The Effect of Memantine on Functional Outcomes and Motor... | NCT00409721

Studies
The Effect of Memantine on Functional Outcomes and Motor Neuron Degeneration in Amyotrophic Lateral Sclerosis (ALS)

NCT00409721

Sponsor

University of Alberta

Status

Completed

Last Update Posted

Mar 2, 2011Estimated

Enrollment

42Estimated

Phase

Phase 2

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Memantine

Countries

Canada

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
EB2006ALS

Status Module

Record Verification Date

Mar 2011

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

Mar 2007

Primary Completion Date

Dec 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Dec 8, 2006

First Submission Date that Met QC Criteria

Dec 8, 2006

First Posted Date

Dec 11, 2006Estimated

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

Mar 1, 2011

Last Update Posted Date

Mar 2, 2011Estimated

Name	Class
ALS Association	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 the study is to investigate the effects of memantine in ALS patients using functional outcome measures.

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

42Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Memantine Low Dose	Experimental		Drug: Memantine
Memantine High Dose	Experimental		Drug: Memantine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Memantine	Drug		Memantine High Dose Memantine Low Dose

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
ALS Functional Rating Scale-Revised (ALSFRS-R)
Forced vital capacity (FVC)
Manual Muscle Testing (MMT)
Addenbrooke Cognitive Examination (ACE)

Secondary Outcomes

Measure	Description	Time Frame
Motor unit number estimates of hand and foot muscles
N-acetylaspartate in the motor cortex

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

El Escorial Classification of laboratory supported probable, probable,or definite ALS
Age 18 - 80 years,
ALS symptoms for no more than 3 years,
FVC greater than or equal to 60% predicted,
Riluzole naïve or have been on a stable dose of Riluzole for at least 2 months,
Patients must have the ability to attend monthly study visits in Edmonton or Calgary, Alberta

Exclusion Criteria:

Presence of significant sensory abnormalities, dementia, other neurologic diseases, uncompensated medical illness and psychiatric illness
Female patients who are breastfeeding
Use of concurrent investigational drugs,
Patient unlikely to comply with study requirements
Poor adherence to study protocol during run-in phase

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
Ming Chan, MD	University of Alberta	Principal Investigator
Sanjay Kalra, MD	University of Alberta	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Calgary ALS Neuromuscular Clinic		Calgary	Alberta	T2N 4N1	Canada
University of Alberta ALS Clinic

References Module

Citations

Not provided

Label	URL
ALS Association of America (ALSA)	View source
ALS Society of Alberta	View source
ALS Society of Canada	View source

ID	Term
D000690	Amyotrophic Lateral Sclerosis
D016472	Motor Neuron Disease

ID	Term
D013118	Spinal Cord Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D019636	Neurodegenerative Diseases

ID	Term
D000547	Amantadine
D000218	Adamantane
D001952	Bridged-Ring Compounds
D006844	Hydrocarbons, Cyclic