Effect of Doxycycline in Levodopa Treated Parkinson’s Disease Patients

Overview

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.

Full Title of Study: “Effect of Doxycycline in Levodopa Treated Parkinson’s Disease Patients: Randomized, Double-Blind, Placebo-Controlled Trial.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: January 1, 2023

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.

Interventions

  • Drug: Doxycycline
    • Doxycycline 50 mg capsule twice daily for 8 weeks.
  • Drug: Placebo
    • Oral placebo identical to Doxycycline

Arms, Groups and Cohorts

  • Experimental: Doxycyline- Patients receiving Doxycycline .
    • Drug generic name: Doxycycline Dosage form- oral capsule Dosage- (50mg) one capsule Frequency- twice daily Duration- 8 weeks.
  • Placebo Comparator: Control- Patients receiving placebo
    • Patient will receive one capsule of placebo twice daily

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dr. Shahanaz Parvin, MBBS – Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
  • Overall Official(s)
    • Shahanaz Parvin, MBBS, Principal Investigator, Bangabandhu Sheikh Mujib Medical University (BSMMU)
  • Overall Contact(s)
    • Shahanaz Parvin, MBBS, +8801783996305, bably.shahanaz@gmail.com

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