Effect of Doxycycline in Levodopa Treated Parkinson's Disease Patients

Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh (Other)
Overall Status
Recruiting
CT.gov ID
NCT05492019
Collaborator
(none)
60
1
2
6
9.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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 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.
Masking:
Double (Participant, Investigator)
Masking Description:
Participants and investigators will not know which arm patients have been assigned to or if they receive doxycycline or placebo.
Primary Purpose:
Treatment
Official Title:
Effect of Doxycycline in Levodopa Treated Parkinson's Disease Patients: Randomized, Double-Blind, Placebo-Controlled Trial.
Actual Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Effect of doxycycline on improvement of motor performance and cognitive functions of Parkinson's disease. [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 Outcome Measures

    1. High sensitive C-reactive protein [8 weeks]

      will be measured before and after intervention

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bangabandhu Sheikh Mujib Medical University (BSMMU) Dhaka Bangladesh 1217

    Sponsors and Collaborators

    • Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Shahanaz Parvin, MBBS, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
    ClinicalTrials.gov Identifier:
    NCT05492019
    Other Study ID Numbers:
    • 3914
    First Posted:
    Aug 8, 2022
    Last Update Posted:
    Aug 8, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Dr. Shahanaz Parvin, MBBS, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 8, 2022