Condition category
Eye Diseases
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
19/04/2007
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Irene Gottlob

ORCID ID

Contact details

University Hospitals of Leicester
c/o Research and Development Office
Leicester General Hospital NHS Trust
Leicester
LE1 4PW
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0123112717

Study information

Scientific title

Acronym

PTCN

Study hypothesis

To investigate whether memantine and gabapentin improve nystagmus.

Ethics approval

Leicestershire Ethics Committee

Study design

Placebo controlled randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Nystagmus

Intervention

Administration of gabapentin, memantine or a placebo

Intervention type

Drug

Phase

Not Specified

Drug names

Memantine and gabapentin

Primary outcome measures

Visual acuity

Secondary outcome measures

Nystagmus amplitude

Overall trial start date

01/08/2004

Overall trial end date

01/03/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Congenital nystagmus
2. Over 18 years of age

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

48

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

United Kingdom

Trial participating centre

University Hospitals of Leicester
Leicester
LE1 4PW
United Kingdom

Sponsor information

Organisation

University Hospitals Leicester (UK)

Sponsor details

Gwendolen House
Gwendolen Road
Leicester
LE5 4QF
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Nystagmus Network UK

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Ulverscroft Foundation

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United Kingdom

Funder name

University Hospitals of Leicester NHS Trust

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results on http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17279539

Publication citations

  1. Results

    McLean R, Proudlock F, Thomas S, Degg C, Gottlob I, Congenital nystagmus: randomized, controlled, double-masked trial of memantine/gabapentin., Ann. Neurol., 2007, 61, 2, 130-138, doi: 10.1002/ana.21065.

Additional files

Editorial Notes