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Study of the Safety and Effectiveness of NXN-188 for the Treatment of Migraine Headache Without Aura

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ClinicalTrials.gov Identifier: NCT00959751
Recruitment Status : Completed
First Posted : August 17, 2009
Results First Posted : July 11, 2014
Last Update Posted : July 23, 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 Without Aura
Interventions Drug: NXN-188
Drug: Placebo
Enrollment 195
Recruitment Details Study Period - 6 months. First subject screened 28 July 2009, Last subject completed the study 9 February 2010.
Pre-assignment Details  
Arm/Group Title Placebo NXN-188 600 mg
Hide Arm/Group Description 3 x capsules, PRN 3 x 200 mg capsules, PRN
Period Title: Overall Study
Started 97 98
Completed 88 86
Not Completed 9 12
Reason Not Completed
Lost to Follow-up             2             3
Consent Withdrawn             0             1
Non-compliance to Study Procedures             0             1
No migraine headache without aura             7             7
Arm/Group Title NXN-188 Placebo Total
Hide Arm/Group Description 3 x 200 mg capsules 3 x 0 mg capsules Total of all reporting groups
Overall Number of Baseline Participants 86 88 174
Hide Baseline Analysis Population Description
Of the 195 subjects randomized, 174 subjects received study drug: the 174 subjects constitute the Safety Population.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 86 participants 88 participants 174 participants
40.2  (12.34) 38.4  (12.63) 39.3  (12.49)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 86 participants 88 participants 174 participants
Female
66
  76.7%
74
  84.1%
140
  80.5%
Male
20
  23.3%
14
  15.9%
34
  19.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 86 participants 88 participants 174 participants
Hispanic or Latino
21
  24.4%
13
  14.8%
34
  19.5%
Not Hispanic or Latino
65
  75.6%
75
  85.2%
140
  80.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 86 participants 88 participants 174 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   1.1%
1
   0.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
13
  15.1%
19
  21.6%
32
  18.4%
White
72
  83.7%
66
  75.0%
138
  79.3%
More than one race
1
   1.2%
2
   2.3%
3
   1.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 86 participants 88 participants 174 participants
74.94  (14.695) 74.74  (17.066) 74.84  (15.893)
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 86 participants 88 participants 174 participants
168.33  (8.502) 165.91  (9.960) 167.10  (9.321)
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 86 participants 88 participants 174 participants
26.2  (4.09) 27.2  (5.28) 26.7  (4.74)
Type of Migraine   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 86 participants 88 participants 174 participants
Without Aura 86 88 174
With Aura 0 0 0
[1]
Measure Description: Subjects are counted once within each type where at least one migraine is recorded.
Number of Previous Migraines   [1] 
Mean (Standard Deviation)
Unit of measure:  Migraine episodes
Number Analyzed 86 participants 88 participants 174 participants
1.1  (0.30) 1.1  (0.23) 1.1  (0.27)
[1]
Measure Description: Previous Migraines for each subject was based on the total number of migraine entries reported on the Migraine History CRF
1.Primary Outcome
Title Headache Relief (Modified LOCF - Efficacy Evaluable Analysis Set)
Hide Description Headache relief at 2 hours post administration defined as reduction from Baseline moderate or severe score to mild or none.
Time Frame 2 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Modified LOCF - Efficacy Evaluable Analysis Set
Arm/Group Title NXN-188 600 mg Placebo
Hide Arm/Group Description:
3 x 200 mg capsules, PRN
3 x 0 mg capsules, PRN
Overall Number of Participants Analyzed 80 79
Measure Type: Number
Unit of Measure: Participants
42 30
2.Primary Outcome
Title Headache Recurrence (Modified LOCF - Efficacy Evaluable Analysis Set)
Hide Description 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.
Time Frame 4 hours
Hide Outcome Measure Data
Hide Analysis Population Description
30 and 42 placebo and NXN-188 subjects, respectivley, experienced headache relief at 2 hours. 41 and 55 placebo and NXN-188 subjects, respectively, experienced headache relief at 4 hours.
Arm/Group Title NXN-188 600 mg Placebo
Hide Arm/Group Description:
3 x 200 mg capsules, PRN
3 x 0 mg capsules, PRN
Overall Number of Participants Analyzed 80 79
Measure Type: Number
Unit of Measure: Participants
Headache Recurrence - 2 hours 3 6
Headache Recurrence - 4 hours 2 4
3.Secondary Outcome
Title Headache Relief Based on a 2-Point Reduction From Baseline (Modified LOCF - Efficacy Evaluable Analysis Set)
Hide Description The Headache Severity Score (HSS) assessment was recorded in the diary by the subject and used the following categories: 0 = no pain; 1 = mild pain; 2 = moderate pain; and, 3 = severe pain
Time Frame 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NXN-188 600 mg Placebo
Hide Arm/Group Description:
3 x 200 mg capsules, PRN
3 x 0 mg capsules, PRN
Overall Number of Participants Analyzed 80 79
Measure Type: Number
Unit of Measure: Participants
Headache Relief - 2 hours 28 17
Headache Relief - 4 hours 45 26
Headache Relief - 24 hours 59 42
Headache Relief - 72 hours 54 47
4.Secondary Outcome
Title Headache Relief Based on a 1-Point Reduction From Baseline (Modified LOCF - Efficacy Evaluable Analysis Set)
Hide Description The Headache Severity Score (HSS) assessment was recorded in the diary by the subject and used the following categories: 0 = no pain; 1 = mild pain; 2 = moderate pain; and, 3 = severe pain
Time Frame 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NXN-188 600 mg Placebo
Hide Arm/Group Description:
3 x 200 mg capsules, PRN
3 x 0 mg capsules, PRN
Overall Number of Participants Analyzed 80 79
Measure Type: Number
Unit of Measure: Participants
Headache Relief - 2 hours 52 40
Headache Relief - 4 hours 63 46
Headache Relief - 24 hours 64 52
Headache Relief - 72 hours 62 52
5.Secondary Outcome
Title Complete Headache Relief (Efficacy Evaluable Analysis Set)
Hide Description [Not Specified]
Time Frame 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NXN-188 600 mg Placebo
Hide Arm/Group Description:
3 x 200 mg capsules, PRN
3 x 0 mg capsules, PRN
Overall Number of Participants Analyzed 80 79
Measure Type: Number
Unit of Measure: Participants
Complete Headache Relief - 2 hours 19 9
Complete Headache Relief - 4 hours 35 19
Complete Headache Relief - 24 hours 56 36
Complete Headache Relief - 72 hours 54 43
6.Secondary Outcome
Title Time (Hours) to First Use of Rescue Medication (Full Analysis Set)
Hide Description Subjects who do not require rescue medication are censored at the time of their last diary assessment completed up to 24 hours following study drug administration.
Time Frame 24 Hours
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set includes all subjects in the Safety Population who had at least one post-dose observation for headache severity recorded in his or her diary.
Arm/Group Title NXN-188 600 mg Placebo
Hide Arm/Group Description:
3 x 200 mg capsules, PRN
3 x 0 mg capsules, PRN
Overall Number of Participants Analyzed 86 88
Median (95% Confidence Interval)
Unit of Measure: Participants who required rescue
NA [1] 
(NA to NA)
NA [2] 
(19.6 to NA)
[1]
Median times not estimable by Kaplan-Meier because too few subjects required rescue medication within 25 hrs
[2]
Median times not estimable by Kaplan-Meier because too few subjects required rescue medication within 24 hrs
7.Secondary Outcome
Title Overall Evaluation of Study Medication at 24 Hours Post Administration (Full Analysis Set)
Hide Description Overall evaluation of the study drug was measured with a 4-point scale at 24 hours and used the following categories: 1 = Poor; 2 = Moderate; 3 = Good; and,4 = Excellent
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set includes all subjects in the Safety Population who had at least one post-dose observation for headache severity recorded in his or her diary.
Arm/Group Title NXN-188 600 mg Placebo
Hide Arm/Group Description:
3 x 200 mg capsules, PRN
3 x 0 mg capsules, PRN
Overall Number of Participants Analyzed 86 88
Measure Type: Number
Unit of Measure: Participants
1 = Poor 20 37
2 = Moderate 22 19
3 = Good 26 21
4 = Excellent 18 11
8.Post-Hoc Outcome
Title Sustained Complete Headache Relief (Efficacy Evaluable Analysis Set)
Hide Description Exploratory Post-hoc Analysis: Sustained complete headache relief is defined as a reduction in headache severity from moderate or severe to absent over all indicated time points.
Time Frame 2 - 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy Evaluable Analysis Set includes all subjects in the Full Analysis Set with an observed or imputed HSS (using rules predefined in the Statistical Analysis Plan [SAP]) at both the 2-hour time point and the 4-hour time point when using the modified LOCF approach
Arm/Group Title NXN-188 600 mg Placebo
Hide Arm/Group Description:
3 x 200 mg capsules, PRN
3 x 0 mg capsules, PRN
Overall Number of Participants Analyzed 80 79
Measure Type: Number
Unit of Measure: Participants
2-24 hours 17 8
4-24 hours 32 18
2-48 hours 16 8
4-48 hours 29 18
Time Frame Adverse event data were collected throughout the study beginning with the dosing of study drug and ending 15 days (± 2 days) p.a.
Adverse Event Reporting Description All AE summaries were restricted to TEAEs, which were defined as those AEs that occurred after dosing and those existing AEs that worsened during the study.
 
Arm/Group Title NXN-188 600 mg Placebo
Hide Arm/Group Description 3 x 200 mg capsules, PRN 3 x 0 mg capsules, PRN
All-Cause Mortality
NXN-188 600 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
NXN-188 600 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/86 (0.00%)      1/88 (1.14%)    
Nervous system disorders     
Syncope  1  0/86 (0.00%)  0 1/88 (1.14%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
NXN-188 600 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   17/86 (19.77%)      13/88 (14.77%)    
Gastrointestinal disorders     
Nausea  1  4/86 (4.65%)  4 7/88 (7.95%)  7
Abdominal pain upper  1  2/86 (2.33%)  2 1/88 (1.14%)  1
General disorders     
Chills  1  2/86 (2.33%)  2 0/88 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Sensation of heaviness  1  2/86 (2.33%)  3 0/88 (0.00%)  0
Nervous system disorders     
Dizziness  1  5/86 (5.81%)  8 3/88 (3.41%)  3
Somnolence  1  1/86 (1.16%)  1 2/88 (2.27%)  2
Renal and urinary disorders     
Proteinuria  1  2/86 (2.33%)  2 0/88 (0.00%)  0
Indicates events were collected by 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 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: NCT00959751     History of Changes
Other Study ID Numbers: NXN-188-204
First Submitted: August 14, 2009
First Posted: August 17, 2009
Results First Submitted: May 8, 2013
Results First Posted: July 11, 2014
Last Update Posted: July 23, 2014