DDrare: Database of Drug Development for Rare Diseases

告示番号	疾患名（ページ内リンク）	臨床試験数
6	パーキンソン病	6
299	嚢胞性線維症	1

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT03541356 (ClinicalTrials.gov)	May 8, 2018	5/4/2018	Therapeutic Potential for Intranasal Levodopa in Parkinson's Disease -Off Reversal	A Phase IIa, Randomized, Double Blind, Placebo Controlled, Single Ascending Dose, Safety and Pharmacokinetic/Pharmacodynamic Study of INP103 (POD L-dopa) Administered in the Presence of DCI to L-dopa Responsive Parkinson's Disease Patients	Parkinson's Disease	Combination Product: Placebo;Combination Product: L-dopa 35 mg;Combination Product: L-dopa 70mg;Combination Product: L-dopa 140 mg;Combination Product: L-dopa 70mg/carbidopa 7mg	Impel NeuroPharma Inc.	NULL	Completed	40 Years	80 Years	All	32	Phase 2	Australia
2	JPRN-jRCTs051180098	09/06/2016	06/03/2019	The DAT-SPECT study for the benefit of Selegilline or Zonisamide in Parkinson's Disease	A comparative randomized study for the evaluation of the overlaying effect of Selegiline or Zonisamide over Levodopa in Parkinson's disease	Parkinson's disease;034034	L-Dopa/DCI only : The drug is administered per oral at 300 mg/day. The treatment is started within 14 days after registration and continued until day 365. L-Dopa/DCI + selegiline : L-Dopa/DCI is administered per oral at 300 mg/day and selegiline is administered at 5 mg/day. The treatment is started within 14 days after registration and continued until day 365. L-Dopa/DCI + zonisamide : L-Dopa/DCI is administered per oral at 300 mg/day and zonisamide is administered at 25 mg/day. The treatment is started within 14 days after registration and continued until day 365.	Ito Hidefumi	NULL	Recruiting	>= 55age old	< 80age old	Both	120	Phase 2	Japan
3	JPRN-UMIN000022533	2016/06/01	01/06/2016	A comparative randomized study for the evaluation of the overlaying effect of Selegiline or Zonisamide over Levodopa in Parkinson's disease		Parkinson's disease	L-Dopa/DCI only The drug is administered per oral at 150 to 300 mg/day. The treatment is started within 14days after registration and continued until day 365. L-Dopa/DCI + selegiline L-Dopa/DCI is administered per oral at 150 to 300 mg/day and selegiline is administered at 5mg/day. The treatment is started within 14days after registration and continued until day 365. L-Dopa/DCI + zonisamide L-Dopa/DCI is administered per oral at 150 to 300 mg/day and zonisamide is administered at 25mg/day. The treatment is started within 14days after registration and continued until day 365.	Osaka Redcross HospitalWakayama Prefectural Medical College	NULL	Recruiting	55years-old	80years-old	Male and Female	180	Phase 2	Japan
4	JPRN-jRCTs041180070	04/11/2015	07/03/2019	Trerief Impact in PD PET Study	Randomized, multicenter, open-label, comparative study on neuroprotective effects of zonisamide (Trerief), anti-parkinsonian drug, in patients with early Parkinson's disease: Evaluation by functional PET (positron emission tomography) images - TIPPS	Parkinson's disease Parkinson's disease;D010300	[1] Zonisamide treatment group Zonisamide (25 mg) once daily in addition to levodopa/DCI with fixed dosage and administration. Note that after one-year fixed protocol period, the followings are allowed; 1) one or two tablets per day in case of developing wearing off phenomenon, 2) change of dose and/or administration of levodopa/DCI, and 3) addition of other anti-parkinsonian drugs due to exacerbation of symptoms. [2] Zonisamide non-treatment group Only levodopa/DCI with fixed dosage and administration. Note that after one-year fixed protocol period, the followings are allowed; 1) change of dose and/or administration of levodopa/DCI and 2) addition of other anti-parkinsonian drugs except for zonisamide due to exacerbation of symptoms.	Ouchi Yasuomi	NULL	Not Recruiting	Not applicable	< 80age old	Both	20	N/A	Japan
5	JPRN-UMIN000019524	2015/10/01	28/10/2015	Randomized, multicenter, open-label, comparative study on neuroprotective effects of zonisamide (Trerief), anti-parkinsonian drug, in patients with early Parkinson's disease: Evaluation by functional PET (positron emission tomography) images	Randomized, multicenter, open-label, comparative study on neuroprotective effects of zonisamide (Trerief), anti-parkinsonian drug, in patients with early Parkinson's disease: Evaluation by functional PET (positron emission tomography) images - Trerief Impact in PD PET Study (TIPPS)	Parkinson's Disease	Zonisamide treatment group: Zonisamide (25 mg) once daily in addition to levodopa/DCI with fixed dosage and administration. Note that after one-year fixed protocol period, the followings are allowed; 1) one or two tablets per day in case of developing wearing off phenomenon, 2) change of dose and/or administration of levodopa/DCI, and 3) addition of other anti-parkinsonian drugs due to exacerbation of symptoms. Zonisamide non-treatment group: Only Levodopa/DCI with fixed dosage and administration. Note that after one-year fixed protocol period, the followings are allowed; 1) change of dose and/or administration of levodopa/DCI and 2) addition of other anti-parkinsonian drugs except for zonisamide due to exacerbation of symptoms.	Hamamatsu University School of Medicine	NULL	Complete: follow-up complete	Not applicable	80years-old	Male and Female	20	Not applicable	Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
6	NCT00224263 (ClinicalTrials.gov)	September 2005	20/9/2005	Efficacy and Safety of Lingzhi in Patients With Early Parkinson's Disease	A Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Assess the Efficacy and Safety of Lingzhi in Patients With Early Parkinson's Disease Receiving Stable L-dopa/DCI	Parkinson's Disease	Drug: Lingzhi (Ganoderma)	Xuanwu Hospital, Beijing	NULL	Completed	30 Years	80 Years	Both	360	Phase 2	China

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT03541356
(ClinicalTrials.gov)

May 8, 2018

5/4/2018

Therapeutic Potential for Intranasal Levodopa in Parkinson's Disease -Off Reversal

A Phase IIa, Randomized, Double Blind, Placebo Controlled, Single Ascending Dose, Safety and Pharmacokinetic/Pharmacodynamic Study of INP103 (POD L-dopa) Administered in the Presence of DCI to L-dopa Responsive Parkinson's Disease Patients

Parkinson's Disease

Combination Product: Placebo;Combination Product: L-dopa 35 mg;Combination Product: L-dopa 70mg;Combination Product: L-dopa 140 mg;Combination Product: L-dopa 70mg/carbidopa 7mg

Impel NeuroPharma Inc.

NULL

Completed

40 Years

80 Years

All

Phase 2

Australia

JPRN-jRCTs051180098

09/06/2016

06/03/2019

The DAT-SPECT study for the benefit of Selegilline or Zonisamide in Parkinson's Disease

A comparative randomized study for the evaluation of the overlaying effect of Selegiline or Zonisamide over Levodopa in Parkinson's disease

Parkinson's disease;034034

L-Dopa/DCI only : The drug is administered per oral at 300 mg/day. The treatment is started within 14 days after registration and continued until day 365.
L-Dopa/DCI + selegiline : L-Dopa/DCI is administered per oral at 300 mg/day and selegiline is administered at 5 mg/day. The treatment is started within 14 days after registration and continued until day 365.
L-Dopa/DCI + zonisamide : L-Dopa/DCI is administered per oral at 300 mg/day and zonisamide is administered at 25 mg/day. The treatment is started within 14 days after registration and continued until day 365.

Ito Hidefumi

NULL

Recruiting

>= 55age old

< 80age old

Both

120

Phase 2

Japan

JPRN-UMIN000022533

2016/06/01

01/06/2016

A comparative randomized study for the evaluation of the overlaying effect of Selegiline or Zonisamide over Levodopa in Parkinson's disease

Parkinson's disease

L-Dopa/DCI only
The drug is administered per oral at 150 to 300 mg/day. The treatment is started within 14days after registration and continued until day 365.
L-Dopa/DCI + selegiline
L-Dopa/DCI is administered per oral at 150 to 300 mg/day and selegiline is administered at 5mg/day. The treatment is started within 14days after registration and continued until day 365.
L-Dopa/DCI + zonisamide
L-Dopa/DCI is administered per oral at 150 to 300 mg/day and zonisamide is administered at 25mg/day. The treatment is started within 14days after registration and continued until day 365.

Osaka Redcross HospitalWakayama Prefectural Medical College

NULL

Recruiting

55years-old

80years-old

Male and Female

180

Phase 2

Japan

JPRN-jRCTs041180070

04/11/2015

07/03/2019

Trerief Impact in PD PET Study

Randomized, multicenter, open-label, comparative study on neuroprotective effects of zonisamide (Trerief), anti-parkinsonian drug, in patients with early Parkinson's disease: Evaluation by functional PET (positron emission tomography) images - TIPPS

Parkinson's disease
Parkinson's disease;D010300

[1] Zonisamide treatment group
Zonisamide (25 mg) once daily in addition to levodopa/DCI with fixed dosage and administration.
Note that after one-year fixed protocol period, the followings are allowed; 1) one or two tablets per day in case of developing wearing off phenomenon, 2) change of dose and/or administration of levodopa/DCI, and 3) addition of other anti-parkinsonian drugs due to exacerbation of symptoms.
[2] Zonisamide non-treatment group
Only levodopa/DCI with fixed dosage and administration.
Note that after one-year fixed protocol period, the followings are allowed; 1) change of dose and/or administration of levodopa/DCI and 2) addition of other anti-parkinsonian drugs except for zonisamide due to exacerbation of symptoms.

Ouchi Yasuomi

NULL

Not Recruiting

Not applicable

< 80age old

Both

N/A

Japan

JPRN-UMIN000019524

2015/10/01

28/10/2015

Parkinson's Disease

Zonisamide treatment group:

Zonisamide (25 mg) once daily in addition to levodopa/DCI with fixed dosage and administration.
Note that after one-year fixed protocol period, the followings are allowed; 1) one or two tablets per day in case of developing wearing off phenomenon, 2) change of dose and/or administration of levodopa/DCI, and 3) addition of other anti-parkinsonian drugs due to exacerbation of symptoms.
Zonisamide non-treatment group:

Only Levodopa/DCI with fixed dosage and administration.
Note that after one-year fixed protocol period, the followings are allowed; 1) change of dose and/or administration of levodopa/DCI and 2) addition of other anti-parkinsonian drugs except for zonisamide due to exacerbation of symptoms.

Hamamatsu University School of Medicine

NULL

Complete: follow-up complete

Not applicable

80years-old

Male and Female

Not applicable

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT00224263
(ClinicalTrials.gov)

September 2005

20/9/2005

Efficacy and Safety of Lingzhi in Patients With Early Parkinson's Disease

A Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Assess the Efficacy and Safety of Lingzhi in Patients With Early Parkinson's Disease Receiving Stable L-dopa/DCI

Parkinson's Disease

Drug: Lingzhi (Ganoderma)

Xuanwu Hospital, Beijing

NULL

Completed

30 Years

80 Years

Both

360

Phase 2

China