Cirrhosis Related ParkinsonismNCT02265484
To Study the Efficacy of Bromocriptine in Patients With Hepatic/Cirrhosis Related Parkinsonism
A study testing Lactulose+Rifaximin +Bromocriptine in people with Cirrhosis Related Parkinsonism, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis Related Parkinsonism
- What is being tested?
- Lactulose+Rifaximin +Bromocriptine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIndia
- Study dates
- Nov 2013to Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with cirrhosis of liver with signs of parkinsonisms
- Patients consented for the study protocol by signing the informed consent.
Who cannot join
- 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
Show all 13Show fewer
- Atypical Parkinsonism
- Pregnancy
- Hypotension
- Uncontrolled hypertension
- CAD
- Psychiatric illness
- Acute episode of Hepatic encephlopathy
Trial locations and contacts
1 site in 1 country.
India1 site
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
About this study
Official title: A Randomized Open Labelled Placebo Controlled Trial 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.
- Conditions
- Cirrhosis Related Parkinsonism
- Being tested
- Lactulose+Rifaximin +Bromocriptine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactulose+Rifaximin +BromocriptineDrug
| Study group | Role | What they receive |
|---|---|---|
| Lactulose + Rifaximin + Bromocriptine | Experimental | Not described Receives: Drug: Lactulose+Rifaximin +Bromocriptine |
| Lactulose+Rifaximin+Placebo | Active comparator | Not described Receives: Drug: Lactulose+Rifaximin +Bromocriptine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome will be decrement in UPDRS (Unified Parkinson's Disease Rating Scale) score by 30 %.
Measured: 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%.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2014 (estimated)
- Study startNov 2013
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cirrhosis Related ParkinsonismStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amrish Sahney, MD, Principal investigator, Institute of Liver & Biliary Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02265484
- Sponsor's protocol ID
- ILBS-bromocriptine-01
- Status last verified
- Apr 2013
- First submitted
- 12 Sep 2014
- Last updated
- 22 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30554466
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Open Labelled Placebo Controlled Trial to Study the Efficacy of Bromocriptine in Patients With Hepatic/Cirrhosis Related Parkinsonism
- ClinicalTrials.gov ID
- NCT02265484
- Acronym / sponsor ID
- ILBS-bromocriptine-01
- Conditions
- Cirrhosis Related Parkinsonism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 16 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactulose + Rifaximin + Bromocriptine | Experimental | Drug: Lactulose+Rifaximin +Bromocriptine |
| Lactulose+Rifaximin+Placebo | Active comparator | Drug: Lactulose+Rifaximin +Bromocriptine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with cirrhosis of liver with signs of parkinsonisms
- Patients consented for the study protocol by signing the informed consent.
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactulose+Rifaximin +Bromocriptine | Drug | Lactulose + Rifaximin + Bromocriptine, Lactulose+Rifaximin+Placebo |
Primary outcome
The primary outcome will be decrement in UPDRS (Unified Parkinson's Disease Rating Scale) score by 30 %.
Time frame: 3 months
1 secondary outcome
The secondary end point will be decrement in UPDRS (Unified Parkinson's Disease Rating Scale) score of 10% to 30%.
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2016.
- Derived from this study: PubMed 30554466Sahney 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amrish Sahney, MD principal investigator
Institute of Liver & Biliary Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactulose+Rifaximin +Bromocriptine in people with Cirrhosis Related Parkinsonism, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome will be decrement in UPDRS (Unified Parkinson's Disease Rating Scale) score by 30 %. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02265484, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2016.