
Organization: NeurAxon, Inc
Phone: 417 673 6697
Responsible Party: NeurAxon Inc.
ClinicalTrials.gov Identifier: NCT00920686     History of Changes
Other Study ID Numbers: NXN-188-203
First Submitted: June 12, 2009
First Posted: June 15, 2009
Results First Submitted: May 8, 2013
Results First Posted: August 11, 2014
Last Update Posted: August 11, 2014