臨床研究等提出・公開システム

A Phase I/II Study of NPC-22 in Patients with Amyotrophic Lateral Sclerosis (NPC-22-4)

Phase I/II study of NPC-22

Katsunori Miyoshi

Nobelpharma Co., Ltd.

NMF Kayabacho Bldg., 1-17-24, Shinkawa, Chuo-ku, Tokyo

miyoshi.katsunori@nobelpharma.co.jp

Katsunori Miyoshi

Nobelpharma Co., Ltd.

NMF Kayabacho Bldg., 1-17-24, Shinkawa, Chuo-ku, Tokyo

+81-3-6670-3810

miyoshi.katsunori@nobelpharma.co.jp

Complete

Feb. 28, 2022

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

other

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

(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

Both

Sialorrhea

Transdermal administration of NPC-22 or placebo once daily for 7 days

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

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

+81-476-35-5607

Feb. 10, 2022

No

none