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| The pharmacological treatment of nystagmus |
| Source of record | UK Trials |
| ISRCTN | ISRCTN58592532 |
| Date ISRCTN assigned | 05/12/2007 |
| Local reference number(s) | Version 2 October 2007 |
| Public title | The pharmacological treatment of nystagmus |
| Scientific title | Pharmacological treatment of nystagmus: a randomised double masked, placebo-controlled crossover study using gabapentin and mematine |
| Acronym | N/A |
| Disease/condition/study domain | Nystagmus |
| Study hypothesis | Nystagmus consists of involuntary to and fro eye movements and severely affects visual function. It occurs in approximately 2.4 in 1000 people. It can be congenital idiopathic, due to retinal diseases and low vision, or associated with neurological diseases. Nystagmus is one of the most distressing eye disorders with symptoms causing blurred vision and oscillopsia (illusory motion of the environment). To date, there is little knowledge in the treatment of nystagmus. Our hypothesis is that congenital and acquired nystagmus can be treated pharmacologically. Research questions: 1. How do memantine and gabapentin compare for treatment of nystagmus? 2. Is there a specific nystagmus form, which responds better to pharmacological treatment with memantine or gabapentin? Please note that the pilot study to this trial is assigned to ISRCTN65414827: Pharmacological Treatment of Congenital Nystagmus (see http://www.controlled-trials.com/ISRCTN65414827). |
| Design/methodology | Randomised, single-centre, double-masked placebo controlled crossover study |
| Research ethics review | We plan to submit to the Leicestershire Local Research Ethics Commitees. The application is currently being looked over by the University Hospital Leicester Research and Development (UHL R&D) office (our sponsor) to ensure the application is complete and then we will submit to the ethics committee. |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Patients with congenital or acquired nystagmus 2. Over the age of 16 years |
| Participants - exclusion criteria | 1. Contraindication for gabapentin or memantine such as epilepsy, renal impairment, pregnancy or breast-feeding 2. For women of childbearing potential, a pregnancy test will be performed and documentation of adequate contraception during the study drug administration will be obtained 3. Patients on medication incompatible with gabapentin or memantine, such as amantadin |
| Patient information material | |
| Anticipated start date | 01/01/2008 |
| Anticipated end date | 01/01/2013 |
| Status of trial | Ongoing |
| Target number of participants | 180 patients with nystagmus |
| Interventions | 180 patients with nystagmus (45 with Idiopathic Infantile Nystagmus [IIN], 45 with nystagmus secondary to albinism, 45 with nystagmus secondary to other eye diseases and 45 with acquired nystagmus) were recruited. Gabapentin, memantine and placebo will be administered (orally) in random order with 6 week wash out periods in between according to the following scheme: 1. Gabapentin (300 mg units): Day 0: Examination Day 1 - 5: 600 mg/day in two divided doses Day 6 - 10: 900 mg/day in three divided doses Day 11 - 15: 1200 mg/day in three divided doses Day 15: Examination Day 16 - 57: 1200 mg/day in three divided doses Day 57: Examination Day 58 - 62: 1500 mg/day in three divided doses Day 63 - 67: 1800 mg/day in three divided doses Day 68 - 72: 2100 mg/day in three divided doses Day 73 - 77: 2400 mg/day in three divided doses Day 77: Examination Day 78 - 119: 2400 mg/day in three divided doses Day 119: Examination 2. Memantine (5 mg units): Day 0: Examination Day 1 - 5: 10 mg/day in two divided doses Day 6 - 10: 15 mg/day in three divided doses Day 11 - 15: 20 mg/day in three divided doses Day 15: Examination Day 16 - 57: 20 mg/day in three divided doses Day 57: Examination Day 58 - 62: 25 mg/day in three divided doses Day 63 - 67: 30 mg/day in three divided doses Day 68 - 72: 35 mg/day in three divided doses Day 73 - 77: 40 mg/day in three divided doses Day 77: Examination Day 78 - 119: 40 mg/day in three divided doses Day 119: Examination Placebo will follow the same regime. The same number of capsules will be administered as the active medication at each point in the scheme. Total duration time of all treatment arms and washout periods will be 483 days (119 per drug with a washout period of 42 days per drug). Patients will be followed up at just 6 weeks after taking the last medication of the final arm to which they are randomised. |
| Primary outcome measure(s) | Change in distance in Logarithm of the Minimum Angle of Resolution (LogMAR) visual acuity between memantine, gabapentin and placebo. Each of the primary and secondary outcomes will be measured at day 0, 15, 57, 77 and 119 of each treatment arm. |
| Secondary outcome measure(s) | 1. Change in near LogMAR visual acuity between memantine, gabapentin and placebo 2. Change in nystagmus intensity (expanded Nystagmus Acuity Function [NAFX]) function and reading speed will be evaluated as described above at 1.2 m for the different fixation points tested and at near for null point between memantine and gabapentin and placebo 3. Subjective changes in visual function by self-assessment on Visual Function 14 (VF14) questionnaire between memantine and gabapentin and placebo Each of the primary and secondary outcomes will be measured at day 0, 15, 57, 77 and 119 of each treatment arm. |
| Sources of funding | The Childrens Research Fund (UK) |
| Sponsor name | University Hospitals of Leicester (UK) |
| Sponsor details | c/o John Hampton Research and Development Leicester General Hospital Leicester United Kingdom LE5 4PW |
| Sponsor telephone | +44 (0)116 249 0490 |
| Sponsor fax | +44 (0)116 258 4666 |
| Sponsor email | john.hampton@uhl-tr.nhs.uk |
| Sponsor website | http://www.uhl-tr.nhs.uk/ |
| Contact name | Prof Irene Gottlob |
| Contact details | University of Leicester Ophthalmology Group RKCSB Leicster Royal Infirmary Leicester United Kingdom LE2 7LX |
| Contact telephone | +44 (0)116 258 6291 |
| Contact fax | +44 (0)116 255 8810 |
| Contact email | ig15@le.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN58592532 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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