Disease-modifying Potential of Transdermal NICotine in Early Parkinson's Disease

Status unconfirmed · Phase 2 · Has a placebo group

Conditions studied: Parkinson's Disease

In brief

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).

Key facts

Study ID

NCT01560754

Run by

James BOYD MD

People needed

160

Starts

2012-10-01

Expected to finish

2016-12-01

Last updated by the study team

2015-09-29

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Written informed consent
• Capability and willingness to comply with the study related procedures
• Age >/= 30 y
• Usage of effective contraception (see below) in fertile pre-menopausal female participants (from inclusion until end of wash out) Acceptable forms of effective contraception include established use of oral, injected or implanted hormonal methods of contraception, placement of an intrauterine device (IUD) or intrauterine system (IUS), barrier methods of contraception (condom or occlusive cap /diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository or male / female sterilization / or true abstinence.
• 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
• Unstable or worsening angina pectoris,
• History of recent myocardial infarction or cardiac failure (NYHA from II to IV), myocardial insufficiency
• History at inclusion of serious cardiac arrhythmia,
• History of recent stroke or occlusive peripheral vascular disease, vasospasm
• History of structural brain disease, cerebrovascular diseases
• History of severe uncontrolled arterial hypertension
• History of severe pulmonary disease (asthma, COPD)
• History of auto-immune disease
• History of Hyperthyroidism
• History of Pheochromocytoma

Where it is running

• University of Southern California — Los Angeles, California, United States
• The Parkinsons Institute — Sunnyvale, California, United States
• Pacific Health Research & Education Institute — Honolulu, Hawaii, United States
• The University of Kansas Medical Center — Kansas City, Kansas, United States
• Struthers Parkinson'S Center — Golden Valley, Minnesota, United States
• Feinstein Institute For Medical Research, North Shore-Lij Health System — Manhasset, New York, United States
• Pennsylvania Hospital — Philadelphia, Pennsylvania, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• University of Vermont — Burlington, Vermont, United States
• Universitatsklinikum Giessen U. Marburg GmbH — Standort Marburg, Marburg, Germany
• Charite Campus Virchow Klinikum — Berlin, Germany
• Klinikum Bremerhaven — Bremerhaven, Germany
• Universitaetsklinikum CarlGustav Carus — Dresden, Germany
• Neurologische Klinik der, Dusseldorf — Düsseldorf, Germany
• Neurologische Universitaetsklinik Freiburg — Freiburg im Breisgau, Germany
• Klinikum Hanau GmbH — Hanau, Germany
• Universitaetsklinikum des Saarlandes — Homburg/Saar, Germany
• Paracelsus-Elena-Klinik Kassel — Kassel, Germany
• Universitaetsklinikum Schlewsig-Holstein — Kiel, Germany
• Universitaetsklinikum Leipzig — Leipzig, Germany
• Otto-von-Guericke-Universitat — Magdeburg, Germany
• Klinikum rechts der Isar — München, Germany
• Universitaetsklinikum Tubingen — Tübingen, Germany
• Universitaetsklinikum Ulm — Ulm, Germany

Full record on ClinicalTrials.gov

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