A phase II/III study of NPC-22

JRCT ID: jRCT2031240163

Registered date:14/06/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: chronic sialorrhea
• Date of first enrollment: 14/06/2024
• Target sample size: 135
• Study type: Interventional
• Intervention(s): NPC-22 Dose 1, NPC-22 Dose 2, or placebo will be administered once daily.

Outcome(s)

• Primary Outcome: Change from baseline (at the start of the double-blind period) in salivary flow rate to four weeks after the start of treatment

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

(1) Patients who can provide their own informed consent, fulfill comply with their responsibility as study participants, undergo a medical examination and test specified in the protocol, and report their condition, etc.
(2) Male or female patients aged=>18 and <=80 years at the time of informed consent
(3) Patients with sialorrhea (Sialorrhea Scoring Scale [SSS] of =>5)
(4) Group A:
<ALS> Patients who meet eitherhave definite or probable ALS according to the El Escorial and the revised Airlie House
diagnostic criteria
<PD> Patients diagnosed with clinically probable Parkinson's disease according to MDS clinical diagnostic criteria
Group B:
<Patients with chronic sialorrhea excluding ALS and PD>
Patients who have a disease that causes sialorrhea
Examples: Clinically diagnosed progressive supranuclear palsy, spinocerebellar degeneration, multiple system atrophy,
corticobasal degeneration, stroke, traumatic brain injury, etc.

Exclude criteria

<Exclusion criteria applicable to Group A and Group B>
(1) Patients who need to use prohibited concomitant drugs, including anticholinergic drugs or tricyclic antidepressants, or
undergo prohibited concomitant therapy from 28 days before the start of investigational product administration through the
end of the follow-up period
(2) Patients who have received an injection of botulinum toxin within 16 weeks before the start of investigational product
administration (within one year for sialorrhea)
(3) Patients with angle closure glaucoma, open-angle glaucoma, or dysuria caused by prostatic hypertrophy or those with serious
heart disease, congestive heart failure, arrhythmia, paralytic ileus, ileus, ulcerative colitis, asthma, hyperthyroidism, epilepsy,
hepatitis, or other conditions that are disqualified from participation in the study by the investigator or sub-investigator
(4) Patients withypersensitivity to patches
(5) Patients with or with a history of skin diseases or abnormalities at the site of investigational product administration that
interfere with evaluation and those who are receiving treatment at the site of investigational product administration that
interfere with evaluation (such as topical corticosteroids)
(6) Patients in whom it is difficult to measure salivary flow rate
(7) Patients who have marked dental or intraoral lesions
(8) Patients whose dental or oral hygiene is extremely poor and may hinder safe participation in the study in the opinion of the
investigator or sub-investigator
(9) Patients who have dementia or an MMSE-J score of <=23
<Exclusion criteria only applicable to Group A>
(10)Patients with sialorrhea not caused by ALS or PD
(11)Patients who need to change therapeutics for ALS or anti-PD drugs, change the method of using restricted concomitant
therapy, or undergo new restricted concomitant therapy for the period from 28 days before the start of investigational product
administration to the end of the double-blind period

Related Information

• Primary Sponsor: Miyoshi Katsunori