Safety and Efficacy of Amantadine Tablets for the Treatment of Parkinsons Disease (A disorder of the central nervous system that affects movement, often including tremors) and Drug-induced Extrapyramidal Reactions (involuntary or uncontrollable movements, tremors, muscle contractions) in Patients
- Conditions
- Parkinsons disease,
- Registration Number
- CTRI/2023/04/051973
- Lead Sponsor
- Sun Pharma Laboratories Limited (SPLL)
- Brief Summary
The patient will be screened only after obtaining written informed consent and will be undergoing various assessments as mentioned in Schedule of Assessment (Appendix I). Screening number will be allotted to every screened patient. At screening visit, the Investigator or his/her designee will provide prospective patient with a detailed description of the study objectives, study participation requirements, as well as potential health risks and benefits associated with study participation. After obtaining written informed consent, study-specific screening [including inclusion and exclusion criteria, medical and medication history, demography, vitals, physical and laboratory examination, 12-Lead Electrocardiogram (ECG), MoCA score (for PD patients), Hoehn and Yahr Rating Scale Staging (for PD patients), and ESRS score (for patients with drug-induced extrapyramidal reactions)] will be performed. Evaluation of concomitant medications and adverse/serious adverse events will be done.
PD patients will be provided with 24-hour PD Home Diary (pre-enrolment) at Screening to record the number of daily asleep hours, daily ON hours without troublesome dyskinesia, and daily ON hours with troublesome dyskinesia, daily ON hours with dyskinesia, and daily OFF hours for 3 consecutive days in the week prior to enrolment (Day 1).
Treatment period
After confirming the eligibility, patients will be enrolled by allotting the enrollment number. The enrolled patients will be given the study drug, Amantadine Extended Release Tablets 129 mg or 193 mg as
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 163
Patients of either gender aged between 30 to 85 years both inclusive who agree to provide written informed consent Patients who can be managed on outpatient basis as per the Investigators judgment The patient or caregiver must demonstrate the ability to complete an accurate home diary based on training and evaluation during the screening period Women of childbearing potential must have a negative urine pregnancy test before study entry and agree to use highly effective methods of contraception to prevent pregnancy from study entry till at least two weeks after the last dose of the study medication such contraception may include hormonal birth control eg combined estrogen and progestogen containing oral intravaginal or transdermal or progesterone only oral injectable or implantable hormonal contraception associated with inhibition of ovulation intrauterine devices intrauterine hormone releasing system OR bilateral tubal occlusion vasectomized partner or total sexual abstinence Note Women with childbearing potential are defined as those who are not surgically sterile bilateral oophorectomy hysterectomy or bilateral tubal ligation or post menopausal Post menopausal woman will be defined as Woman not using hormonal replacement therapy and have had at least twelve continuous months of natural spontaneous amenorrhea and be greater than forty five years of age Male patients must have had a successful vasectomy confirmed azoospermia or they and their female partners must meet the criteria above ie not of childbearing potential or practicing highly effective contraception throughout the study period No sperm donation is allowed during the study period Patients with diagnosis of idiopathic Parkinsons disease as per the United Kingdom UK Parkinsons Disease Society Brain Bank criteria Patients who are on stable dose of anti parkinsonian medications and require additional medications to control PD symptoms Patients should be on stable dose of any anti parkinsonian medications including any levodopa preparation for at least thirty days prior to enrolment and be willing to remain on the same doses throughout the trial Patients on stable dose of medications before screening such as typical and atypical antipsychotics antidepressants eg SSRIs SNRIs antiemetics eg metoclopramide domperidone levosulpiride or antiepileptic drugs eg valproate phenytoin and experiencing extrapyramidal symptoms such as parkinsonism and or akathisia and or dystonia and or tardive dyskinesia.
Patients having secondary parkinsonian syndrome such as vascular post inflammatory drug induced neoplastic and post traumatic parkinsonism or any atypical parkinsonian syndrome bipolar disorder untreated inadequately treated major depressive disorder Patients on stable dose of selective serotonin reuptake inhibitors or serotonin and norepinephrine reuptake inhibitors for last two months prior to enrolment are eligible schizophrenia or other psychotic disorder history of exposure to a known neurotoxin or any neurological features not consistent with the diagnosis of PD as assessed by the Investigator History of neurosurgical intervention for treating Parkinsons disease ie pallidotomy or implanted with a deep brain stimulator Patients taking any medication for the treatment of extrapyramidal reactions within thirty days prior to Screening Patients with any of the underlying conditions that may cause extrapyramidal symptoms including but not limited to dementia hydrocephalus subdural haemorrhage hypoparathyroidism neurodegeneration and pantothenate kinase associated neurodegeneration Patients taking amantadine within thirty days prior to screening Patients with previously documented inability to tolerate amantadine or lack of response to prior amantadine treatment Patients taking rimantadine for influenza prophylaxis or any other indication memantine or apomorphine within thirty days prior to screening History of any cancer within five years of screening Patients who are at imminent risk of suicide or had a suicide attempt within last one year of screening Patients who have received Live Attenuated Influenza Vaccine within two weeks prior to Screening Patients who have plans to undergo major elective surgery during the course of the study Patients with end stage renal disease eGFR less than 15 mL/min/1.73 m2 calculated by MDRD method at the time of screening and enrolment History of or currently has any of the following clinically significant conditions such as cardiovascular respiratory renal hepatic endocrine or gastrointestinal disease History or known case of HIV-AIDS hepatitis B and hepatitis C History of hypersensitivity or allergic reaction to amantadine rimantadine or memantine or to any of the excipients used in the study medication Participation in other studies involving investigational drugs or surgeries within the last thirty days or investigational biologics within the last 6 months prior to screening Pregnant or lactating women Investigator study personnel Sponsor representatives and their first degree relatives.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients with treatment-emergent adverse events (TEAEs) [Time frame: Throughout the study period]
- Secondary Outcome Measures
Name Time Method Change from baseline in the MDS-UPDRS PART III score baseline to Days 14, 28, 56, 70, 77, and 84 Change from baseline in daily OFF hours baseline to Days 14, 28, 56, 70, 77, and 84 Change from baseline in the MDS-UPDRS Parts I, II, and IV score baseline to Days 14, 28, 56, 70, 77, and 84 Change from baseline in the MDS-UPDRS total Part I II III IV score baseline to Days 14, 28, 56, 70, 77, and 84 Change from baseline in Quality of life (daily life activities) total score using PD questionnaire-39 baseline to Days 14, 28, 56, 70, 77, and 84 Change from baseline in daily ON hours with dyskinesia baseline to Days 14, 28, 56, 70, 77, and 84 Change from baseline in daily ON hours without troublesome dyskinesia baseline to Days 14, 28, 56, 70, 77, and 84 Change from baseline in Extrapyramidal Symptom Rating Scale (ESRS) total score Change from baseline in daily ON hours with troublesome dyskinesia baseline to Days 14, 28, 56, 70, 77, and 84 Change from baseline in ESRS Part I, II, III & IV Subscores From baseline to Days 7, 14, 28, 35, 42, 49, and 56
Trial Locations
- Locations (10)
Apex Hospital Pvt Ltd
🇮🇳Jaipur, RAJASTHAN, India
City Neurology Centre
🇮🇳Varanasi, UTTAR PRADESH, India
Excel Hospital
🇮🇳Medchal, TELANGANA, India
GMC & GGH, Podila Prasad Superspeciality
🇮🇳Guntur, ANDHRA PRADESH, India
GNRC
🇮🇳Kamrup, ASSAM, India
GSVM, Medical College
🇮🇳Dehat, UTTAR PRADESH, India
Jawahar Lal Nehru Medical College
🇮🇳Ajmer, RAJASTHAN, India
Surya Multispeciality Hospital
🇮🇳Nashik, MAHARASHTRA, India
V.S. General Hospital
🇮🇳Ahmadabad, GUJARAT, India
Victoria Hospital
🇮🇳Bangalore, KARNATAKA, India
Apex Hospital Pvt Ltd🇮🇳Jaipur, RAJASTHAN, IndiaDr BrijlalPrincipal investigator9636961084brijlalchaudhary40@gmail.com