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
13	多発性硬化症／視神経脊髄炎	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	EUCTR2015-003147-19-GR (EUCTR)	18/07/2016	25/05/2016	To confirm the safety and efficacy of NEUROASPIS PLP10® in the treatment of individuals, who have been diagnosed with relapsing remitting multiple sclerosis (MS).	Novel Oral Nutraceutical Intervention NEUROASPIS PLP10® for the Treatment of Relapsing-Remitting Multiple Sclerosis: A Multicenter, Parallel-group, Phase III, Double-blind, Randomized, Placebo-Controlled, Add-on with Interferon Beta, Trial of Efficacy and Safety. - Efficacy and Safety study of NEUROASPIS PLP10® versus placebo	Relapsing-Remitting Multiple Sclerosis (RRMS) MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: NEUROASPIS PLP10® INN or Proposed INN: FISH OIL,RICH IN OMEGA 3 ACIDS Other descriptive name: FISH OIL, RICH IN OMEGA-3-ACIDS INN or Proposed INN: BORAGE OIL 20% GLA Other descriptive name: BORAGE OIL INN or Proposed INN: beta-Carotene Other descriptive name: BETACAROTENE INN or Proposed INN: Gamma-tocopherol	PALUPA Medical Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	220	Phase 3	Greece

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

EUCTR2015-003147-19-GR
(EUCTR)

18/07/2016

25/05/2016

To confirm the safety and efficacy of NEUROASPIS PLP10® in the treatment of individuals, who have been diagnosed with relapsing remitting multiple sclerosis (MS).

Novel Oral Nutraceutical Intervention NEUROASPIS PLP10® for the Treatment of Relapsing-Remitting Multiple Sclerosis: A Multicenter, Parallel-group, Phase III, Double-blind, Randomized, Placebo-Controlled, Add-on with Interferon Beta, Trial of Efficacy and Safety. - Efficacy and Safety study of NEUROASPIS PLP10® versus placebo

Relapsing-Remitting Multiple Sclerosis (RRMS)
MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: NEUROASPIS PLP10®
INN or Proposed INN: FISH OIL,RICH IN OMEGA 3 ACIDS
Other descriptive name: FISH OIL, RICH IN OMEGA-3-ACIDS
INN or Proposed INN: BORAGE OIL 20% GLA
Other descriptive name: BORAGE OIL
INN or Proposed INN: beta-Carotene
Other descriptive name: BETACAROTENE
INN or Proposed INN: Gamma-tocopherol

PALUPA Medical Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

220

Phase 3

Greece