Effect of Doxycycline in Levodopa Treated Parkinson's Disease Patients
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 parkinson-disease
Started Jul 2022
Shorter than P25 for phase_2 parkinson-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2022
CompletedFirst Submitted
Initial submission to the registry
August 4, 2022
CompletedFirst Posted
Study publicly available on registry
August 8, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2023
CompletedAugust 8, 2022
August 1, 2022
6 months
August 4, 2022
August 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effect of doxycycline on improvement of motor performance and cognitive functions of Parkinson's disease.
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 Outcomes (1)
High sensitive C-reactive protein
8 weeks
Study Arms (2)
Doxycyline- Patients receiving Doxycycline .
EXPERIMENTALDrug generic name: Doxycycline Dosage form- oral capsule Dosage- (50mg) one capsule Frequency- twice daily Duration- 8 weeks.
Control- Patients receiving placebo
PLACEBO COMPARATORPatient will receive one capsule of placebo twice daily
Interventions
Doxycycline 50 mg capsule twice daily for 8 weeks.
Eligibility Criteria
You may qualify if:
- Diagnosed Parkinson's disease patient taking Levodopa
- Age: More than 18 years
- Sex: All
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bangabandhu Sheikh Mujib Medical University (BSMMU)
Dhaka, 1217, Bangladesh
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shahanaz Parvin, MBBS
Bangabandhu Sheikh Mujib Medical University (BSMMU)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Participants and investigators will not know which arm patients have been assigned to or if they receive doxycycline or placebo.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MBBS
Study Record Dates
First Submitted
August 4, 2022
First Posted
August 8, 2022
Study Start
July 1, 2022
Primary Completion
January 1, 2023
Study Completion
January 1, 2023
Last Updated
August 8, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share