Trial Outcomes & Findings for Valproic Acid and Dihydroergotamine as Abortive Therapy in Pediatric Migraine (NCT NCT03885154)
NCT ID: NCT03885154
Last Updated: 2021-10-07
Results Overview
Change in pain perception measured by the 10-point visual analogue scale (VAS), where 0 is "no pain" and 10 is "pain as bad as it could be."
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
Baseline to 24 hours
Results posted on
2021-10-07
Participant Flow
Participant milestones
| Measure |
Valproic Acid
An initial dose of Valproic Acid (VPA) will be given IV at 20mg/kg, followed by continuous infusion of 1mg/kg/hour for 24 hours. Serum levels of VPA will be checked at 4 and 24 hours, with additional timepoints possible at 8 and 12 hours based on drug levels.
Valproic Acid (VPA): IV VPA load 20mg/kg, followed by continuous infusion of 1mg/kg/hr for 24 hours
|
Dihydroergotamine
Dihydroergotamine (DHE) will be given as weight-based dosing, with no single dose \>1mg and not exceeding 3mg over 24 hours.
Dihydroergotamine (DHE): 0 hour: 0.50 x (wt in kg) x (0.014) =Xmg 8 hour: 0.75 x (wt in kg) x (0.014) =Xmg 24 hour: 1.00 x (wt in kg) x (0.014) =Xmg
|
Cross-Over to Dihydroergotamine
An initial dose of Valproic Acid (VPA) will be given IV at 20mg/kg, followed by continuous infusion of 1mg/kg/hour for 24 hours. Serum levels of VPA will be checked at 4 and 24 hours, with additional timepoints possible at 8 and 12 hours based on drug levels. Patients who do not respond to VPA after 24 hours will be given Dihydroergotamine (DHE) for the next 24 hours. Dihydroergotamine (DHE) will be given as weight-based dosing, with no single dose \>1mg and not exceeding 3mg over 24 hours.
Valproic Acid (VPA): IV VPA load 20mg/kg, followed by continuous infusion of 1mg/kg/hr for 24 hours
Dihydroergotamine (DHE): 0 hour: 0.50 x (wt in kg) x (0.014) =Xmg 8 hour: 0.75 x (wt in kg) x (0.014) =Xmg 24 hour: 1.00 x (wt in kg) x (0.014) =Xmg
|
Cross-Over to Valproic Acid
Dihydroergotamine (DHE) will be given as weight-based dosing, with no single dose \>1mg and not exceeding 3mg over 24 hours. Patients who do not respond to DHE after 24 hours will be given Valproic Acid (VPA) for the next 24 hours. An initial dose of Valproic Acid (VPA) will be given IV at 20mg/kg, followed by continuous infusion of 1mg/kg/hour for 24 hours. Serum levels of VPA will be checked at 4 and 24 hours, with additional timepoints possible at 8 and 12 hours based on drug levels.
Valproic Acid (VPA): IV VPA load 20mg/kg, followed by continuous infusion of 1mg/kg/hr for 24 hours
Dihydroergotamine (DHE): 0 hour: 0.50 x (wt in kg) x (0.014) =Xmg 8 hour: 0.75 x (wt in kg) x (0.014) =Xmg 24 hour: 1.00 x (wt in kg) x (0.014) =Xmg
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
10
|
0
|
2
|
|
Overall Study
COMPLETED
|
12
|
10
|
0
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Valproic Acid and Dihydroergotamine as Abortive Therapy in Pediatric Migraine
Baseline characteristics by cohort
| Measure |
Valproic Acid
n=12 Participants
An initial dose of Valproic Acid (VPA) will be given IV at 20mg/kg, followed by continuous infusion of 1mg/kg/hour for 24 hours. Serum levels of VPA will be checked at 4 and 24 hours, with additional timepoints possible at 8 and 12 hours based on drug levels.
Valproic Acid (VPA): IV VPA load 20mg/kg, followed by continuous infusion of 1mg/kg/hr for 24 hours
|
Dihydroergotamine
n=10 Participants
Dihydroergotamine (DHE) will be given as weight-based dosing, with no single dose \>1mg and not exceeding 3mg over 24 hours.
Dihydroergotamine (DHE): 0 hour: 0.50 x (wt in kg) x (0.014) =Xmg 8 hour: 0.75 x (wt in kg) x (0.014) =Xmg 24 hour: 1.00 x (wt in kg) x (0.014) =Xmg
|
Cross-Over to Dihydroergotamine
An initial dose of Valproic Acid (VPA) will be given IV at 20mg/kg, followed by continuous infusion of 1mg/kg/hour for 24 hours. Serum levels of VPA will be checked at 4 and 24 hours, with additional timepoints possible at 8 and 12 hours based on drug levels. Patients who do not respond to VPA after 24 hours will be given Dihydroergotamine (DHE) for the next 24 hours. Dihydroergotamine (DHE) will be given as weight-based dosing, with no single dose \>1mg and not exceeding 3mg over 24 hours.
Valproic Acid (VPA): IV VPA load 20mg/kg, followed by continuous infusion of 1mg/kg/hr for 24 hours
Dihydroergotamine (DHE): 0 hour: 0.50 x (wt in kg) x (0.014) =Xmg 8 hour: 0.75 x (wt in kg) x (0.014) =Xmg 24 hour: 1.00 x (wt in kg) x (0.014) =Xmg
|
Cross-Over to Valproic Acid
n=2 Participants
Dihydroergotamine (DHE) will be given as weight-based dosing, with no single dose \>1mg and not exceeding 3mg over 24 hours. Patients who do not respond to DHE after 24 hours will be given Valproic Acid (VPA) for the next 24 hours. An initial dose of Valproic Acid (VPA) will be given IV at 20mg/kg, followed by continuous infusion of 1mg/kg/hour for 24 hours. Serum levels of VPA will be checked at 4 and 24 hours, with additional timepoints possible at 8 and 12 hours based on drug levels.
Valproic Acid (VPA): IV VPA load 20mg/kg, followed by continuous infusion of 1mg/kg/hr for 24 hours
Dihydroergotamine (DHE): 0 hour: 0.50 x (wt in kg) x (0.014) =Xmg 8 hour: 0.75 x (wt in kg) x (0.014) =Xmg 24 hour: 1.00 x (wt in kg) x (0.014) =Xmg
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
15.6 years
STANDARD_DEVIATION 1.2 • n=5 Participants
|
14.1 years
STANDARD_DEVIATION 2.0 • n=7 Participants
|
—
|
16.0 years
STANDARD_DEVIATION 1.4 • n=4 Participants
|
15.0 years
STANDARD_DEVIATION 1.6 • n=21 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
—
|
2 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
—
|
2 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
10 participants
n=7 Participants
|
—
|
2 participants
n=4 Participants
|
24 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline to 24 hoursPopulation: No participants were enrolled in the cross-over to dihydroergotamine arm. Participants were analyzed on a per-arm basis. Data were not collected for DHE only for the two participants who crossed over to Valproic Acid; only the combination of treatments.
Change in pain perception measured by the 10-point visual analogue scale (VAS), where 0 is "no pain" and 10 is "pain as bad as it could be."
Outcome measures
| Measure |
Valproic Acid
n=12 Participants
An initial dose of Valproic Acid (VPA) will be given IV at 20mg/kg, followed by continuous infusion of 1mg/kg/hour for 24 hours. Serum levels of VPA will be checked at 4 and 24 hours, with additional timepoints possible at 8 and 12 hours based on drug levels.
Valproic Acid (VPA): IV VPA load 20mg/kg, followed by continuous infusion of 1mg/kg/hr for 24 hours
|
Dihydroergotamine
n=10 Participants
Dihydroergotamine (DHE) will be given as weight-based dosing, with no single dose \>1mg and not exceeding 3mg over 24 hours.
Dihydroergotamine (DHE): 0 hour: 0.50 x (wt in kg) x (0.014) =Xmg 8 hour: 0.75 x (wt in kg) x (0.014) =Xmg 24 hour: 1.00 x (wt in kg) x (0.014) =Xmg
|
Cross-Over to Dihydroergotamine
An initial dose of Valproic Acid (VPA) will be given IV at 20mg/kg, followed by continuous infusion of 1mg/kg/hour for 24 hours. Serum levels of VPA will be checked at 4 and 24 hours, with additional timepoints possible at 8 and 12 hours based on drug levels. Patients who do not respond to VPA after 24 hours will be given Dihydroergotamine (DHE) for the next 24 hours. Dihydroergotamine (DHE) will be given as weight-based dosing, with no single dose \>1mg and not exceeding 3mg over 24 hours.
Valproic Acid (VPA): IV VPA load 20mg/kg, followed by continuous infusion of 1mg/kg/hr for 24 hours
Dihydroergotamine (DHE): 0 hour: 0.50 x (wt in kg) x (0.014) =Xmg 8 hour: 0.75 x (wt in kg) x (0.014) =Xmg 24 hour: 1.00 x (wt in kg) x (0.014) =Xmg
|
Cross-Over to Valproic Acid
n=2 Participants
Dihydroergotamine (DHE) will be given as weight-based dosing, with no single dose \>1mg and not exceeding 3mg over 24 hours. Patients who do not respond to DHE after 24 hours will be given Valproic Acid (VPA) for the next 24 hours. An initial dose of Valproic Acid (VPA) will be given IV at 20mg/kg, followed by continuous infusion of 1mg/kg/hour for 24 hours. Serum levels of VPA will be checked at 4 and 24 hours, with additional timepoints possible at 8 and 12 hours based on drug levels.
Valproic Acid (VPA): IV VPA load 20mg/kg, followed by continuous infusion of 1mg/kg/hr for 24 hours
Dihydroergotamine (DHE): 0 hour: 0.50 x (wt in kg) x (0.014) =Xmg 8 hour: 0.75 x (wt in kg) x (0.014) =Xmg 24 hour: 1.00 x (wt in kg) x (0.014) =Xmg
|
|---|---|---|---|---|
|
Change in Pain Perception
|
-6.2 change in score on a scale
Standard Deviation 3.6
|
-5.8 change in score on a scale
Standard Deviation 2.9
|
—
|
-5 change in score on a scale
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: Baseline, 4, 8, 12 and 24 hoursPopulation: No participants were enrolled in the cross-over to dihydroergotamine arm. Participants were analyzed on a per-arm basis. Data were not collected for DHE only for the two participants who crossed over to Valproic Acid; only the combination of treatments.
Presence of absence of photophobia
Outcome measures
| Measure |
Valproic Acid
n=12 Participants
An initial dose of Valproic Acid (VPA) will be given IV at 20mg/kg, followed by continuous infusion of 1mg/kg/hour for 24 hours. Serum levels of VPA will be checked at 4 and 24 hours, with additional timepoints possible at 8 and 12 hours based on drug levels.
Valproic Acid (VPA): IV VPA load 20mg/kg, followed by continuous infusion of 1mg/kg/hr for 24 hours
|
Dihydroergotamine
n=10 Participants
Dihydroergotamine (DHE) will be given as weight-based dosing, with no single dose \>1mg and not exceeding 3mg over 24 hours.
Dihydroergotamine (DHE): 0 hour: 0.50 x (wt in kg) x (0.014) =Xmg 8 hour: 0.75 x (wt in kg) x (0.014) =Xmg 24 hour: 1.00 x (wt in kg) x (0.014) =Xmg
|
Cross-Over to Dihydroergotamine
An initial dose of Valproic Acid (VPA) will be given IV at 20mg/kg, followed by continuous infusion of 1mg/kg/hour for 24 hours. Serum levels of VPA will be checked at 4 and 24 hours, with additional timepoints possible at 8 and 12 hours based on drug levels. Patients who do not respond to VPA after 24 hours will be given Dihydroergotamine (DHE) for the next 24 hours. Dihydroergotamine (DHE) will be given as weight-based dosing, with no single dose \>1mg and not exceeding 3mg over 24 hours.
Valproic Acid (VPA): IV VPA load 20mg/kg, followed by continuous infusion of 1mg/kg/hr for 24 hours
Dihydroergotamine (DHE): 0 hour: 0.50 x (wt in kg) x (0.014) =Xmg 8 hour: 0.75 x (wt in kg) x (0.014) =Xmg 24 hour: 1.00 x (wt in kg) x (0.014) =Xmg
|
Cross-Over to Valproic Acid
n=2 Participants
Dihydroergotamine (DHE) will be given as weight-based dosing, with no single dose \>1mg and not exceeding 3mg over 24 hours. Patients who do not respond to DHE after 24 hours will be given Valproic Acid (VPA) for the next 24 hours. An initial dose of Valproic Acid (VPA) will be given IV at 20mg/kg, followed by continuous infusion of 1mg/kg/hour for 24 hours. Serum levels of VPA will be checked at 4 and 24 hours, with additional timepoints possible at 8 and 12 hours based on drug levels.
Valproic Acid (VPA): IV VPA load 20mg/kg, followed by continuous infusion of 1mg/kg/hr for 24 hours
Dihydroergotamine (DHE): 0 hour: 0.50 x (wt in kg) x (0.014) =Xmg 8 hour: 0.75 x (wt in kg) x (0.014) =Xmg 24 hour: 1.00 x (wt in kg) x (0.014) =Xmg
|
|---|---|---|---|---|
|
Percentage of Participants With Presence of Photophobia
Baseline
|
100 percentage of participants w/photophobia
|
100 percentage of participants w/photophobia
|
—
|
100 percentage of participants w/photophobia
|
|
Percentage of Participants With Presence of Photophobia
4 hours
|
58 percentage of participants w/photophobia
|
42 percentage of participants w/photophobia
|
—
|
50 percentage of participants w/photophobia
|
|
Percentage of Participants With Presence of Photophobia
8 hours
|
17 percentage of participants w/photophobia
|
17 percentage of participants w/photophobia
|
—
|
0 percentage of participants w/photophobia
|
|
Percentage of Participants With Presence of Photophobia
12 hours
|
0 percentage of participants w/photophobia
|
17 percentage of participants w/photophobia
|
—
|
0 percentage of participants w/photophobia
|
|
Percentage of Participants With Presence of Photophobia
24 hours
|
0 percentage of participants w/photophobia
|
17 percentage of participants w/photophobia
|
—
|
0 percentage of participants w/photophobia
|
SECONDARY outcome
Timeframe: Baseline, 4, 8, 12 and 24 hoursPopulation: No participants were enrolled in the cross-over to dihydroergotamine arm. Participants were analyzed on a per-arm basis. Data were not collected for DHE only for the two participants who crossed over to Valproic Acid; only the combination of treatments.
Presence of absence of phonophobia
Outcome measures
| Measure |
Valproic Acid
n=12 Participants
An initial dose of Valproic Acid (VPA) will be given IV at 20mg/kg, followed by continuous infusion of 1mg/kg/hour for 24 hours. Serum levels of VPA will be checked at 4 and 24 hours, with additional timepoints possible at 8 and 12 hours based on drug levels.
Valproic Acid (VPA): IV VPA load 20mg/kg, followed by continuous infusion of 1mg/kg/hr for 24 hours
|
Dihydroergotamine
n=10 Participants
Dihydroergotamine (DHE) will be given as weight-based dosing, with no single dose \>1mg and not exceeding 3mg over 24 hours.
Dihydroergotamine (DHE): 0 hour: 0.50 x (wt in kg) x (0.014) =Xmg 8 hour: 0.75 x (wt in kg) x (0.014) =Xmg 24 hour: 1.00 x (wt in kg) x (0.014) =Xmg
|
Cross-Over to Dihydroergotamine
An initial dose of Valproic Acid (VPA) will be given IV at 20mg/kg, followed by continuous infusion of 1mg/kg/hour for 24 hours. Serum levels of VPA will be checked at 4 and 24 hours, with additional timepoints possible at 8 and 12 hours based on drug levels. Patients who do not respond to VPA after 24 hours will be given Dihydroergotamine (DHE) for the next 24 hours. Dihydroergotamine (DHE) will be given as weight-based dosing, with no single dose \>1mg and not exceeding 3mg over 24 hours.
Valproic Acid (VPA): IV VPA load 20mg/kg, followed by continuous infusion of 1mg/kg/hr for 24 hours
Dihydroergotamine (DHE): 0 hour: 0.50 x (wt in kg) x (0.014) =Xmg 8 hour: 0.75 x (wt in kg) x (0.014) =Xmg 24 hour: 1.00 x (wt in kg) x (0.014) =Xmg
|
Cross-Over to Valproic Acid
n=2 Participants
Dihydroergotamine (DHE) will be given as weight-based dosing, with no single dose \>1mg and not exceeding 3mg over 24 hours. Patients who do not respond to DHE after 24 hours will be given Valproic Acid (VPA) for the next 24 hours. An initial dose of Valproic Acid (VPA) will be given IV at 20mg/kg, followed by continuous infusion of 1mg/kg/hour for 24 hours. Serum levels of VPA will be checked at 4 and 24 hours, with additional timepoints possible at 8 and 12 hours based on drug levels.
Valproic Acid (VPA): IV VPA load 20mg/kg, followed by continuous infusion of 1mg/kg/hr for 24 hours
Dihydroergotamine (DHE): 0 hour: 0.50 x (wt in kg) x (0.014) =Xmg 8 hour: 0.75 x (wt in kg) x (0.014) =Xmg 24 hour: 1.00 x (wt in kg) x (0.014) =Xmg
|
|---|---|---|---|---|
|
Percentage of Participants With Presence of Phonophobia
4 hours
|
42 percentage of participants w/phonophobia
|
25 percentage of participants w/phonophobia
|
—
|
0 percentage of participants w/phonophobia
|
|
Percentage of Participants With Presence of Phonophobia
8 hours
|
8 percentage of participants w/phonophobia
|
8 percentage of participants w/phonophobia
|
—
|
0 percentage of participants w/phonophobia
|
|
Percentage of Participants With Presence of Phonophobia
12 hours
|
8 percentage of participants w/phonophobia
|
0 percentage of participants w/phonophobia
|
—
|
0 percentage of participants w/phonophobia
|
|
Percentage of Participants With Presence of Phonophobia
24 hours
|
0 percentage of participants w/phonophobia
|
0 percentage of participants w/phonophobia
|
—
|
0 percentage of participants w/phonophobia
|
|
Percentage of Participants With Presence of Phonophobia
Baseline
|
100 percentage of participants w/phonophobia
|
92 percentage of participants w/phonophobia
|
—
|
50 percentage of participants w/phonophobia
|
SECONDARY outcome
Timeframe: Baseline, 4, 8, 12 and 24 hoursPopulation: No participants were enrolled in the cross-over to dihydroergotamine arm. Participants were analyzed on a per-arm basis. Data were not collected for DHE only for the two participants who crossed over to Valproic Acid; only the combination of treatments.
Presence or absence of nausea
Outcome measures
| Measure |
Valproic Acid
n=12 Participants
An initial dose of Valproic Acid (VPA) will be given IV at 20mg/kg, followed by continuous infusion of 1mg/kg/hour for 24 hours. Serum levels of VPA will be checked at 4 and 24 hours, with additional timepoints possible at 8 and 12 hours based on drug levels.
Valproic Acid (VPA): IV VPA load 20mg/kg, followed by continuous infusion of 1mg/kg/hr for 24 hours
|
Dihydroergotamine
n=10 Participants
Dihydroergotamine (DHE) will be given as weight-based dosing, with no single dose \>1mg and not exceeding 3mg over 24 hours.
Dihydroergotamine (DHE): 0 hour: 0.50 x (wt in kg) x (0.014) =Xmg 8 hour: 0.75 x (wt in kg) x (0.014) =Xmg 24 hour: 1.00 x (wt in kg) x (0.014) =Xmg
|
Cross-Over to Dihydroergotamine
An initial dose of Valproic Acid (VPA) will be given IV at 20mg/kg, followed by continuous infusion of 1mg/kg/hour for 24 hours. Serum levels of VPA will be checked at 4 and 24 hours, with additional timepoints possible at 8 and 12 hours based on drug levels. Patients who do not respond to VPA after 24 hours will be given Dihydroergotamine (DHE) for the next 24 hours. Dihydroergotamine (DHE) will be given as weight-based dosing, with no single dose \>1mg and not exceeding 3mg over 24 hours.
Valproic Acid (VPA): IV VPA load 20mg/kg, followed by continuous infusion of 1mg/kg/hr for 24 hours
Dihydroergotamine (DHE): 0 hour: 0.50 x (wt in kg) x (0.014) =Xmg 8 hour: 0.75 x (wt in kg) x (0.014) =Xmg 24 hour: 1.00 x (wt in kg) x (0.014) =Xmg
|
Cross-Over to Valproic Acid
n=2 Participants
Dihydroergotamine (DHE) will be given as weight-based dosing, with no single dose \>1mg and not exceeding 3mg over 24 hours. Patients who do not respond to DHE after 24 hours will be given Valproic Acid (VPA) for the next 24 hours. An initial dose of Valproic Acid (VPA) will be given IV at 20mg/kg, followed by continuous infusion of 1mg/kg/hour for 24 hours. Serum levels of VPA will be checked at 4 and 24 hours, with additional timepoints possible at 8 and 12 hours based on drug levels.
Valproic Acid (VPA): IV VPA load 20mg/kg, followed by continuous infusion of 1mg/kg/hr for 24 hours
Dihydroergotamine (DHE): 0 hour: 0.50 x (wt in kg) x (0.014) =Xmg 8 hour: 0.75 x (wt in kg) x (0.014) =Xmg 24 hour: 1.00 x (wt in kg) x (0.014) =Xmg
|
|---|---|---|---|---|
|
Percentage of Participants With Presence of Nausea
Baseline
|
100 percentage of participants w/nausea
|
100 percentage of participants w/nausea
|
—
|
100 percentage of participants w/nausea
|
|
Percentage of Participants With Presence of Nausea
4 hours
|
58 percentage of participants w/nausea
|
58 percentage of participants w/nausea
|
—
|
0 percentage of participants w/nausea
|
|
Percentage of Participants With Presence of Nausea
8 hours
|
8 percentage of participants w/nausea
|
33 percentage of participants w/nausea
|
—
|
0 percentage of participants w/nausea
|
|
Percentage of Participants With Presence of Nausea
12 hours
|
8 percentage of participants w/nausea
|
33 percentage of participants w/nausea
|
—
|
0 percentage of participants w/nausea
|
|
Percentage of Participants With Presence of Nausea
24 hours
|
0 percentage of participants w/nausea
|
25 percentage of participants w/nausea
|
—
|
0 percentage of participants w/nausea
|
Adverse Events
Valproic Acid
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dihydroergotamine
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Valproic Acid
n=14 participants at risk
An initial dose of Valproic Acid (VPA) will be given IV at 20mg/kg, followed by continuous infusion of 1mg/kg/hour for 24 hours. Serum levels of VPA will be checked at 4 and 24 hours, with additional timepoints possible at 8 and 12 hours based on drug levels.
Valproic Acid (VPA): IV VPA load 20mg/kg, followed by continuous infusion of 1mg/kg/hr for 24 hours
|
Dihydroergotamine
n=12 participants at risk
Dihydroergotamine (DHE) will be given as weight-based dosing, with no single dose \>1mg and not exceeding 3mg over 24 hours.
Dihydroergotamine (DHE): 0 hour: 0.50 x (wt in kg) x (0.014) =Xmg 8 hour: 0.75 x (wt in kg) x (0.014) =Xmg 24 hour: 1.00 x (wt in kg) x (0.014) =Xmg
|
|---|---|---|
|
Cardiac disorders
Tightness in chest
|
0.00%
0/14 • Participants were assessed at baseline, 4 hour, 8 hour, 12, 24 hours per intervention.
No participants were enrolled in the cross-over to dihydroergotamine arm so there was no risk for all-cause mortality.
|
16.7%
2/12 • Number of events 2 • Participants were assessed at baseline, 4 hour, 8 hour, 12, 24 hours per intervention.
No participants were enrolled in the cross-over to dihydroergotamine arm so there was no risk for all-cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/14 • Participants were assessed at baseline, 4 hour, 8 hour, 12, 24 hours per intervention.
No participants were enrolled in the cross-over to dihydroergotamine arm so there was no risk for all-cause mortality.
|
8.3%
1/12 • Number of events 1 • Participants were assessed at baseline, 4 hour, 8 hour, 12, 24 hours per intervention.
No participants were enrolled in the cross-over to dihydroergotamine arm so there was no risk for all-cause mortality.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place