Migraine in ChildrenPhase 2NCT03885154
Valproic Acid and Dihydroergotamine as Abortive Therapy in Pediatric Migraine
A Phase 2 study testing Valproic Acid (VPA) and Dihydroergotamine (DHE) in people with Migraine in Children, run by Kimberly S Jones at 1 site in United States.
Trial summary
The objective of this study is to compare clinical efficacy and tolerability of valproic acid (VPA) therapy versus dihydroergotamine (DHE) as abortive therapy in pediatric migraine. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Migraine in Children
- What is being tested?
- Valproic Acid (VPA) and Dihydroergotamine (DHE)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2017to 19 Mar 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- acute migraine as per ICHD-II criteria
- pediatric (age 10-18)
Who cannot join
- For Valproic Acid (VPA)
- Pregnancy
- Liver disease (Acute or Chronic)
- Urea Cycle Disorder
- Mitochondrial Disease
- For Dihydroergotamine (DHE)
Show all 13Show fewer
- Pregnancy
- Peripheral vascular disease, coronary heart disease
- History of cerebrovascular event
- Severe or poorly controlled hypertension
- Impaired liver or renal function
- Triptan given in last 24 hours
- Hemiplegic migraine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Valproic Acid and Dihydroergotamine as Abortive Therapy in Pediatric Migraine: An Open-Label Randomized Trial.
The objective of this study is to compare clinical efficacy and tolerability of valproic acid (VPA) therapy versus dihydroergotamine (DHE) as abortive therapy in pediatric migraine.
Read the detailed description
The purpose of this study is to compare valproic acid (VPA) and dihydroergotamine (DHE) alone and sequentially in the treatment of pediatric migraines.
Inpatient pediatric migraine patients (based on International Classification of Headache Disorders, ICHD-II criteria) or those admitted to the University of Kentucky emergency department will receive standard of care acute headache management as per AAP/AAN guidelines. Those who fail to respond will be considered for further eligibility. Informed consent/assent will be obtained from the patients, parents or legal guardian.
Baseline labs will be collected prior to the start of the study.
- Complete Blood Count (CBC)
- Comprehensive Metabolic Panel (CMP)
- Prothrombin Time/Activated Partial Thromboplastin Time/International Normalized Ratio (PT/APTT/INR)
- Magnesium and phosphorous
Patients will initially be randomized into two groups (VPA or DHE) and treated for 24 hours. Those patients whose migraines resolve will end the study at 24 hours. Patients who are refractory to treatment will switch interventions and continue treatment for an additional 24 hours.
Intervention 1: VPA Intervention 2: DHE
Patients in Group 1 will be treated with VPA for 24 hours. They will be given an initial dose of IV VPA 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; depending on drug levels they may also be checked at 8 and 12 hours. The target serum concentration is 100 (+/-10) ug/mL.
Patients in Group 2 will be treated with DHE for 24 hours. Dosing will be weight-based with no single dose >1mg and total 24 hour dose <3mg.
0 hour: 0.5 x (wt in kg) x (0.014) =Xmg 8 hour: 0.75 x (wt in kg) x (0.014) =Xmg 24 hour: 1.0 x (wt in kg) x (0.014) =Xmg
Patients will be assessed for migraine severity at baseline, 4, 8, 12, and 24 hours.
- pain (using the standard 0-10 point VAS pain scale)
- presence or absence of photophobia
- presence or absence of phonophobia
- presence or absence of nausea
The endpoint criterion is successful migraine resolution (improvement in VAS and resolution of photophobia, phonophobia, and nausea). Patients meeting this criterion will not continue forward in the study.
At 24 hours, those patients that are refractory to treatment will cross over to the alternate intervention, i.e. patients receiving VPA first will then get DHE, and patients receiving DHE first will then get VPA. Outcomes will be measured for the next 24 hour period as described above.
- Conditions
- Migraine in Children
- Being tested
- Valproic Acid (VPA), Dihydroergotamine (DHE)
- Keywords
- Migraine, Headache, Valproic acid, Dihydroergotamine, Pediatric
- Medical subject headings
- Migraine Disorders, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valproic Acid (VPA)Drug
Also called Depakene
IV VPA load 20mg/kg, followed by continuous infusion of 1mg/kg/hr for 24 hours
Dihydroergotamine (DHE)Drug
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
| Study group | Role | What they receive |
|---|---|---|
| Valproic Acid | Active comparator | 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. Receives: Drug: Valproic Acid (VPA) |
| Dihydroergotamine | Active comparator | Dihydroergotamine (DHE) will be given as weight-based dosing, with no single dose >1mg and not exceeding 3mg over 24 hours. Receives: Drug: Dihydroergotamine (DHE) |
| Cross-Over to Dihydroergotamine | Active comparator | 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. Receives: Drug: Valproic Acid (VPA); Drug: Dihydroergotamine (DHE) |
| Cross-Over to Valproic Acid | Active comparator | 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. Receives: Drug: Valproic Acid (VPA); Drug: Dihydroergotamine (DHE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Perception
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."
Measured: Baseline to 24 hours
Secondary outcomes (3)
Percentage of Participants With Presence of Photophobia
Presence of absence of photophobia
Measured: Baseline, 4, 8, 12 and 24 hours
Percentage of Participants With Presence of Phonophobia
Presence of absence of phonophobia
Measured: Baseline, 4, 8, 12 and 24 hours
Percentage of Participants With Presence of Nausea
Presence or absence of nausea
Measured: Baseline, 4, 8, 12 and 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start3 Oct 2017
- Primary completion19 Mar 2019
- Study completion19 Mar 2019
Why it stopped: Difficulty recruiting participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Migraine in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kimberly S Jones
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kimberly S Jones, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03885154
- Sponsor's protocol ID
- 44243
- Status last verified
- Sep 2021
- First submitted
- 20 Mar 2019
- Last updated
- 7 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Valproic Acid and Dihydroergotamine as Abortive Therapy in Pediatric Migraine: An Open-Label Randomized Trial.
- ClinicalTrials.gov ID
- NCT03885154
- Acronym / sponsor ID
- 44243
- Conditions
- Migraine in Children
- Keywords
- Migraine, Headache, Valproic acid, Dihydroergotamine, Pediatric
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty recruiting participants
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Kimberly S JonesUniversity, hospital or other
- Study start
- 3 Oct 2017 (actual)
- Primary completion
- 19 Mar 2019 (actual)
- Study completion
- 19 Mar 2019 (actual)
- First posted
- 21 Mar 2019 (actual)
- Results
- Posted 7 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to compare clinical efficacy and tolerability of valproic acid (VPA) therapy versus dihydroergotamine (DHE) as abortive therapy in pediatric migraine.
Detailed description
The purpose of this study is to compare valproic acid (VPA) and dihydroergotamine (DHE) alone and sequentially in the treatment of pediatric migraines.
Inpatient pediatric migraine patients (based on International Classification of Headache Disorders, ICHD-II criteria) or those admitted to the University of Kentucky emergency department will receive standard of care acute headache management as per AAP/AAN guidelines. Those who fail to respond will be considered for further eligibility. Informed consent/assent will be obtained from the patients, parents or legal guardian.
Baseline labs will be collected prior to the start of the study.
- Complete Blood Count (CBC)
- Comprehensive Metabolic Panel (CMP)
- Prothrombin Time/Activated Partial Thromboplastin Time/International Normalized Ratio (PT/APTT/INR)
- Magnesium and phosphorous
Patients will initially be randomized into two groups (VPA or DHE) and treated for 24 hours. Those patients whose migraines resolve will end the study at 24 hours. Patients who are refractory to treatment will switch interventions and continue treatment for an additional 24 hours.
Intervention 1: VPA Intervention 2: DHE
Patients in Group 1 will be treated with VPA for 24 hours. They will be given an initial dose of IV VPA 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; depending on drug levels they may also be checked at 8 and 12 hours. The target serum concentration is 100 (+/-10) ug/mL.
Patients in Group 2 will be treated with DHE for 24 hours. Dosing will be weight-based with no single dose >1mg and total 24 hour dose <3mg.
0 hour: 0.5 x (wt in kg) x (0.014) =Xmg 8 hour: 0.75 x (wt in kg) x (0.014) =Xmg 24 hour: 1.0 x (wt in kg) x (0.014) =Xmg
Patients will be assessed for migraine severity at baseline, 4, 8, 12, and 24 hours.
- pain (using the standard 0-10 point VAS pain scale)
- presence or absence of photophobia
- presence or absence of phonophobia
- presence or absence of nausea
The endpoint criterion is successful migraine resolution (improvement in VAS and resolution of photophobia, phonophobia, and nausea). Patients meeting this criterion will not continue forward in the study.
At 24 hours, those patients that are refractory to treatment will cross over to the alternate intervention, i.e. patients receiving VPA first will then get DHE, and patients receiving DHE first will then get VPA. Outcomes will be measured for the next 24 hour period as described above.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Valproic Acid | Active comparator | Drug: Valproic Acid (VPA)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. |
| Dihydroergotamine | Active comparator | Drug: Dihydroergotamine (DHE)Dihydroergotamine (DHE) will be given as weight-based dosing, with no single dose >1mg and not exceeding 3mg over 24 hours. |
| Cross-Over to Dihydroergotamine | Active comparator | Drug: Valproic Acid (VPA), Drug: Dihydroergotamine (DHE)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. |
| Cross-Over to Valproic Acid | Active comparator | Drug: Valproic Acid (VPA), Drug: Dihydroergotamine (DHE)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. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- acute migraine as per ICHD-II criteria
- pediatric (age 10-18)
Key exclusion criteria (13 listed)
- For Valproic Acid (VPA)
- Pregnancy
- Liver disease (Acute or Chronic)
- Urea Cycle Disorder
- Mitochondrial Disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Valproic Acid (VPA)Also: DepakeneIV VPA load 20mg/kg, followed by continuous infusion of 1mg/kg/hr for 24 hours | Drug | Cross-Over to Dihydroergotamine, Cross-Over to Valproic Acid, Valproic Acid |
| 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 | Drug | Cross-Over to Dihydroergotamine, Cross-Over to Valproic Acid, Dihydroergotamine |
Primary outcome
Change in Pain Perception
Time frame: Baseline to 24 hours
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."
3 secondary outcomes
Percentage of Participants With Presence of Photophobia
Time frame: Baseline, 4, 8, 12 and 24 hours
Percentage of Participants With Presence of Phonophobia
Time frame: Baseline, 4, 8, 12 and 24 hours
Percentage of Participants With Presence of Nausea
Time frame: Baseline, 4, 8, 12 and 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Valproic Acid (VPA) and Dihydroergotamine (DHE) in people with Migraine in Children, run by Kimberly S Jones at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Perception (time frame: Baseline to 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2021.