Efficacy and Safety of YAM80 in Amyotrophic Lateral Scler... | NCT00886977

Studies
Efficacy and Safety of YAM80 in Amyotrophic Lateral Sclerosis (ALS)

NCT00886977

Sponsor

Yoshino Neurology Clinic

Status

Unknown status

Last Update Posted

Oct 25, 2010Estimated

Enrollment

25Estimated

Phase

Phase 2

Conditions

Amyotrophic Lateral Sclerosis

Interventions

YAM80

Countries

Japan

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

Status Module

Record Verification Date

Apr 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

Dec 2010Estimated

Completion Date

Not provided

First Submitted Date

Apr 21, 2009

First Submission Date that Met QC Criteria

Apr 22, 2009

First Posted Date

Apr 23, 2009Estimated

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

Oct 22, 2010

Last Update Posted Date

Oct 25, 2010Estimated

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

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

25Estimated

Name	Type	Description	Arm Group Labels	Other Names
YAM80	Drug	Oral administration, 2 to 6 mg, once a day.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
ALSFRS-R		24w + follow-up period
Safety		24w and the follow up period

Secondary Outcomes

Measure	Description	Time Frame
Manual Muscle Testing		24w + follow-up period
Grip/pinch strength		24w + followup period
Pulmonary function (forced vital capacity)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients aged between 25 and 65 years
ALS patients who can visit the clinic for six months
Forced Vital Capacity (FVC) > 70%
Patients who can walk by themselves
Change in ALSFRS-R score from -1 to -4 during 12 weeks before the initial administration
Patients who are willing to give informed consent

Exclusion Criteria:

Tracheotomy and invasive ventilation
Pregnant or possibly pregnant female patients
Female patients of childbearing potential who cannot practice contraception during and two years after the administration, and male patients who cannot practice contraception during and six months after the administration
Patients with clinically significant conditions such as cardiovascular, respiratory, haematological, and renal diseases.
Patients who are being treated with investigational drugs
Patients who are treated with other ALS drugs within 2 weeks prior to the first administration

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

65 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
Hiide Yoshino, M.D.	Yoshino Neurology Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Yoshino Neurology Clinic		Tokyo			Japan

Condition Browse Module

MeSH Terms

ID	Term
D000690	Amyotrophic Lateral Sclerosis

Ancestor Terms

ID	Term
D013118	Spinal Cord Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D016472	Motor Neuron Disease

Browse Leaves

Not provided

Browse Branches

Not provided