Parkinson DiseasePhase 2NCT07375693
Effect of Melatonin on Oxidative Stress Parameters in Levodopa-Treated Parkinson's Disease Patients
A Phase 2 study testing MELATONIN (MELATL07959) in people with Parkinson Disease, run by Bangladesh Medical University at 1 site in Bangladesh.
Trial summary
In Bangladesh Melatonin is currently used for insomnia. Its potential therapeutic benefits beyond sleep regulation. This study aimss to evaluate the effects of melatonin supplementation on oxidative stress markers, neuroinflammation and clinical outcomes in patients with Parkinson's disease. Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- MELATONIN (MELATL07959)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteBangladesh
- Study dates
- 17 Feb 2026to 15 Sep 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosesd Parkinson's disease patients taking levodopa
- mild to moderate PD pt according to Hohen and Yahr staging, stage-I,II,III
- age:>45 years
- both male and female
Who cannot join
- secondary causes of PD
- Prior stereotactic surgery for PD
- suffering from active malignancy
- known hypersensitivity to melatonin
- Patients taking anticonvulsants, OCP, DMARD
- pt with autoimmune disease
- pregnancy or lactating mother
- has any clinically significant medical condition that could interfere with the subject's ability to safely participate in the study or to be followed
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Melatonin on Oxidative Stress Parameters in Levodopa-Treated Parkinson's Disease Patients: A Randomized, Double-Blind, Placebo-Controlled Trial.
In Bangladesh Melatonin is currently used for insomnia. Its potential therapeutic benefits beyond sleep regulation. This study aimss to evaluate the effects of melatonin supplementation on oxidative stress markers, neuroinflammation and clinical outcomes in patients with Parkinson's disease. The main question it aims to answer:
In patients with Parkinson's disease receiving levodopa, does melatonin supplementation, compared to levodopa treatment alone, improve the symptoms of PD over a 12 week of period.
Read more
Participants will:
Take Melatonin 10mg or placebo everyday for 3 months at night 30minutes before bedtime. Visit the clinic once every 6 weeks for checkups and tests keep a diary of their symptoms,UPDRS score. At the end of 12 weeks will reaper hs-CRP, MDA and GSH.
Read the detailed description
This research will be conducted in the Department of Pharmacology in collaboration with the Department of Neurology, at Bangabandhu Sheikh Mujib Medical University.
Patients will be recruited from the PD clinic, OPD at Department of Neurology.
Study procedure:
Mild to moderate Parkinson's disease patients receiving levodopa according to Hoehn and Yahr staging, stage -I, II, Ill will be selected from the outpatient department of the Neurology, BSMMU. The objective, nature, purpose and potential risk of all the procedures used for the study will be explained in detail to each subject, with a cordial attitude emphasizing the benefits he/she might obtain from this study.
Total of 70 patients will be assessed. Informed written consent from each patient will be taken in a prescribed form. Then demographic Information, address, mobile number, and medical history will be recorded in a preformed data schedule. For giving intervention, patients will be divided into two groups group A and group B by randomization. A total of 70 patients will be randomized, for (group A n=35) and Group B (n=35). At baseline, the MDS-UPDRS score will be evaluated by the present researcher and 6 ml blood will be collected for the baseline measurement of MDA, GSH, and hs-CRP levels. Then patients will be assigned to the respective groups. Tab. Melatonin 10mg/day (1 tablet 1 hour before bedtime) will be given to the patient of group A for 12 weeks and Tab. Placebo will be given to the patient of group B for 12 weeks. Regular medicine intake will be confirmed by talking to the patients or the care giver over the telephone and from the compliance sheet of the patients. The disease severity will be assessed by MDS-UPDRS(Part-II) score at the end of the12 weeks treatment. 6 ml blood will be collected to measure MDA, GSH and hs-CRP levels at the end of the 12 weeks of treatment. Patients will be asked to report any unwanted effects of the medicine like excessive fatigue, depression and weight loss given during the study.
First, the suspected PD patients will be evaluated by a neurologist in the neurology department. The proposed study will be conducted among outdoor patients with Parkinson's disease in the PD clinic, will be made clinically using to scale by an expert neurologist following inclusion and exclusion criteria.
- Conditions
- Parkinson Disease
- Being tested
- MELATONIN (MELATL07959)
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MELATONIN (MELATL07959)Drug
Also called Tab. melatonin 10 mg
melatonin 10 mg orally 1 tab daily 30 min before bedtime for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | participants received Melatonin 10 mg orally 1 tab daily 30 min before bedtime for 12 weeks Receives: Drug: MELATONIN (MELATL07959) |
| placebo group | Placebo comparator | participants received placebo for 12 weeks Receives: Drug: MELATONIN (MELATL07959) |
What is being measured
The primary outcome is the main question the study is designed to answer.
effect of melatonin 2) Antioxidant marker erythrocyte glutathione (GSH) This study involves a comparison of MDA and GSH levels between the control and intervention groups at baseline and after 12 weeks.
To evaluate the effect of melatonin on oxidative stress, neuroinflammation, and the improvement of symptoms in levodopa-treated PD patients.
Measured: 0 week and 12 weeks
Secondary outcomes (3)
the level of oxidative stress markers
To compare the level of oxidative stress markers including MDA and GSH in levodopa-treated PD patients
Measured: 0 week and 12 weeks
the serum hs-CRP level
To estimate and compare the serum hs-CRP level in levodopa-treated PD patients
Measured: 0 weeks and12 weeks
using the MDS-UPDRS (Part-II)
To assess and compare the severity score of motor activity in Levodopa treated PD patients
Measured: 0 week and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start17 Feb 2026 (estimated)
- Primary completion23 Aug 2026 (estimated)
- Study completion15 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bangladesh Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Farzana Akter, Bangladesh Medical University
- Investigators
- Farzana Akter, MBBS, Principal investigator, Bangladesh Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07375693
- Sponsor's protocol ID
- BSMMU/2025/4251
- Status last verified
- May 2025
- First submitted
- 10 Dec 2025
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Melatonin on Oxidative Stress Parameters in Levodopa-Treated Parkinson's Disease Patients: A Randomized, Double-Blind, Placebo-Controlled Trial.
- ClinicalTrials.gov ID
- NCT07375693
- Acronym / sponsor ID
- BSMMU/2025/4251
- Conditions
- Parkinson Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Bangladesh Medical UniversityUniversity, hospital or other
- Study start
- 17 Feb 2026 (estimated)
- Primary completion
- 23 Aug 2026 (estimated)
- Study completion
- 15 Sep 2026 (estimated)
- First posted
- 29 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In Bangladesh Melatonin is currently used for insomnia. Its potential therapeutic benefits beyond sleep regulation. This study aimss to evaluate the effects of melatonin supplementation on oxidative stress markers, neuroinflammation and clinical outcomes in patients with Parkinson's disease. The main question it aims to answer:
In patients with Parkinson's disease receiving levodopa, does melatonin supplementation, compared to levodopa treatment alone, improve the symptoms of PD over a 12 week of period.
Participants will:
Take Melatonin 10mg or placebo everyday for 3 months at night 30minutes before bedtime. Visit the clinic once every 6 weeks for checkups and tests keep a diary of their symptoms,UPDRS score. At the end of 12 weeks will reaper hs-CRP, MDA and GSH.
Detailed description
This research will be conducted in the Department of Pharmacology in collaboration with the Department of Neurology, at Bangabandhu Sheikh Mujib Medical University.
Patients will be recruited from the PD clinic, OPD at Department of Neurology.
Study procedure:
Mild to moderate Parkinson's disease patients receiving levodopa according to Hoehn and Yahr staging, stage -I, II, Ill will be selected from the outpatient department of the Neurology, BSMMU. The objective, nature, purpose and potential risk of all the procedures used for the study will be explained in detail to each subject, with a cordial attitude emphasizing the benefits he/she might obtain from this study.
Total of 70 patients will be assessed. Informed written consent from each patient will be taken in a prescribed form. Then demographic Information, address, mobile number, and medical history will be recorded in a preformed data schedule. For giving intervention, patients will be divided into two groups group A and group B by randomization. A total of 70 patients will be randomized, for (group A n=35) and Group B (n=35). At baseline, the MDS-UPDRS score will be evaluated by the present researcher and 6 ml blood will be collected for the baseline measurement of MDA, GSH, and hs-CRP levels. Then patients will be assigned to the respective groups. Tab. Melatonin 10mg/day (1 tablet 1 hour before bedtime) will be given to the patient of group A for 12 weeks and Tab. Placebo will be given to the patient of group B for 12 weeks. Regular medicine intake will be confirmed by talking to the patients or the care giver over the telephone and from the compliance sheet of the patients. The disease severity will be assessed by MDS-UPDRS(Part-II) score at the end of the12 weeks treatment. 6 ml blood will be collected to measure MDA, GSH and hs-CRP levels at the end of the 12 weeks of treatment. Patients will be asked to report any unwanted effects of the medicine like excessive fatigue, depression and weight loss given during the study.
First, the suspected PD patients will be evaluated by a neurologist in the neurology department. The proposed study will be conducted among outdoor patients with Parkinson's disease in the PD clinic, will be made clinically using to scale by an expert neurologist following inclusion and exclusion criteria.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Drug: MELATONIN (MELATL07959)participants received Melatonin 10 mg orally 1 tab daily 30 min before bedtime for 12 weeks |
| placebo group | Placebo comparator | Drug: MELATONIN (MELATL07959)participants received placebo for 12 weeks |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosesd Parkinson's disease patients taking levodopa
- mild to moderate PD pt according to Hohen and Yahr staging, stage-I,II,III
- age:>45 years
- both male and female
Key exclusion criteria (8 listed)
- secondary causes of PD
- Prior stereotactic surgery for PD
- suffering from active malignancy
- known hypersensitivity to melatonin
- Patients taking anticonvulsants, OCP, DMARD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MELATONIN (MELATL07959)Also: Tab. melatonin 10 mgmelatonin 10 mg orally 1 tab daily 30 min before bedtime for 12 weeks | Drug | Intervention group, placebo group |
Primary outcome
effect of melatonin 2) Antioxidant marker erythrocyte glutathione (GSH) This study involves a comparison of MDA and GSH levels between the control and intervention groups at baseline and after 12 weeks.
Time frame: 0 week and 12 weeks
To evaluate the effect of melatonin on oxidative stress, neuroinflammation, and the improvement of symptoms in levodopa-treated PD patients.
3 secondary outcomes
the level of oxidative stress markers
Time frame: 0 week and 12 weeks
the serum hs-CRP level
Time frame: 0 weeks and12 weeks
using the MDS-UPDRS (Part-II)
Time frame: 0 week and 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Farzana Akter, MBBS principal investigator
Bangladesh Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MELATONIN (MELATL07959) in people with Parkinson Disease, run by Bangladesh Medical University at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effect of melatonin 2) Antioxidant marker erythrocyte glutathione (GSH) This study involves a comparison of MDA and GSH levels between the control and intervention groups at baseline and after 12 weeks. (time frame: 0 week and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.