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

Phase 3

Completed

• Registration Number: CTRI/2010/091/000043
• Lead Sponsor: Sun Pharmaceutical Industries Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 200

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified