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About
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).
Full description
In order to prove the disease-modifying potential of transdermal nicotine treatment, an explanatory design with a 2 months wash-out phase before endpoint assessment will be performed. 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, see 3.1). The total UPDRS score will be determined by an independent rater, who is not involved in any other study-related procedure (e.g. reporting of adverse events). Change in total UPDRS score is the most widely applied measure in similar clinical trials assessing long-term beneficial effects of drugs. The investigators will also 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. For this purpose the UPDRS will be determined three times after placebo/nicotine withdrawal at the end of the study during Visit 7,8, and 9 (i.e. four times including Visit 6).
Approximately 250 subjects will be screened at 25-30 centers in Germany and the USA. The recruitment period will be 18 months. In the screening phase, subjects will be evaluated for eligibility for enrolment into the treatment phase. The investigators expect that screening of 250 subjects will result in 160 eligible subjects who will be randomly assigned 1:1 to treatment with either transdermal nicotine or transdermal placebo patch.
The treatment phase consists of a titration period (16 weeks, to find the highest dosage tolerated by the subject with a target of 28 mg) and a maintenance period (week 17 to week 52 with the highest tolerated dosage of nicotine).
The treatment phase will be followed by an 8 week wash-out phase (3 weeks down titration and 5 weeks run out).
Dose adjustments are permitted for adverse events and have to be documented thoroughly.
Enrollment
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Inclusion criteria
Exclusion criteria
Clinical signs indicating a Parkinson syndrome other than idiopathic PD e.g.:
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
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
History of seizures / epilepsy
History of amyosthenia / myasthenia gravis, pseudo-myasthenic syndrome
Dementia defined as Mini Mental State Examination (MMSE) score ≤ 24
Moderate depression (BDI-II score >24)
Suicide or suicide ideation
History or presence of specific psychiatric disorders, acute psychosis, hallucinations, pathologic gambling, alcohol or substance abuse
Patients under treatment with dihydropyridines (e.g. nifedipine, nicardipine, amlodipine)
History of uncontrolled diabetes
History of recent gastroduodenal ulcer (< 3 months) or presence of severe (acute and chronic) gastritis
History of known hepatobiliary or renal insufficiency
Pregnancy or lactation period
Simultaneous participation or previous participation within 60 days before screening in another clinical drug or medical device study. Other Trials that do not affect the NIC-PD Study (NIT, health economics evaluations, questionnaires, genetic studies) could be allowed, but have to be approved and documented by the steering committee
Primary purpose
Allocation
Interventional model
Masking
160 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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