Effect of Doxycycline in Levodopa Treated Parkinson's Disease Patients

August 4, 2022 updated by: Dr. Shahanaz Parvin, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Effect of Doxycycline in Levodopa Treated Parkinson's Disease Patients: Randomized, Double-Blind, Placebo-Controlled Trial.

This study is a Randomized, Double-Blind, Placebo-Controlled Trial. The objective of the study is to assess the effect of doxycycline in levodopa treated Parkinson's disease patients regarding motor performance and cognitive functions. Parkinson's disease patients on levodopa medications will be assigned to receive doxycycline 50mg twice daily or placebo over 8 weeks. The motor and cognitive symptoms of Parkinson's disease will be assessed after 4 weeks and 8 weeks follow up.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Parkinson's disease is a progressive neurodegenerative disorder that is caused by degeneration of dopaminergic neuron in the substantia nigra. Most commonly used drug, levodopa can improve the dopamine level in brain but cannot give neuroprotection and also induces motor fluctuations and dyskinesia in many patients. Doxycycline has been shown anti-inflammatory and neuroprotective effects against Parkinson's disease on animal model. It also reduced Levodopa induced dyskinesia without compromising the motor benefits of Levodopa. Therefore, the present study is to attempt to improve the sign symptoms of Parkinson's disease by giving doxycycline along with Levodopa.

This study is a Randomized, Double-Blind, Placebo-Controlled Trial and conducting at Department of Pharmacology, BSMMU in collaboration with Department of Neurology, BSMMU. A total of 60 patients suffering from Parkinson's disease is selected according to inclusion and exclusion criteria. The diagnosis of the patients suffering from Parkinson's disease will be performed by a neurologist at movement disorder clinic of department of Neurology, BSMMU. Patients will undergo MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) to assess the severity of the disease. The patients will be randomly allocated into two arms: control and intervention. Patients in intervention arm consisted of 30 patients who will receive levodopa plus doxycycline orally for 8 weeks. On the other hand, control arm consisted of 30 patients who will receive levodopa plus placebo for 8 weeks. The severity of Parkinson's disease will be assessed after 4 weeks and 8 weeks follow up.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Prof. A. K. M. Mosharrof Hossain, MBBS,PhD
  • Phone Number: +8801718605876
  • Email: mosharrofah@gmail.com

Study Locations

  • Bangladesh
      • Dhaka, Bangladesh, 1217
        • Recruiting
        • Bangabandhu Sheikh Mujib Medical University (BSMMU)
        • Contact:
        • Principal Investigator:
          • Shahanaz Parvin, MBBS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosed Parkinson's disease patient taking Levodopa
  • Age: More than 18 years
  • Sex: All

Exclusion Criteria:

  • Secondary causes of parkinsonism
  • Atypical parkinsonian syndromes
  • Prior stereotaxic surgery for Parkinson's disease
  • Known hypersensitivity to doxycycline
  • Pregnancy and lactation
  • Suffering from active malignancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Doxycyline- Patients receiving Doxycycline .
Drug generic name: Doxycycline Dosage form- oral capsule Dosage- (50mg) one capsule Frequency- twice daily Duration- 8 weeks.
Drug: Doxycycline
Doxycycline 50 mg capsule twice daily for 8 weeks.
Other Names:
  • Brand name- Doxin
Placebo Comparator: Control- Patients receiving placebo
Patient will receive one capsule of placebo twice daily
Drug: Placebo
Oral placebo identical to Doxycycline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of doxycycline on improvement of motor performance and cognitive functions of Parkinson's disease.
Time Frame: 8 weeks
Assessing and comparing the severity of symptoms of Parkinson's disease of two groups by using MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) at baseline, 4 weeks and 8 weeks following doxycycline and placebo supplementation.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
High sensitive C-reactive protein
Time Frame: 8 weeks
will be measured before and after intervention
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Investigators

  • Principal Investigator: Shahanaz Parvin, MBBS, Bangabandhu Sheikh Mujib Medical University (BSMMU)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2022

Primary Completion (Anticipated)

January 1, 2023

Study Completion (Anticipated)

January 1, 2023

Study Registration Dates

First Submitted

August 4, 2022

First Submitted That Met QC Criteria

August 4, 2022

First Posted (Actual)

August 8, 2022

Study Record Updates

Last Update Posted (Actual)

August 8, 2022

Last Update Submitted That Met QC Criteria

August 4, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3914

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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