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

NCT02656160 | Completed Phase 2 Results

• 1 other identifier: BWH-2014P001033C
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

In this protocol the investigators will test the effect of dalfampridine (a potassium channel blocker) on genioglossus muscle activity (EMG GG) during wakefulness and sleep in healthy control subjects.

Conditions

Sleep Apnea, Obstructive

Outcome Measures

Primary Outcomes (1)

• Genioglossus Activity During Sleep Expressed as %Wakefulness Value (Before Drug/Placebo Administration).

  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).

  1 night

Secondary Outcomes (1)

• Change in EMG GG for cmH2O Change in Epiglottic Pressure. (GG%Max/cmH2O)

  1 night

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Dalfampridine

ACTIVE COMPARATOR

Drug: Dalfampridine

Interventions

Placebo DRUG

Placebo 3 hrs before sleep

Placebo

Dalfampridine DRUG

Dalfampridine 10 mg extended release 3 hrs before sleep

Dalfampridine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy control subjects

You may not qualify if:

• Cardiovascular disease other than well controlled hypertension
• History of seizures

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Sleep Disorders Research Program Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• Taranto-Montemurro L, Sands SA, Azarbarzin A, Marques M, de Melo CM, Edwards BA, Eckert DJ, Messineo L, White DP, Wellman A. Effect of 4-Aminopyridine on Genioglossus Muscle Activity during Sleep in Healthy Adults. Ann Am Thorac Soc. 2017 Jul;14(7):1177-1183. doi: 10.1513/AnnalsATS.201701-006OC.

  PMID: 28387543 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

4-Aminopyridine

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Aminopyridines; Amines; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Andrew Wellman, MD, PhD
• Organization: Brigham and women's Hospital

awellman@rics.bwh.harvard.edu

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Sleep Disordered Breathing Lab, Brigham and Women's Hospital

Study Record Dates

• First Submitted: January 12, 2016
• First Posted: January 14, 2016
• Study Start: January 1, 2016
• Primary Completion: May 1, 2016
• Study Completion: July 1, 2016
• Last Updated: August 15, 2017
• Results First Posted: June 7, 2017

Record last verified: 2017-07

Locations

US (1)