Rotigotine Versus Placebo to Evaluate the Efficacy on Depressive Symptoms in Idiopathic Parkinson's Disease Patients

NCT01523301 | Completed Phase 4 Results

• 1 other identifier: SP1041
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 29

Brief Summary

The purpose of this study was to show superiority of Rotigotine over placebo on improvement of depressive symptoms in subjects with idiopathic Parkinson's disease.

Conditions

Idiopathic Parkinson's Disease

Keywords

Rotigotine; Neupro; Depressive Symptom; Idiopathic Parkinson's disease

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to the End of Maintenance Period in the Score of the Hamilton Depression Scale (HAM-D)

  The HAM-D consists of 17 items. Nine of the items are scored on a 5-point scale, ranging from 0 to 4. The remaining 8 items are scored on a 3-point scale, from 0 to 2. Therefore, the total score ranges between 0 to 52, with a cutoff score of 15/16 diagnosing major depressive disorder.

  From Baseline (Week 0) to end of Maintenance Period (up to Week 15)

Secondary Outcomes (6)

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

  From Baseline (Week 0) to end of Maintenance Period (up to Week 15)

• Change From Baseline to the End of Maintenance Period in the Score of Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living-ADL Subscale)

  From Baseline (Week 0) to end of Maintenance Period (up to Week 15)

• Change From Baseline to the End of Maintenance Period in the Score of Unified Parkinson's Disease Rating Scale (UPDRS) Part III (Motor Subscale)

  From Baseline (Week 0) to end of Maintenance Period (up to Week 15)

• Change From Baseline to the End of Maintenance Period in the Combined Score of Unified Parkinson's Disease Rating Scale (UPDRS) Part II (ADL) Plus Part III (Motor Subscale)

  From Baseline (Week 0) to end of Maintenance Period (up to Week 15)

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

  From Baseline (Week 0) to end of Maintenance Period (up to Week 15)

Study Arms (2)

Rotigotine

EXPERIMENTAL

Rotigotine, daily doses, treatment group

Drug: Rotigotine

Placebo

PLACEBO COMPARATOR

Placebo, daily doses, placebo group

Drug: Placebo

Interventions

Rotigotine DRUG

Transdermal Patch Content: 2 mg /24 h (10 cm\^2), 4 mg /24 h (20 cm\^2), 6 mg /24 h (30 cm\^2), 8 mg /24 h (40 cm\^2) * For early-stage Parkinson's disease, Subjects received Rotigotine patches in escalating weekly dose (starting with daily doses 2 mg/24 h to 8 mg/24 h) for a maximum 4-week Titration Period, then 8 week Maintenance period * For advanced-stage Parkinson's disease, Subjects received Rotigotine patches in escalating weekly dose (starting with daily doses 4 mg/24 h to 16 mg/24 h) for a maximum 7-week Titration Period, then 8 week Maintenance period

Rotigotine

Placebo DRUG

Transdermal Patch Size: 10 cm\^2, 20 cm\^2, 30 cm\^2, 40 cm\^2 Subjects randomized to placebo received matching placebo patches

Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects ≥ 20 years old
• Subjects diagnosed with idiopathic Parkinson's disease (according to the United Kingdom Parkinson's Disease Society Brain Bank Diagnostic Criteria for Parkinson's disease) at modified Hoehn and Yahr Scale stages I-III; do not have motor fluctuations, dyskinesia, and have stable motor symptom at least 4 weeks prior to the Screening Visit as judged by the local investigator
• Subject has a Beck Depression Inventory II (BDI-II) score ≥ 16 as evidenced by depression rating scale study in Parkinson's disease (Schrag A et al, 2007)
• Subject has a Mini-Mental State Examination (MMSE) score ≥ 24
• If subject is taking Levodopa (L-DOPA) and derivatives, Monoamine Oxidase (MAO) B-inhibitors, anticholinergics agents, Catechol-O-Methyl Transferase (COMT) inhibitor or N-Methyl-D-Aspartate (NMDA) antagonist, he/she must have been on stable dose for at least 28 days prior to the Screening Visit
• If subject is taking an antidepressant drug such as selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), bupropion, tricyclic antidepressants (TCAs), he/she must have been on a stable dose for at least 28 days prior to the Screening Visit and be maintained on that dose for the duration of the trial

You may not qualify if:

• Subject has any medical or psychiatric condition (ie, bipolar disorder, dementia, hallucinations or psychosis) that, in the opinion of the investigator, could jeopardize or would compromise the subject's ability to participate in this study
• Subject has a lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response ('Yes') to either Question 4 or Question 5 of the C-SSRS at Screening (Visit 1)
• Current psychotherapy or behavior therapy while participating in this study
• Subject has received electroconvulsive therapy within 12 weeks of the Screening Visit
• Subject who has received dopamine agonists within 28 days of the Screening Visit
• Subject who has received neuroleptics, methylphenidate, reserpine, alpha-methyldopa, metoclopramide, levosulpiride or amphetamine derivatives within 28 days of the Screening Visit

Sponsors & Collaborators

• UCB Korea Co., Ltd.: lead

Study Sites (29)

03

Ansan, South Korea

Location

19

Anyang, South Korea

Location

08

Busan, South Korea

Location

26

Busan, South Korea

Location

04

Daegu, South Korea

Location

05

Daegu, South Korea

Location

16

Daejeon, South Korea

Location

28

Goyang, South Korea

Location

24

Gwangju, South Korea

Location

29

Gwangju, South Korea

Location

11

Gyeonggi-do, South Korea

Location

15

Jinju, South Korea

Location

23

Jungbuk, South Korea

Location

01

Seoul, South Korea

Location

02

Seoul, South Korea

Location

06

Seoul, South Korea

Location

07

Seoul, South Korea

Location

09

Seoul, South Korea

Location

10

Seoul, South Korea

Location

12

Seoul, South Korea

Location

13

Seoul, South Korea

Location

14

Seoul, South Korea

Location

17

Seoul, South Korea

Location

18

Seoul, South Korea

Location

20

Seoul, South Korea

Location

21

Seoul, South Korea

Location

22

Seoul, South Korea

Location

27

Seoul, South Korea

Location

25

Yangsan, South Korea

Location

Related Publications (1)

• Chung SJ, Asgharnejad M, Bauer L, Ramirez F, Jeon B. Evaluation of rotigotine transdermal patch for the treatment of depressive symptoms in patients with Parkinson's disease. Expert Opin Pharmacother. 2016 Aug;17(11):1453-61. doi: 10.1080/14656566.2016.1202917. Epub 2016 Jul 7.

  PMID: 27322571 DERIVED

MeSH Terms

Conditions

Parkinson Disease; Depression

Interventions

rotigotine

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Study Director
• Organization: UCB

+1877 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: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: January 27, 2012
• First Posted: February 1, 2012
• Study Start: April 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: December 18, 2015
• Results First Posted: December 18, 2015

Record last verified: 2015-11

Locations

KR (29)