A clinical trial to study the effects of two drugs, Armodafinil and Modafinil in patients with excessive daytime sleepiness associated with narcolepsy.

Evaluation of efficacy and safety of armodafinil versus Modafinil in the treatment of patients with excessive daytime sleepiness associated with narcolepsy: a randomized, open label, comparative, multi-centre trial.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000043

Enrollment

200

Registered

2010-01-13

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Armodafinil:: Once daily Control Intervention1: Modafinil:: Once daily

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male or female patients aged between 18 and 65 years. 2. Patients diagnosed with excessive sleepiness associated with narcolepsy. 3. Patient willing to give their informed consent.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women and women of childbearing potential who are not on acceptable birth control methods. 2. Women using steroidal contraceptives. 3. Patients who have probable diagnosis of a current sleep disorder other than narcolepsy in opinion of the investigator. 4. Patients having any significant uncontrolled medical or psychiatric disorder, other than narcolepsy, that can cause excessive sleepiness. 5. Patients consuming > 600 mg/day of caffeine. 6. Patients having history of alcohol, narcotic or drug abuse. 7. Patients using any of the drugs such as sodium oxybate, lithium, St. John's Wort, methylphenidate, amphetamines, pemoline, antipsychotics, benzodiazepines, zolpidem, zopiclone, MAO inhibitors, anticoagulants, anticonvulsants. 8. Patients with severe renal and hepatic impairment. 9. Patients with known hypersensitivity to armodafinil and modafinil or its inactive ingredients. 10. Has a serum creatinine of > 1.5 x upper limit of normal. 11. Has thyroid stimulating hormone value outside the normal range. 12. Patients having risk of cardiovascular events. 13. Patients having participated in another clinical trial in proceeding one month period.

Design outcomes

Primary

Measure	Time frame
1) Epworth Sleepiness Scale (ESS) 2) Clinical Global Impression on Severity (CGI-S)Timepoint: 1) Day 0, Day 28, Day 56, Day 84 2) Day 0, Day 84	—

Secondary

Measure	Time frame
Clinical Global Impression on Improvement (CGI-I)Timepoint: Day 28, Day 56, Day 84	—

Countries

India

Contacts

Public ContactDr. Surendra Borgharkar

medical.services@sunpharma.com02266969696

Outcome results