MedDataX Logo

Efficacy and Safety Study of Neramexane to Treat Congenital and Acquired Nystagmus

NCT ID: NCT00661440

Last Updated: 2009-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to investigate the safety and efficacy of neramexane mesylate in the treatment of congenital idiopathic nystagmus (CIN) in comparison to placebo. In addition, a subgroup of multiple sclerosis (MS) patients suffering from acquired nystagmus will be included; this subgroup will be analyzed in an exploratory manner only.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Nystagmus, Congenital Idiopathic Nystagmus, Acquired

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Group Type OTHER

Neramexane mesylate

Intervention Type DRUG

2 double-blind, cross-over treatment periods of 7 weeks separated by a wash-out phase, up to 75 mg Neramexane mesylate per day

2

Group Type OTHER

Neramexane mesylate

Intervention Type DRUG

2 double-blind, cross-over treatment periods of 7 weeks separated by a wash-out phase, up to 75 mg Neramexane mesylate per day

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Neramexane mesylate

2 double-blind, cross-over treatment periods of 7 weeks separated by a wash-out phase, up to 75 mg Neramexane mesylate per day

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

- verum, placebo - placebo, verum

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* patients with congenital idiopathic nystagmus or acquired nystagmus subsequent to multiple sclerosis
* male or female outpatients
* aged between 18 and 80 years (inclusive) at screening

Exclusion Criteria

* patients with evidence of neurologic disorders other than CIN such as congenital nystagmus due to albinism or retinal diseases and/or acquired nystagmus (exemption: secondary to MS)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Merz Pharmaceuticals GmbH

INDUSTRY

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Irene Gottlob, Prof., MD

Role: PRINCIPAL_INVESTIGATOR

University of Leicester, Leicester, United Kingdom

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Leicester, Leicester Royal Infirmary, Ophthalmology Group

Leicester, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EudraCT Number 2007-002595-34

Identifier Type: -

Identifier Source: secondary_id

MRZ 92579-0707/1

Identifier Type: -

Identifier Source: org_study_id