A new combined treatment for post-concussion syndrome: a pilot trial
| ISRCTN | ISRCTN45733939 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45733939 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 1005607 |
| Protocol serial number | 1.0, IRAS 1005607 |
| Sponsor | Durham University |
| Funder | Northern Accelerator |
- Submission date
- 15/03/2022
- Registration date
- 30/03/2022
- Last edited
- 12/05/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Deferred
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Post-concussion syndrome (PCS) is a complex disorder for which there is currently no cure. It is a collection of symptoms that some people develop after they have had a concussion. PCS can profoundly affect quality of life through symptoms such as pressure headache, migraine, dizziness, fatigue, sleep disturbances, blurred vision, and cognitive complaints such as forgetfulness and concentration difficulties. The complexity of PCS presents an ongoing challenge in clinical practice. Current approaches for treating PCS focus on the relief of individual symptoms. This study will investigate the effectiveness of a repurposed drug combination for PCS. This is a pilot trial, which means that it has been designed to provide initial evidence that will be used to inform a future larger trial.
Who can participate?
Patients aged 18 to 64 years with PCS
What does the study involve?
The study involves taking the combined drug intervention daily until PCS resolves or until the end of the 3-month maximum trial duration. There will be two clinic visits and a telephone appointment mid-trial and 2 months after the trial.
What are the possible benefits and risks of participating?
The overall benefit of taking part in this study is that the treatment may improve or resolve PCS. Participants will receive a copy of the overall trial results at the close of the study. As with all drug treatments, there is a risk of side effects. The side effects associated with the drugs used in this study have been reported to be minimal and the drugs are routinely prescribed by clinicians in the UK. Any suspected side effects are to be reported to the clinical lead straight away.
Where is the study run from?
The study is led by Durham University and the lead clinical site is Walkergate Park Centre for Neurorehabilitation and Neuropsychiatry in Newcastle upon Tyne (UK)
When is the study starting and how long is it expected to run for?
July 2021 to December 2025
Who is funding the study?
Northern Accelerator (UK)
Who is the main contact?
paul.chazot@durham.ac.uk
Contact information
Principal investigator
Department of Biosciences
Stockton Road
Durham
DH1 3LE
United Kingdom
 ORCID ID |
0000-0002-5453-0379 |
|---|---|
| Phone | +44 (0)191 334 2000 |
| paul.chazot@durham.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-arm pilot intervention trial |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | A new combined treatment for post-concussion syndrome: a pilot trial |
| Study objectives | An investigational neuroactive combination therapy for post-concussion syndrome (PCS) is effective for the treatment of post-concussion syndrome. |
| Ethics approval(s) |
Approved 23/12/2022, North West - Liverpool Central REC (3rd Floor, Barlow House, 4 Minshull Street, Manchester, M1 3DZ, United Kingdom; +44 (0)207 104 8118; liverpoolcentral.rec@hra.nhs.uk), ref: 22/NW/0285 |
| Health condition(s) or problem(s) studied | Post-concussion syndrome |
| Intervention | 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 treatment intervention. |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Investigational neuroactive combination therapy for PCS |
| Primary outcome measure(s) |
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 |
| Key secondary outcome measure(s) |
Pain and fatigue measured using the visual analogue scale at baseline and week 12 or at full resolution of symptoms, whichever comes first |
| Completion date | 01/12/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 64 Years |
| Sex | All |
| Target sample size at registration | 18 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 16/05/2023 |
| Date of final enrolment | 01/03/2025 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Newcastle upon Tyne
NE6 4QD.
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
12/05/2025: Internal review.
07/02/2025: A retrospective deferral of study information was granted by the HRA on 06/02/2025. IRAS number corrected.
14/10/2024: The following changes were made to the trial record:
1. A contact was removed.
2. The ethics approval was added.
09/09/2024: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/09/2024 to 01/03/2025.
2. The overall end date was changed from 01/06/2025 to 01/12/2025.
3. The plain English summary was updated to reflect these changes.
4. The intention to publish date was changed from 01/01/2026 to 01/06/2026.
01/09/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/09/2023 to 01/09/2024.
2. The overall end date was changed from 30/06/2024 to 01/06/2025.
3. The plain English summary was updated to reflect these changes.
4. The intention to publish date was changed from 01/01/2025 to 01/01/2026.
05/06/2023: The following changes have been made:
1. The recruitment start date has been changed from 16/05/2022 to 16/05/2023.
2. The recruitment end date has been changed from 30/09/2022 to 30/09/2023.
3. The overall study end date has been changed from 30/06/2023 to 30/06/2024 and the plain English summary updated accordingly.
4. The intention to publish date has been changed from 01/01/2024 to 01/01/2025.
28/03/2022: Trial's existence confirmed by the Northern Accelerator.
