Health Condition 1: G35-G37- Demyelinating diseases of the central nervous system
Conditions
Interventions
Intervention1: Dalfampridine extended release tablets 10 mg: Dosage and Administration:
One tablet two times a day should be taken orally daily (approximately 12 hours apart) with or without food
Ta
Sponsors
Sun Pharma Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male or female patient aged between 18 and 65 years (both inclusive) 2.Patient has history of confirmed clinically defined multiple sclerosis since 4 months of screening 3.The patient has MS-related walking impairment but has sufficient ambulatory ability to be able to complete two trials of the Timed 25 Foot Walk (T25FW) in an average time of 8-45 seconds at the screening visit 4.Patient is able to perform all the required study procedure 5.Female patient of childbearing potential must be willing to use acceptable method of contraception (female of childbearing potential is defined as one who has not been postmenopausal for at least one year, or has not been surgically sterilised, or has not had a hysterectomy at least three months prior to the start of this study. Acceptable method of contraception includes (e.g., barrier method with spermicide). The "calendar method," withdrawal, or an IUD is NOT an acceptable method.
Exclusion criteria
Exclusion criteria: 1.Patient is pregnant or lactating 2.Patient on concurrent treatment with OCT2 (Organic Cation Transporter 2) inhibitors like cimetidine, pilsicainide, cetirizine, quinidine, rifampicin, naringin, ritonavir 3.Patient has any history of seizures or current evidence of epileptiform activity on EEG 4.Patient has renal impairment as defined by creatinine clearance of = 80 mL/min 5.Patient has active urinary tract infection (UTI) at screening or within the 4 weeks before screening 6.Patient had an onset (as assessed by the treating physician) of MS exacerbation within 60 days prior to the screening visit 7.Patient has received cyclophosphamide or mitoxantrone for MS treatment within six months prior to the screening visit 8.Patient has received corticosteroid (other than topical preparations) within 30 days prior to the screening visit and/or is expected to receive regularly scheduled corticosteroid treatment during the course of the study 9.Patient has been administered botulinum toxin in the lower extremities within six months prior to the screening visit and/or is expected to receive botulinum toxin in the lower extremities during the course of the study 10.Patient planning to use other forms of 4-aminopyridine (e.g. 4-AP, fampridine) concomitantly during the trial 11.Patient allergic to pyridine-containing substances (e.g. esomeprazole, loratidine, crizotinib, montelukast, pioglitazone, eszopiclone, imatinib, lansoprazole, mirtazapine) having hypersensitivity including anaphylaxis or any other contraindication to Investigational product or any of the component of study treatment 12.Patient starting immunomodulatory treatment within 90 days prior to screening visit or any change in the dosing regimen of these drugs within 30 days prior to screening visit 13.Patient started a concomitant medication regimen within the preceding 3 weeks of screening or their concomitant medication regimen expected to change during the course of trial 14.Patient has a history of drug or alcohol abuse within past year as per DSM-5 15.Patient with history of HIV and/ or Hepatitis B and/ or Hepatitis C 16.Patient has clinically significant abnormal laboratory values or an abnormal ECG in the opinion of investigator 17.Patient has any medical condition (including psychiatric disease) in the opinion of investigator that would interfere with the interpretation of the study results or the conduct of the study 18.Patient has angina, uncontrolled hypertension (BP = 140/90 mm of Hg), clinically significant cardiac arrhythmias, or any other clinically significant cardiovascular abnormality or any other clinically significant disorder 19.Patient has participated in an investigational drug/ device trial within 30 days prior to screening visit or plan to enroll in any investigational drug/ device trial at any time during the trial 20.Patient operating heavy complex machinery or who intend to drive 21.Patient judged unfit for this study by investigator 22.Investigator, study personnel, sponsor representatives and their first degree relatives
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Safety Outcome Measure: 1.Proportion of participants with adverse events and serious adverse eventsTimepoint: 1.Time frame: 11 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Efficacy outcome measure(s): 1.Responder rate based on consistency of walking speed improvement. A time walked responder is defined as a patient with a faster walking speed for at least 3 of the five visits during treatment period than the maximum speed for any of the first two off treatment visits (screening and baseline) or post treatment visit (visit 08)/ early treatment visit 2.Clinical Global Impression of ImprovementTimepoint: 1.Time frame: 11 weeks 2.Time frame: 02, 04, 06, 08, 09 weeks | — |
Countries
India
Contacts
Public ContactChaitali Bornare
Sun Pharma Laboratories Limited (SPLL)
Outcome results
None listed