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OpenTrials
Completed

NCT Number: NCT02265484

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

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.

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Key information

Conditions

Cirrhosis Related Parkinsonism

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lactulose+Rifaximin +Bromocriptine

Drug

Primary outcomes

  1. The primary outcome will be decrement in UPDRS (Unified Parkinson's Disease Rating Scale) score by 30 %.

    Time frame: 3 months

Secondary outcomes

  1. The secondary end point will be decrement in UPDRS (Unified Parkinson's Disease Rating Scale) score of 10% to 30%.

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Institute of Liver and Biliary Sciences, India

Other

Registry information

Official study title

A Randomized Open Labelled Placebo Controlled Trial to Study the Efficacy of Bromocriptine in Patients With Hepatic/Cirrhosis Related Parkinsonism

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Oct 16, 2014
Registry last updated
Nov 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.