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Effect of Dalfampridine (4-AP) on Genioglossus Muscle Activity in Healthy Adults (APIGLOSS)

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ClinicalTrials.gov Identifier: NCT02656160
Recruitment Status : Completed
First Posted : January 14, 2016
Results First Posted : June 7, 2017
Last Update Posted : August 15, 2017
Sponsor:
Information provided by (Responsible Party):
David Andrew Wellman, Brigham and Women's Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition Sleep Apnea, Obstructive
Interventions Drug: Placebo
Drug: Dalfampridine
Enrollment 13
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 4-AP First, Placebo Second Placebo First, 4-AP Second
Hide Arm/Group Description 4-AP 10 mg administered 3 hours before normal sleep time on first study night, then a 1-week non-treatment period, then placebo-matching 4-AP administered 3 hours before normal sleep time on second study night. Placebo-matching 4-AP administered 3 hours before normal sleep time on first study night, then a 1-week non-treatment period, then 4-AP administered 3 hours before normal sleep time on second study night.
Period Title: First Study Night
Started 7 6
Completed 7 6
Not Completed 0 0
Period Title: Second Study Night
Started 4 [1] 6
Completed 4 6
Not Completed 0 0
[1]
3 subjects did not return for the second study night
Arm/Group Title All Analyzed Participants
Hide Arm/Group Description All participants who were randomized, completed both study nights, and were included in the analysis.
Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 10 participants
28
(25.3 to 33.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
6
  60.0%
Male
4
  40.0%
1.Primary Outcome
Title Genioglossus Activity During Sleep Expressed as %Wakefulness Value (Before Drug/Placebo Administration).
Hide Description The EMG GG was quantified in arbitrary units derived from signal processing of the raw signal and as a percentage of wakefulness (%wake) for between-nights comparison of baseline sleep EMG GG activity. EMG GG analysis was performed on a breath-by-breath basis to identify a maximum value and a minimum value during inspiration and expiration, respectively (EMG GG peak and tonic). The difference between peak and tonic values was used to estimate respiratory related phasic activity. Wakefulness EMG GG values were obtained from a minimum of 10 epochs (30 s each) with the subject lying in the lateral position. Criteria for breath selection during wakefulness were (1) stable breathing (constant epiglottic pressure swings) and (2) absence of movement artifacts (i.e., swallowing, speech, yawns).
Time Frame 1 night
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Dalfampridine
Hide Arm/Group Description:
Placebo: Placebo 3 hrs before sleep
Dalfampridine: Dalfampridine 10 mg extended release 3 hrs before sleep
Overall Number of Participants Analyzed 10 10
Median (Inter-Quartile Range)
Unit of Measure: percentage of wakefulness value
Tonic genioglossus activity during sleep
166
(101 to 333)
136
(90 to 576)
Phasic genioglossus activity during sleep
245
(88 to 428)
163
(109 to 793)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Dalfampridine
Comments tonic
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.85
Comments P<0.05 considered statistically significant
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Dalfampridine
Comments Phasic activity
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.322
Comments P<0.05 considered statistically significant
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Secondary Outcome
Title Change in EMG GG for cmH2O Change in Epiglottic Pressure. (GG%Max/cmH2O)
Hide Description Effect of dalfampridine on genioglossus muscle responsiveness to increased epiglottic pressure swings during sleep in healthy controls during NREM sleep. The variation of EMG GG is expressed here as % of maximal activation.
Time Frame 1 night
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Dalfampridine
Hide Arm/Group Description:
Placebo: Placebo 3 hrs before sleep
Dalfampridine: Dalfampridine 10 mg extended release 3 hrs before sleep
Overall Number of Participants Analyzed 10 10
Median (Inter-Quartile Range)
Unit of Measure: %max/cmH2O
-0.23
(-0.57 to -0.09)
-0.36
(-1.06 to -0.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Dalfampridine
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.42
Comments P<0.05 considered statistically significant
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame 2 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Dalfampridine
Hide Arm/Group Description Placebo: Placebo 3 hrs before sleep Dalfampridine: Dalfampridine 10 mg extended release 3 hrs before sleep
All-Cause Mortality
Placebo Dalfampridine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)      0/10 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Dalfampridine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      0/10 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Dalfampridine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      1/10 (10.00%)    
Nervous system disorders     
Headache  [1]  0/10 (0.00%)  0 1/10 (10.00%)  1
Indicates events were collected by systematic assessment
[1]
Headache after 1 hour from administration of dalfampridine, spontaneously recovered after approximately 1.5 hours
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Andrew Wellman, MD, PhD
Organization: Brigham and women's Hospital
EMail: awellman@rics.bwh.harvard.edu
Layout table for additonal information
Responsible Party: David Andrew Wellman, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02656160     History of Changes
Other Study ID Numbers: BWH-2014P001033C
First Submitted: January 12, 2016
First Posted: January 14, 2016
Results First Submitted: March 29, 2017
Results First Posted: June 7, 2017
Last Update Posted: August 15, 2017