---
title: "Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease-Associated Pain"
nct_id: NCT01744496
overall_status: COMPLETED
phase: PHASE4
sponsor: UCB BIOSCIENCES GmbH
study_type: INTERVENTIONAL
primary_condition: "Advanced Idiopathic Parkinson's Disease"
countries: United States, Germany, Poland, Slovakia
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01744496.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01744496"
ct_last_update_post_date: 2015-05-01
last_seen_at: "2026-05-12T07:00:22.085Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease-Associated Pain

**Official Title:** A Multicenter, Multinational, Double-Blind, Placebo-Controlled, 2-Arm Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease-Associated Pain

**NCT ID:** [NCT01744496](https://clinicaltrials.gov/study/NCT01744496)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE4
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 68
- **Lead Sponsor:** UCB BIOSCIENCES GmbH
- **Conditions:** Advanced Idiopathic Parkinson's Disease
- **Start Date:** 2012-11
- **Completion Date:** 2014-01
- **CT.gov Last Update:** 2015-05-01

## Brief Summary

This trial is being conducted to compare the impact of Rotigotine and Placebo on Chronic Pain associated with Parkinson's Disease among patients with advanced stages of the disease.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Patient has advanced idiopathic Parkinson's Disease associated chronic pain assessed by a Likert Pain Scale
* Patient is taking Levodopa with a stable daily dose of at least 200 mg for at least 21 days prior to start
* Hoehn and Yahr stage score of II to IV
* Mini-Mental State Examination (MMSE) score ≥ 25
* If an antidepressant drug is taken, the dose must be stable for at least 21 days

Exclusion Criteria:

* Therapy with a Dopamine Agonist within 21 days prior to start
* Discontinuation from previous Dopamine Agonist Therapy due to lack of efficacy
* Therapy with Dopamine-modulating substances 21 days prior to start
* Therapy with analgesics for the treatment for pain, unless the dose has been stable
* Chronic alcohol or drug abuse
* Medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the patient's ability to participate in this study
* Hypersensitivity to any components of the Investigational Medicinal Product (IMP) or comparative drugs
* Atypical Parkinson's Disease Syndrome due to drugs
* History of deep brain stimulation
* Significant skin disease that would make transdermal drug use inappropriate
* Electroconvulsive therapy within 12 weeks prior to start
* Evidence of an Impulse Control Disorder
* Previous diagnosis of severe Restless Legs Syndrome
* Chronic Migraine
* Severe Depression
* Symptomatic Orthostatic Hypotension
```

## Arms

- **Rotigotine** (EXPERIMENTAL) — Rotigotine Transdermal Patches
- **Placebo** (PLACEBO_COMPARATOR) — Placebo Transdermal Patches

## Interventions

- **Rotigotine** (DRUG) — Patches will contain 4 mg / 24 h (20 cm\^2), 6 mg/ 24 h (30 cm\^2), or 8 mg /24 h (40 cm\^2) of Rotigotine. Application of study medication starts at the Baseline Visit. Rotigotine will be administered once daily starting at 4 mg / 24 h. Doses will then be up-titrated in weekly increments of 2 mg / 24 h until optimal or maximum dose (16 mg / 24 h) is reached and the Maintenance Period can be started. The duration of the Titration Period will vary from 1 to 7 weeks ± 3 days. The Maintenance Period will last 12 weeks ± 5 days. Thereafter, during the De-escalation Period, the dose of study medication will be decreased by 2 mg / 24 h every other day. The De-escalation Period may last up to 12 days.
- **Placebo** (DRUG) — Placebo patches match the size of active patches 20 cm\^2, 30 cm\^2, or 40 cm\^2 and will contain Placebo. Application of Placebo patches starts at the Baseline Visit. Placebo patches will be administered once daily starting with the equivalent of 4 mg / 24 h. Doses will then be up-titrated in weekly equivalents to 2 mg / 24 h until either optimal dose or maximum dose is reached. The maximum dose is the equivalent to 16 mg / 24 h. The duration of the Titration Period will vary from 1 to 7 weeks. The Maintenance Period will last 12 weeks ± 5 days. During the De-escalation Period, the dose of Placebo will be decreased by the equivalent to 2 mg / 24 h every other day. The De-escalation Period may last up to 12 days.

## Primary Outcomes

- **Change From Baseline to the End of the Maintenance Period in Pain Severity Assessed Using an 11-point Likert Pain Scale** _(time frame: Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after an up to 7 weeks Titration Period))_ — An 11-Point Likert Scale was used to assess patients' average daily pain. The subject rated his/her average pain from 0 (no pain) to 10 (worst pain ever experienced).

The average pain experienced in the last 7 days was calculated by the mean of the daily Likert Pain Scores within the 7 days prior to the respective visit (ie, Likert Pain Scores with a date of assessment before the date of visit and on or after the date of visit - 7 days). A negative value indicates an improvement.

## Secondary Outcomes

- **Percentage of Responders at the End of the Maintenance Period** _(time frame: Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period))_
- **Change From Baseline to the End of the Maintenance Period in the Sum Score of the 8-Item Parkinson's Disease Questionnaire (PDQ-8)** _(time frame: Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period))_
- **Change From Baseline to the End of the Maintenance Period in the 7-Item Depression Subscore of the Hospital Anxiety and Depression Scale (HADS)** _(time frame: Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period))_
- **Change From Baseline to the End of the Maintenance Period in the 7-Item Anxiety Subscore of the Hospital Anxiety and Depression Scale (HADS)** _(time frame: Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period))_
- **Change From Baseline to the End of the Maintenance Period in the Combined Score of the Unified Parkinson's Disease Rating Scale (UPDRS) Parts II (Activities of Daily Living [ADL] Subscale) and III (Motor Subscale)** _(time frame: Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period))_
- **Change From Baseline to the End of the Maintenance Period in the 7 Domain Scores of Classification of Pain in Parkinson's Disease** _(time frame: Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period))_

## Locations (16)

- 2113, Gilbert, Arizona, United States
- 2120, Sunnyvale, California, United States
- 2109, Tampa, Florida, United States
- 2107, Chicago, Illinois, United States
- 2102, Lexington, Kentucky, United States
- 2118, Advance, North Carolina, United States
- 2117, Cincinnati, Ohio, United States
- 2103, Tulsa, Oklahoma, United States
- 2101, Roanoke, Virginia, United States
- 2104, Milwaukee, Wisconsin, United States
- 1204, Gera, Germany
- 1607, Gdansk, Poland
- 1603, Krakow, Poland
- 1609, Olsztyn, Poland
- 1804, Bratislava, Slovakia
- 1805, Dubnica nad Váhom, Slovakia

## 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)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `locations.1609|olsztyn||poland` — added _(2026-05-12)_
- `locations.1804|bratislava||slovakia` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.2113|gilbert|arizona|united states` — added _(2026-05-12)_
- `locations.2120|sunnyvale|california|united states` — added _(2026-05-12)_
- `locations.2109|tampa|florida|united states` — added _(2026-05-12)_
- `locations.2107|chicago|illinois|united states` — added _(2026-05-12)_
- `locations.2102|lexington|kentucky|united states` — added _(2026-05-12)_
- `locations.2118|advance|north carolina|united states` — added _(2026-05-12)_
- `locations.2117|cincinnati|ohio|united states` — added _(2026-05-12)_
- `locations.2103|tulsa|oklahoma|united states` — added _(2026-05-12)_
- `locations.2101|roanoke|virginia|united states` — added _(2026-05-12)_
- `locations.2104|milwaukee|wisconsin|united states` — added _(2026-05-12)_
- `locations.1204|gera||germany` — added _(2026-05-12)_
- `locations.1607|gdansk||poland` — added _(2026-05-12)_
- `locations.1603|krakow||poland` — added _(2026-05-12)_
- `locations.1805|dubnica nad váhom||slovakia` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01744496.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01744496*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*