Efficacy, Safety, Tolerability and Pharmacokinetics of SUN13837 to Treat Acute Stroke

• Sponsor: Daiichi Sankyo, Inc. (Industry)
• Overall Status: Withdrawn
• CT.gov ID: NCT02258880
• Collaborator: Syneos Health (Other)
• Enrollment: 0
• Locations: 53
• Arms: 2
• Duration (Months): 20
• Patients Per Site: 0
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of SUN13837 and to determine whether SUN13837 improves the physical performance, relative to placebo, following an acute stroke in adult subjects.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Drug: SUN13837; Drug: placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase 2, Multicenter, Multinational, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of SUN13837 Administered 28 Doses (27/28 Days) to Adult Subjects With an Acute Ischemic Stroke
• Study Start Date: Sep 1, 2014
• Anticipated Primary Completion Date: May 1, 2016
• Anticipated Study Completion Date: May 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SUN13837 Drug: SUN13837 daily for 28 days.	Drug: SUN13837
Placebo Comparator: Placebo Placebo: Matching Placebo daily for 28 days	Drug: placebo

Outcome Measures

Primary Outcome Measures

1. Mean change from baseline in the Physical Performance Assessment in Stroke (PPAS) [84 days]

Secondary Outcome Measures

1. The proportion of responders as measured by the PPAS [84 days]

2. Mean change from baseline in PPAS Patient Reported Outcome Subscale [84 days]

3. Mean change from baseline in Short Form-36 Physical Functioning Scale (SF-36 PF) [84 days]

4. Mean change from baseline in Gait Speed [84 days]

5. Proportion of responders as measured by the Modified Rankin Scale (mRS) [84 days]

6. Safety/Tolerability - Number of Participants with Adverse Events [84 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Each subject must meet all of the following criteria to participate in the study:

1. Male or female subjects between 18 and 85 years, inclusive

2. Subjects with no prior history of stroke (unless the stroke was not associated with a motor deficit)

3. Subjects must score at least 16 points on the standard MMSE during baseline assessments

4. Subjects must have a total score between 7 and 30, inclusive, out of 35 on the S-STREAM administered between 24 and 48 hours after the onset of acute stroke

5. Subjects must have an estimated pre-stroke mRS of 0 or 1

6. Male subjects agree to be heterosexually abstinent or use appropriate contraception

7. Female subjects must have undergone menopause or, if premenopausal, must have a negative pregnancy test at baseline. Female subjects of childbearing potential agree to be sexually abstinent or must be willing to utilize adequate contraception

8. Subjects must be willing to provide verbal/nonverbal informed consent indicating voluntary consent to participate in the study (if a subject is unable to provide informed consent, but able to comply with other study procedures, the subject's LAR may provide consent)

Exclusion Criteria:

Subjects who meet any of the following criteria will be excluded from the study:

1. Prior exposure to SUN13837

2. History of severe allergic reaction, whether explained or not, requiring a visit to the ER and/or medical intervention with epinephrine

3. Development of hemodynamic instability following the acute stroke

4. History of dementia, advanced Parkinson's disease, other significant movement disorders, or other clinically significant diseases which would jeopardize the safety of the subject or impact the validity of the study results

5. Presence of significant global or receptive aphasia

6. Presence of clinically significant abnormal laboratory values at the time of presentation in the ER

7. History of malabsorption or any gastrointestinal abnormality that could impair oral absorption

8. Finding of Grade 3 or 4 proliferative retinopathy on routine fundoscopic examination or history of proliferative retinopathy (Grade 3 or 4) in subjects with diabetes mellitus

9. Unable, as determined by the investigator, or unwilling to discontinue use of potent cytochrome (CYP) P450 3A4/5 inhibitors, potent CYP2D6 inhibitors, CYP3A inducers, or potent P glycoprotein (P gp) inhibitors

10. Current participation in another clinical study involving administration of an investigational product or history of such participation within 30 days of acute stroke onset

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Mobile	Alabama	United States	36693
2		Encinita	California	United States	92024
3		Oceanside	California	United States	92056
4		Sarasota	Florida	United States	34239
5		Tampa	Florida	United States	33606
6		Atlanta	Georgia	United States	30322
7		Savannah	Georgia	United States	31405
8		Lexington	Kentucky	United States	40536
9		Marrero	Louisiana	United States	70072
10		New Orleans	Louisiana	United States	70112
11		New Orleans	Louisiana	United States	70121
12		Worcester	Massachusetts	United States	01655
13		Detroit	Michigan	United States	48201
14		Detroit	Michigan	United States	48236
15		Novi	Michigan	United States	48374
16		Southfield	Michigan	United States	48705
17		Kalispell	Montana	United States	59901
18		Reno	Nevada	United States	89502
19		Edison	New Jersey	United States	08818
20		Summit	New Jersey	United States	07901
21		Brooklyn	New York	United States	11220
22		Chapel Hill	North Carolina	United States	27599
23		Columbus	Ohio	United States	43210
24		Portland	Oregon	United States	97201
25		Portland	Oregon	United States	97213
26		Portland	Oregon	United States	97225
27		Bryn Mawr	Pennsylvania	United States	19010
28		Hershey	Pennsylvania	United States	17033
29		Paoli	Pennsylvania	United States	19301
30		Philadelphia	Pennsylvania	United States	19102
31		Columbia	South Carolina	United States	29203
32		Chattanooga	Tennessee	United States	37404
33		Houston	Texas	United States	77030
34		Mechanicsville	Virginia	United States	23116
35		Midlothian	Virginia	United States	23114
36		Richmond	Virginia	United States	23226
37		Richmond	Virginia	United States	23298
38		Edmonton	Alberta	Canada	T6G 2B7
39		Victoria	British Columbia	Canada	V8R 1J8
40		St-Jerome	Quebec	Canada	J7Z 5T3
41		Haifa		Israel	3109601
42		Haifa		Israel	3339419
43		Holon		Israel	5822012
44		Kfar-Saba		Israel	4428164
45		Naharyia		Israel	2210001
46		Ramat Gan		Israel	5262100
47		Tel-Aviv		Israel	6423906
48		Bloemfontein	Free State	South Africa	9301
49		Alberton	Gauteng	South Africa	1449
50		Krugersdorp	Gauteng	South Africa	1739
51		Bellville	Western Cape	South Africa	7350
52		Somerset West	Western Cape	South Africa	7130
53		Worcester	Western Cape	South Africa	6850

Sponsors and Collaborators

• Daiichi Sankyo, Inc.
• Syneos Health

Investigators

• Study Director: Ger Rikken, MD, Asubio Pharmaceuticals, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Daiichi Sankyo, Inc.
• ClinicalTrials.gov Identifier: NCT02258880
• Other Study ID Numbers: ASBI 802
• First Posted: Oct 8, 2014
• Last Update Posted: Oct 20, 2015
• Last Verified: Oct 1, 2015

• Keywords provided by Daiichi Sankyo, Inc.: Acute Stroke; Outcome Measures; Physical Performance
• Additional relevant MeSH terms: Stroke

Study Results

No Results Posted as of Oct 20, 2015