Effect of Folic Acid in Levodopa Treated Parkinson's Disease Patients

Last updated: September 23, 2023
Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

Folic Acid Tablet

Placebo

Clinical Study ID

NCT05959044
BSMMU/2023/6247
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This is a prospective single center, randomized, double-blind, 2 arm placebo-controlled study in subjects with Parkinson's disease receiving levodopa .The patients will be randomized to receive tablet Folic Acid 10 mg per day or placebo for 8 weeks. The safety and efficacy outcome measures will be assessed at baseline and 8 weeks.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosed PD patients taking levodopa for at least 6months.
  • Mild to moderate Parkinson's disease patient according to Hoehn and Yahr staging,stage -I, II, III
  • Homocysteine level ≥ 13 µmol/L

Exclusion

Exclusion Criteria:

  • Secondary causes of parkinsonism
  • Prior stereotactic surgery for PD
  • Suffering from active malignancy
  • Known hypersensitivity to folic acid
  • Multivitamin supplementation within 30 days of enrollment
  • Patients taking anticonvulsant, oral contraceptive pill, disease modifyinganti-rheumatic drugs
  • Pregnancy or lactating mother
  • Has any clinically significant medical condition that could interfere with thesubject's ability to safely participate in the study or to be followed

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Folic Acid Tablet
Phase: 2
Study Start date:
April 16, 2023
Estimated Completion Date:
July 16, 2024

Study 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 levodapa causes hyperhomocysteinmia as a result increse neurotoxicity,oxidative stress and motor fluctuations and dyskinesia in many patients. Folic acid has been reduced homocystein level in levodopa treated Parkinson's disease on animal model and 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 folic acid 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 folic acid 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 8 weeks follow up.

Connect with a study center

  • BSMMU

    Dhaka, 1000
    Bangladesh

    Active - Recruiting

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