Efficacy and Safety Study of Neramexane to Treat Congenit... | NCT00661440

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

NCT00661440

Sponsor

Merz Pharmaceuticals GmbH

Status

Completed

Last Update Posted

Nov 26, 2009Estimated

Enrollment

48Estimated

Phase

Phase 2

Conditions

Nystagmus, Congenital Idiopathic
Nystagmus, Acquired

Interventions

Neramexane mesylate

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
EudraCT Number 2007-002595-34

Status Module

Record Verification Date

Nov 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2008

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Apr 15, 2008

First Submission Date that Met QC Criteria

Apr 17, 2008

First Posted Date

Apr 18, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 25, 2009

Last Update Posted Date

Nov 26, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

48Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Other		Drug: Neramexane mesylate
2	Other		Drug: Neramexane mesylate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Neramexane mesylate	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	1 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Visual acuity		Screening, Baseline, Week 3, 7, 11, 14, 18, and Follow-up

Secondary Outcomes

Measure	Description	Time Frame
nystagmus intensity, expanded nystagmus acuity function, reading ability, questionnaires, safety parameter

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Irene Gottlob, Prof., MD	University of Leicester, Leicester, United Kingdom	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Leicester, Leicester Royal Infirmary, Ophthalmology Group		Leicester		LE2 7LX	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D009759	Nystagmus, Pathologic

Ancestor Terms

ID	Term
D015835	Ocular Motility Disorders
D003389	Cranial Nerve Diseases
D009422	Nervous System Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided