Trial to Evaluate The Efficacy Of Rotigotine on Parkinson's Disease-Associated Motor Symptoms And Apathy

NCT01782222 | Completed Phase 4 Results

• 2 other identifiers: PD00052012-002840-26
• Study Type: interventional
• Target: 122
• Locations: 6 countries
• Sites: 41

Brief Summary

This trial is being conducted to assess the effects of Rotigotine over Placebo on improvement of Apathy and motor symptoms in subjects with early-stage and advanced stage idiopathic Parkinson´s Disease.

Conditions

Idiopathic Parkinson's Disease

Keywords

Parkinson's Disease; Rotigotine; Apathy; Nonmotor; Motor; Neupro

Outcome Measures

Primary Outcomes (2)

• Change From Baseline to the End of the Maintenance Period in the Score of the Apathy Evaluation Scale (AS) Rated by the Patient

  The Apathy Scale (AS) is an abbreviated version of the Apathy Evaluation Scale. The AS (Starkstein et al, 1992) consists of 14 items phrased as questions by the examiner that are to be answered on a 4-point Likert scale. It was developed specifically for subjects with Parkinson's disease because the Apathy Evaluation Scale was considered too demanding. The questions comprising the AS were answered by the subject. The total scores for Apathy Evaluation Scale ranges from 0 (best possible outcome) to 42 (worst possible outcome).

  Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline)

• Change From Baseline to the End of the Maintenance Period in the Total Score of the Unified Parkinson's Disease Rating Scale (UPDRS) Parts II (Activities of Daily Living) + III (Motor Symptoms)

  Part II of the Unified Parkinson's Disease Rating Scale (UPDRS) assesses the subject's activities of daily living. Part III assesses motor function. The UPDRS is completed by questioning the subject about his/her general state in conjunction with any observations made by the investigator (or designee) since the previous visit. Part II is subject-rated and Part III is physician-rated. The UPDRS Part II (Activities of Daily Living) consists of 13 items scored between 0 and 4. The sum score was calculated as the sum of these 13 individual scores. The UPDRS Part III (motor subscale) consists of 27 items and sub items scored between 0 and 4. The sum score was calculated as sum of these 27 individual scores. The sum score of UPDRS Parts II and III is the sum of the corresponding single sum scores. A negative value indicates an improvement.

  Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline)

Secondary Outcomes (7)

• Change From Baseline to the End of the Maintenance Period in the Score of the Apathy Evaluation Scale (AS) Rated by the Caregiver (Where Available)

  Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline)

• Change From Baseline to the End of the Maintenance Period in the Sum Score of the 8-item Parkinson's Disease Questionnaire (PDQ-8)

  Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline)

• Change From Baseline to the End of the Maintenance Period in the Sum Score of the Mood / Cognition Domain of the Nonmotor Symptom Assessment Scale (NMSS)

  Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline)

• Change From Baseline to the End of the Maintenance Period in the Sum Score of the Snaith Hamilton Pleasure Scale (SHAPS)

  Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline)

• Change From Baseline to the End of the Maintenance Period in the Sum Score of the Beck Depression Inventory Second Edition (BDI-II)

  Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline)

Study Arms (3)

Rotigotine, high dose

EXPERIMENTAL

Rotigotine, transdermal patches, maximal 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease

Drug: Rotigotine

Rotigotine, low dose

EXPERIMENTAL

Rotigotine, transdermal patches, optimal dose, maximal 8 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours for those with early Parkinson's Disease

Drug: Rotigotine

Placebo

PLACEBO COMPARATOR

Placebo transdermal patches

Other: Placebo

Interventions

Rotigotine DRUG

Rotigotine, transdermal patches: 10 cm\^2 (2 mg / 24 hours); 20 cm\^2 (4 mg / 24 hours); 30 cm\^2 (6 mg / 24 hours); 40 cm\^2 (8 mg / 24 hours) The maximum Rotigotine dose allowed is 8 mg / 24 hours or 16 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours or 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)

Also known as: (6S)-6-propyl-[2 (2 thienyl)ethyl]amino-5,6,7,8-tetrahydro-1-naphthalenol

Rotigotine, high dose; Rotigotine, low dose

Placebo OTHER

Placebo, matching transdermal patches Duration: up to 21 weeks (including de-escalation)

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with early or advanced idiopathic Parkinson's Disease
• Patients with advanced idiopathic Parkinson's Disease: intake of Levodopa on a stable dose of at least 200 mg/day
• Unsatisfactory control of Parkinson's Disease motor symptoms under current treatment
• Patients experiencing Apathy associated with Parkinson's Disease
• Hoehn and Yahr stage score of I to IV
• Mini-Mental State Examination score ≥ 25
• If an antidepressant drug is taken, the dose must be stable

You may not qualify if:

• Therapy with a Dopamine agonist
• Discontinuation from pervious therapy with a dopamine agonist after an adequate length of treatment, at adequate dose, due to lack of efficacy
• Any medical or psychiatric condition that jeopardizes / compromises patient's ability for participation
• Patient has received Neuroleptics, Dopamine releasing substances, Dopamine modulating substances, Alpha-Methyldopa, Metoclopramide, MAO-A inhibitors, Budipine, or Tolcapone
• Electroconvulsive therapy
• Patient has a
• current/anticipated psychotherapy or behavior therapy
• history of deep brain stimulation
• history of suicide attempt or has suicidal ideation
• impulse control disorder
• severe Depression

Sponsors & Collaborators

• UCB BIOSCIENCES GmbH: lead

Study Sites (42)

4320

Birmingham, Alabama, United States

Location

4309

Oxnard, California, United States

Location

4306

Ormond Beach, Florida, United States

Location

4311

Palm Beach Gardens, Florida, United States

Location

4313

Tampa, Florida, United States

Location

4314

Decatur, Georgia, United States

Location

4318

Chicago, Illinois, United States

Location

4316

Winfield, Illinois, United States

Location

4322

Des Moines, Iowa, United States

Location

4304

Kansas City, Kansas, United States

Location

4326

Springfield, Massachusetts, United States

Location

4330

Ocean Springs, Mississippi, United States

Location

4302

Las Vegas, Nevada, United States

Location

4303

Commack, New York, United States

Location

4317

New York, New York, United States

Location

4323

New York, New York, United States

Location

4319

Asheville, North Carolina, United States

Location

4325

Charlotte, North Carolina, United States

Location

4329

Akron, Ohio, United States

Location

4312

Cincinnati, Ohio, United States

Location

4324

Beaufort, South Carolina, United States

Location

4332

Charleston, South Carolina, United States

Location

4305

San Antonio, Texas, United States

Location

4307

Salt Lake City, Utah, United States

Location

4333

Virginia Beach, Virginia, United States

Location

3001

Innsbruck, Austria

Location

3003

Linz, Austria

Location

3301

Budapest, Hungary

Location

3302

Debrecen, Hungary

Location

3509

Gdansk, Poland

Location

3506

Gdynia, Poland

Location

3504

Poznan, Poland

Location

3801

Banská Bystrica, Slovakia

Location

3805

Bratislava, Slovakia

Location

3806

Krompachy, Slovakia

Location

3807

Žilina, Slovakia

Location

3901

Ljubljana, Slovenia

Location

4001

Barcelona, Spain

Location

4006

Barcelona, Spain

Location

4009

Oviedo, Spain

Location

4005

Seville, Spain

Location

4010

Seville, Spain

Location

Related Publications (1)

• Hauser RA, Slawek J, Barone P, Dohin E, Surmann E, Asgharnejad M, Bauer L. Evaluation of rotigotine transdermal patch for the treatment of apathy and motor symptoms in Parkinson's disease. BMC Neurol. 2016 Jun 7;16:90. doi: 10.1186/s12883-016-0610-7.

  PMID: 27267880 DERIVED

Related Links

• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Parkinson Disease; Lethargy

Interventions

rotigotine

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: UCB Cares
• Organization: UCB

+1 877 822 9493

Study Officials

• UCB Clinical Trial Call Center

  +1 877 822 9493 (UCB)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2013
• First Posted: February 1, 2013
• Study Start: February 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: March 1, 2014
• Last Updated: August 31, 2018
• Results First Posted: January 19, 2015

Record last verified: 2018-07

Locations

SL (4); ES (5); PL (3); US (25); AU (2); HU (2)