Ketamine infusion for Chronic Daily Headache

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Chronic Daily HeadacheKetamine - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is a multicenter, placebo-controlled, parallel group randomized trial with blinding of participants and observers with the goal of comprehensively assessing the effect of high-dose IV ketamine infusion (1 mg.kg-1.h-1 for six hours) on the frequency and intensity of headaches, mood, activity, sleep, quality of life and safety of ketamine for three months after the interventions.

Eligible Conditions
  • Chronic Daily Headache

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 14 Secondary · Reporting Duration: At 1 month, 2 months and 3 months

Month 3
Impact after ketamine infusion on daily activity
Impact of ketamine infusion on analgesic consumption
Impact of ketamine infusion on patient satisfaction
Impact of ketamine on headache duration after infusion
Impact of ketamine on headache frequency after infusion
Impact of ketamine on headache intensity after infusion
Impact of on emotional well being (for catastrophizing) after ketamine infusion
Anxiety
Impact of on emotional well being for depression after ketamine infusion
Impact on physical activity after ketamine infusion
Impact on quality of life after ketamine infusion
Impact on quality of sleep after ketamine infusion
Impact on sleep efficiency after ketamine infusion
At 4 weeks
Difference in headache days between the 2 groups
Immediately after the infusion
Side effects after ketamine infusion

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Ketamine infusion
1 of 2
Placebo infusion
1 of 2

Active Control

Non-Treatment Group

56 Total Participants · 2 Treatment Groups

Primary Treatment: Ketamine infusion · Has Placebo Group · Phase 3

Placebo infusion
Other
PlaceboComparator Group · 1 Intervention: 0.9% Saline · Intervention Types: Other
Ketamine infusion
Drug
ActiveComparator Group · 1 Intervention: Ketamine · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at 1 month, 2 months and 3 months

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,380 Previous Clinical Trials
473,383 Total Patients Enrolled
The Canadian Pain SocietyOTHER
3 Previous Clinical Trials
305 Total Patients Enrolled
PfizerIndustry Sponsor
4,304 Previous Clinical Trials
7,094,723 Total Patients Enrolled
Yasmine Hoydonckx, MD, FIPPPrincipal InvestigatorUniversity Health Network, Toronto
Yasmine Hoydonckx, MD, MSc, FIPPPrincipal InvestigatorUniversity Health Network, Toronto

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You must be between the ages of 18 and 65 years old.
You have headache episodes lasting for 4 or more hours occurring on 15 or more days in a month for 3 or more months.