Pharmacological Treatment of Congenital Nystagmus
| ISRCTN | ISRCTN65414827 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65414827 |
| Secondary identifying numbers | N0123112717 |
- 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
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
| Study design | Placebo controlled randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | PTCN |
| Study hypothesis | To investigate whether memantine and gabapentin improve nystagmus. |
| Ethics approval(s) | Leicestershire Ethics Committee |
| Condition | Nystagmus |
| Intervention | Administration of gabapentin, memantine or a placebo |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Memantine and gabapentin |
| Primary outcome measure | Visual acuity |
| Secondary outcome measures | Nystagmus amplitude |
| Overall study start date | 01/08/2004 |
| Overall study end date | 01/03/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 48 |
| Participant inclusion criteria | 1. Congenital nystagmus 2. Over 18 years of age |
| Participant exclusion criteria | 1. Other neurological condition 2. Pregnancy or breastfeeding 3. Unable or unwilling to give consent |
| Recruitment start date | 01/08/2004 |
| Recruitment end date | 01/03/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University Hospitals of Leicester
Leicester
LE1 4PW
United Kingdom
LE1 4PW
United Kingdom
Sponsor information
University Hospitals Leicester (UK)
University/education
University/education
Gwendolen House
Gwendolen Road
Leicester
LE5 4QF
England
United Kingdom
"ROR" |
https://ror.org/02fha3693 |
|---|
Funders
Funder type
Charity
Nystagmus Network UK
No information available
Ulverscroft Foundation
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Location
- United Kingdom
University Hospitals of Leicester NHS Trust
No information available
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? |
|---|---|---|---|---|---|
| Results article | Results | 01/02/2007 | Yes | No |
