To Study the Efficacy of Bromocriptine in Patients With H... | NCT02265484

Studies
To Study the Efficacy of Bromocriptine in Patients With Hepatic/Cirrhosis Related Parkinsonism

NCT02265484

Sponsor

Institute of Liver and Biliary Sciences, India

Status

Completed

Last Update Posted

Nov 22, 2016Estimated

Enrollment

50Actual

Phase

Not Applicable

Conditions

Cirrhosis Related Parkinsonism

Interventions

Lactulose+Rifaximin +Bromocriptine

Countries

India

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 2013

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

Nov 2013

Primary Completion Date

Jan 2015Actual

Completion Date

Jan 2015Actual

First Submitted Date

Sep 12, 2014

First Submission Date that Met QC Criteria

Oct 10, 2014

First Posted Date

Oct 16, 2014Estimated

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 21, 2016

Last Update Posted Date

Nov 22, 2016Estimated

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

After successful screening of liver cirrhosis patients attending ILBS OPD for signs of parkinsonism ( tremor, rigidity or bradykinesia, any 2 of 3). Diagnosis of hepatic/cirrhosis related parkinsonism will be made. Patients will be randomized into Bromocriptine and Placebo. Patients will be followed up every month in OPD (Out Patient Department), ILBS (Institute of liver & Biliary Sciences) for 3 months. Detailed neurological examination will be done at each visit & UPDRS (Unified Parkinson's Disease Rating Scale ) score will be calculated.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lactulose + Rifaximin + Bromocriptine	Experimental		Drug: Lactulose+Rifaximin +Bromocriptine
Lactulose+Rifaximin+Placebo	Active Comparator		Drug: Lactulose+Rifaximin +Bromocriptine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lactulose+Rifaximin +Bromocriptine	Drug		Lactulose + Rifaximin + Bromocriptine Lactulose+Rifaximin+Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The primary outcome will be decrement in UPDRS (Unified Parkinson's Disease Rating Scale) score by 30 %.		3 months

Secondary Outcomes

Measure	Description	Time Frame
The secondary end point will be decrement in UPDRS (Unified Parkinson's Disease Rating Scale) score of 10% to 30%.		3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with cirrhosis of liver with signs of parkinsonisms
Patients consented for the study protocol by signing the informed consent.

Exclusion Criteria:

Age < 18 years.
Patient s with HCC (Hepatocellular Carcinoma).
Patients diagnosed as Wilsons disease.
Patient who withdrew or non complaint to the study protocol.
ALF (Acute Liver failure)
Classical Parkinsonism
Atypical Parkinsonism
Pregnancy
Hypotension
Uncontrolled hypertension
CAD
Psychiatric illness
Acute episode of Hepatic encephlopathy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Amrish Sahney, MD	Institute of Liver & Biliary Sciences	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institute of Liver & Biliary Sciences		New Delhi	National Capital Territory of Delhi	110070	India

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30554466	Derived	Sahney A, Sharma BC, Jindal A, Anand L, Arora V, Vijayaraghavan R, Dhamija RM, Kumar G, Bhardwaj A, Sarin SK. A double-blind randomized controlled trial to assess efficacy of bromocriptine in cirrhotic patients with hepatic parkinsonism. Liver Int. 2019 Apr;39(4):684-693. doi: 10.1111/liv.14024. Epub 2019 Feb 4.