Trial · NCT05306899
Multi-center RCT of IV Ketamine Efficacy and Safety in Chronic Daily Headaches
NCT05306899, Phase 3, Recruiting, University Health Network, Toronto
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Multi-center RCT of IV Ketamine Efficacy and Safety in Chronic Daily Headaches. Trials, record NCT05306899. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05306899
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Multi-center RCT of IV Ketamine Efficacy and Safety in Chronic Daily Headaches
- NCT number
- NCT05306899
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 56 participants, estimated
- Lead sponsor
- University Health Network, Toronto
- Conditions
- Chronic Daily Headache
- Interventions
- Ketamine, 0.9% Saline
- First posted
- 2022-04-01
- Last updated
- 2026-06-08
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Difference in headache days between the 2 groups | At 4 weeks | Between-group difference in the number of headache days in the first 4 weeks after the infusion. (Defined as a day in which the headache lasts 4 or more hours, or a headache of any duration for which abortive treatment (anti-inflammatories, triptans, ergot derivatives, opioids) are taken. Patients will be asked to keep track of their headache days in a diary) |
| Secondary | Impact of ketamine on headache intensity after infusion | At 1 month, 2 months and 3 months | Impact of ketamine on headache intensity at one month (4 weeks), two month (week 5-8) and three month (week 9-12) month after infusion, using Numerical Rating Scale (0-10) |
| Secondary | Impact of ketamine on headache frequency after infusion | At 1 month, 2 months and 3 months | Impact of ketamine on headache frequency at one month (4 weeks), two month (week 5-8) and three month (week 9-12) month after infusion, as number of headache episodes per day |
| Secondary | Impact of ketamine on headache duration after infusion | At 1 month, 2 months and 3 months | Impact of ketamine on duration of headache at one month (4 weeks), two month (week 5-8) and three month (week 9-12) month after infusion, from the headache diary maintained by patient |
| Secondary | Impact on sleep efficiency after ketamine infusion | At 1 month, 2 months and 3 months | Impact of ketamine on efficiency of sleep at one month (4 weeks), two month (week 5-8) and three month (week 9-12) month after infusion, measured with an actigraphy device |
| Secondary | Impact on quality of sleep after ketamine infusion | At 1 month, 2 months and 3 months | Impact of ketamine on quality of sleepat one month (4 weeks), two month (week 5-8) and three month (week 9-12) month after infusion, assessed with the PSQI (Pittsburgh Sleep Quality Index) questionnaire |
| Secondary | Impact on physical activity after ketamine infusion | At 1 month, 2 months and 3 months | Impact of ketamine on physical activity at one month (4 weeks), two month (week 5-8) and three month (week 9-12) month after infusion, measured with actigraphy device |
| Secondary | Impact after ketamine infusion on daily activity | At 1 month, 2 months and 3 months | Impact of ketamine on seven daily activities (e.g. general activity, walking, mood etc.) at one month (4 weeks), two month (week 5-8) and three month (week 9-12) month after infusion, measured with Brief Pain Inventory (BPI) scale |
| Secondary | Impact of on emotional well being (for catastrophizing) after ketamine infusion | At 1 month, 2 months and 3 months | Impact of ketamine on emotional well being at one month (4 weeks), two month (week 5-8) and three month (week 9-12) month after infusion, using the PCS (pain catastrophizing scale) scale |
| Secondary | Impact of on emotional well being for anxiety after ketamine infusion | At 1 month, 2 months and 3 months | Impact of ketamine on emotional well being at one month (4 weeks), two month (week 5-8) and three month (week 9-12) month after infusion, using anxiety (GAD7- Generalized Anxiety Disorder-7) scale |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05306899
GET https://conductscience.org/api/trials/v1/NCT05306899/registered