Clinical trial NCT02191137: Measuring Outcomes In Patients With Pulmonary Arterial Hypertension Not on Active Treatment (MOTION)
Official title: A Phase IV, Prospective, Single-Arm, Open-Label Study to Measure Outcomes in Patients With Pulmonary Arterial Hypertension Not on Active Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension, Pulmonary
Keywords: Pulmonary Hypertension,Riociguat,Living with Pulmonary Hypertension Questionnaire
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2014-07-16
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The MOTION study was a prospective, Phase IV study for patients with Pulmonary Arterial Hypertension (PAH). The study was designed to further explore patient-reported outcomes in PAH subjects who were not on active treatment and living in the United States. In addition, the study explored the use of new telemetric technology (Accelerator band) to evaluate if this technology correlates with improvements in 6 Minute Walking Distance 6MWD in patients with PAH.


Eligibility criteria: Inclusion Criteria:

* Male or female patients, 18 to 80 years of age at Visit 0
* Women of childbearing potential must have a negative pre-treatment pregnancy test, negative monthly pregnancy test, and must use reliable methods of contraception according to the Risk Evaluation Mitigation Strategies (REMS) guidance
* Symptomatic pulmonary arterial hypertension, World Health Organization Group 1 with a pulmonary vascular resistance (PVR) \>300 dyn\*sec\*cm-5, mean pulmonary artery pressure (PAP mean) ≥25 mmHg, and pulmonary capillary wedge pressure (PCWP) ≤15 mmHg as assessed by right heart catheterization within 6 months prior to Screening (Visit 0)
* PAH of the following types:

Idiopathic (IPAH) Familial (FPAH)

Associated with PAH (APAH) due to:

Connective tissue disease Congenital heart disease, but only if patient underwent surgical repair more than one year before enrollment Anorexigen or amphetamine use Portal hypertension with liver cirrhosis

* Not treated with PAH-specific pulmonary medications within 14 days of Screening (Visit 0)
* 6MWD between 150 meters and 450 meters

Exclusion Criteria:

* Patients who are pregnant
* Patients currently on nitrate and/or nitric oxide (NO) donor therapy; patients currently taking phosphodiesterase 5 (PDE5) inhibitors (such as sildenafil, tadalafil, vardenafil) and non-specific PDE inhibitors (theophylline, dipyridamole)
* Non-WHO group 1 Pulmonary Hypertension
* Severe restrictive lung disease
* History of uncontrolled high blood pressure or hypotension
* A medical disorder, condition, or history that in the opinion of the Investigator would impair their ability to participate or complete this study
* Active state of hemoptysis or pulmonary hemorrhage, including those events managed by bronchial artery embolization

Primary outcomes:
measure: Change From Baseline to Week 24 in the Living With Pulmonary Hypertension (LPH) Questionnaire Total Score
timeFrame: Baseline to Week 24
Secondary outcomes:
measure: Change From Baseline to Weeks 4 and 16 in the LPH Total Score
timeFrame: Baseline to Week 4 and Week 16
measure: Change From Week 16 to Week 24 in the LPH Total Score (Completers Analysis Set Only)
timeFrame: Week 16 to Week 24
measure: Change From Baseline to Weeks 4, 16, and 24 in the LPH Physical Dimension Score
timeFrame: Baseline to Weeks 4, 16, and 24
measure: Change From Week 16 to Week 24 in the LPH Physical Dimension Score (Completers Analysis Set Only)
timeFrame: Week 16 to Week 24
measure: Change From Baseline to Weeks 4, 16, and 24 in the LPH Emotional Dimension Score
timeFrame: Baseline to Week 4, Week 16 and Week 24
measure: Change From Week 16 to Week 24 in the LPH Emotional Dimension Score (Completers Analysis Set Only)
timeFrame: Week 16 to Week 24
measure: Percentage of Patients With a Minimal Clinically Significant Important Difference (MCID) From Baseline in LPH Total Score at Weeks 4, 16, and 24
timeFrame: Baseline to Week 4, Week 16 and Week 24
measure: Percentage of Patients With an MCID From Baseline in LPH Physical Dimension Score at Weeks 4, 16, and 24
timeFrame: Baseline to Week 4, Week 16 and Week 24
measure: Percentage of Patients With an MCID From Baseline in LPH Emotional Dimension Score at Weeks 4, 16, and 24
timeFrame: Baseline to Week 4, Week 16 and Week 24
measure: Percentage of Patients With an MCID From Week 16 in LPH Total Score at Week 24 (Completers Analysis Set Only)
timeFrame: Week 16 to Week 24
measure: Percentage of Patients With an MCID From Week 16 in Physical Dimension Score at Week 24 (Completers Analysis Set Only)
timeFrame: Week 16 to Week 24
measure: Percentage of Patients With an MCID From Week 16 in Emotional Dimension Score at Week 24 (Completers Analysis Set Only)
timeFrame: Week 16 to Week 24
measure: Change From Baseline to Weeks 4, 16, and 24 in the WLQ Time Management, Physical Demands, Mental-Interpersonal Demands and Output Demands Scores
timeFrame: Baseline to Week 4, Week 16 and Week 24
measure: Change From Baseline to Weeks 4, 16, and 24 in the WLQ Percentage of Productivity Loss
timeFrame: Baseline to Week 4, Week 16 and Week 24
measure: Change From Week 16 to Week 24 in the WLQ Time Management, Physical Demands, Mental-Interpersonal Demands, and Output Demands Scores (Completers Analysis Set Only)
timeFrame: Week 16 to Week 24
measure: Change From Week 16 to Week 24 in the WLQ Percentage of Productivity Loss (Completers Analysis Set Only)
timeFrame: Week 16 to Week 24
measure: Change From Baseline to Weeks 4, 16, and 24 in the Short Form-12 Health Survey (SF-12) Physical Component Summary (PCS) Score and Mental Component Summary (MCS) Score
timeFrame: Baseline to Week 4, Week 16 and Week 24
measure: Change From Week 16 to Week 24 in the SF-12 PCS Score and MCS Score (Completers Analysis Set Only)
timeFrame: Week 16 to Week 24
measure: Change From Baseline to Weeks 4, 16, and 24 in the WHO Functional Class
timeFrame: Baseline to Week 4, Week 16 and Week 24
measure: Change From Week 16 to Week 24 in the WHO Functional Class (Completers Analysis Set Only)
timeFrame: Week 16 to Week 24
measure: Change From Baseline to Weeks 16 and 24 in the Modified Borg Dyspnea Scale
timeFrame: Week 16 to Week 24
measure: Change From Week 16 to Week 24 in the Modified Borg Dyspnea Scale (Completers Analysis Set Only)
timeFrame: Week 16 to Week 24
measure: Change From Baseline to Weeks 16 and 24 in the 6MWD
timeFrame: Week 16 to Week 24
measure: Change From Week 16 to Week 24 in the 6MWD (Completers Analysis Set Only)
timeFrame: Week 16 to Week 24
Other outcomes:
Locations:
city: Tucson
country: United States
state: Arizona
city: La Jolla
country: United States
state: California
city: Moreno Valley
country: United States
state: California
city: Pomona
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Juan Capistrano
country: United States
state: California
city: Santa Barbara
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Hartford
country: United States
state: Connecticut
city: Celebration
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Miami Beach
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Weston
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Augusta
country: United States
state: Georgia
city: Austell
country: United States
state: Georgia
city: Marietta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Fort Wayne
country: United States
state: Indiana
city: Indianapolis
country: United States
state: Indiana
city: Iowa City
country: United States
state: Iowa
city: Louisville
country: United States
state: Kentucky
city: New Orleans
country: United States
state: Louisiana
city: Boston
country: United States
state: Massachusetts
city: Boston
country: United States
state: Massachusetts
city: North Dartmouth
country: United States
state: Massachusetts
city: Detroit
country: United States
state: Michigan
city: Troy
country: United States
state: Michigan
city: Pascagoula
country: United States
state: Mississippi
city: Lincoln
country: United States
state: Nebraska
city: Omaha
country: United States
state: Nebraska
city: Newark
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Albany
country: United States
state: New York
city: Brooklyn
country: United States
state: New York
city: Liverpool
country: United States
state: New York
city: Mineola
country: United States
state: New York
city: New Hyde Park
country: United States
state: New York
city: Stony Brook
country: United States
state: New York
city: Syracuse
country: United States
state: New York
city: Cincinnati
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Toledo
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Providence
country: United States
state: Rhode Island
city: Sioux Falls
country: United States
state: South Dakota
city: El Paso
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Temple
country: United States
state: Texas
city: Milwaukee
country: United States
state: Wisconsin
city: Milwaukee
country: United States
state: Wisconsin
city: Guaynabo
country: Puerto Rico
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Mathai SC, Minai O, Sullivan SD, Lerner D, Levine D. Rationale and study design of MOTION: A phase 4, prospective, single-arm, open-label study to measure outcomes in patients with pulmonary arterial hypertension not on active treatment. Respir Med. 2017 Jan;122 Suppl 1:S23-S27. doi: 10.1016/j.rmed.2016.11.002. Epub 2016 Nov 2.