--- title: Measuring Outcomes In Patients With Pulmonary Arterial Hypertension Not on Active Treatment (MOTION) nct_id: NCT02191137 overall_status: COMPLETED phase: PHASE4 sponsor: Bayer study_type: INTERVENTIONAL primary_condition: Hypertension, Pulmonary countries: United States, Puerto Rico canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02191137.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02191137" ct_last_update_post_date: 2017-10-13 last_seen_at: "2026-05-12T06:25:55.185Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # 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 **NCT ID:** [NCT02191137](https://clinicaltrials.gov/study/NCT02191137) ## Key Facts - **Status:** COMPLETED - **Phase:** PHASE4 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 75 - **Lead Sponsor:** Bayer - **Conditions:** Hypertension, Pulmonary - **Start Date:** 2014-09-23 - **Completion Date:** 2016-07-16 - **CT.gov Last Update:** 2017-10-13 ## 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 - **Minimum age:** 18 Years - **Maximum age:** 80 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` 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 ``` ## Arms - **Riociguat 0.5mg to 2.5 mg** (EXPERIMENTAL) — Single arm, open label ## Interventions - **Riociguat (Adempas, BAY63-2521)** (DRUG) — Participants received therapy with riociguat during a 10-week titration phase. The starting dose for riociguat for all patients was 0.5 milligram (mg) three times a day (TID). The dose of riociguat was increased every 2 weeks in 0.5 mg increments to 1.0, 1.5, 2.0, and 2.5 mg until patients reached their individual optimal dose based on their systolic blood pressure and well-being. After reaching their optimal dose, patients then entered a maintenance phase and remained on this dose for an additional 14 weeks. End of treatment was reached at Visit 10 after 24 weeks of treatment with riociguat. ## Primary Outcomes - **Change From Baseline to Week 24 in the Living With Pulmonary Hypertension (LPH) Questionnaire Total Score** _(time frame: Baseline to Week 24)_ — The Living with Pulmonary Hypertension (LPH) questionnaire with Heart Failure questionnaire comprises 21 items, responded to on a 6-point Likert scale ranging from 0 'No' to 5 'Very much'. A total score ranging from 0 (best) to 105 (worst) is calculated by summing the responses to all 21 questions. ## Secondary Outcomes - **Change From Baseline to Weeks 4 and 16 in the LPH Total Score** _(time frame: Baseline to Week 4 and Week 16)_ - **Change From Week 16 to Week 24 in the LPH Total Score (Completers Analysis Set Only)** _(time frame: Week 16 to Week 24)_ - **Change From Baseline to Weeks 4, 16, and 24 in the LPH Physical Dimension Score** _(time frame: Baseline to Weeks 4, 16, and 24)_ - **Change From Week 16 to Week 24 in the LPH Physical Dimension Score (Completers Analysis Set Only)** _(time frame: Week 16 to Week 24)_ - **Change From Baseline to Weeks 4, 16, and 24 in the LPH Emotional Dimension Score** _(time frame: Baseline to Week 4, Week 16 and Week 24)_ - **Change From Week 16 to Week 24 in the LPH Emotional Dimension Score (Completers Analysis Set Only)** _(time frame: Week 16 to Week 24)_ - **Percentage of Patients With a Minimal Clinically Significant Important Difference (MCID) From Baseline in LPH Total Score at Weeks 4, 16, and 24** _(time frame: Baseline to Week 4, Week 16 and Week 24)_ - **Percentage of Patients With an MCID From Baseline in LPH Physical Dimension Score at Weeks 4, 16, and 24** _(time frame: Baseline to Week 4, Week 16 and Week 24)_ - **Percentage of Patients With an MCID From Baseline in LPH Emotional Dimension Score at Weeks 4, 16, and 24** _(time frame: Baseline to Week 4, Week 16 and Week 24)_ - **Percentage of Patients With an MCID From Week 16 in LPH Total Score at Week 24 (Completers Analysis Set Only)** _(time frame: Week 16 to Week 24)_ - **Percentage of Patients With an MCID From Week 16 in Physical Dimension Score at Week 24 (Completers Analysis Set Only)** _(time frame: Week 16 to Week 24)_ - **Percentage of Patients With an MCID From Week 16 in Emotional Dimension Score at Week 24 (Completers Analysis Set Only)** _(time frame: Week 16 to Week 24)_ - **Change From Baseline to Weeks 4, 16, and 24 in the WLQ Time Management, Physical Demands, Mental-Interpersonal Demands and Output Demands Scores** _(time frame: Baseline to Week 4, Week 16 and Week 24)_ - **Change From Baseline to Weeks 4, 16, and 24 in the WLQ Percentage of Productivity Loss** _(time frame: Baseline to Week 4, Week 16 and Week 24)_ - **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)** _(time frame: Week 16 to Week 24)_ - **Change From Week 16 to Week 24 in the WLQ Percentage of Productivity Loss (Completers Analysis Set Only)** _(time frame: Week 16 to Week 24)_ - **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** _(time frame: Baseline to Week 4, Week 16 and Week 24)_ - **Change From Week 16 to Week 24 in the SF-12 PCS Score and MCS Score (Completers Analysis Set Only)** _(time frame: Week 16 to Week 24)_ - **Change From Baseline to Weeks 4, 16, and 24 in the WHO Functional Class** _(time frame: Baseline to Week 4, Week 16 and Week 24)_ - **Change From Week 16 to Week 24 in the WHO Functional Class (Completers Analysis Set Only)** _(time frame: Week 16 to Week 24)_ - **Change From Baseline to Weeks 16 and 24 in the Modified Borg Dyspnea Scale** _(time frame: Week 16 to Week 24)_ - **Change From Week 16 to Week 24 in the Modified Borg Dyspnea Scale (Completers Analysis Set Only)** _(time frame: Week 16 to Week 24)_ - **Change From Baseline to Weeks 16 and 24 in the 6MWD** _(time frame: Week 16 to Week 24)_ - **Change From Week 16 to Week 24 in the 6MWD (Completers Analysis Set Only)** _(time frame: Week 16 to Week 24)_ ## Locations (59) - Tucson, Arizona, United States - La Jolla, California, United States - Moreno Valley, California, United States - Pomona, California, United States - Sacramento, California, United States - San Juan Capistrano, California, United States - Santa Barbara, California, United States - Aurora, Colorado, United States - Hartford, Connecticut, United States - Celebration, Florida, United States - Jacksonville, Florida, United States - Miami, Florida, United States - Miami Beach, Florida, United States - Orlando, Florida, United States - Weston, Florida, United States - Atlanta, Georgia, United States - Augusta, Georgia, United States - Austell, Georgia, United States - Marietta, Georgia, United States - Chicago, Illinois, United States - Fort Wayne, Indiana, United States - Indianapolis, Indiana, United States - Iowa City, Iowa, United States - Louisville, Kentucky, United States - New Orleans, Louisiana, United States - Boston, Massachusetts, United States - Boston, Massachusetts, United States - North Dartmouth, Massachusetts, United States - Detroit, Michigan, United States - Troy, Michigan, United States - Pascagoula, Mississippi, United States - Lincoln, Nebraska, United States - Omaha, Nebraska, United States - Newark, New Jersey, United States - Albuquerque, New Mexico, United States - Albany, New York, United States - Brooklyn, New York, United States - Liverpool, New York, United States - Mineola, New York, United States - New Hyde Park, New York, United States - Stony Brook, New York, United States - Syracuse, New York, United States - Cincinnati, Ohio, United States - Cincinnati, Ohio, United States - Cincinnati, Ohio, United States - Cleveland, Ohio, United States - Columbus, Ohio, United States - Toledo, Ohio, United States - Portland, Oregon, United States - Philadelphia, Pennsylvania, United States - Pittsburgh, Pennsylvania, United States - Providence, Rhode Island, United States - Sioux Falls, South Dakota, United States - El Paso, Texas, United States - Houston, Texas, United States - Temple, Texas, United States - Milwaukee, Wisconsin, United States - Milwaukee, Wisconsin, United States - Guaynabo, Puerto Rico ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - 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`locations.|aurora|colorado|united states` — added _(2026-05-12)_ - `locations.|hartford|connecticut|united states` — added _(2026-05-12)_ - `locations.|celebration|florida|united states` — added _(2026-05-12)_ - `locations.|jacksonville|florida|united states` — added _(2026-05-12)_ - `locations.|miami|florida|united states` — added _(2026-05-12)_ - `locations.|miami beach|florida|united states` — added _(2026-05-12)_ - `locations.|orlando|florida|united states` — added _(2026-05-12)_ - `locations.|weston|florida|united states` — added _(2026-05-12)_ - `locations.|atlanta|georgia|united states` — added _(2026-05-12)_ - `locations.|augusta|georgia|united states` — added _(2026-05-12)_ - `locations.|austell|georgia|united states` — added _(2026-05-12)_ - `locations.|marietta|georgia|united states` — added _(2026-05-12)_ - `locations.|chicago|illinois|united states` — added _(2026-05-12)_ - `locations.|fort wayne|indiana|united states` — added _(2026-05-12)_ - `locations.|indianapolis|indiana|united states` — added _(2026-05-12)_ - `locations.|iowa city|iowa|united states` — added _(2026-05-12)_ - `locations.|louisville|kentucky|united states` — added _(2026-05-12)_ - `locations.|new orleans|louisiana|united states` — added _(2026-05-12)_ - `locations.|boston|massachusetts|united states` — added _(2026-05-12)_ - `locations.|north dartmouth|massachusetts|united states` — added _(2026-05-12)_ - `locations.|detroit|michigan|united states` — added _(2026-05-12)_ - `locations.|troy|michigan|united states` — added _(2026-05-12)_ - `locations.|pascagoula|mississippi|united states` — added _(2026-05-12)_ - `locations.|lincoln|nebraska|united states` — added _(2026-05-12)_ - `locations.|omaha|nebraska|united states` — added _(2026-05-12)_ - `locations.|newark|new jersey|united states` — added _(2026-05-12)_ - `locations.|albuquerque|new mexico|united states` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT02191137.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT02191137* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*