Persisting Symptoms After ConcussionPhase 1PatACTNCT06615908
Treatment of Persisting Symptoms After Concussion With Psilocybin Assisted Therapy
A Phase 1 study testing Psilocybin in people with Persisting Symptoms After Concussion, run by University of Calgary at 1 site in Canada.
Trial summary
The goal of this randomized controlled trial is to evaluate the safety, feasibility, and efficacy of psilocybin assisted therapy as an intervention to reduce symptom burden in adult patients (aged 18-65) with persisting symptoms after concussion (PSaC). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Persisting Symptoms After Concussion
- What is being tested?
- Psilocybin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 27 May 2025to 30 Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Individuals of all sexes, gender identities, and ethnicities
- Ages 18 to 65 years at the time of screening
- Diagnosis of concussion based on the 2024 ACRM criteria
- Meet ICD-10 criteria for PSaC for at least 3-months to a maximum of 5 years
- Have an overall RPQ score ≥ 13 with 3 or more symptoms scored ≥3
- Limited lifetime use of serotonergic hallucinogens
- Ability to read/write English
An individual who meets any of the following criteria will be excluded from participation in this study:
- Severe or moderate substance use disorder other than nicotine in past 6 months
- Lifetime diagnosis of schizophrenia or bipolar disorders (or first or second-degree relative)
- Active suicidal ideation or serious attempt within the past 1 year.
- Current pregnancy or nursing, trying to become pregnant
- Any notable abnormality on ECG or routine medical blood laboratory test
- Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycemia
- Epilepsy with a history of seizures
- Current or recent (within 12 weeks) participation in a clinical trial
- Cognitive impairment (SLUMS score <20)
- Suffered a moderate/severe TBI at least once in lifetime
- Any other circumstances that, in the opinion of the investigators, compromises participant safety
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University of Calgary
Calgary, Alberta, T2N 2T9
Chantel T Debert, MD MSc FRCPC CSCN, (403) 944-4500, cdebert@ucalgary.ca
Christina Campbell, MSc, 403-944-8649, PATACTstudy@ucalgary.ca
About this study
Official title: A Randomized Double-blinded Controlled Trial for the Treatment of Persisting Symptoms After Concussion With Psilocybin-assisted Therapy: A Safety and Feasibility Trial
The goal of this randomized controlled trial is to evaluate the safety, feasibility, and efficacy of psilocybin assisted therapy as an intervention to reduce symptom burden in adult patients (aged 18-65) with persisting symptoms after concussion (PSaC).
This trail will test the following 2 aims:
Read more
AIM 1 : To test the safety and feasibility of an active psilocybin-assisted psychotherapy to an active control for patients with PSaC.
AIM 2: To evaluate the efficacy of an active psilocybin-assisted psychotherapy compared to an active control as a treatment for PSaC.
Participants will be asked to:
- Complete a 2-part screening process
- Attend a baseline assessment
- Complete a psychoeducation preparation session(s)
- Attend psilocybin administration session (receive high dose [25mg] or low dose psilocybin [1mg])
- Complete 5 weekly sessions of Acceptance and commitment therapy (ACT)
- Repeat outcome measures at 1-week, 4 weeks, 3 months, and 6 months post-psilocybin administration (online only at 6 months).
Read the detailed description
The overall objective of this study is to evaluate the safety, feasibility, and efficacy of psilocybin assisted therapy administered with Acceptance and Commitment Therapy (ACT) as an intervention to reduce symptom burden in patients with persisting symptoms after concussion (PSaC).
This trail will test the following 2 aims:
AIM 1 : To test the safety and feasibility of an active/high dose (25mg) psilocybin-assisted psychotherapy to an active control (1mg) for adults with PSaC. Safety will be determined through the reporting of adverse events and response following psilocybin for each participant up to 6-months. Feasibility will be determined through recruitment, enrollment, and adherence rates.
AIM 2: To evaluate the efficacy of an active/high dose (25mg) psilocybin-assisted psychotherapy compared to an active control (1mg) as a treatment for PPCS at 1-week, 4 weeks, 3 months, and 6 months post-psilocybin administration. The primary efficacy outcome will be the change in PSaC burden (RPQ).
The secondary efficacy outcomes will include measures of headache, dizziness, mood, anxiety, post-traumatic stress, cognitive flexibility, emotional regulation, and quality of life.
A total of 40 male and female patients between the ages of 18-65 with a diagnosis of mild traumatic brain injury (American College of Rehabilitation Medicine 2023 criteria) who meet criteria for persisting symptoms after concussion (ICD-10) within 3 months to 5 years will be recruited from Calgary brain injury clinics and the community.
All patients will undergo a thorough, 2-part screening procedure. Eligible participants will be randomly allocated 1:1 to either the high dose (20 participants) or low dose (20 participants) psilocybin groups. All participants will be asked to attend a baseline session consisting of clinical and behavioural outcome measures, followed by a pre-dosing psychoeducation session. Following the single dosing session, participants will complete 5 weekly ACT sessions. Outcome measure assessments will be repeated at 1-week, 4 weeks, 3 months, and 6 months post-dosing.
- Conditions
- Persisting Symptoms After Concussion
- Being tested
- Psilocybin
- Keywords
- Psychotherapy, Psilocybin, Concussion, Mild Traumatic Brain Injury, Acceptance and Commitment Therapy
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsilocybinDrug
Also called magic mushrooms, PEX010
See treatment arm description.
| Study group | Role | What they receive |
|---|---|---|
| High dose (25mg) | Experimental | High Dose (25mg) PEX010 (Oral Psilocybin), 25mg; single dose (20 participants) administered 24hrs prior to first ACT session Receives: Drug: Psilocybin |
| Low dose (1mg) | Active comparator | Low Dose (1mg) PEX010 (Oral Psilocybin), 1mg; single dose (20 participants)administered 24hrs prior to first ACT session Receives: Drug: Psilocybin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Safety will be determined based on adverse reactions and symptom reporting (categorized as mild, moderate, and severe)
Measured: Throughout study completion, an average of 6 months
Study protocol efficacy
The primary efficacy outcome is the Rivermead Post-Concussion Symptoms Questionnaire (RPQ).The RPQ assesses the severity of 16 commonly experienced PSaC symptoms using a scale of 0 ("not experienced") to 4 ("severe problem"), with higher scores indicating greater PSaC symptom burden.
Measured: Throughout study completion, an average of 6 months
Study protocol feasibility
The feasibility will be determined based on recruitment (greater than 30% of those screened eligible), attendance (70% intervention appointment attendance), retention (70% complete study protocol)
Measured: Screening, enrolment, intervention, and participation up to study end point (6-months)
Secondary outcomes (14)
Montgomery-Asberg Depression Rating Scale Self report (MADRS-S)
The MADRS is a 10-item assessment of depressive symptoms using a recall period of the past 7 days. Total scores range from 0-60, with higher scores indicating greater depression.
Measured: Throughout study completion, an average of 6 months [assessed at baseline, and 1-week, 4 weeks, 3 months, and 6 months post-dosing]
Generalized Anxiety Disorder-7 (GAD-7).
The GAD-7 is a 7-item tool which assess anxiety. Individuals rate how often they have been bothered by seven listed problems and score their responses from 0 ("not at all") to 3 ("nearly every day"). Total scores for anxiety severity are: 0-4: minimal anxiety; 5-9: mild; 10-14: moderate; 15-21: severe anxiety.
Measured: Throughout study completion, an average of 6 months [assessed at baseline, and 1-week, 4 weeks, 3 months, and 6 months post-dosing]
Sleep and Concussion Questionnaire (SCQ)
During the SCQ-initial, participants use the timeframe of the 6-months prior to the concussion, and since the concussion. The SCQ-follow-up will have a recall period of since the most recent SCQ was completed. Total scores of 0-7 indicate no clinically significant change; 8-15: subclinical change; 16-22: clinical changes of moderate severity; 23-36: clinically severe changes in sleep or wakefulness.
Measured: Throughout study completion, an average of 6 months [assessed at baseline, and 1-week, 4 weeks, 3 months, and 6 months post-dosing]
Headache Impact Test (HIT-6).
This 6-item tool assesses how headache intensity impacts daily life functioning. Headache intensity and frequency are measured from "never" to "always", with greater scores indicating greater impact on daily life function due to headache. Total scores of 49 or less indicate headaches have little to no impact on daily life; 50-55: headaches have some impact on life; 56-59: headaches have substantial impact on life; 60 or more: headaches have severe impact on life.
Measured: Throughout study completion, an average of 6 months [assessed at baseline, and 1-week, 4 weeks, 3 months, and 6 months post-dosing]
Dizziness Handicap Questionnaire (DHI)
A 25-item self-reported questionnaire which assesses the impact of dizziness on daily life. Scores from functional, emotional, and physical domains are summed to give a score between 0-100 with greater scores indicating greater impact.
Measured: Throughout study completion, an average of 6 months [assessed at baseline, and 1-week, 4 weeks, 3 months, and 6 months post-dosing]
PTSD Checklist for DSM-5 (PCL-5)
A 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. Greater symptom scores indicate greater symptom burden
Measured: Throughout study completion, an average of 6 months [assessed at baseline, and 1-week, 4 weeks, 3 months, and 6 months post-dosing]
The Quality of Life after Brain Injury (QOLIBRI)
This questionnaire measures health-related quality of life specific to individuals after traumatic brain injury. Covers six domains of health-related quality of life (cognition, self, daily life and autonomy, social relationships, emotions, and physical problems) to provide an overall score, with higher scores indicating greater quality of life.
Measured: Throughout study completion, an average of 6 months [assessed at baseline, and 1-week, 4 weeks, 3 months, and 6 months post-dosing]
Difficulties in Emotion Regulation Scale (DERS)
A 36-item self-report scale designed to assess multiple aspects of emotion dysregulation. Six subscale scores and a total score are calculated.
Measured: Throughout study completion, an average of 6 months [assessed at baseline, and 1-week, 4 weeks, 3 months, and 6 months post-dosing]
Think Aloud Task
The Thinking Aloud Task (TAT) measures cognitive flexibility in relation to thought dynamics, tapping into the speed and expansiveness of thoughts, which relate to real-time emotion regulation and overall social and emotional well-being.
Measured: Throughout study completion, an average of 6 months [assessed at baseline, and 1-week, 4 weeks, and 3 months post-dosing]
Probabilistic Reversal Learning Task
The Probabilistic Reversal Learning (PRL) task is a measure of reward-related cognitive flexibility that requires participants to choose a shape that fits an inferred rule and adapt behavior once rules switch
Measured: Throughout study completion, an average of 6 months [assessed at baseline, and 1-week, 4 weeks, and 3 months post-dosing]
The Acceptance and Action Questionnaire II (AAQ-II)
A 7-item questionnaire measuring psychological flexibility. Scores range from 0 to 49 with higher scores indicating greater psychological flexibility
Measured: Throughout study completion, an average of 6 months [assessed at baseline, and 1-week, 4 weeks, 3 months, and 6 months post-dosing]
The Acceptance and Action after Brain Injury Questionnaire (AAQ-ABI)
A 7-item questionnaire which measures psychological flexibility about the thoughts and feelings related to brain injury. Scored on a 5-point Likert scale, scores range from 0-36 with higher scores indicating greater psychological flexibility
Measured: Throughout study completion, an average of 6 months [assessed at baseline, and 1-week, 4 weeks, 3 months, and 6 months post-dosing]
Cognitive Fusion Questionnaire (CFQ-7)
A 7-point Likert scale measuring cognitive fusion. Scores range from 0 to 49 with higher scores indicating greater fusion with one's thoughts.
Measured: Throughout study completion, an average of 6 months [assessed at baseline, and 1-week, 4 weeks, 3 months, and 6 months post-dosing]
Bergs Card Sorting Task
Cognitive flexibility task - Participants must select the stimulus that is different from others based on feedback and adapt their responses once the criteria for correct choice switches. Perseverative errors are defined as the number of instances in which three incorrect responses are made based on a previous rule, and they are thought to reflect less cognitive flexibility (or cognitive rigidity)
Measured: Throughout study completion, an average of 6 months [assessed at baseline, and 1-week, 4 weeks, and 3 months post-dosing]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start27 May 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persisting Symptoms After ConcussionStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blinded randomized control trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- University of British Columbia
- Responsible party
- Sponsor
- Investigators
- Chantel T Debert, MD MSc FRCPC, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06615908
- Sponsor's protocol ID
- REB24-0334
- Acronym
- PatACT
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2024
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-blinded Controlled Trial for the Treatment of Persisting Symptoms After Concussion With Psilocybin-assisted Therapy: A Safety and Feasibility Trial
- ClinicalTrials.gov ID
- NCT06615908
- Acronym / sponsor ID
- PatACT / REB24-0334
- Conditions
- Persisting Symptoms After Concussion
- Keywords
- Psychotherapy, Psilocybin, Concussion, Mild Traumatic Brain Injury, Acceptance and Commitment Therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- University of British Columbia
- Study start
- 27 May 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 27 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this randomized controlled trial is to evaluate the safety, feasibility, and efficacy of psilocybin assisted therapy as an intervention to reduce symptom burden in adult patients (aged 18-65) with persisting symptoms after concussion (PSaC).
This trail will test the following 2 aims:
AIM 1 : To test the safety and feasibility of an active psilocybin-assisted psychotherapy to an active control for patients with PSaC.
AIM 2: To evaluate the efficacy of an active psilocybin-assisted psychotherapy compared to an active control as a treatment for PSaC.
Participants will be asked to:
- Complete a 2-part screening process
- Attend a baseline assessment
- Complete a psychoeducation preparation session(s)
- Attend psilocybin administration session (receive high dose [25mg] or low dose psilocybin [1mg])
- Complete 5 weekly sessions of Acceptance and commitment therapy (ACT)
- Repeat outcome measures at 1-week, 4 weeks, 3 months, and 6 months post-psilocybin administration (online only at 6 months).
Detailed description
The overall objective of this study is to evaluate the safety, feasibility, and efficacy of psilocybin assisted therapy administered with Acceptance and Commitment Therapy (ACT) as an intervention to reduce symptom burden in patients with persisting symptoms after concussion (PSaC).
This trail will test the following 2 aims:
AIM 1 : To test the safety and feasibility of an active/high dose (25mg) psilocybin-assisted psychotherapy to an active control (1mg) for adults with PSaC. Safety will be determined through the reporting of adverse events and response following psilocybin for each participant up to 6-months. Feasibility will be determined through recruitment, enrollment, and adherence rates.
AIM 2: To evaluate the efficacy of an active/high dose (25mg) psilocybin-assisted psychotherapy compared to an active control (1mg) as a treatment for PPCS at 1-week, 4 weeks, 3 months, and 6 months post-psilocybin administration. The primary efficacy outcome will be the change in PSaC burden (RPQ).
The secondary efficacy outcomes will include measures of headache, dizziness, mood, anxiety, post-traumatic stress, cognitive flexibility, emotional regulation, and quality of life.
A total of 40 male and female patients between the ages of 18-65 with a diagnosis of mild traumatic brain injury (American College of Rehabilitation Medicine 2023 criteria) who meet criteria for persisting symptoms after concussion (ICD-10) within 3 months to 5 years will be recruited from Calgary brain injury clinics and the community.
All patients will undergo a thorough, 2-part screening procedure. Eligible participants will be randomly allocated 1:1 to either the high dose (20 participants) or low dose (20 participants) psilocybin groups. All participants will be asked to attend a baseline session consisting of clinical and behavioural outcome measures, followed by a pre-dosing psychoeducation session. Following the single dosing session, participants will complete 5 weekly ACT sessions. Outcome measure assessments will be repeated at 1-week, 4 weeks, 3 months, and 6 months post-dosing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blinded randomized control trial
| Arm | Type | Receives |
|---|---|---|
| High dose (25mg) | Experimental | Drug: PsilocybinHigh Dose (25mg) PEX010 (Oral Psilocybin), 25mg; single dose (20 participants) administered 24hrs prior to first ACT session |
| Low dose (1mg) | Active comparator | Drug: PsilocybinLow Dose (1mg) PEX010 (Oral Psilocybin), 1mg; single dose (20 participants)administered 24hrs prior to first ACT session |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| PsilocybinAlso: magic mushrooms, PEX010See treatment arm description. | Drug | High dose (25mg), Low dose (1mg) |
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Throughout study completion, an average of 6 months
Safety will be determined based on adverse reactions and symptom reporting (categorized as mild, moderate, and severe)
Study protocol efficacy
Time frame: Throughout study completion, an average of 6 months
The primary efficacy outcome is the Rivermead Post-Concussion Symptoms Questionnaire (RPQ).The RPQ assesses the severity of 16 commonly experienced PSaC symptoms using a scale of 0 ("not experienced") to 4 ("severe problem"), with higher scores indicating greater PSaC symptom burden.
Study protocol feasibility
Time frame: Screening, enrolment, intervention, and participation up to study end point (6-months)
The feasibility will be determined based on recruitment (greater than 30% of those screened eligible), attendance (70% intervention appointment attendance), retention (70% complete study protocol)
14 secondary outcomes
Montgomery-Asberg Depression Rating Scale Self report (MADRS-S)
Time frame: Throughout study completion, an average of 6 months [assessed at baseline, and 1-week, 4 weeks, 3 months, and 6 months post-dosing]
Generalized Anxiety Disorder-7 (GAD-7).
Time frame: Throughout study completion, an average of 6 months [assessed at baseline, and 1-week, 4 weeks, 3 months, and 6 months post-dosing]
Sleep and Concussion Questionnaire (SCQ)
Time frame: Throughout study completion, an average of 6 months [assessed at baseline, and 1-week, 4 weeks, 3 months, and 6 months post-dosing]
Headache Impact Test (HIT-6).
Time frame: Throughout study completion, an average of 6 months [assessed at baseline, and 1-week, 4 weeks, 3 months, and 6 months post-dosing]
Dizziness Handicap Questionnaire (DHI)
Time frame: Throughout study completion, an average of 6 months [assessed at baseline, and 1-week, 4 weeks, 3 months, and 6 months post-dosing]
PTSD Checklist for DSM-5 (PCL-5)
Time frame: Throughout study completion, an average of 6 months [assessed at baseline, and 1-week, 4 weeks, 3 months, and 6 months post-dosing]
The Quality of Life after Brain Injury (QOLIBRI)
Time frame: Throughout study completion, an average of 6 months [assessed at baseline, and 1-week, 4 weeks, 3 months, and 6 months post-dosing]
Difficulties in Emotion Regulation Scale (DERS)
Time frame: Throughout study completion, an average of 6 months [assessed at baseline, and 1-week, 4 weeks, 3 months, and 6 months post-dosing]
Think Aloud Task
Time frame: Throughout study completion, an average of 6 months [assessed at baseline, and 1-week, 4 weeks, and 3 months post-dosing]
Probabilistic Reversal Learning Task
Time frame: Throughout study completion, an average of 6 months [assessed at baseline, and 1-week, 4 weeks, and 3 months post-dosing]
The Acceptance and Action Questionnaire II (AAQ-II)
Time frame: Throughout study completion, an average of 6 months [assessed at baseline, and 1-week, 4 weeks, 3 months, and 6 months post-dosing]
The Acceptance and Action after Brain Injury Questionnaire (AAQ-ABI)
Time frame: Throughout study completion, an average of 6 months [assessed at baseline, and 1-week, 4 weeks, 3 months, and 6 months post-dosing]
Cognitive Fusion Questionnaire (CFQ-7)
Time frame: Throughout study completion, an average of 6 months [assessed at baseline, and 1-week, 4 weeks, 3 months, and 6 months post-dosing]
Bergs Card Sorting Task
Time frame: Throughout study completion, an average of 6 months [assessed at baseline, and 1-week, 4 weeks, and 3 months post-dosing]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- 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.
Chantel T Debert, MD MSc FRCPC principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Psilocybin in people with Persisting Symptoms After Concussion, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: looking for participants now, as of the sponsor's last update on 9 Sep 2026. 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 Canada. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chantel T Debert, MD MSc FRCPC ((403) 944-4500, cdebert@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: Throughout study completion, an average of 6 months). The study lists 3 primary outcomes in all. 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 9 Sep 2026.