To Study the Efficacy of Bromocriptine in Patients With Hepatic/Cirrhosis Related Parkinsonism
Primary Purpose
Cirrhosis Related Parkinsonism
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Lactulose+Rifaximin +Bromocriptine
Sponsored by
About this trial
This is an interventional treatment trial for Cirrhosis Related Parkinsonism
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
Sites / Locations
- Institute of Liver & Biliary Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Lactulose + Rifaximin + Bromocriptine
Lactulose+Rifaximin+Placebo
Arm Description
Outcomes
Primary Outcome Measures
The primary outcome will be decrement in UPDRS (Unified Parkinson's Disease Rating Scale) score by 30 %.
Secondary Outcome Measures
The secondary end point will be decrement in UPDRS (Unified Parkinson's Disease Rating Scale) score of 10% to 30%.
Full Information
NCT ID
NCT02265484
First Posted
September 12, 2014
Last Updated
November 21, 2016
Sponsor
Institute of Liver and Biliary Sciences, India
1. Study Identification
Unique Protocol Identification Number
NCT02265484
Brief Title
To Study the Efficacy of Bromocriptine in Patients With Hepatic/Cirrhosis Related Parkinsonism
Official Title
A Randomized Open Labelled Placebo Controlled Trial to Study the Efficacy of Bromocriptine in Patients With Hepatic/Cirrhosis Related Parkinsonism
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Liver and Biliary Sciences, India
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis Related Parkinsonism
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lactulose + Rifaximin + Bromocriptine
Arm Type
Experimental
Arm Title
Lactulose+Rifaximin+Placebo
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Lactulose+Rifaximin +Bromocriptine
Primary Outcome Measure Information:
Title
The primary outcome will be decrement in UPDRS (Unified Parkinson's Disease Rating Scale) score by 30 %.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
The secondary end point will be decrement in UPDRS (Unified Parkinson's Disease Rating Scale) score of 10% to 30%.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amrish Sahney, MD
Organizational Affiliation
Institute of Liver & Biliary Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Liver & Biliary Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110070
Country
India
12. IPD Sharing Statement
Citations:
PubMed Identifier
30554466
Citation
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.
Results Reference
derived
Learn more about this trial
To Study the Efficacy of Bromocriptine in Patients With Hepatic/Cirrhosis Related Parkinsonism
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