MORFEO CR: Sleep Satisfaction and Psychomotor Performance of Adults

• Sponsor: Sanofi (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01097382
• Collaborator: (none)
• Enrollment: 30
• Locations: 6
• Arm: 1
• Duration (Months): 13
• Patients Per Site: 5
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

Primary Objective:

To assess sleep satisfaction before and after Zolpidem CR (Ambien CR) administration

Secondary Objective:

To assess Psychomotor Performance before and after Zolpidem CR (Ambien CR) administration

Condition or Disease	Intervention/Treatment	Phase
Sleep Disorders	Drug: ZOLPIDEM	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: National, Multicenter, Open Label, Phase IV, Before-after Design Study, in Adult Patients With Primary Insomnia to Evaluate Sleep Satisfaction and Psychomotor Performance After 1 Month of Treatment With Zolpidem CR (Ambien®CR) in 6 Sites in Argentina
• Study Start Date: Mar 1, 2010
• Actual Primary Completion Date: Apr 1, 2011
• Actual Study Completion Date: Apr 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AMBIEN CR AMBIEN CR 12.5 mg once daily immediately before bedtime or in elderly/hepatically impaired patients: 6.25 mg once daily immediately before bedtime	Drug: ZOLPIDEM; Pharmaceutical form: tablet Route of administration: oral Dose regimen: once daily

Outcome Measures

Primary Outcome Measures

1. Sleep satisfaction score (LSEQ = Leeds sleep evaluation questionnaire) [at Baseline, at V2 (26 +/- 2 days)]

Secondary Outcome Measures

1. Psychomotor Performance (DSST / Digit Symbol Substitution Test and ESS / Epworth Sleepiness Scale) [at Baseline, at V2 (26 +/- 2 days)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion criteria:

• Patients consulting Psychiatrists (private or hospital) -whatever the reason for consulting- who present with chronic primary insomnia from the DSM IV (Diagnostic and Statistical Manual - Revision 4).

• Accepting to participate in the study and signing informed consent

Exclusion criteria:

• Pregnancy or breastfeeding.

• Current severe neuropsychiatric disorder (i.e. psychosis, obsessive compulsive disorder, major depression, dementia of Alzheimer or vascular type) according to DSM IV criteria.

• History of substance abuse or dependence (including alcohol) within the past year.

• Hypersensitivity to zolpidem or its excipients.

• Severe hepatic insufficiency

• Severe and/or acute respiratory insufficiency

• Myasthenia gravis.

• OTC (Over The Counter) sleep remedies or prescription sleep medications within 2 weeks or 5 half-life before screening.

• Severe medical illness.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Investigational Site Number 10	Buenos Aires		Argentina
2	Investigational Site Number 1	C.a.b.a.		Argentina
3	Investigational Site Number 4	C.a.b.a.		Argentina
4	Investigational Site Number 6	C.a.b.a.		Argentina
5	Investigational Site Number 2	Capital Federal		Argentina	C1181ACH
6	Investigational Site Number 3	La Plata		Argentina

Sponsors and Collaborators

• Sanofi

Investigators

• Study Director: Clinical Sciences & Operations, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sanofi
• ClinicalTrials.gov Identifier: NCT01097382
• Other Study ID Numbers: ZOLPI_L_04551; U1111-1116-9105
• First Posted: Apr 1, 2010
• Last Update Posted: Jul 17, 2012
• Last Verified: Jul 1, 2012

• Additional relevant MeSH terms: Sleep Wake Disorders; Zolpidem

Study Results

No Results Posted as of Jul 17, 2012