Valproic Acid and Dihydroergotamine as Abortive Therapy in Pediatric Migraine

NCT03885154 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: 44243
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Migraine in Children

Keywords

Migraine; Headache; Valproic acid; Dihydroergotamine; Pediatric

Outcome Measures

Primary Outcomes (1)

• 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."

  Baseline to 24 hours

Secondary Outcomes (3)

• Percentage of Participants With Presence of Photophobia

  Baseline, 4, 8, 12 and 24 hours

• Percentage of Participants With Presence of Phonophobia

  Baseline, 4, 8, 12 and 24 hours

• Percentage of Participants With Presence of Nausea

  Baseline, 4, 8, 12 and 24 hours

Study Arms (4)

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.

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.

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.

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.

Drug: Valproic Acid (VPA); Drug: Dihydroergotamine (DHE)

Interventions

Valproic Acid (VPA) DRUG

IV VPA load 20mg/kg, followed by continuous infusion of 1mg/kg/hr for 24 hours

Also known as: Depakene

Cross-Over to Dihydroergotamine; Cross-Over to Valproic Acid; Valproic Acid

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

Cross-Over to Dihydroergotamine; Cross-Over to Valproic Acid; Dihydroergotamine

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• acute migraine as per ICHD-II criteria
• pediatric (age 10-18)

You may not qualify if:

• For Valproic Acid (VPA)
• Pregnancy
• Liver disease (Acute or Chronic)
• Urea Cycle Disorder
• Mitochondrial Disease
• For Dihydroergotamine (DHE)
• 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

Sponsors & Collaborators

• Kimberly S Jones: lead

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Migraine Disorders; Headache

Interventions

Valproic Acid; Dihydroergotamine

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids; Ergotamines; Ergot Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Kimberly Jones, MD
• Organization: University of Kentucky

kimberly.jones@uky.edu

859-218-5011

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Neurology and Pediatrics

Study Record Dates

• First Submitted: March 20, 2019
• First Posted: March 21, 2019
• Study Start: October 3, 2017
• Primary Completion: March 19, 2019
• Study Completion: March 19, 2019
• Last Updated: October 7, 2021
• Results First Posted: October 7, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)