NCT01560754

Brief Summary

The primary objective of this study is to demonstrate that transdermal nicotine treatment retards disease progression as measured by change in total Unified Parkinson's Disease Rating Scale (UPDRS)(part I, II, III)score between baseline and after 52 weeks of study treatment plus two more months wash out (60 weeks).

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2012

Typical duration for phase_2

Geographic Reach
2 countries

24 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 22, 2012

Completed
6 months until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

September 29, 2015

Status Verified

September 1, 2015

Enrollment Period

3.8 years

First QC Date

March 9, 2012

Last Update Submit

September 28, 2015

Conditions

Parkinson's Disease

Keywords

RandomizedPlacebo-controlledDouble-blindMulti-centerDisease-modifying potentialtransdermal nicotine

Outcome Measures

Primary Outcomes (1)

  • The primary endpoint is calculated as the difference between the nicotine arm and the placebo arm in the change in total UPDRS I-III score between baseline and 60 weeks (14 months) (52 weeks treatment plus 8 weeks wash-out).

    The primary objective is to demonstrate superiority measured by the difference between the nicotine arm and the placebo arm in the change in total UPDRS score (part I-III) between baseline and end of month 14 (12 months treatment and 2 months wash-out

    From Baseline to week 60

Secondary Outcomes (12)

  • The change in total UPDRS I-III score between baseline and 52 weeks (12 months)

    Baseline to 52 weeks

  • Parkinson's Disease Questionaire - 8(PDQ-8) that is calculated as the change between baseline and 60 weeks

    Baseline and week 60

  • The frequency of adverse events will be analyzed

    Baseline through week 60

  • The 'time to initiation of a symptomatic treatment' is calculated from the date of randomization to the date that a subject initiates symptomatic therapy

    Baseline to initiation of symptomatic therapy, this timeframe will vary from subject to subject based on duration of disease and how well their PD is currently being managed

  • Determine whether the slope of the curves for the total UPDRS score in active- and placebo-treated subjects show a tendency to converge over time

    Baseline to week 52 and week 60

  • +7 more secondary outcomes

Study Arms (2)

Transdermal nicotine patch

EXPERIMENTAL

Subjects will apply a combination of 7 or 14 mg nicotine transdermal patches until reaching their highest well tolerated dose of 7 to 28 mg/day.

Drug: nicotine transdermal patch

Transdermal placebo patch

PLACEBO COMPARATOR

Subjects will apply a combination of 7 or 14 mg placebo transdermal patches until reaching their highest well tolerated dose.

Drug: nicotine transdermal patch

Interventions

nicotine transdermal patchDRUG

Transdermal patches containing 7 or 14 mg nicotine or placebo with subjects titrating up until reaching their highest tolerated dose of 7 to 28mg/day.

Also known as: Habitrol Transdermal patch (US), Nicotinell Transdermal patch (Germany)
Transdermal nicotine patchTransdermal placebo patch

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed consent
  • Capability and willingness to comply with the study related procedures
  • Age \>/= 30 y
  • Diagnosis of PD according to the UK Brain Bank Diagnostic Criteria
  • Early PD subjects within 18 months of diagnosis
  • Hoehn and Yahr stage ≤ 2
  • Patients not receiving or needing dopamine agonist or levodopa therapy presently or for the next year
  • Stable treatment (\>2 months) with MAO-B inhibitor (selegiline up to 10 mg/d or rasagiline up to 1 mg/d) allowable

You may not qualify if:

  • Clinical signs indicating a Parkinson syndrome other than idiopathic PD e.g.:
  • Supranuclear gaze palsy
  • Signs of frontal dementia
  • History of repeated strokes with stepwise progression of Parkinsonian features
  • History of repeated head injury or history of definite encephalitis
  • Cerebellar signs
  • Early severe autonomic involvement
  • Babinski's sign
  • History of exposure to or current treatment with neuroleptic drugs or anticraving substances
  • History of nicotine use within five years of the baseline visit
  • Previous history of allergic response to nicotine application or any of the patch excipients (see protocol sec. 10.2)
  • Previous history of allergic response to transdermal patches
  • Pre-existing dermatological disorder that could disturb transdermal patch application in the opinion of the investigator (e.g. generalized / systemic or local neurodermatitis, psoriasis, chronic dermatitis, urticaria, etc.)
  • Previous treatment with antiparkinsonian drugs (e.g. levodopa, dopamine agonists, etc.) other than MAO-B inhibitors
  • History of unstable or serious cardiovascular diseases
  • +21 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

University of Southern California

Los Angeles, California, 90033, United States

Location

The Parkinsons Institute

Sunnyvale, California, 94085, United States

Location

Pacific Health Research & Education Institute

Honolulu, Hawaii, 96819, United States

Location

The University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Struthers Parkinson'S Center

Golden Valley, Minnesota, 55427, United States

Location

Feinstein Institute For Medical Research, North Shore-Lij Health System

Manhasset, New York, 11030, United States

Location

Pennsylvania Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

University of Vermont

Burlington, Vermont, 05405, United States

Location

Universitatsklinikum Giessen U. Marburg GmbH

Standort Marburg, Marburg, Germany

Location

Charite Campus Virchow Klinikum

Berlin, Germany

Location

Klinikum Bremerhaven

Bremerhaven, Germany

Location

Universitaetsklinikum CarlGustav Carus

Dresden, Germany

Location

Neurologische Klinik der, Dusseldorf

Düsseldorf, Germany

Location

Neurologische Universitaetsklinik Freiburg

Freiburg im Breisgau, Germany

Location

Klinikum Hanau GmbH

Hanau, Germany

Location

Universitaetsklinikum des Saarlandes

Homburg/Saar, Germany

Location

Paracelsus-Elena-Klinik Kassel

Kassel, Germany

Location

Universitaetsklinikum Schlewsig-Holstein

Kiel, Germany

Location

Universitaetsklinikum Leipzig

Leipzig, Germany

Location

Otto-von-Guericke-Universitat

Magdeburg, D-39120, Germany

Location

Klinikum rechts der Isar

München, Germany

Location

Universitaetsklinikum Tubingen

Tübingen, Germany

Location

Universitaetsklinikum Ulm

Ulm, Germany

Location

Related Publications (1)

  • Oertel WH, Muller HH, Unger MM, Schade-Brittinger C, Balthasar K, Articus K, Brinkman M, Venuto CS, Tracik F, Eberling J, Eggert KM, Kamp C, Kieburtz K, Boyd JT. Transdermal Nicotine Treatment and Progression of Early Parkinson's Disease. NEJM Evid. 2023 Sep;2(9):EVIDoa2200311. doi: 10.1056/EVIDoa2200311. Epub 2023 Aug 22.

    PMID: 38320207DERIVED

MeSH Terms

Conditions

Parkinson Disease

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Wolfgang Oertel, MD

    Philipps-University Marburg, Germany / Global and German Principal Investigator

    PRINCIPAL INVESTIGATOR

  • James Boyd, MD

    University of Vermont / United States Principal Investigator

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
United States Principal Investigator

Study Record Dates

First Submitted

March 9, 2012

First Posted

March 22, 2012

Study Start

October 1, 2012

Primary Completion

August 1, 2016

Study Completion

December 1, 2016

Last Updated

September 29, 2015

Record last verified: 2015-09

Locations

DE(15)US(9)