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
2	筋萎縮性側索硬化症	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	JPRN-UMIN000008527	2009/01/01	25/07/2012	Study of efficacy and safety of NDDPX08 in ALS patients		Amyotrophic Lateral Sclerosis	For patients who begin to receive Rilutek treatment at the start or 4 weeks before the start of the observation period, the 12-week treatment with Rilutek alone (100 mg/day) during the observation period is followed by combined treatment (Rilutek + NDDPX08). The NDDPX08 dose level begins at 1.25 mg/day and is increased in steps to 15 mg/day during the 12-week treatment period according to the dose escalation schedule given on the next page (Fig. 1). If any serious adverse reaction arises following a dose increase to 10 mg/day and it is judged to be difficult to maintain this dose level, the dose level of 7.5 mg/day is regarded as the maintenance dose level. If alleviation of symptoms is noted during dose escalation steps, the dose level producing alleviation of symptoms is used as the maintenance dose level. The total NDDPX08 treatment period is 58-90 weeks (including the 4 weeks during which the dose level is reduced in steps). Follow-up of adverse events is continued until 1 month after the end of NDDPX08 treatment. Placebo (lactose) is administered to 10 of the 50 subjects planned to be enrolled in the study.	FeGALS	NULL	Complete: follow-up complete	20years-old	75years-old	Male and Female	50	Not selected	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

JPRN-UMIN000008527

2009/01/01

25/07/2012

Study of efficacy and safety of NDDPX08 in ALS patients

Amyotrophic Lateral Sclerosis

For patients who begin to receive Rilutek treatment at the start or 4 weeks before the start of the observation period, the 12-week treatment with Rilutek alone (100 mg/day) during the observation period is followed by combined treatment (Rilutek + NDDPX08). The NDDPX08 dose level begins at 1.25 mg/day and is increased in steps to 15 mg/day during the 12-week treatment period according to the dose escalation schedule given on the next page (Fig. 1). If any serious adverse reaction arises following a dose increase to 10 mg/day and it is judged to be difficult to maintain this dose level, the dose level of 7.5 mg/day is regarded as the maintenance dose level. If alleviation of symptoms is noted during dose escalation steps, the dose level producing alleviation of symptoms is used as the maintenance dose level.
The total NDDPX08 treatment period is 58-90 weeks (including the 4 weeks during which the dose level is reduced in steps). Follow-up of adverse events is continued until 1 month after the end of NDDPX08 treatment.
Placebo (lactose) is administered to 10 of the 50 subjects planned to be enrolled in the study.

FeGALS

NULL

Complete: follow-up complete

20years-old

75years-old

Male and Female

Not selected

Japan