Phase I/II study of NPC-22

Phase 1

Recruiting

• Conditions: Sialorrhea

• Registration Number: JPRN-jRCT2031210612
• Lead Sponsor: Katsunori Miyoshi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-02-17
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

The Japanese ALS patients who meet all inclusion criteria
(1) Patients who have provided their own written informed consent, who have complied with the requirements for participation in the study, who have undergone the medical examinations and tests specified in the study protocol, and who are able to report their symptoms, etc.
(2) Patients aged =>20 and =<80 years at the time of imformed consent, regardless of gender
(3) Patients who meet either definite or probable of the revised Airlie House diagnostic criteria for El Escorial
(4) Patients with drooling (salivary secretion below 3 on ALSFRS-R for more than 28 days) whose volume can be measured

Exclusion Criteria

(1) Patients with malignant tumors undergoing treatment
(2) Patients who are suffering or have a history of any skin disease or skin abnormality at the site of study drug administration (postauricular area) that may prevent evaluation or are receiving treatment at the site of study drug administration that may prevent evaluation (e.g., topical corticosteroids)
(3) Patients who have previously received treatment that affects the salivary glands (botulinum toxin injection, surgery, or radiation therapy)
(4) Patients who have received medication to treat drooling within 14 days (Day-14) prior to the start of study drug administration
(5) Patients with significant dental or oral lesions.
(6) Patients who are hypersensitive to scopolamine or atropine (belladonna alkaloid) or have a complication or a history of drug allergy
(7) Patients with any concurrent illnesses such as angle closure glaucoma, open angle glaucoma, benign prostatic hyperplasia, urinary retention, severe heart disease, congestive heart failure, arrhythmia, paralytic ileus, pyloric stenosis, ileus, ulcerative colitis, asthma, hyperthyroidism, epilepsy, hepatitis who are judged by the investigator or sub-investigator to be ineligible for participation in the study
(8) Patients with infectious diseases requiring treatment who are judged by the investigator or sub-investigator to be ineligible for participation in the study.
(9) Patients who are unable to cooperate with contraception from the time of obtaining consent until the end of observation
(10) Patients who are premenopausal (Menopause is defined here as the absence of menstruation for more than 12 months without any other medical reason)
(11) Patients who received another study drug within 12 weeks prior to the start of study drug administration
(12) Patients who are unsuitable as a subject in this study in the judgement of the principal investigator or a sub-investigator due to other reasons

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety: Adverse events, vital signs, 12-lead electrocardiogram (ECG), laboratory test values and C-SSRS

Secondary Outcome Measures

Name	Time	Method
- Pharmacodynamics: Amount of salivation, salivation scores (assessed by subjects on the visual analog scale [VAS])<br>- Pharmacokinetics: Plasma concentration of unchanged scopolamine<br>- Degree of drooling: Exploratory for the next phase study<br>- The following scale will be used to assess the degree of drooling<br> ALSFRS-R saliva secretion and Sialorrhea scoring scale (SSS)<br>- Adhesion status of NPC-22 Tape: Adhesion status when NPC-22 tape is removed