Pharmacological Treatment of Congenital Nystagmus
| ISRCTN | ISRCTN65414827 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65414827 |
| Protocol serial number | N0123112717 |
| Sponsor | University Hospitals Leicester (UK) |
| Funders | Nystagmus Network UK, Ulverscroft Foundation, University Hospitals of Leicester NHS Trust |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 19/04/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Irene Gottlob
Scientific
Scientific
University Hospitals of Leicester
c/o Research and Development Office
Leicester General Hospital NHS Trust
Leicester
LE1 4PW
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Placebo controlled randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | PTCN |
| Study objectives | To investigate whether memantine and gabapentin improve nystagmus. |
| Ethics approval(s) | Leicestershire Ethics Committee |
| Health condition(s) or problem(s) studied | Nystagmus |
| Intervention | Administration of gabapentin, memantine or a placebo |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Memantine and gabapentin |
| Primary outcome measure(s) |
Visual acuity |
| Key secondary outcome measure(s) |
Nystagmus amplitude |
| Completion date | 01/03/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 48 |
| Key inclusion criteria | 1. Congenital nystagmus 2. Over 18 years of age |
| Key exclusion criteria | 1. Other neurological condition 2. Pregnancy or breastfeeding 3. Unable or unwilling to give consent |
| Date of first enrolment | 01/08/2004 |
| Date of final enrolment | 01/03/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
University Hospitals of Leicester
Leicester
LE1 4PW
United Kingdom
LE1 4PW
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 01/02/2007 | Yes | No |