Open-label pilot study of memantine in chronic cough patients attending a specialist clinic
| ISRCTN | ISRCTN99941214 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN99941214 |
| EudraCT/CTIS number | 2011-005151-13 |
| Secondary identifying numbers | 12508 |
- Submission date
- 05/09/2012
- Registration date
- 10/09/2012
- Last edited
- 23/06/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Plain English summary of protocol
Background and study aims
People cough in order to clear their airways. Most coughs are caused by viruses and settle down by themselves, but some people develop persistent coughing which can last for many years. This is called chronic cough. People with chronic cough find the symptom very upsetting and it can have a major impact on their quality of life. There are currently no effective treatments for chronic cough. This study aims to investigate whether a drug called Memantine helps to reduces coughing. Memantine is a similar medication to that found in many over the counter treatments for cough (Dextromethorphan). Memantine is currently licensed to treat patients with Alzheimer’s disease. It has never been tested on patients with chronic cough.
Who can participate?
People aged 18 - 90 with chronic cough.
What does the study involve?
Fifteen patients attending the specialist chronic cough service at Wythenshawe Hospital will be invited to attend the North West Lung Research Centre up to 7 times over a maximum 8-week period. During the course of the study they will be asked to take increasing doses of Memantine, have a blood test, electrocardiogram (recording the electrical activity of the heart), undergo 24-hour cough monitoring, and answer cough-related questionnaires.
What are the possible benefits and risks of participating?
Not provided at time of registration.
Where is the study run from?
North West Lung Research Centre at Wythenshawe Hospital (UK).
When is the study starting and how long is it expected to run for?
September 2012 to March 2013.
Who is funding the study?
Medical Research Council (UK).
Who is the main contact?
Danielle Yuill
danielle.yuill@manchester.ac.uk
Contact information
Scientific
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom
| danielle.yuill@manchester.ac.uk |
Study information
| Study design | Non-randomised interventional trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Open-label pilot study of memantine in chronic cough patients attending a specialist clinic |
| Study objectives | This study aims to investigate whether a drug called Memantine helps to reduces coughing. More details can be found at http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=12508 |
| Ethics approval(s) | NRES Committee North West - Haydock, 20/12/2011 ref: 11/NW/0840 |
| Health condition(s) or problem(s) studied | Chronic cough |
| Intervention | Memantine, escalating dose from 10 mg/day to 40 mg/day |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Memantine |
| Primary outcome measure | To evaluate the change in objectively recorded cough frequency in chronic cough patients after treatment |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 03/09/2012 |
| Completion date | 01/03/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 90 Years |
| Sex | Both |
| Target number of participants | UK Sample Size: 15 |
| Total final enrolment | 14 |
| Key inclusion criteria | 1. Chronic cough (>8 weeks) 2. Normal chest x-ray 3. FEV1 and FVC >70% predicted measured using spirometry 4. Idiopathic or treatment resistant chronic cough, defined as a cough for which no objective evidence of an underlying trigger can be determined after routine clinical investigation (idiopathic) or a cough that did not respond to standard treatment for identified underlying triggers (treatment-resistant) 5. Females will be non-pregnant and non-lactating with no intention of pregnancy during study treatment 6. Male and female participants aged 18 - 90 years |
| Key exclusion criteria | 1. Recent upper respiratory tract infection (<4 weeks) 2. Pregnancy/breastfeeding. Women of childbearing potential (not >2 years postmenopausal and/or not surgically sterilised) must have a negative blood serum pregnancy test, performed at visit 1 prior to administration of study medication 3. Current smokers or ex-smokers with <6 months abstinence or cumulative history of >10 pack years 4. Current treatment with ACE inhibitors 5. Drug or alcohol abuse 6. Uncontrolled hypertension (i.e., >140/90 mmHg despite adequate medical therapy) 7. Recent myocardial infarction, or history of congestive cardiac failure 8. Any clinically significant neurological disorder 9. Prior renal transplant, current renal dialysis, patients with creatinine clearance <30ml/min or history of renal tubular acidosis 10. Severe hepatic impairment 11. Fructose intolerance 12. Any clinically significant or unstable medical or psychiatric condition that would interfere with the patient's ability to participate in the study |
| Date of first enrolment | 03/09/2012 |
| Date of final enrolment | 01/03/2013 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
M23 9LT
United Kingdom
Sponsor information
Hospital/treatment centre
Wythenshawe Hospital
Southmoor Road
Wythenshawe
Manchester
M23 9LT
England
United Kingdom
| Website | http://www.uhsm.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/00he80998 |
Funders
Funder type
Research council
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 23/06/2020 | No | No | ||
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
23/06/2020: The following changes were made to the trial record:
1. Added clinicaltrialsregister.eu link to basic results (scientific).
2. The total final enrollment was added.
07/12/2017: No publications found in PubMed, verifying study status with principal investigator.
