Post-concussion syndrome Mental and Behavioural Disorders Postconcussional syndrome
Conditions
Interventions
The treatment comprises two generic drugs in tablet form, to be taken with water, three times daily until PCS resolves or the end of the 3-month trial duration. All participants will receive the treat
Sponsors
Durham University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. PCS patients, aged 18 to 64 years. PCS is defined as the persistence of concussion symptoms, for more than 3 months after the initial concussion event 2. Current PCS confirmed by the presence of more than three symptoms on the Rivermead PCS 3. Not using any other pharmaceutical treatment for the management of PCS, e.g. antidepressants 4. Can provide signed informed consent
Exclusion criteria
Exclusion criteria: 1. Pregnancy 2. Breastfeeding 3. Hepatic insufficiency 4. Renal impairment 5. Any of the following BNF contraindications: acute porphyrias; epilepsy; Parkinson's disease; prostatic hypertrophy; pyloroduodenal obstruction; susceptibility to angle-closure glaucoma; urinary retention 6. Any of the following BNF contraindications: gastric ulcer; history of haemorrhagic stroke; increased risk of bleeding; recent or planned major surgery; underlying disorders of haemostasis; cerebral haemorrhage; Huntington's chorea
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The presence of post-concussion measured using the Rivermead Post Concussion Syndrome Questionnaire at baseline and week 12 or at full resolution of symptoms, whichever comes first | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain and fatigue measured using the visual analogue scale at baseline and week 12 or at full resolution of symptoms, whichever comes first | — |
Countries
England, United Kingdom
Outcome results
None listed