Effect of Doxycycline in Levodopa Treated Parkinson's Disease Patients
Primary Purpose
Parkinson Disease
Status
Recruiting
Phase
Phase 2
Locations
Bangladesh
Study Type
Interventional
Intervention
Doxycycline
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring "Parkinson's disease" "Doxycycline"
Eligibility Criteria
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
Sites / Locations
- Bangabandhu Sheikh Mujib Medical University (BSMMU)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Doxycyline- Patients receiving Doxycycline .
Control- Patients receiving placebo
Arm Description
Drug generic name: Doxycycline Dosage form- oral capsule Dosage- (50mg) one capsule Frequency- twice daily Duration- 8 weeks.
Patient will receive one capsule of placebo twice daily
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
High sensitive C-reactive protein
will be measured before and after intervention
Full Information
NCT ID
NCT05492019
First Posted
August 4, 2022
Last Updated
August 4, 2022
Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
1. Study Identification
Unique Protocol Identification Number
NCT05492019
Brief Title
Effect of Doxycycline in Levodopa Treated Parkinson's Disease Patients
Official Title
Effect of Doxycycline in Levodopa Treated Parkinson's Disease Patients: Randomized, Double-Blind, Placebo-Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
January 1, 2023 (Anticipated)
Study Completion Date
January 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
"Parkinson's disease" "Doxycycline"
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantInvestigator
Masking Description
Participants and investigators will not know which arm patients have been assigned to or if they receive doxycycline or placebo.
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Doxycyline- Patients receiving Doxycycline .
Arm Type
Experimental
Arm Description
Drug generic name: Doxycycline Dosage form- oral capsule Dosage- (50mg) one capsule Frequency- twice daily Duration- 8 weeks.
Arm Title
Control- Patients receiving placebo
Arm Type
Placebo Comparator
Arm Description
Patient will receive one capsule of placebo twice daily
Intervention Type
Drug
Intervention Name(s)
Doxycycline
Other Intervention Name(s)
Brand name- Doxin
Intervention Description
Doxycycline 50 mg capsule twice daily for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral placebo identical to Doxycycline
Primary Outcome Measure Information:
Title
Effect of doxycycline on improvement of motor performance and cognitive functions of Parkinson's disease.
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
High sensitive C-reactive protein
Description
will be measured before and after intervention
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shahanaz Parvin, MBBS
Phone
+8801783996305
Email
bably.shahanaz@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Prof. A. K. M. Mosharrof Hossain, MBBS,PhD
Phone
+8801718605876
Email
mosharrofah@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shahanaz Parvin, MBBS
Organizational Affiliation
Bangabandhu Sheikh Mujib Medical University (BSMMU)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bangabandhu Sheikh Mujib Medical University (BSMMU)
City
Dhaka
ZIP/Postal Code
1217
Country
Bangladesh
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Registrar
Phone
+88028612550-4
Email
registrar@bsmmu.edu.bd
First Name & Middle Initial & Last Name & Degree
Shahanaz Parvin, MBBS
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Doxycycline in Levodopa Treated Parkinson's Disease Patients
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