An Extension of the HORIZON Protocol Evaluating the Safet... | NCT01085266

Studies
An Extension of the HORIZON Protocol Evaluating the Safety of Dimebon (Latrepirdine) in Subjects With Huntington Disease

NCT01085266

Sponsor

Medivation, Inc.

Status

Terminated

Last Update Posted

Oct 12, 2016Estimated

Enrollment

362Actual

Phase

Phase 3

Conditions

Huntington Disease

Interventions

Dimebon (latrepirdine)

Countries

Not provided

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

Oct 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2010

Primary Completion Date

Jun 2011Actual

Completion Date

Not provided

First Submitted Date

Mar 10, 2010

First Submission Date that Met QC Criteria

Mar 10, 2010

First Posted Date

Mar 11, 2010Estimated

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

Oct 11, 2016

Certification/Extension First Submitted that Passed QC Review

Oct 11, 2016

Certification/Extension First Posted Date

Oct 12, 2016Estimated

Last Update Submitted Date

Oct 11, 2016

Last Update Posted Date

Oct 12, 2016Estimated

Name	Class
Pfizer	INDUSTRY

Description Module

Brief Summary

An open-label extension study of the HORIZON protocol evaluating the safety of dimebon (latrepirdine)in subjects with Huntington disease.

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

362Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dimebon (latrepirdine)	Experimental	Patients receive dimebon 10mg orally 3 times per day for 1 week and 20 mg orally 3 times per day thereafter.	Drug: Dimebon (latrepirdine)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dimebon (latrepirdine)	Drug		Dimebon (latrepirdine)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Successful completion of 26 weeks of blinded treatment in the HORIZON study

Exclusion Criteria:

Any other medical illness or unstable medical condition that may interfere with their ability to comply with study procedures and abide by study restrictions, or may interfere with the ability to interpret safety information.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006816	Huntington Disease

Ancestor Terms

ID	Term
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C010119	latrepirdine

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided