Trial Outcomes & Findings for Study of NXN 188 for the Treatment of Migraine With Aura (NCT NCT00920686)
NCT ID: NCT00920686
Last Updated: 2014-08-11
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
239 participants
Primary outcome timeframe
24 hours
Results posted on
2014-08-11
Participant Flow
First Patient Screened: 17 June 2009 Last Patient: 17 December 2009
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.
Participant milestones
| Measure |
Placebo
3 x 0 mg capsules
|
NXN-188 600 mg
3 x 200 mg capsules
|
Sumatriptan Succinate 100 mg
1 x 100 mg, 2 x 0 mg capsules
|
|---|---|---|---|
|
Overall Study
STARTED
|
82
|
82
|
75
|
|
Overall Study
COMPLETED
|
63
|
60
|
62
|
|
Overall Study
NOT COMPLETED
|
19
|
22
|
13
|
Reasons for withdrawal
| Measure |
Placebo
3 x 0 mg capsules
|
NXN-188 600 mg
3 x 200 mg capsules
|
Sumatriptan Succinate 100 mg
1 x 100 mg, 2 x 0 mg capsules
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
1
|
|
Overall Study
Study drug dosing criteria not met
|
17
|
19
|
12
|
Baseline Characteristics
Study of NXN 188 for the Treatment of Migraine With Aura
Baseline characteristics by cohort
| Measure |
Placebo
n=63 Participants
3 x 0 mg capsules
|
NXN-188 600 mg
n=60 Participants
3 x 200 mg capsules
|
Sumatriptan Succinate 100 mg
n=62 Participants
1 x 100 mg, 2 x 0 mg capsules
|
Total
n=185 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
37.2 years
STANDARD_DEVIATION 10.90 • n=5 Participants
|
41.4 years
STANDARD_DEVIATION 13.02 • n=7 Participants
|
41.2 years
STANDARD_DEVIATION 12.03 • n=5 Participants
|
39.9 years
STANDARD_DEVIATION 12.10 • n=4 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
101 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
84 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
60 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
173 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
53 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
154 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Weight
|
76.6 kg
STANDARD_DEVIATION 16.95 • n=5 Participants
|
76.3 kg
STANDARD_DEVIATION 16.61 • n=7 Participants
|
74.2 kg
STANDARD_DEVIATION 14.50 • n=5 Participants
|
75.7 kg
STANDARD_DEVIATION 16.00 • n=4 Participants
|
|
Height
|
169.5 cm
STANDARD_DEVIATION 9.01 • n=5 Participants
|
167.8 cm
STANDARD_DEVIATION 8.67 • n=7 Participants
|
166.3 cm
STANDARD_DEVIATION 8.82 • n=5 Participants
|
167.9 cm
STANDARD_DEVIATION 8.89 • n=4 Participants
|
|
Body Mass Index (BMI)
|
26.5 kg/m^2
STANDARD_DEVIATION 4.54 • n=5 Participants
|
27.0 kg/m^2
STANDARD_DEVIATION 5.31 • n=7 Participants
|
26.9 kg/m^2
STANDARD_DEVIATION 4.48 • n=5 Participants
|
26.8 kg/m^2
STANDARD_DEVIATION 4.76 • n=4 Participants
|
|
Applicable Aura Symptoms for Qualifying Migraine
Flickering lights
|
33 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
112 Participants
n=4 Participants
|
|
Applicable Aura Symptoms for Qualifying Migraine
Spots
|
43 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
129 Participants
n=4 Participants
|
|
Applicable Aura Symptoms for Qualifying Migraine
Lines
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
|
Applicable Aura Symptoms for Qualifying Migraine
Loss of Vision
|
22 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
|
Applicable Aura Symptoms for Qualifying Migraine
Pins and needles
|
11 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
|
Applicable Aura Symptoms for Qualifying Migraine
Numbness
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Applicable Aura Symptoms for Qualifying Migraine
Dysphasia (speech disturbance)
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Type of Migraine
Without Aura
|
35 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
95 Participants
n=4 Participants
|
|
Type of Migraine
With Aura
|
61 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
182 Participants
n=4 Participants
|
|
Number of Previous Migraines per month
|
1.6 migraines per month
STANDARD_DEVIATION 0.59 • n=5 Participants
|
1.5 migraines per month
STANDARD_DEVIATION 0.50 • n=7 Participants
|
1.5 migraines per month
STANDARD_DEVIATION 0.50 • n=5 Participants
|
1.5 migraines per month
STANDARD_DEVIATION 0.53 • n=4 Participants
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: 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.
Outcome measures
| Measure |
Placebo
n=63 Participants
Three capsules containing placebo
|
NXN-188
n=60 Participants
600 mg of NXN-188 provided as 3 x 200 mg capsules.
|
Sumatriptan Succinate
n=62 Participants
100 mg of sumatriptan succinate provided as 1 capsule containing 100 mg of sumatriptan and 2 capsules containing placebo
|
|---|---|---|---|
|
Time (Hours) to First Use of Rescue Medication
|
NA hours
Interval 10.1 to
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.
|
NA hours
Interval 6.4 to
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.
|
NA hours
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.
|
SECONDARY outcome
Timeframe: 2, 4 and up to 24 hoursPopulation: Number of subjects who experienced headache relief within 4 hours
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.
Outcome measures
| Measure |
Placebo
n=60 Participants
Three capsules containing placebo
|
NXN-188
n=62 Participants
600 mg of NXN-188 provided as 3 x 200 mg capsules.
|
Sumatriptan Succinate
n=63 Participants
100 mg of sumatriptan succinate provided as 1 capsule containing 100 mg of sumatriptan and 2 capsules containing placebo
|
|---|---|---|---|
|
Headache Relief and Recurrence (Observed Cases)
Headache Recurrence
|
5.6 percentage of participants
|
11.1 percentage of participants
|
13.9 percentage of participants
|
|
Headache Relief and Recurrence (Observed Cases)
Headache Relief - 2 hours
|
59.6 percentage of participants
|
62.0 percentage of participants
|
69.1 percentage of participants
|
|
Headache Relief and Recurrence (Observed Cases)
Headache Relief - 4 hours
|
73.5 percentage of participants
|
81.1 percentage of participants
|
81.8 percentage of participants
|
SECONDARY outcome
Timeframe: 2 hoursPopulation: Number of subjects with headache relief at 2 hours.
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
Outcome measures
| Measure |
Placebo
n=47 Participants
Three capsules containing placebo
|
NXN-188
n=50 Participants
600 mg of NXN-188 provided as 3 x 200 mg capsules.
|
Sumatriptan Succinate
n=55 Participants
100 mg of sumatriptan succinate provided as 1 capsule containing 100 mg of sumatriptan and 2 capsules containing placebo
|
|---|---|---|---|
|
2 Hours Post Administration - Incidence of Complete Headache Relief, Photophobia, Phonophobia and Nausea
Complete Headache Relief-Observed Cases
|
12 Participants
|
6 Participants
|
12 Participants
|
|
2 Hours Post Administration - Incidence of Complete Headache Relief, Photophobia, Phonophobia and Nausea
Nausea Score-Improvement from Baseline
|
18 Participants
|
17 Participants
|
23 Participants
|
|
2 Hours Post Administration - Incidence of Complete Headache Relief, Photophobia, Phonophobia and Nausea
Photophobia-Shift from Baseline (present-absent)
|
16 Participants
|
14 Participants
|
30 Participants
|
|
2 Hours Post Administration - Incidence of Complete Headache Relief, Photophobia, Phonophobia and Nausea
Phonophobia-Shift from Baseline (present-absent)
|
18 Participants
|
30 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: 4 hoursPopulation: Number of subjects with headache relief at 4 hours.
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
Outcome measures
| Measure |
Placebo
n=49 Participants
Three capsules containing placebo
|
NXN-188
n=43 Participants
600 mg of NXN-188 provided as 3 x 200 mg capsules.
|
Sumatriptan Succinate
n=44 Participants
100 mg of sumatriptan succinate provided as 1 capsule containing 100 mg of sumatriptan and 2 capsules containing placebo
|
|---|---|---|---|
|
4 Hours Post Administration - Incidence of Complete Headache Relief, Photophobia, Phonophobia and Nausea
Complete Headache Relief-Observed Cases
|
21 Participants
|
19 Participants
|
22 Participants
|
|
4 Hours Post Administration - Incidence of Complete Headache Relief, Photophobia, Phonophobia and Nausea
Photophobia-Shift from Baseline (present-absent)
|
31 Participants
|
29 Participants
|
30 Participants
|
|
4 Hours Post Administration - Incidence of Complete Headache Relief, Photophobia, Phonophobia and Nausea
Phonophobia-Shift from Baseline (present-absent)
|
25 Participants
|
25 Participants
|
21 Participants
|
|
4 Hours Post Administration - Incidence of Complete Headache Relief, Photophobia, Phonophobia and Nausea
Nausea Score-Improvement from Baseline
|
23 Participants
|
26 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: 24 hoursPopulation: Number of subjects with headache relief at 24 hours.
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
Outcome measures
| Measure |
Placebo
n=62 Participants
Three capsules containing placebo
|
NXN-188
n=56 Participants
600 mg of NXN-188 provided as 3 x 200 mg capsules.
|
Sumatriptan Succinate
n=58 Participants
100 mg of sumatriptan succinate provided as 1 capsule containing 100 mg of sumatriptan and 2 capsules containing placebo
|
|---|---|---|---|
|
24 Hours Post Administration - Incidence of Complete Headache Relief, Photophobia, Phonophobia and Nausea
Complete Headache Relief-Observed Cases
|
37 Participants
|
35 Participants
|
38 Participants
|
|
24 Hours Post Administration - Incidence of Complete Headache Relief, Photophobia, Phonophobia and Nausea
Photophobia-Shift from Baseline (present-absent)
|
51 Participants
|
49 Participants
|
48 Participants
|
|
24 Hours Post Administration - Incidence of Complete Headache Relief, Photophobia, Phonophobia and Nausea
Phonophobia-Shift from Baseline (present-absent)
|
47 Participants
|
41 Participants
|
38 Participants
|
|
24 Hours Post Administration - Incidence of Complete Headache Relief, Photophobia, Phonophobia and Nausea
Nausea Score-Improvement from Baseline
|
39 Participants
|
40 Participants
|
44 Participants
|
|
24 Hours Post Administration - Incidence of Complete Headache Relief, Photophobia, Phonophobia and Nausea
Overall Eval-Study Medication-(Good/Excellent)
|
24 Participants
|
30 Participants
|
35 Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
NXN-188
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Sumatriptan Succinate
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=63 participants at risk
Three placebo capsules were provided. All capsules were taken at the same time.
|
NXN-188
n=60 participants at risk
600 mg NXN-188. Three capsules each containing 200 mg of NXN-188 were provided. All capsules were taken at the same time.
|
Sumatriptan Succinate
n=62 participants at risk
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.
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
6.3%
4/63 • Number of events 4 • AE data were collected beginning at Randomization until 30 days after study drug administration.
|
6.7%
4/60 • Number of events 4 • AE data were collected beginning at Randomization until 30 days after study drug administration.
|
12.9%
8/62 • Number of events 8 • AE data were collected beginning at Randomization until 30 days after study drug administration.
|
|
Gastrointestinal disorders
Vomiting
|
4.8%
3/63 • Number of events 3 • AE data were collected beginning at Randomization until 30 days after study drug administration.
|
3.3%
2/60 • Number of events 2 • AE data were collected beginning at Randomization until 30 days after study drug administration.
|
0.00%
0/62 • AE data were collected beginning at Randomization until 30 days after study drug administration.
|
|
Gastrointestinal disorders
Dry Mouth
|
3.2%
2/63 • Number of events 2 • AE data were collected beginning at Randomization until 30 days after study drug administration.
|
0.00%
0/60 • AE data were collected beginning at Randomization until 30 days after study drug administration.
|
0.00%
0/62 • AE data were collected beginning at Randomization until 30 days after study drug administration.
|
|
Nervous system disorders
Dizziness
|
1.6%
1/63 • Number of events 1 • AE data were collected beginning at Randomization until 30 days after study drug administration.
|
5.0%
3/60 • Number of events 3 • AE data were collected beginning at Randomization until 30 days after study drug administration.
|
1.6%
1/62 • Number of events 1 • AE data were collected beginning at Randomization until 30 days after study drug administration.
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/63 • AE data were collected beginning at Randomization until 30 days after study drug administration.
|
0.00%
0/60 • AE data were collected beginning at Randomization until 30 days after study drug administration.
|
3.2%
2/62 • Number of events 2 • AE data were collected beginning at Randomization until 30 days after study drug administration.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
1.6%
1/63 • Number of events 1 • AE data were collected beginning at Randomization until 30 days after study drug administration.
|
3.3%
2/60 • Number of events 2 • AE data were collected beginning at Randomization until 30 days after study drug administration.
|
0.00%
0/62 • AE data were collected beginning at Randomization until 30 days after study drug administration.
|
|
General disorders
Fatigue
|
1.6%
1/63 • Number of events 1 • AE data were collected beginning at Randomization until 30 days after study drug administration.
|
3.3%
2/60 • Number of events 2 • AE data were collected beginning at Randomization until 30 days after study drug administration.
|
0.00%
0/62 • AE data were collected beginning at Randomization until 30 days after study drug administration.
|
|
Investigations
Blood calcium increased
|
0.00%
0/63 • AE data were collected beginning at Randomization until 30 days after study drug administration.
|
3.3%
2/60 • Number of events 2 • AE data were collected beginning at Randomization until 30 days after study drug administration.
|
0.00%
0/62 • AE data were collected beginning at Randomization until 30 days after study drug administration.
|
|
Ear and labyrinth disorders
Hyperacusis
|
3.2%
2/63 • Number of events 2 • AE data were collected beginning at Randomization until 30 days after study drug administration.
|
1.7%
1/60 • Number of events 1 • AE data were collected beginning at Randomization until 30 days after study drug administration.
|
1.6%
1/62 • Number of events 1 • AE data were collected beginning at Randomization until 30 days after study drug administration.
|
|
Eye disorders
Photophobia
|
3.2%
2/63 • Number of events 2 • AE data were collected beginning at Randomization until 30 days after study drug administration.
|
1.7%
1/60 • Number of events 1 • AE data were collected beginning at Randomization until 30 days after study drug administration.
|
1.6%
1/62 • Number of events 1 • AE data were collected beginning at Randomization until 30 days after study drug administration.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor may request the Investigator or Institution not to publish or disclose information related to the clinical study.
- Publication restrictions are in place
Restriction type: OTHER