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Prokinetic Agent

IV Metoclopramide for Post-Concussive Headache

N/A
Waitlist Available
Led By David W Harrison, MD
Research Sponsored by Vancouver General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Immediate and transient post traumatic impairment of neurological functions defined as alteration of consciousness, amnesia, disorientation, disturbance of vision or equilibrium
Onset of headache within one hour of trauma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial will help determine if metoclopramide is effective in treating concussion headaches and preventing long-term symptoms.

Who is the study for?
This trial is for adults over 19 who've had a concussion with headaches starting within an hour of the injury, in the last 24 hours. It's not for those with seizures, pregnancy, drug/alcohol-induced CNS depression, metoclopramide allergy, severe GI issues, pheochromocytoma (a type of tumor), psychiatric treatments or serious brain injuries on CT scans.Check my eligibility
What is being tested?
The study tests if metoclopramide can relieve post-concussive headaches and prevent post-concussion syndrome when given intravenously. Participants will be randomly assigned to receive either this drug or a saltwater placebo and followed up by phone after 1, 4, and 8 weeks.See study design
What are the potential side effects?
Metoclopramide may cause side effects like fatigue, restlessness, sleepiness; rarely it can lead to more serious conditions such as movement disorders or changes in blood pressure. The placebo group risks no active medication side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I experienced temporary confusion or memory loss after a head injury.
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I started having headaches within an hour after an injury.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The of acute PCH relief will be determined by measuring the difference between VAS score at baseline and after the last dose of study drug.
Secondary outcome measures
The of PCS will be measured by telephone questionnaire using the Rivermead Post Concussion Symptoms Questionnaire at 1, 4 and 8 weeks after injury

Find a Location

Who is running the clinical trial?

Vancouver General HospitalLead Sponsor
40 Previous Clinical Trials
19,575 Total Patients Enrolled
David W Harrison, MDPrincipal InvestigatorUniversity of British Columbia

Media Library

Metoclopramide (Prokinetic Agent) Clinical Trial Eligibility Overview. Trial Name: NCT00237705 — N/A
Post Concussive Headache Research Study Groups:
Post Concussive Headache Clinical Trial 2023: Metoclopramide Highlights & Side Effects. Trial Name: NCT00237705 — N/A
Metoclopramide (Prokinetic Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00237705 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this scientific experiment have any additional vacancies for participants?

"Contrary to what is listed on clinicaltrials.gov, this particular trial does not have current openings for participants. It was first posted in May of 2004 and most recently updated two years later in December 2006. Notwithstanding that fact, there are 153 other active studies at this time searching for individuals willing to take part."

Answered by AI
~2 spots leftby Apr 2025