Efficacy of Transdermal Nicotine, on Motor Symptoms in Advanced Parkinson's Disease

What Was Tested

In this phase 2 trial, researchers set out to test Therapeutic nicotine (patch, non-peptide) for parkinson's disease.

Medical treatment of idiopathic Parkinson disease motor symptoms requires dopaminergic drugs, with long term disabling side effects.

However, controlled studies provided conflicting results.

It had two arms (groups): 1 (experimental) and 2 (active comparator).

Experimental drug.

Usual treatment.

The registry classes the interventions as drug and other.

More on the Plan

Experimental plan Phase II controled study, in 40 patients, randomised in single blind, and in 2 groups: * One group treated by transdermal nicotine-therapy (N= 20), * One group without additional therapy (N= 20).

Who Took Part

Enrollment: 40 actual participants took part.

It was open to people of any sex aged from 35 years up to 70 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Patients aged between 35 and 70 years inclusive,. L-Dopa treatment since at least three years,. Patients with Parkinson's disease stage maximum IV ("OFF" state) according to the modified Hoehn and Yahr classification (without treatment since at least 12 hours), and III maximum in "ON" state,. Signed Informed Consent.

The full record lists 7 inclusion and 24 exclusion criteria; among the exclusions: previous neurosurgery for parkinson's disease,; weight \< 45 kg or \> 100 kg,; previous parkinson's disease treatment by transdermal nicotine-therapy discontinued less than 6 months before inclusion,.

How the Study Was Run

Design: randomized, parallel-group and open-label.

The parkinson's disease participants were allocated by chance, so the Therapeutic nicotine (patch, non-peptide) group and the comparison group should start out alike.

The Therapeutic nicotine (patch, non-peptide) group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Therapeutic nicotine (patch, non-peptide) study: the parkinson's disease participants and staff both knew the treatment.

It started in 2009-02 with completion listed for 2012-12.

It ran at 1 site in France.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 15 secondary outcomes, for example Evaluation of UPDRS III motor score assessed in "defined OFF" condition, Evaluation of neuroprotection, (SPECT DaTSCAN and UPDRS "OFF"), Compliance to nicotine treatment and Tolerance of transdermal nicotine.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Therapeutic nicotine (patch, non-peptide) in 40 people with parkinson's disease.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Therapeutic nicotine (patch, non-peptide) compound page, Parkinson's disease research.