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Sponsored by: |
Merz Pharmaceuticals GmbH |
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Information provided by: | Merz Pharmaceuticals GmbH |
ClinicalTrials.gov Identifier: | NCT00773591 |
This proof-of-concept study is to assess the potential benefit of botulinum toxin for patients with sleep-related breathing disorders.
Condition | Intervention | Phase |
---|---|---|
Sleep-Disordered Breathing |
Drug: NT 201, a Botulinum neurotoxin type A, free of complexing proteins |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Effect of NT 201 (Botulinum Neurotoxin Type A Free of Complexing Proteins) on Sleep-Related Breathing Disorders (Snoring Study) |
Estimated Enrollment: | 18 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Botulinum Toxin Typ A: Active Comparator | Drug: NT 201, a Botulinum neurotoxin type A, free of complexing proteins |
Placebo: Placebo Comparator | Drug: NT 201, a Botulinum neurotoxin type A, free of complexing proteins |
Mono-center, double-blind, 1:1 randomized, placebo-controlled trial 18 treated patients, 9 patients per group.
Patients will be randomly assigned to treatment with NT 201 or placebo in a ratio of 1:1. In addition, within each treatment group patients will be randomly assigned to injection into the left or right soft palate.
Primary variable:
Comparison of the ratio of snoring time over sleeping time (Snoring Index). Other secondary variables will be analysed.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Patients with known hypersensitivity to:
Presence of concomitant diseases:
Patients likely to need concomitant medication as follows:
Contact: Nicole Albala | +49/(0)69/1503- ext 1409 | nicole.albala@merz.de |
Contact: Christine Kliebe-Frisch, PhD | +49/(0)69/1503- ext 868 | Christine.Kliebe@merz.de |
Germany, Nordrhein-Westfalen | |
Somnolab Dortmund, Christian Guilleminault Schlaflabor | |
Dortmund, Nordrhein-Westfalen, Germany, D-44263 |
Responsible Party: | Merz Pharmaceuticals GmbH ( Nicole Albala, Study Manager ) |
Study ID Numbers: | MRZ 60201 SB_2001 |
Study First Received: | October 15, 2008 |
Last Updated: | October 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00773591 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Sleep-related breathing disorders Snoring |
Sleep Apnea Syndromes Respiratory Tract Diseases Apnea Respiration Disorders |
Snoring Dyssomnias Sleep Disorders Sleep Disorders, Intrinsic |
Nervous System Diseases |