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NCT05446597: SMART
SMART Concussion Trial: Symptom Management vs Alternative Randomized Treatment of Concussion Trial
NA trial testing Symptom-specific Headache Treatment in Mild Traumatic Brain Injury in 164 participants. Status unknown.
30 April 2025
Quick facts
| Lead sponsor | University of Calgary |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 164 |
| Start date | 10 April 2023 |
| Primary completion | 30 April 2025 |
| Estimated completion | 30 April 2025 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- Symptom-specific Headache Treatment
- Symptom-specific Dizziness &/or Neck Pain Treatment
- Multimodal Concussion Treatment
Conditions studied
- Mild Traumatic Brain Injury — all drugs for Mild Traumatic Brain Injury →
- Headaches Posttraumatic — all drugs for Headaches Posttraumatic →
- Neck Pain — all drugs for Neck Pain →
- Dizziness — all drugs for Dizziness →
Sponsor
University of Calgary
Who can join
Adults 13 to 19, any sex, with Mild Traumatic Brain Injury or Headaches Posttraumatic. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Given the rising rates of concussion in youth ages 10-19 and the significant proportion of young people who remain symptomatic for months following concussion, research evaluating the efficacy of multifaceted treatment options following concussion is imperative. Studies examining the efficacy of treatment strategies following concussion in children and adults are surprisingly limited, and most focus on one treatment approach, have small sample sizes, are not randomized controlled trials, and focus on individuals with prolonged recovery (months). There is a need for a multifaceted treatment trial to examine the early implementation of treatment approaches that may reduce prolonged recovery while considering the heterogeneous presentation of symptoms and patient preferences in the sub-acute stage following concussion. Randomized controlled trials that consider a multifaceted transdisciplinary approach to treatment in the early period following concussion are needed to raise the bar regarding evidence-informed management following concussion
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05446597
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other University of Calgary trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05446597 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Calgary
- Last refreshed: 11 September 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05446597.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing