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

Phase 4

Completed

• Conditions: Health Condition 1: G20- Parkinsons disease

• Registration Number: CTRI/2023/04/051973
• Lead Sponsor: Sun Pharma Laboratories Limited (SPLL)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2023-10-18
• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 163

Inclusion Criteria

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

Exclusion Criteria

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)Timepoint: [Time frame: Throughout the study period]