A Trial to Explore Symptomatic Therapy for Application Site Reaction to SPM962 in Healthy Subject

An Open-Label Trial to Explore Symptomatic Therapy for Application Site Reaction to SPM962 in Healthy Subject

To investigate the efficacy of symptomatic therapy with topical steroids and antihistamines for application site reaction (ASR) after administration of SPM 962 in healthy subjects

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Topical steroid (Dexamethasone); Drug: Topical antihistamine (Diphenhydramine)

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Kyeonggi-do, Korea, Republic of
    • Seoul National University Bundang Hospital
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subject is a male or female and aged between 20 and 45 years of age (inclusive)
• Subject is of normal body weight as determined by a body-mass index (BMI) between 18 and 28 kg/m2
• Subject is healthy as determined by EA (medical history, physical examination, skin evaluation, vital signs, ECG, hematology, clinical chemistry, urinalysis)
• Subject is surgically sterile; subject has been postmenopausal for at least 12 consecutive months if female; or subject agrees to remain abstinent or to follow two acceptable methods of birth control from EA to the end of observation period. (fore male and female subjects)

Exclusion Criteria:

• Subject has a history or complication of epilepsy and/or seizures
• Subject has clinically relevant changes in the ECG, such as second- or third-degree AV block, a complete bundle branch block, prolongation of the QRS complex over 120 ms, or of the QTcB (QT interval corrected for HR by Bazett´s formula) over 500 ms at EA
• Subject has a clinically relevant hepatic dysfunction
• Subject has a clinically relevant renal dysfunction
• Subject has a history of significant skin hypersensitivity to adhesives or other transdermal products or recent unresolved contact dermatitis
• Subject has a history or complication of atopic or eczematous dermatitis, psoriasis, and/or an active skin disease or skin tumors
• Subject has more than 1 known or suspected drug hypersensitivity, in particular to any component of the trial medication
• Subject has a history of chronic alcohol or drug abuse within the last 5 years
• Subject is tested positive for HIV-1/2Ab, HBsAg or HCV-Ab
• Subject tests positive for alcohol and/or drugs at EA
• Subject is taking any prohibited concomitant medication
• Subject has a history or complication of narrow angle glaucoma
• Subject has a history or complication of respiratory or cardiovascular disorders (e.g., heart failure, coronary heart disease, hypertension, arrhythmia, tachyarrhythmia, or myocardial infarction)
• Subject has a history or complication of psychic abnormality, psychiatric or neurologic illness, or autonomic neuropathy
• Subject has a history or complication of diabetes mellitus and/or thyroid dysfunction, especially hyperthyroidism or other endocrine disorders
• Subject has a history or complication of malignancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Topical Steroid; Topical medication of steroid (Dexamethasone) to the application sites after the patch removal	Drug: Topical steroid (Dexamethasone); for SPM 962: 1 mg/24h patch for 48 hours as Acceleration period, then 2 mg/24h patch to the other site for 24 hours as Dose-escalation period, for steroid: twice daily administration of Dexamethasone (1 mg/g cream) to the application sites after the patch removal
EXPERIMENTAL: Topical antihistamine; Topical medication of antihistamine(Diphenhydramine) to the application sites after the patch removal	Drug: Topical antihistamine (Diphenhydramine); for SPM 962: 1 mg/24h patch for 48 hours as Acceleration period, then 2 mg/24h patch to the other site for 24 hours as Dose-escalation period, for antihistamine: twice daily administration of Diphenhydramine (10 mg/g cream) to the application sites after the patch removal
NO_INTERVENTION: No-treatment; No treatment to the application sites after the patch removal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin Irritation Score of the Application Site	Skin irritation score of the application site 24 hours after 2 mg/24 hour patch removal (dose-escalation period) and difference between Steroid or Antihistamine and No-treatment. The scale scoring criteria are 0(-): Negative, 0.5(±): Faint erythema, 1(+): Erythema, 2(++): Erythema + edema, 3(+++): Erythema + edema + papules, serous papule, vesicles, 4(++++): Coalescing vesicles.	24 hours after 2 mg/24 hr patch removal
Itching of Application Site Evaluated by the Visual Analogue Scale (VAS)	Itching of application site evaluated by the visual analogue scale (VAS) 24 hours after 2 mg/24 hour patch removal (dose-escalation period) and difference between Steroid or Antihistamine and No-treatment. The score ranges from 0 (no itching) to 100 (strongest imaginable itching).	24 hours after 2 mg/24 hr patch removal

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin Irritation Score After Patch Removal	Numbers of subjects with each skin irritation score. The scale scoring criteria are 0(-): Negative, 0.5(±): Faint erythema, 1(+): Erythema, 2(++): Erythema + edema, 3(+++): Erythema + edema + papules, serous papule, vesicles, 4(++++): Coalescing vesicles.	Up to 72 hours after patch removal
Itching of Application Site Evaluated by VAS After Patch Removal	Changes of itching of application site evaluated by VAS after patch removal (acceleration and dose-escalation periods). The score ranges from 0 (no itching) to 100 (strongest imaginable itching).	Up to 96 hours after patch removal

Collaborators and Investigators

• Sponsor: Otsuka Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (ACTUAL): October 1, 2012
• Study Completion (ACTUAL): November 1, 2012

Study Registration Dates

• First Submitted: November 25, 2012
• First Submitted That Met QC Criteria: November 29, 2012
• First Posted (ESTIMATE): November 30, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): April 29, 2014
• Last Update Submitted That Met QC Criteria: March 26, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: rotigotine; SPM 962; application site reaction
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dermatologic Agents; Hypnotics and Sedatives; Anesthetics, Local; Anti-Allergic Agents; Sleep Aids, Pharmaceutical; Histamine Agents; Antipruritics; Dexamethasone; Diphenhydramine; Promethazine; Histamine H1 Antagonists; Histamine Antagonists
• Other Study ID Numbers: 243-12-002