Trial Outcomes & Findings for Nuedexta for the Prevention and Modification of Disease Progression in Episodic Migraine (NCT NCT02176018)
NCT ID: NCT02176018
Last Updated: 2018-04-03
Results Overview
The average number of headache days at treatment period months 1, 2, and 3 (28 day periods for each month) for the Nuedexta arm and the Placebo arm. Headache days were defined as any patient reported head pain during the prior 24 hour period.
COMPLETED
PHASE2
76 participants
Treatment Month 1, Treatment Month 2, and End of Treatment Period Month 3 (Day 116)
2018-04-03
Participant Flow
A total of 90 participants were screened, 14 failed to meet the inclusion criteria and were screen failed. 76 participants were enrolled into a 28-day run-in period. 31 were excluded from the study prior to being assigned to a treatment arm, due to failure to meet inclusion criteria. A total of 45 participants were randomized.
Participant milestones
| Measure |
Nuedexta
One capsule will be taken (dextromethorphan HB and quinidine sulfate, 20 mg/10 mg) daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months.
Dextromethorphan and quinidine
|
Placebo
One capsule will be taken of placebo to match daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months.
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
23
|
|
Overall Study
COMPLETED
|
17
|
17
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
Reasons for withdrawal
| Measure |
Nuedexta
One capsule will be taken (dextromethorphan HB and quinidine sulfate, 20 mg/10 mg) daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months.
Dextromethorphan and quinidine
|
Placebo
One capsule will be taken of placebo to match daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months.
Placebo
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
Baseline Characteristics
Randomized subjects were required to complete at least one full month of treatment period to be included in the analyses. These criteria excluded 6 subjects in the Placebo arm and 2 subjects in the Nuedexta arm from the analysis data sets. Thus, 37 participants were analyzed for this Baseline Measurement.
Baseline characteristics by cohort
| Measure |
Nuedexta
n=22 Participants
One capsule will be taken (dextromethorphan HB and quinidine sulfate, 20 mg/10 mg) daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months.
Dextromethorphan and quinidine
|
Placebo
n=23 Participants
One capsule will be taken of placebo to match daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months.
Placebo
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.23 years
STANDARD_DEVIATION 9.62 • n=22 Participants
|
44.17 years
STANDARD_DEVIATION 11.62 • n=23 Participants
|
44.69 years
STANDARD_DEVIATION 10.58 • n=45 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=22 Participants
|
19 Participants
n=23 Participants
|
40 Participants
n=45 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=22 Participants
|
4 Participants
n=23 Participants
|
5 Participants
n=45 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=45 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=22 Participants
|
23 Participants
n=23 Participants
|
45 Participants
n=45 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=45 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=45 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=45 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=45 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=22 Participants
|
2 Participants
n=23 Participants
|
3 Participants
n=45 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=22 Participants
|
21 Participants
n=23 Participants
|
42 Participants
n=45 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=45 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=45 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=22 Participants
|
23 participants
n=23 Participants
|
45 participants
n=45 Participants
|
|
Headache Days
|
10.5 Number of Headache Days
STANDARD_DEVIATION 2.5 • n=20 Participants • Randomized subjects were required to complete at least one full month of treatment period to be included in the analyses. These criteria excluded 6 subjects in the Placebo arm and 2 subjects in the Nuedexta arm from the analysis data sets. Thus, 37 participants were analyzed for this Baseline Measurement.
|
10.29 Number of Headache Days
STANDARD_DEVIATION 5.28 • n=17 Participants • Randomized subjects were required to complete at least one full month of treatment period to be included in the analyses. These criteria excluded 6 subjects in the Placebo arm and 2 subjects in the Nuedexta arm from the analysis data sets. Thus, 37 participants were analyzed for this Baseline Measurement.
|
10.4 Number of Headache Days
STANDARD_DEVIATION 3.96 • n=37 Participants • Randomized subjects were required to complete at least one full month of treatment period to be included in the analyses. These criteria excluded 6 subjects in the Placebo arm and 2 subjects in the Nuedexta arm from the analysis data sets. Thus, 37 participants were analyzed for this Baseline Measurement.
|
|
Migraine Days
|
9 Number of Migraine days
STANDARD_DEVIATION 2.15 • n=20 Participants • Randomized subjects were required to complete at least one full month of treatment period to be included in the analyses. These criteria excluded 6 subjects in the Placebo arm and 2 subjects in the Nuedexta arm from the analysis data sets. Thus, 37 participants were analyzed for this Baseline Measurement.
|
8 Number of Migraine days
STANDARD_DEVIATION 2.5 • n=17 Participants • Randomized subjects were required to complete at least one full month of treatment period to be included in the analyses. These criteria excluded 6 subjects in the Placebo arm and 2 subjects in the Nuedexta arm from the analysis data sets. Thus, 37 participants were analyzed for this Baseline Measurement.
|
8.54 Number of Migraine days
STANDARD_DEVIATION 2.34 • n=37 Participants • Randomized subjects were required to complete at least one full month of treatment period to be included in the analyses. These criteria excluded 6 subjects in the Placebo arm and 2 subjects in the Nuedexta arm from the analysis data sets. Thus, 37 participants were analyzed for this Baseline Measurement.
|
|
Headache Severity
|
2.02 units on a scale
STANDARD_DEVIATION 0.386 • n=20 Participants • Randomized subjects were required to complete at least one full month of treatment period to be included in the analyses. These criteria excluded 6 subjects in the Placebo arm and 2 subjects in the Nuedexta arm from the analysis data sets. Thus, 37 participants were analyzed for this Baseline Measurement.
|
2.17 units on a scale
STANDARD_DEVIATION 0.326 • n=17 Participants • Randomized subjects were required to complete at least one full month of treatment period to be included in the analyses. These criteria excluded 6 subjects in the Placebo arm and 2 subjects in the Nuedexta arm from the analysis data sets. Thus, 37 participants were analyzed for this Baseline Measurement.
|
2.09 units on a scale
STANDARD_DEVIATION 0.362 • n=37 Participants • Randomized subjects were required to complete at least one full month of treatment period to be included in the analyses. These criteria excluded 6 subjects in the Placebo arm and 2 subjects in the Nuedexta arm from the analysis data sets. Thus, 37 participants were analyzed for this Baseline Measurement.
|
|
Headache Duration
|
6.14 Hours
STANDARD_DEVIATION 2.12 • n=20 Participants • Randomized subjects were required to complete at least one full month of treatment period to be included in the analyses. These criteria excluded 6 subjects in the Placebo arm and 2 subjects in the Nuedexta arm from the analysis data sets. Thus, 37 participants were analyzed for this Baseline Measurement.
|
5.54 Hours
STANDARD_DEVIATION 2.03 • n=17 Participants • Randomized subjects were required to complete at least one full month of treatment period to be included in the analyses. These criteria excluded 6 subjects in the Placebo arm and 2 subjects in the Nuedexta arm from the analysis data sets. Thus, 37 participants were analyzed for this Baseline Measurement.
|
5.86 Hours
STANDARD_DEVIATION 2.07 • n=37 Participants • Randomized subjects were required to complete at least one full month of treatment period to be included in the analyses. These criteria excluded 6 subjects in the Placebo arm and 2 subjects in the Nuedexta arm from the analysis data sets. Thus, 37 participants were analyzed for this Baseline Measurement.
|
|
Acute Medication Use
|
16.4 Number of medications
STANDARD_DEVIATION 9.58 • n=20 Participants • Randomized subjects were required to complete at least one full month of treatment period to be included in the analyses. These criteria excluded 6 subjects in the Placebo arm and 2 subjects in the Nuedexta arm from the analysis data sets. Thus, 37 participants were analyzed for this Baseline Measurement.
|
13.4 Number of medications
STANDARD_DEVIATION 7.44 • n=17 Participants • Randomized subjects were required to complete at least one full month of treatment period to be included in the analyses. These criteria excluded 6 subjects in the Placebo arm and 2 subjects in the Nuedexta arm from the analysis data sets. Thus, 37 participants were analyzed for this Baseline Measurement.
|
15.0 Number of medications
STANDARD_DEVIATION 8.68 • n=37 Participants • Randomized subjects were required to complete at least one full month of treatment period to be included in the analyses. These criteria excluded 6 subjects in the Placebo arm and 2 subjects in the Nuedexta arm from the analysis data sets. Thus, 37 participants were analyzed for this Baseline Measurement.
|
PRIMARY outcome
Timeframe: Treatment Month 1, Treatment Month 2, and End of Treatment Period Month 3 (Day 116)Population: Randomized subjects were required to complete at least one full month of treatment period to be included in the analyses. These criteria excluded 6 subjects in the Placebo arm and 2 subjects in the Nuedexta arm from the analysis data sets. Thus, 37 participants were analyzed for this measure.
The average number of headache days at treatment period months 1, 2, and 3 (28 day periods for each month) for the Nuedexta arm and the Placebo arm. Headache days were defined as any patient reported head pain during the prior 24 hour period.
Outcome measures
| Measure |
Nuedexta
n=20 Participants
One capsule will be taken (dextromethorphan HB and quinidine sulfate, 20 mg/10 mg) daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months.
Dextromethorphan and quinidine
|
Placebo
n=17 Participants
One capsule will be taken of placebo to match daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months.
Placebo
|
|---|---|---|
|
Headache Days in Each Treatment Period Month
Treatment Month 1
|
7.1 Number of Headache days
Standard Deviation 3.31
|
10.88 Number of Headache days
Standard Deviation 6.25
|
|
Headache Days in Each Treatment Period Month
Treatment Month 2
|
7.05 Number of Headache days
Standard Deviation 3.82
|
9.47 Number of Headache days
Standard Deviation 6.15
|
|
Headache Days in Each Treatment Period Month
Treatment Month 3
|
7.10 Number of Headache days
Standard Deviation 3.8
|
9.77 Number of Headache days
Standard Deviation 7.09
|
SECONDARY outcome
Timeframe: End of Treatment Period Month 3 (Day 116)Population: Randomized subjects were required to complete at least one full month of treatment period to be included in the analyses. These criteria excluded 6 subjects in the Placebo arm and 2 subjects in the Nuedexta arm from the analysis data sets. Thus, 37 participants were analyzed for this measure.
The average number of headache days at treatment period month 3 (28 day period) for the Nuedexta arm and the Placebo arm. Headache days were defined as any patient reported head pain during the prior 24 hour period.
Outcome measures
| Measure |
Nuedexta
n=20 Participants
One capsule will be taken (dextromethorphan HB and quinidine sulfate, 20 mg/10 mg) daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months.
Dextromethorphan and quinidine
|
Placebo
n=17 Participants
One capsule will be taken of placebo to match daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months.
Placebo
|
|---|---|---|
|
Headache Days in Treatment Period Month 3
|
7.1 Number of headache days
Standard Deviation 3.8
|
9.77 Number of headache days
Standard Deviation 7.09
|
SECONDARY outcome
Timeframe: Treatment Month 1, Month 2, and End of Treatment Period Month 3 (Day 116)Population: Randomized subjects were required to complete at least one full month of treatment period to be included in the analyses. These criteria excluded 6 subjects in the Placebo arm and 2 subjects in the Nuedexta arm from the analysis data sets. Thus, 37 participants were analyzed for this measure.
The average number of migraine days at treatment period months 1, 2, and 3 (28 day periods for each month) for the Nuedexta arm and the Placebo arm.
Outcome measures
| Measure |
Nuedexta
n=20 Participants
One capsule will be taken (dextromethorphan HB and quinidine sulfate, 20 mg/10 mg) daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months.
Dextromethorphan and quinidine
|
Placebo
n=17 Participants
One capsule will be taken of placebo to match daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months.
Placebo
|
|---|---|---|
|
Migraine Days in Each Treatment Period Month
Treatment Month 1
|
5.65 Number of Migraine days
Standard Deviation 3.35
|
7.65 Number of Migraine days
Standard Deviation 2.71
|
|
Migraine Days in Each Treatment Period Month
Treatment Month 2
|
5.85 Number of Migraine days
Standard Deviation 3.48
|
6.94 Number of Migraine days
Standard Deviation 4.05
|
|
Migraine Days in Each Treatment Period Month
Treatment Month 3
|
6.05 Number of Migraine days
Standard Deviation 3.63
|
7.29 Number of Migraine days
Standard Deviation 4.3
|
SECONDARY outcome
Timeframe: Treatment Month 1, Month 2, and End of Treatment Period Month 3 (Day 116)Population: Randomized subjects were required to complete at least one full month of treatment period to be included in the analyses. Additionally, participants who were unavailable for the assessment at a particular time point were excluded. These criteria excluded 6 subjects in the Placebo arm and 3 subjects in the Nuedexta arm from the analysis data sets.
The average headache severity at treatment period months 1, 2, and 3 (28 day periods for each month) for the Nuedexta arm and the Placebo arm. Headache pain severity was measured on a scale from 1 = Mild, to 3 = Severe. Higher numbers indicating more severe headache pain.
Outcome measures
| Measure |
Nuedexta
n=19 Participants
One capsule will be taken (dextromethorphan HB and quinidine sulfate, 20 mg/10 mg) daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months.
Dextromethorphan and quinidine
|
Placebo
n=17 Participants
One capsule will be taken of placebo to match daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months.
Placebo
|
|---|---|---|
|
Headache Severity in Each Treatment Period Month
Treatment Month 1
|
1.69 units on a scale
Standard Deviation 0.37
|
2.04 units on a scale
Standard Deviation 0.43
|
|
Headache Severity in Each Treatment Period Month
Treatment Month 2
|
1.81 units on a scale
Standard Deviation 0.52
|
1.96 units on a scale
Standard Deviation 0.45
|
|
Headache Severity in Each Treatment Period Month
Treatment Month 3
|
1.74 units on a scale
Standard Deviation 0.46
|
1.86 units on a scale
Standard Deviation 0.51
|
SECONDARY outcome
Timeframe: Treatment Month 1, Month 2, and End of Treatment Period Month 3 (Day 116)Population: Randomized subjects were required to complete at least one full month of treatment period to be included in the analyses. Additionally, participants who were unavailable for the assessment at a particular time point were excluded. These criteria excluded 6 subjects in the Placebo arm and 3 subjects in the Nuedexta arm from the analysis data sets.
The average headache duration (time of onset to pain free) at treatment period months 1, 2, and 3 (28 day periods for each month) for the Nuedexta arm and the Placebo arm. Headache duration was measured in hours.
Outcome measures
| Measure |
Nuedexta
n=19 Participants
One capsule will be taken (dextromethorphan HB and quinidine sulfate, 20 mg/10 mg) daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months.
Dextromethorphan and quinidine
|
Placebo
n=17 Participants
One capsule will be taken of placebo to match daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months.
Placebo
|
|---|---|---|
|
Headache Duration in Each Treatment Period Month
Treatment Month 1
|
5.39 Hours
Standard Deviation 2.38
|
5.30 Hours
Standard Deviation 2.25
|
|
Headache Duration in Each Treatment Period Month
Treatment Month 2
|
6.33 Hours
Standard Deviation 4.06
|
5.75 Hours
Standard Deviation 2.78
|
|
Headache Duration in Each Treatment Period Month
Treatment Month 3
|
6.60 Hours
Standard Deviation 4.81
|
5.46 Hours
Standard Deviation 2.72
|
SECONDARY outcome
Timeframe: Baseline (Day 0) to Treatment Period Month 3 (Day 116)Population: Randomized subjects were required to complete at least one full month of treatment period to be included in the analyses. These criteria excluded 6 subjects in the Placebo arm and 2 subjects in the Nuedexta arm from the analysis data sets. Thus, 37 participants were analyzed for this measure.
The number of subjects with at least a 50% reduction in number of headache days comparing baseline to each visit (treatment period months 1, 2, and 3: 28 day for each month) in the Nuedexta arm vs. the placebo arm.
Outcome measures
| Measure |
Nuedexta
n=20 Participants
One capsule will be taken (dextromethorphan HB and quinidine sulfate, 20 mg/10 mg) daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months.
Dextromethorphan and quinidine
|
Placebo
n=17 Participants
One capsule will be taken of placebo to match daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months.
Placebo
|
|---|---|---|
|
50% Headache Reduction
Treatment Month 1
|
6 Participants
|
0 Participants
|
|
50% Headache Reduction
Treatment Month 2
|
7 Participants
|
2 Participants
|
|
50% Headache Reduction
Treatment Month 3
|
8 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Treatment Month 1, Month 2, and End of Treatment Period Month 3 (Day 116)Population: Randomized subjects were required to complete at least one full month of treatment period to be included in the analyses. These criteria excluded 6 subjects in the Placebo arm and 2 subjects in the Nuedexta arm from the analysis data sets.
The average number of doses of acute medication taken at treatment period months 1, 2, and 3 (28 day periods for each month) for the Nuedexta arm and the Placebo arm
Outcome measures
| Measure |
Nuedexta
n=20 Participants
One capsule will be taken (dextromethorphan HB and quinidine sulfate, 20 mg/10 mg) daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months.
Dextromethorphan and quinidine
|
Placebo
n=17 Participants
One capsule will be taken of placebo to match daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months.
Placebo
|
|---|---|---|
|
Acute Medication Use in Each Treatment Period Month
Treatment Month 1
|
9.45 Number of medication doses
Standard Deviation 6.82
|
13.06 Number of medication doses
Standard Deviation 12.30
|
|
Acute Medication Use in Each Treatment Period Month
Treatment Month 2
|
9.50 Number of medication doses
Standard Deviation 7.08
|
11.41 Number of medication doses
Standard Deviation 12.52
|
|
Acute Medication Use in Each Treatment Period Month
Treatment Month 3
|
11.55 Number of medication doses
Standard Deviation 11.01
|
10.94 Number of medication doses
Standard Deviation 12.95
|
SECONDARY outcome
Timeframe: Visit 2 (Day 28) to Visit 5 (Day 116)Population: Randomized subjects were required to complete at least one full month of treatment period to be included in the analyses. These criteria excluded 6 subjects in the Placebo arm and 2 subjects in the Nuedexta arm from the analysis data sets.
MIDAS scores at Visit 2 and Visit 5 (end of treatment period month 3). The MIDAS is a questionnaire consisting of five (5) "how many days in the last 3 months..." questions. Thus the range for the MIDAS is from, 0 to a maximum possible score 93 (31 days X 3 months). The MIDAS is scored according to the following: 0-5, MIDAS Grade I, Little or No Disability 6-10, MIDAS Grade II, Mild Disability 11-20, MIDAS Grade III, Moderate Disability 21+, MIDAS Grade IV, Severe Disability
Outcome measures
| Measure |
Nuedexta
n=20 Participants
One capsule will be taken (dextromethorphan HB and quinidine sulfate, 20 mg/10 mg) daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months.
Dextromethorphan and quinidine
|
Placebo
n=17 Participants
One capsule will be taken of placebo to match daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months.
Placebo
|
|---|---|---|
|
Migraine Disability Assessment Scale (MIDAS)
Visit 2 (Day28)
|
34.95 units on a scale
Standard Deviation 22.65
|
32.88 units on a scale
Standard Deviation 29.95
|
|
Migraine Disability Assessment Scale (MIDAS)
Visit 5 (Day 116)
|
22.50 units on a scale
Standard Deviation 17.41
|
30.35 units on a scale
Standard Deviation 42.47
|
SECONDARY outcome
Timeframe: Visit 2 (Day 28), Visit 3 (Day 57), Visit 4 (Day 85), and Visit 5 (Day 116)Population: Randomized subjects were required to complete at least one full month of treatment period to be included in the analyses. These criteria excluded 6 subjects in the Placebo arm and 2 subjects in the Nuedexta arm from the analysis data sets.
Headache Health Score at Visit 2 (Day 28), Visit 3 (Day 57), Visit 4 (Day 85), and Visit 5 (Day 116) for the Nuedexta arm and the placebo arm. The Headache Health Score is measured using a scale from 0 to 100, with higher scores indicating less headache impact on the subject's life.
Outcome measures
| Measure |
Nuedexta
n=20 Participants
One capsule will be taken (dextromethorphan HB and quinidine sulfate, 20 mg/10 mg) daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months.
Dextromethorphan and quinidine
|
Placebo
n=17 Participants
One capsule will be taken of placebo to match daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months.
Placebo
|
|---|---|---|
|
Headache Health Score
Visit 2 (Day 28)
|
78.71 units on a scale
Standard Deviation 5.25
|
81.07 units on a scale
Standard Deviation 7.37
|
|
Headache Health Score
Visit 3 (Day 57)
|
87.62 units on a scale
Standard Deviation 6.57
|
80.30 units on a scale
Standard Deviation 10.62
|
|
Headache Health Score
Visit 4 (Day 85)
|
87.14 units on a scale
Standard Deviation 8.31
|
82.28 units on a scale
Standard Deviation 10.77
|
|
Headache Health Score
Visit 5 (Day 116)
|
87.57 units on a scale
Standard Deviation 6.97
|
84.10 units on a scale
Standard Deviation 10.76
|
SECONDARY outcome
Timeframe: Baseline (Day 0) to Treatment Period Month 3 (Day 116)Compare the number of adverse events in the Nuedexta arm vs. the placebo arm.
Outcome measures
| Measure |
Nuedexta
n=22 Participants
One capsule will be taken (dextromethorphan HB and quinidine sulfate, 20 mg/10 mg) daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months.
Dextromethorphan and quinidine
|
Placebo
n=23 Participants
One capsule will be taken of placebo to match daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months.
Placebo
|
|---|---|---|
|
Adverse Events
|
9 Number of Adverse Events
|
35 Number of Adverse Events
|
Adverse Events
Nuedexta
Placebo
Serious adverse events
| Measure |
Nuedexta
n=22 participants at risk
One capsule will be taken (dextromethorphan HB and quinidine sulfate, 20 mg/10 mg) daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months.
Dextromethorphan and quinidine
|
Placebo
n=23 participants at risk
One capsule will be taken of placebo to match daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months.
Placebo
|
|---|---|---|
|
Cardiac disorders
Chest Pain
|
0.00%
0/22 • 116 days
|
4.3%
1/23 • Number of events 1 • 116 days
|
Other adverse events
| Measure |
Nuedexta
n=22 participants at risk
One capsule will be taken (dextromethorphan HB and quinidine sulfate, 20 mg/10 mg) daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months.
Dextromethorphan and quinidine
|
Placebo
n=23 participants at risk
One capsule will be taken of placebo to match daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months.
Placebo
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/22 • 116 days
|
8.7%
2/23 • Number of events 2 • 116 days
|
|
Gastrointestinal disorders
Abdominal discomfort
|
9.1%
2/22 • Number of events 2 • 116 days
|
0.00%
0/23 • 116 days
|
|
Nervous system disorders
Dizziness
|
0.00%
0/22 • 116 days
|
8.7%
2/23 • Number of events 2 • 116 days
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/22 • 116 days
|
8.7%
2/23 • Number of events 2 • 116 days
|
|
Gastrointestinal disorders
Nausea
|
4.5%
1/22 • Number of events 1 • 116 days
|
13.0%
3/23 • Number of events 3 • 116 days
|
|
Infections and infestations
Sinusitis
|
4.5%
1/22 • Number of events 1 • 116 days
|
4.3%
1/23 • Number of events 3 • 116 days
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/22 • 116 days
|
8.7%
2/23 • Number of events 2 • 116 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60